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Browsing by Author "Hildick-Smith, David (8089365300)"

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    Abbreviated Antiplatelet Therapy After Coronary Stenting in Patients With Myocardial Infarction at High Bleeding Risk
    (2022)
    Smits, Pieter C. (35952782900)
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    Frigoli, Enrico (36702683200)
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    Vranckx, Pascal (6603261242)
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    Ozaki, Yukio (57192966790)
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    Morice, Marie-Claude (7005332224)
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    Chevalier, Bernard (12772595100)
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    Onuma, Yoshinobu (15051093400)
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    Windecker, Stephan (7003473419)
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    Tonino, Pim A.L. (23020530900)
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    Roffi, Marco (7004532440)
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    Lesiak, Maciej (57208415591)
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    Mahfoud, Felix (26428326200)
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    Bartunek, Jozef (7006397762)
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    Hildick-Smith, David (8089365300)
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    Colombo, Antonio (35354455800)
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    Stankovic, Goran (59150945500)
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    Iñiguez, Andrés (7005329352)
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    Schultz, Carl (7202476533)
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    Kornowski, Ran (16947378300)
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    Ong, Paul J.L. (7102312670)
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    Alasnag, Mirvat (24479281000)
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    Rodriguez, Alfredo E. (35515288300)
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    Paradies, Valeria (26431508400)
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    Kala, Petr (57203043232)
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    Kedev, Sasko (23970691700)
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    Al Mafragi, Amar (57188690658)
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    Dewilde, Willem (16549215600)
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    Heg, Dik (6701630557)
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    Valgimigli, Marco (57222377628)
    Background: The optimal duration of antiplatelet therapy (APT) after coronary stenting in patients at high bleeding risk (HBR) presenting with an acute coronary syndrome remains unclear. Objectives: The objective of this study was to investigate the safety and efficacy of an abbreviated APT regimen after coronary stenting in an HBR population presenting with acute or recent myocardial infarction. Methods: In the MASTER DAPT trial, 4,579 patients at HBR were randomized after 1 month of dual APT (DAPT) to abbreviated (DAPT stopped and 11 months single APT or 5 months in patients with oral anticoagulants) or nonabbreviated APT (DAPT for minimum 3 months) strategies. Randomization was stratified by acute or recent myocardial infarction at index procedure. Coprimary outcomes at 335 days after randomization were net adverse clinical outcomes events (NACE); major adverse cardiac and cerebral events (MACCE); and type 2, 3, or 5 Bleeding Academic Research Consortium bleeding. Results: NACE and MACCE did not differ with abbreviated vs nonabbreviated APT regimens in patients with an acute or recent myocardial infarction (n = 1,780; HR: 0.83; 95% CI: 0.61-1.12 and HR: 0.86; 95% CI: 0.62-1.19, respectively) or without an acute or recent myocardial infarction (n = 2,799; HR: 1.03; 95% CI: 0.77-1.38 and HR: 1.13; 95% CI: 0.80-1.59; Pinteraction = 0.31 and 0.25, respectively). Bleeding Academic Research Consortium 2, 3, or 5 bleeding was significantly reduced in patients with or without an acute or recent myocardial infarction (HR: 0.65; 95% CI: 0.46-0.91 and HR: 0.71; 95% CI: 0.54-0.92; Pinteraction = 0.72) with abbreviated APT. Conclusions: A 1-month DAPT strategy in patients with HBR presenting with an acute or recent myocardial infarction results in similar NACE and MACCE rates and reduces bleedings compared with a nonabbreviated DAPT strategy. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020) © 2022 The Authors
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    Definitions and Standardized Endpoints for Treatment of Coronary Bifurcations
    (2022)
    Lunardi, Mattia (56516613400)
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    Louvard, Yves (7004523655)
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    Lefèvre, Thierry (13608617100)
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    Stankovic, Goran (59150945500)
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    Burzotta, Francesco (7003405739)
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    Kassab, Ghassan S. (7006148822)
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    Lassen, Jens F. (57189389659)
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    Darremont, Olivier (23666794700)
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    Garg, Scot (13104177600)
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    Koo, Bon-Kwon (35285769200)
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    Holm, Niels R. (36156981800)
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    Johnson, Thomas W. (56418917800)
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    Pan, Manuel (7202544866)
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    Chatzizisis, Yiannis S. (13907765800)
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    Banning, Adrian (57957647700)
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    Chieffo, Alaide (57202041611)
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    Dudek, Dariusz (7006649800)
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    Hildick-Smith, David (8089365300)
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    Garot, Jérome (7004240858)
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    Henry, Timothy D. (7102043625)
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    Dangas, George (7006593805)
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    Stone, Gregg W. (7202761439)
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    Krucoff, Mitchell W. (7005760104)
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    Cutlip, Donald (35406176000)
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    Mehran, Roxana (7004992409)
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    Wijns, William (7006420435)
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    Sharif, Faisal (6701725097)
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    Serruys, Patrick W. (34573036500)
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    Onuma, Yoshinobu (15051093400)
    The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients. © 2022 The Authors
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    Definitions and Standardized Endpoints for Treatment of Coronary Bifurcations
    (2023)
    Lunardi, Mattia (56516613400)
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    Louvard, Yves (7004523655)
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    Lefèvre, Thierry (13608617100)
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    Stankovic, Goran (59150945500)
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    Burzotta, Francesco (7003405739)
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    Kassab, Ghassan S. (7006148822)
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    Lassen, Jens F. (57189389659)
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    Darremont, Olivier (23666794700)
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    Garg, Scot (13104177600)
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    Koo, Bon-Kwon (35285769200)
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    Holm, Niels R. (36156981800)
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    Johnson, Thomas W. (56418917800)
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    Pan, Manuel (7202544866)
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    Chatzizisis, Yiannis S. (13907765800)
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    Banning, Adrian (57957647700)
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    Chieffo, Alaide (57202041611)
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    Dudek, Dariusz (7006649800)
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    Hildick-Smith, David (8089365300)
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    Garot, Jérome (7004240858)
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    Henry, Timothy D. (7102043625)
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    Dangas, George (7006593805)
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    Stone, Gregg W. (7202761439)
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    Krucoff, Mitchell W. (7005760104)
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    Cutlip, Donald (35406176000)
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    Mehran, Roxana (7004992409)
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    Wijns, William (7006420435)
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    Sharif, Faisal (6701725097)
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    Serruys, Patrick W. (34573036500)
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    Onuma, Yoshinobu (15051093400)
    The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients. © 2022 The Author(s). Published by Elsevier Inc. on behalf of American College of Cardiology and Europa Digital & Publishing.
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    Design and rationale of the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen (MASTER DAPT) Study
    (2019)
    Frigoli, Enrico (36702683200)
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    Smits, Pieter (35952782900)
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    Vranckx, Pascal (6603261242)
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    Ozaki, Yokio (57192966790)
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    Tijssen, Jan (35412705300)
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    Jüni, Peter (7004263326)
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    Morice, Marie-Claude (7005332224)
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    Onuma, Yoshinobu (15051093400)
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    Windecker, Stephan (7003473419)
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    Frenk, Andrè (57189894833)
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    Spaulding, Christian (54887610400)
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    Chevalier, Bernard (12772595100)
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    Barbato, Emanuele (58118036500)
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    Tonino, Pim (23020530900)
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    Hildick-Smith, David (8089365300)
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    Roffi, Marco (7004532440)
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    Kornowski, Ran (16947378300)
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    Schultz, Carl (7202476533)
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    Lesiak, Maciej (7003484420)
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    Iñiguez, Andrés (7005329352)
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    Colombo, Antonio (35354455800)
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    Alasnag, Mirvat (24479281000)
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    Mullasari, Ajit (6603064378)
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    James, Stefan (34769603200)
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    Stankovic, Goran (59150945500)
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    Ong, Paul J.L (7102312670)
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    Rodriguez, Alfredo E (35515288300)
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    Mahfoud, Felix (26428326200)
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    Bartunek, Jozef (7006397762)
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    Moschovitis, Aris (23668322900)
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    Laanmets, Peep (55345333500)
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    Leonardi, Sergio (36059439800)
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    Heg, Dik (6701630557)
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    Sunnåker, Mikael (36092195200)
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    Valgimigli, Marco (57222377628)
    Background: The optimal duration of antiplatelet therapy in high–bleeding risk (HBR) patients with coronary artery disease treated with newer-generation drug-eluting bioresorbable polymer-coated stents remains unclear. Design: MASTER DAPT (clinicaltrial.gov NCT03023020) is an investigator-initiated, open-label, multicenter, randomized controlled trial comparing an abbreviated versus a standard duration of antiplatelet therapy after bioresorbable polymer-coated Ultimaster (TANSEI) sirolimus-eluting stent implantation in approximately 4,300 HBR patients recruited from ≥100 interventional cardiology centers globally. After a mandatory 30-day dual-antiplatelet therapy (DAPT) run-in phase, patients are randomized to (a) a single antiplatelet regimen until study completion or up to 5 months in patients with clinically indicated oral anticoagulation (experimental 1-month DAPT group) or (b) continue DAPT for at least 5 months in patients without or 2 in patients with concomitant indication to oral anticoagulation, followed by a single antiplatelet regimen (standard antiplatelet regimen). With a final sample size of 4,300 patients, this study is powered to assess the noninferiority of the abbreviated antiplatelet regimen with respect to the net adverse clinical and major adverse cardiac and cerebral events composite end points and if satisfied for the superiority of abbreviated as compared to standard antiplatelet therapy duration in terms of major or clinically relevant nonmajor bleeding. Study end points will be adjudicated by a blinded Clinical Events Committee. Conclusions: The MASTER DAPT study is the first randomized controlled trial aiming at ascertaining the optimal duration of antiplatelet therapy in HBR patients treated with sirolimus-eluting bioresorbable polymer-coated stent implantation. © 2018 Elsevier Inc.
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    Dual antiplatelet therapy after PCI in patients at high bleeding risk
    (2021)
    Valgimigli, Marco (57222377628)
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    Frigoli, Enrico (36702683200)
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    Heg, Dik (6701630557)
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    Tijssen, Jan (35412705300)
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    Juni, Peter (7004263326)
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    Vranckx, Pascal (6603261242)
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    Ozaki, Yukio (57192966790)
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    Morice, Marie-Claude (7005332224)
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    Chevalier, Bernard (12772595100)
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    Onuma, Yoshinobu (15051093400)
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    Windecker, Stephan (7003473419)
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    Tonino, Pim A.L. (23020530900)
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    Roffi, Marco (7004532440)
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    Lesiak, Maciej (57208415591)
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    Mahfoud, Felix (26428326200)
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    Bartunek, Jozef (7006397762)
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    Hildick-Smith, David (8089365300)
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    Colombo, Antonio (35354455800)
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    Stanković, Goran (59150945500)
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    Iniguez, Andres (7005329352)
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    Schultz, Carl (7202476533)
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    Kornowski, Ran (16947378300)
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    Ong, Paul J.L. (7102312670)
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    Alasnag, Mirvat (24479281000)
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    Rodriguez, Alfredo E. (35515288300)
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    Moschovitis, Aris (23668322900)
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    Laanmets, Peep (55345333500)
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    Donahue, Michael (36518403900)
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    Leonardi, Sergio (36059439800)
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    Smits, Pieter C. (35952782900)
    Background: The appropriate duration of dual antiplatelet therapy in patients at high risk for bleeding after the implantation of a drug-eluting coronary stent remains unclear. Methods: One month after they had undergone implantation of a biodegradable-polymer sirolimus-eluting coronary stent, we randomly assigned patients at high bleeding risk to discontinue dual antiplatelet therapy immediately (abbreviated therapy) or to continue it for at least 2 additional months (standard therapy). The three ranked primary outcomes were net adverse clinical events (a composite of death from any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (a composite of death from any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding; cumulative incidences were assessed at 335 days. The first two outcomes were assessed for noninferiority in the per-protocol population, and the third outcome for superiority in the intention-to-treat population. Results: Among the 4434 patients in the per-protocol population, net adverse clinical events occurred in 165 patients (7.5%) in the abbreviated-therapy group and in 172 (7.7%) in the standard-therapy group (difference, -0.23 percentage points; 95% confidence interval [CI], -1.80 to 1.33; P<0.001 for noninferiority). A total of 133 patients (6.1%) in the abbreviated-therapy group and 132 patients (5.9%) in the standard-therapy group had a major adverse cardiac or cerebral event (difference, 0.11 percentage points; 95% CI, -1.29 to 1.51; P = 0.001 for noninferiority). Among the 4579 patients in the intention-to-treat population, major or clinically relevant nonmajor bleeding occurred in 148 patients (6.5%) in the abbreviated-therapy group and in 211 (9.4%) in the standard-therapy group (difference, -2.82 percentage points; 95% CI, -4.40 to -1.24; P<0.001 for superiority). Conclusions: One month of dual antiplatelet therapy was noninferior to the continuation of therapy for at least 2 additional months with regard to the occurrence of net adverse clinical events and major adverse cardiac or cerebral events; abbreviated therapy also resulted in a lower incidence of major or clinically relevant nonmajor bleeding. Conclusions: One month of dual antiplatelet therapy was noninferior to the continuation of therapy for at least 2 additional months with regard to the occurrence of net adverse clinical events and major adverse cardiac or cerebral events; abbreviated therapy also resulted in a lower incidence of major or clinically relevant nonmajor bleeding. (Funded by Terumo; MASTER DAPT ClinicalTrials.gov number, NCT03023020. opens in new tab.) Copyright © 2021 Massachusetts Medical Society.
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    Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial
    (2019)
    Hausenloy, Derek J (6602976997)
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    Kharbanda, Rajesh K (57202041603)
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    Møller, Ulla Kristine (7006233565)
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    Ramlall, Manish (56786381300)
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    Aarøe, Jens (6602662728)
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    Butler, Robert (7401524941)
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    Bulluck, Heerajnarain (53981151600)
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    Clayton, Tim (26322352300)
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    Dana, Ali (15059843000)
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    Dodd, Matthew (57206894090)
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    Engstrom, Thomas (7004069840)
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    Evans, Richard (57204878565)
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    Lassen, Jens Flensted (57189389659)
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    Christensen, Erika Frischknecht (7202966096)
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    Garcia-Ruiz, José Manuel (35955892300)
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    Gorog, Diana A (7003699023)
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    Hjort, Jakob (6602379009)
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    Houghton, Richard F (57211330538)
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    Ibanez, Borja (13907649300)
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    Knight, Rosemary (14009998600)
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    Lippert, Freddy K (7004650443)
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    Lønborg, Jacob T (12240126300)
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    Maeng, Michael (20034699800)
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    Milasinovic, Dejan (24823024500)
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    More, Ranjit (7006807960)
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    Nicholas, Jennifer M (25630004900)
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    Jensen, Lisette Okkels (7403326527)
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    Perkins, Alexander (57201567357)
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    Radovanovic, Nebojsa (10139867800)
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    Rakhit, Roby D (6603035925)
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    Ravkilde, Jan (7004165556)
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    Ryding, Alisdair D (16246250300)
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    Schmidt, Michael R (7404397924)
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    Riddervold, Ingunn Skogstad (56878945000)
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    Sørensen, Henrik Toft (36038149900)
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    Stankovic, Goran (59150945500)
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    Varma, Madhusudhan (57211065395)
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    Webb, Ian (25423460600)
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    Terkelsen, Christian Juhl (7003830752)
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    Greenwood, John P (58588572000)
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    Yellon, Derek M (7103223278)
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    Bøtker, Hans Erik (56962746200)
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    Junker, Anders (7006817075)
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    Kaltoft, Anne (6602937543)
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    Madsen, Morten (35810648300)
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    Christiansen, Evald Høj (16149043800)
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    Jakobsen, Lars (7004161225)
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    Carstensen, Steen (35858179300)
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    Kristensen, Steen Dalby (35334519400)
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    Thim, Troels (14822428500)
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    Pedersen, Karin Møller (58422519200)
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    Korsgaard, Mette Tidemand (57211341374)
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    Iversen, Allan (24474730000)
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    Jørgensen, Erik (35372961000)
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    Joshi, Francis (37052277200)
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    Pedersen, Frants (55414868300)
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    Tilsted, Hans Henrik (23089464900)
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    Alzuhairi, Karam (37013099600)
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    Saunamäki, Kari (7005608992)
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    Holmvang, Lene (6603670977)
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    Ahlehof, Ole (57211339575)
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    Sørensen, Rikke (18635010900)
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    Helqvist, Steffen (6701361402)
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    Mark, Bettina Løjmand (57211329546)
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    Villadsen, Anton Boel (6602480644)
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    Raungaard, Bent (56480714800)
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    Thuesen, Leif (7006326598)
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    Christiansen, Martin Kirk (57211341955)
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    Freeman, Philip (57213032138)
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    Jensen, Svend Eggert (7401855023)
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    Skov, Charlotte Schmidt (57015004300)
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    Aziz, Ahmed (7103371963)
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    Hansen, Henrik Steen (7403334070)
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    Ellert, Julia (35175814800)
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    Veien, Karsten (24172249100)
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    Pedersen, Knud Erik (7201733433)
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    Hansen, Knud Nørregård (17342237800)
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    Ahlehoff, Ole (25932048400)
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    Cappelen, Helle (57191952080)
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    Wittrock, Daniel (57211330017)
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    Hansen, Poul Anders (55909196000)
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    Ankersen, Jens Peter (6507525260)
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    Hedegaard, Kim Witting (57211337434)
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    Kempel, John (57211338262)
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    Kaus, Henning (57211339295)
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    Erntgaard, Dennis (57211342211)
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    Pedersen, Danny Mejsner (55932322100)
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    Giebner, Matthias (36028067400)
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    Hansen, Troels Martin Hansen (7401668134)
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    Radosavljevic-Radovanovic, Mina (10141617200)
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    Prodanovic, Maja (57211335833)
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    Savic, Lidija (16507811000)
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    Pejic, Marijana (58491942500)
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    Matic, Dragan (25959220100)
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    Uscumlic, Ana (56807174000)
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    Subotic, Ida (57213608856)
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    Lasica, Ratko (14631892300)
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    Vukcevic, Vladan (15741934700)
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    Suárez, Alfonso (57201591949)
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    Samaniego, Beatriz (57194448507)
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    Morís, César (57221077664)
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    Segovia, Eduardo (56680965600)
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    Hernández, Ernesto (57197255066)
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    Lozano, Iñigo (35448203700)
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    Pascual, Isaac (24765156600)
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    Vegas-Valle, Jose M. (15052696600)
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    Rozado, José (55933459100)
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    Rondán, Juan (9737126400)
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    Avanzas, Pablo (6603073164)
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    del Valle, Raquel (57221975129)
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    Padrón, Remigio (56814625000)
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    García-Castro, Alfonso (57211338205)
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    Arango, Amalia (57211334813)
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    Medina-Cameán, Ana B. (56298180900)
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    Fente, Ana I. (57211336771)
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    Muriel-Velasco, Ana (6504808603)
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    Pomar-Amillo, Ángeles (57211330414)
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    Roza, César L. (57211336240)
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    Martínez-Fernández, César M. (57211335946)
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    Buelga-Díaz, Covadonga (57211335767)
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    Fernández-Gonzalo, David (57211329736)
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    Fernández, Elena (57211331749)
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    Díaz-González, Eloy (57211329470)
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    Martinez-González, Eugenio (57211331389)
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    Iglesias-Llaca, Fernando (18433859100)
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    Viribay, Fernando M. (57211335779)
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    Fernández-Mallo, Francisco J. (57211337671)
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    Hermosa, Francisco J. (57211342503)
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    Martínez-Bastida, Ginés (57209663244)
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    Goitia-Martín, Javier (57211331283)
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    Vega-Fernández, José L. (57211334404)
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    Tresguerres, Jose M. (57211338699)
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    Rodil-Díaz, Juan A. (57211339335)
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    Villar-Fernández, Lara (57211329788)
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    Alberdi, Lucía (57682138100)
    ;
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    Mehmedbegovic, Zlatko (55778381000)
    ;
    de la Hera Galarza, Jesus Maria (6603245999)
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    Robertson, Steven (57190237733)
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    Van Dyck, Laura (56149567300)
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    Chu, Rebecca (57211084730)
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    Astarci, Josenir (57211329484)
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    Jamal, Zahra (57200532218)
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    Hetherington, Daniel (57211337221)
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    Collier, Lucy (57211331136)
    Background: Remote ischaemic conditioning with transient ischaemia and reperfusion applied to the arm has been shown to reduce myocardial infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). We investigated whether remote ischaemic conditioning could reduce the incidence of cardiac death and hospitalisation for heart failure at 12 months. Methods: We did an international investigator-initiated, prospective, single-blind, randomised controlled trial (CONDI-2/ERIC-PPCI) at 33 centres across the UK, Denmark, Spain, and Serbia. Patients (age >18 years) with suspected STEMI and who were eligible for PPCI were randomly allocated (1:1, stratified by centre with a permuted block method) to receive standard treatment (including a sham simulated remote ischaemic conditioning intervention at UK sites only) or remote ischaemic conditioning treatment (intermittent ischaemia and reperfusion applied to the arm through four cycles of 5-min inflation and 5-min deflation of an automated cuff device) before PPCI. Investigators responsible for data collection and outcome assessment were masked to treatment allocation. The primary combined endpoint was cardiac death or hospitalisation for heart failure at 12 months in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02342522) and is completed. Findings: Between Nov 6, 2013, and March 31, 2018, 5401 patients were randomly allocated to either the control group (n=2701) or the remote ischaemic conditioning group (n=2700). After exclusion of patients upon hospital arrival or loss to follow-up, 2569 patients in the control group and 2546 in the intervention group were included in the intention-to-treat analysis. At 12 months post-PPCI, the Kaplan-Meier-estimated frequencies of cardiac death or hospitalisation for heart failure (the primary endpoint) were 220 (8·6%) patients in the control group and 239 (9·4%) in the remote ischaemic conditioning group (hazard ratio 1·10 [95% CI 0·91–1·32], p=0·32 for intervention versus control). No important unexpected adverse events or side effects of remote ischaemic conditioning were observed. Interpretation: Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI. Funding: British Heart Foundation, University College London Hospitals/University College London Biomedical Research Centre, Danish Innovation Foundation, Novo Nordisk Foundation, TrygFonden. © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license
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    Erratum: Third generation drug eluting stent (DES) with biodegradable polymer in diabetic patients: 5 years follow-up [Cardiovasc Diabetol. (2017)16, 23] 10.1186/s12933-017-0500-3
    (2017)
    Wiemer, Marcus (7003827848)
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    Stojkovic, Sinisa (6603759580)
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    Samol, Alexander (15923652000)
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    Dimitriadis, Zisis (37085103100)
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    Ruiz-Nodar, Juan M. (6602784974)
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    Birkemeyer, Ralf (24167873400)
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    Monsegu, Jacques (6701634628)
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    Finet, Gérard (16554652600)
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    Hildick-Smith, David (8089365300)
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    Tresukosol, Damras (7003853497)
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    Novo, Enrique Garcia (57220415663)
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    Koolen, Jacques J. (7004991760)
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    Barbato, Emanuele (58118036500)
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    Danzi, Gian Battista (57209549829)
    After publication of the original article [1], it came to the authors' attention that there was a typo within the author list. The family name of Sinisa Stojkovic was incorrectly spelled 'Stoikovic'. The author's name appears in its correct form in this erratum.
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    European Bifurcation Club white paper on stenting techniques for patients with bifurcated coronary artery lesions
    (2020)
    Burzotta, Francesco (7003405739)
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    Lassen, Jens Flensted (57189389659)
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    Louvard, Yves (7004523655)
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    Lefèvre, Thierry (13608617100)
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    Banning, Adrian P. (57957647700)
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    Daremont, Olivier (57217487472)
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    Pan, Manuel (7202544866)
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    Hildick-Smith, David (8089365300)
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    Chieffo, Alaide (57202041611)
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    Chatzizisis, Yiannis S. (13907765800)
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    Džavík, Vladimír (7004450973)
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    Gwon, Hyeon-Cheol (6603262426)
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    Hikichi, Yutaka (7006401170)
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    Murasato, Yoshinobu (56200383400)
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    Koo, Bon Kwon (35285769200)
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    Chen, Shao-Liang (35186717200)
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    Serruys, Patrick (34573036500)
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    Stankovic, Goran (59150945500)
    Background: Defining the optimal conduction of percutaneous-coronary-intervention (PCI) to treat bifurcation lesions has been the subject of many clinical studies showing that the applied stenting technique may influence clinical outcome. Accordingly, bifurcation stenting classifications and technical sequences should be standardized to allow proper reporting and comparison. Methods: The European Bifurcation Club (EBC) is a multidisciplinary group dedicated to optimize the treatment of bifurcations and previously created a classification of bifurcation stenting techniques that is based on the first stent implantation site. Since some techniques have been abandoned, others have been refined and dedicated devices became available, EBC promoted an international task force aimed at updating the classification of bifurcation stenting techniques as well as at highlighting the best practices for most popular techniques. Original descriptive images obtained by drawings, bench tests and micro-computed-tomographic reconstructions have been created in order to serve as tutorials in both procedure reporting and clinical practice. Results: An updated Main-Across-Distal-Side (MADS)-2, classification of bifurcation stenting techniques has been realized and is reported in the present article allowing standardized procedure reporting in both clinical practice and scientific studies. The EBC-promoted task force deeply discussed, agreed on and described (using original drawings and bench tests) the optimal steps for the following major bifurcation stenting techniques: (a) 1-stent techniques (“provisional” and “inverted provisional”) and (b) 2-stent techniques (“T/TAP,” “culotte,” and “DK-crush”). Conclusions: The present EBC-promoted paper is intended to facilitate technique selection, reporting and performance for PCI on bifurcated lesions during daily clinical practice. © 2020 Wiley Periodicals LLC.
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    Impact of technique on bifurcation stent outcomes in the European Bifurcation Club Left Main Coronary Trial
    (2023)
    Arunothayaraj, Sandeep (36140221200)
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    Lassen, Jens Flensted (57189389659)
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    Clesham, Gerald J. (57194405814)
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    Spence, Mark S. (7103007124)
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    Koning, René (7005476071)
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    Banning, Adrian P. (57957647700)
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    Lindsay, Mitchell (8056252200)
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    Christiansen, Evald H. (16149043800)
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    Egred, Mohaned (13006459000)
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    Cockburn, James (43661048500)
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    Mylotte, Darren (25628146800)
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    Brunel, Philippe (7006007671)
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    Ferenc, Miroslaw (8933716300)
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    Hovasse, Thomas (25627893900)
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    Wlodarczak, Adrian (56664531100)
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    Pan, Manuel (7202544866)
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    Silvestri, Marc (7006617386)
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    Erglis, Andrejs (6602259794)
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    Kretov, Evgeny (57193843254)
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    Chieffo, Alaide (57202041611)
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    Lefèvre, Thierry (13608617100)
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    Burzotta, Francesco (7003405739)
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    Darremont, Olivier (23666794700)
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    Stankovic, Goran (59150945500)
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    Morice, Marie-Claude (7005332224)
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    Louvard, Yves (7004523655)
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    Hildick-Smith, David (8089365300)
    Background: Techniques for provisional and dual-stent left main bifurcation stenting require optimization. Aim: To identify technical variables influencing procedural outcomes and periprocedural myocardial infarction following left main bifurcation intervention. Methods: Procedural and outcome data were analyzed in 438 patients from the per-protocol cohort of the European Bifurcation Club Left Main Trial (EBC MAIN). These patients were randomized to the provisional strategy or a compatible dual-stent extension (T, T-and-protrude, or culotte). Results: Mean age was 71 years and 37.4% presented with an acute coronary syndrome. Transient reduction of side vessel thrombolysis in myocardial infarction flow occurred after initial stent placement in 5% of procedures but was not associated with periprocedural myocardial infarction. Failure to rewire a jailed vessel during any strategy was more common when jailed wires were not used (9.5% vs. 2.5%, odds ratio [OR]: 6.4, p = 0.002). In the provisional cohort, the use of the proximal optimization technique was associated with less subsequent side vessel intervention (23.3% vs. 41.9%, OR: 0.4, p = 0.048). Side vessel stenting was predominantly required for dissection, which occurred more often following side vessel preparation (15.3% vs. 4.4%, OR: 3.1, p = 0.040). Exclusive use of noncompliant balloons for kissing balloon inflation was associated with reduced need for side vessel intervention in provisional cases (20.5% vs. 38.5%, OR: 0.4, p = 0.013), and a reduced risk of periprocedural myocardial infarction across all strategies (2.9% vs. 7.7%, OR: 0.2, p = 0.020). Conclusion: When performing provisional or compatible dual-stent left main bifurcation intervention, jailed wire use is associated with successful jailed vessel rewiring. Side vessel preparation in provisional patients is linked to increased side vessel dissection requiring stenting. Use of the proximal optimization technique may reduce the need for additional side vessel intervention, and noncompliant balloon use for kissing balloon inflation is associated with a reduction in both side vessel stenting and periprocedural myocardial infarction. Clinical Trial Registration: ClinicalTrials.gov Identifier NCT02497014. © 2023 Wiley Periodicals LLC.
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    Invasive vs. conservative management of older patients with non-ST-elevation acute coronary syndrome: individual patient data meta-analysis
    (2024)
    Kotanidis, Christos P. (57200633315)
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    Mills, Gregory B. (57823021800)
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    Bendz, Bjørn (7003445864)
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    Berg, Erlend S. (57222671651)
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    Hildick-Smith, David (8089365300)
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    Hirlekar, Geir (56338881900)
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    Milasinovic, Dejan (24823024500)
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    Morici, Nuccia (14016177400)
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    Myat, Aung (23489856200)
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    Tegn, Nicolai (57186726100)
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    Sanchis, Juan (7102772290)
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    Savonitto, Stefano (7003310658)
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    De Servi, Stefano (7005676518)
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    Fox, Keith A.A. (35377460800)
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    Pocock, Stuart (35231017100)
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    Kunadian, Vijay (55390915800)
    Background and Older patients with non-ST-elevation acute coronary syndrome (NSTEACS) are less likely to receive guideline-Aims recommended care including coronary angiography and revascularization. Evidence-based recommendations regarding interventional management strategies in this patient cohort are scarce. This meta-analysis aimed to assess the impact of routine invasive vs. conservative management of NSTEACS by using individual patient data (IPD) from all available randomized controlled trials (RCTs) including older patients Methods MEDLINE, Web of Science and Scopus were searched between 1 January 2010 and 11 September 2023. RCTs investigating routine invasive and conservative strategies in persons >70 years old with NSTEACS were included. Observational studies or trials involving populations outside the target range were excluded. The primary endpoint was a composite of all-cause mortality and myocardial infarction (MI) at 1 year. One-stage IPD meta-analyses were adopted by use of random-effects and fixed-effect Cox models. This meta-analysis is registered with PROSPERO (CRD42023379819) Results Six eligible studies were identified including 1479 participants. The primary endpoint occurred in 181 of 736 (24.5%) participants in the invasive management group compared with 215 of 743 (28.9%) participants in the conservative management group with a hazard ratio (HR) from random-effects model of 0.87 (95% CI 0.63–1.22; P = .43). The hazard for MI at 1 year was significantly lower in the invasive group compared with the conservative group (HR from random-effects model 0.62, 95% CI 0.44–0.87; P = .006). Similar results were seen for urgent revascularization (HR from random-effects model 0.41, 95% CI 0.18–0.95; P = .037). There was no significant difference in mortality Conclusions No evidence was found that routine invasive treatment for NSTEACS in older patients reduces the risk of a composite of all-cause mortality and MI within 1 year compared with conservative management. However, there is convincing evidence that invasive treatment significantly lowers the risk of repeat MI or urgent revascularisation. Further evidence is needed from ongoing larger clinical trials. Structured Graphical Abstract Key Question Older patients with non-ST-elevation acute coronary syndrome (NSTEACS) are less likely to receive coronary angiography and revascularization. Evidence-based recommendations regarding interventional strategies are scarce. The present study compared routine invasive with conservative management of older patients with NSTEACS using individual patient data from all contemporary randomized controlled trials. Key Finding At one-year follow-up, routine invasive management was associated with a significantly reduced risk of myocardial infarction or urgent revascularization. No benefit was observed for mortality or a composite of all-cause mortality and myocardial infarction. Take Home Message This study provides robust evidence that a routine invasive strategy is superior to conservative approaches in reducing the risk of myocardial infarction and urgent revascularization at one year. It supports the consideration of routine invasive management in older patients with NSTEACS. Individual patient data from six randomized controlled trials 313 457 106 186 250 167 Italian Elderly ACS After Eighty MOSCA 80+ study RINCAL MOSCA-FRAIL 1479 Routine invasive strategy Initial conservative strategy 736 743 One-year outcomes Composite of all-cause mortality and MI - random effects HR 0.87 (95% CI 0.63–1.22) Composite of all-cause mortality and MI - fixed effects HR 0.82 (95% CI 0.67–1.00) All-cause mortality HR 1.03 (95% CI 0.69–1.53) Cardiovascular mortality HR 0.89 (95% CI 0.57–1.40) MI HR 0.62 (95% CI 0.44–0.87) Urgent revascularization HR 0.41 (95% CI 0.18–0.95) Composite of all-cause mortality and MI - troponin positive HR 0.81 (95% CI 0.58–1.12) Composite of all-cause mortality and MI - troponin negative HR 1.71 (95% CI 0.69–4.25) Using individual patient-level data we show that the risk of myocardial infarction and unplanned urgent revascularization is lower in older patients with non-ST-elevation acute coronary syndrome (NSTEACS) treated with a routine invasive strategy compared to a conservative medical approach. The risk of a composite endpoint of all-cause mortality and reinfarction showed weaker evidence of a potentially lower risk for an invasive strategy, while we observed no evident difference for all-cause mortality, cardiovascular death, and stroke. CI, confidence interval; HR, hazard ratio; MI, myocardial infarction. © 2024 Oxford University Press. All rights reserved.
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    One-year performance of thin-strut cobalt chromium sirolimus-eluting stent versus thicker strut stainless steel biolimus-eluting coronary stent: A propensity-matched analysis of two international all-comers registries
    (2021)
    Vlieger, Selina (57202132865)
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    Danzi, Gian B. (57209549829)
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    Kauer, Floris (26434782400)
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    Oemrawsingh, Rohit M. (24172653000)
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    Stojkovic, Sinisa (6603759580)
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    Ijsselmuiden, Alexander J.J. (6603297809)
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    Routledge, Helen (6601978602)
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    Laanmets, Peep (55345333500)
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    Roffi, Marco (7004532440)
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    Fröbert, Ole (7003840907)
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    Baello, Pascual (6508051562)
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    Wlodarczak, Adrian (56664531100)
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    Puentes, Angel (36157145300)
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    Polad, Jawed (8561333000)
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    Hildick-Smith, David (8089365300)
    Objectives Recent improvements in coronary stent design have focussed on thinner struts, different alloys and architecture, more biocompatible polymers, and shorter drug absorption times. This study evaluates safety and efficacy of a newer generation thin-strut cobalt chromium sirolimus-eluting coronary stent (SES, Ultimaster) in comparison with a second-generation thicker strut stainless steel biolimus-eluting stent (BES, Nobori) in percutaneous coronary intervention (PCI) practice. Methods A propensity score analysis was performed to adjust for differences in baseline characteristics of 8137 SES patients and 2738 BES patients of two PCI registries (e-Ultimaster and NOBORI 2). An independent clinical event committee adjudicated all endpoint-related adverse events. Results The use of SES, as compared with BES was associated with a significantly lower rate of myocardial infarction (MI) (1.2% vs 2.2%; P = 0.0006) and target vessel-related MI (1.1% vs 1.8%; P = 0.002) at 1 year. One-year composite endpoints of all predefined endpoints were lower in patients undergoing SES implantation (target lesion failure: 3.2% vs 4.1%; P = 0.03, target vessel failure: 3.7% vs 5.0%; P = 0.003, patient-oriented composite endpoint 5.7% vs 6.8%; P = 0.03). No significant differences between SES and BES were observed in all-cause death (2.0% vs 1.6%; P = 0.19), cardiac death (1.2% vs 1.2%; P = 0.76) or stent thrombosis (0.6% vs 0.8%; P = 0.43). Conclusions These findings suggest an improved clinical safety and efficacy of a newer generation thin-strut SES as compared with a second-generation thicker strut BES. © 2021 Lippincott Williams and Wilkins. All rights reserved.
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    Percutaneous coronary intervention for bifurcation coronary lesions using optimised angiographic guidance: The 18th consensus document from the European Bifurcation Club
    (2024)
    Burzotta, Francesco (7003405739)
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    Louvard, Yves (7004523655)
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    Lassen, Jens Flensted (57189389659)
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    Lefevre, Thierry (13608617100)
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    Finet, Gerard (16554652600)
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    Collet, Carlos (57189342058)
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    Legutko, Jacek (7004544253)
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    Lesiak, MacIej (57208415591)
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    Hikichi, Yutaka (7006401170)
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    Albiero, Remo (7003819431)
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    Pan, Manuel (7202544866)
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    Chatzizisis, Yiannis S. (13907765800)
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    Hildick-Smith, David (8089365300)
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    Ferenc, Miroslaw (8933716300)
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    Johnson, Thomas W. (56418917800)
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    Chieffo, Alaide (57202041611)
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    Darremont, Olivier (23666794700)
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    Banning, Adrian (57957647700)
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    Serruys, Patrick W. (34573036500)
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    Stankovic, Goran (59150945500)
    The 2023 European Bifurcation Club (EBC) meeting took place in Warsaw in October, and the latest evidence for the use of intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to optimise percutaneous coronary interventions (PCI) on coronary bifurcation lesions (CBLs) was a major focus. The topic generated deep discussions and general appraisal on the potential benefits of IVUS and OCT in PCI procedures. Nevertheless, despite an increasing recognition of IVUS and OCT capabilities and their recognised central role for guidance in complex CBL and left main PCI, it is expected that angiography will continue to be the primary guidance modality for CBL PCI, principally due to educational and economic barriers. Mindful of the restricted access/adoption of intracoronary imaging for CBL PCI, the EBC board decided to review and describe a series of tips and tricks which can help to optimise angiography-guided PCI for CBLs. The identified key points for achieving an optimal angiography-guided PCI include a thorough analysis of pre-PCI images (computed tomography angiography, multiple angiographic views, quantitative coronary angiography vessel estimation), a systematic application of the technical steps suggested for a given selected technique, an intraprocedural or post-PCI use of stent enhancement and a low threshold for bailout use of intravascular imaging. © 2024 Europa Group. All rights reserved.
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    Percutaneous coronary intervention for bifurcation coronary lesions: The 15th consensus document from the European Bifurcation Club
    (2021)
    Burzotta, Francesco (7003405739)
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    Lassen, Jens Flensted (57189389659)
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    Lefèvre, Thierry (13608617100)
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    Banning, Adrian P. (57957647700)
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    Chatzizisis, Yiannis S. (13907765800)
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    Johnson, Thomas W. (56418917800)
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    Ferenc, Miroslaw (8933716300)
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    Rathore, Sudhir (22235271400)
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    Albiero, Remo (7003819431)
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    Pan, Manuel (7202544866)
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    Darremont, Olivier (23666794700)
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    Hildick-Smith, David (8089365300)
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    Chieffo, Alaide (57202041611)
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    Zimarino, Marco (57215992419)
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    Louvard, Yves (7004523655)
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    Stankovic, Goran (59150945500)
    The 15th European Bifurcation Club (EBC) meeting was held in Barcelona in October 2019. It facilitated a renewed consensus on coronary bifurcation lesions (CBL) and unprotected left main (LM) percutaneous interventions. Bifurcation stenting techniques continue to be refined, developed and tested. It remains evident that a provisional approach with optional side branch treatment utilising T, T and small protrusion (TAP) or culotte continues to provide flexible options for the majority of CBL patients. Debate persists regarding the optimal treatment of side branches, including assessment of clinical significance and thresholds for bail-out treatment. In more complex CBL, especially those involving the LM, adoption of dedicated two-stent techniques should be considered. Operators using such techniques have to be fully familiar with their procedural steps and should acknowledge associated limitations and challenges. When using two-stent techniques, failure to perform a final kissing inflation is regarded as a technical failure, since it may jeopardise clinical outcome. The development of novel technical tools and drug regimens deserves attention. In particular, intracoronary imaging, bifurcation simulation, drug-eluting balloon technology and tailored antiplatelet therapy have been identified as promising tools to enhance clinical outcomes. In conclusion, the evolution of a broad spectrum of bifurcation PCI components has resulted from studies extending from bench testing to randomised controlled trials. However, further advances are still needed to achieve the ambitious goal of optimising the clinical outcomes for every patient undergoing PCI on a CBL. © Europa Digital & Publishing 2021.
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    Percutaneous coronary intervention for coronary bifurcation disease: 11th consensus document from the European Bifurcation Club
    (2016)
    Lassen, Jens Flensted (57189389659)
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    Holm, Niels Ramsing (36156981800)
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    Banning, Adrian (57957647700)
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    Burzotta, Francesco (7003405739)
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    Lefèvre, Thierry (13608617100)
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    Chieffo, Alaide (57202041611)
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    Hildick-Smith, David (8089365300)
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    Louvard, Yves (7004523655)
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    Stankovic, Goran (59150945500)
    Coronary bifurcations are involved in 15-20% of all percutaneous coronary interventions (PCI) and remain one of the most challenging lesions in interventional cardiology in terms of procedural success rate as well as long-term cardiac events. The optimal management of bifurcation lesions is, despite a fast growing body of scientific literature, the subject of considerable debate. The European Bifurcation Club (EBC) was initiated in 2004 to support a continuous overview of the field, and aims to facilitate a scientific discussion and an exchange of ideas on the management of bifurcation disease. The EBC hosts an annual, compact meeting, dedicated to bifurcations, which brings together physicians, engineers, biologists, physicists, epidemiologists and statisticians for detailed discussions. Every meeting is finalised with a consensus statement which reflects the unique opportunity of combining the opinions of interventional cardiologists with the opinions of a large variety of other scientists on bifurcation management. The present 11th EBC consensus document represents the summary of the up-to-date EBC consensus and recommendations. It points to the fact that there is a multitude of strategies and approaches to bifurcation stenting within the provisional strategy and in the different two-stent strategies. The main EBC recommendation for PCI of bifurcation lesions remains to use main vessel (MV) stenting with a proximal optimisation technique (POT) and provisional side branch (SB) stenting as a preferred approach. The consensus document covers a moving target. Much more scientific work is needed in non-left main (LM) and LM bifurcation lesions for continuous improvement of the outcome of our patients. © Europa Digital & Publishing 2016. All rights reserved.
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    Percutaneous coronary intervention for obstructive bifurcation lesions: The 14th consensus document from the european bifurcation club
    (2019)
    Banning, Adrian P. (57957647700)
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    Lassen, Jens Flensted (57189389659)
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    Burzotta, Francesco (7003405739)
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    Lefèvre, Thierry (13608617100)
    ;
    Darremont, Olivier (23666794700)
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    Hildick-Smith, David (8089365300)
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    Louvard, Yves (7004523655)
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    Stankovic, Goran (59150945500)
    The European Bifurcation Club recommends an approach to a bifurcation stenosis which involves careful assessment, planning and a sequential provisional approach. In the minority of lesions where two stents are required, careful deployment and optimal expansion are essential to achieve a long-term result. © Europa Digital & Publishing 2019. All rights reserved.
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    Percutaneous coronary intervention for the left main stem and other bifurcation lesions: 12th consensus document from the European Bifurcation Club
    (2018)
    Lassen, Jens Flensted (57189389659)
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    Burzotta, Francesco (7003405739)
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    Banning, Adrian P. (57957647700)
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    Lefèvre, Thierry (13608617100)
    ;
    Darremont, Olivier (23666794700)
    ;
    Hildick-Smith, David (8089365300)
    ;
    Chieffo, Alaide (57202041611)
    ;
    Pan, Manuel (7202544866)
    ;
    Holm, Niels Ramsing (36156981800)
    ;
    Louvard, Yves (7004523655)
    ;
    Stankovic, Goran (59150945500)
    The European Bifurcation Club (EBC) was initiated in 2004 to support a continuous overview of the field of coronary artery bifurcation interventions and aims to facilitate a scientific discussion and an exchange of ideas on the management of bifurcation disease. The EBC hosts an annual, two-day compact meeting, dedicated to bifurcations, which brings together physicians, pathologists, engineers, biologists, physicists, mathematicians, epidemiologists and statisticians for detailed discussions. Every meeting is finalised with a consensus statement that reflects the unique opportunity of combining the opinion of interventional cardiologists with the opinion of a large variety of other scientists on bifurcation management. A series of consensus sessions dedicated to specific topics, to strengthen the consensus debates and focus the discussions, was introduced at this year's meeting. The sessions comprise an intensive overview of the present literature, a pro and con debate and a voting system, to guide the consensus-building process. The present document represents the summary of the up-to-date EBC consensus and recommendations from the 12th annual EBC meeting in 2016 in Rotterdam. © Europa Digital & Publishing 2018.
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    Percutaneous coronary intervention in left main coronary artery disease: The 13th consensus document from the European Bifurcation Club
    (2018)
    Burzotta, Francesco (7003405739)
    ;
    Lassen, Jens Flensted (57189389659)
    ;
    Banning, Adrian P. (57957647700)
    ;
    Lefèvre, Thierry (13608617100)
    ;
    Hildick-Smith, David (8089365300)
    ;
    Chieffo, Alaide (57202041611)
    ;
    Darremont, Olivier (23666794700)
    ;
    Pan, Manuel (7202544866)
    ;
    Chatzizisis, Yiannis S. (13907765800)
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    Albiero, Remo (7003819431)
    ;
    Louvard, Yves (7004523655)
    ;
    Stankovic, Goran (59150945500)
    The 2017 European Bifurcation Club (EBC) meeting was held in Porto (Portugal) and allowed a multidisciplinary international faculty to review and discuss the latest data collected in the field of coronary bifurcation interventions. In particular, the topic of percutaneous coronary intervention (PCI) on left main coronary artery (LM) disease was highlighted as a contemporary priority. Herein, we summarise the key LM anatomy features, the diagnostic modalities and available data that are relevant for a patient's procedural management. Since the clinical outcomes of patients undergoing PCI on LM disease may depend on both PCI team organisation and PCI performance, the optimal catheterisation laboratory set-up and the rationales for device and technique selection are critically reviewed. The best lesion preparation modalities, the different DES implantation technique choices and the strategies to be considered during PCI on unprotected LM for optimal PCI results are reviewed step by step. © Europa Digital & Publishing 2018.
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    Percutaneous coronary intervention of bifurcation lesions
    (2022)
    Hildick-Smith, David (8089365300)
    ;
    Arunothayaraj, Sandeep (36140221200)
    ;
    Stankovic, Goran (59150945500)
    ;
    Chen, Shao-Liang (57206653250)
    Bifurcation coronary artery disease is common as the development of atherosclerosis is facilitated by altered endothelial shear stress. Multiple anatomical and physiological factors need to be considered when treating bifurcation lesions. To achieve optimal results, various stenting techniques have been developed, each with benefits and limitations. In this state-of-the-art review we describe technically important characteristics of bifurcation lesions and summarise the evidence supporting contemporary bifurcation techniques. © Europa Digital & Publishing 2022. All rights reserved.
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    Stepwise provisional versus systematic culotte for stenting of true coronary bifurcation lesions: five-year follow-up of the multicentre randomised EBC TWO Trial
    (2023)
    Arunothayaraj, Sandeep (36140221200)
    ;
    Behan, Miles W. (8862299400)
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    Lefèvre, Thierry (13608617100)
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    Lassen, Jens F. (57189389659)
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    Chieffo, Alaide (57202041611)
    ;
    Stankovic, Goran (59150945500)
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    Burzotta, Francesco (7003405739)
    ;
    Pan, Manuel (7202544866)
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    Ferenc, Miroslaw (8933716300)
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    Hovasse, Thomas (25627893900)
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    Spence, Mark S. (7103007124)
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    Brunel, Philippe (7006007671)
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    Cotton, James M. (7102218822)
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    Cockburn, James (43661048500)
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    Carrié, Didier (7006798967)
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    Baumbach, Andreas (56962775900)
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    Maeng, Michael (20034699800)
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    Louvard, Yves (7004523655)
    ;
    Hildick-Smith, David (8089365300)
    Background: The multicentre European Bifurcation Club Trial (EBC TWO) showed no significant differences in 12-month clinical outcomes between patients randomised to a provisional stenting strategy or systematic culotte stenting in non-left main true bifurcations. Aims: This study aimed to investigate the 5-year clinical results of the EBC TWO Trial. Methods: A total of 200 patients undergoing stent implantation for non-left main bifurcation lesions were recruited into EBC TWO. Inclusion criteria required a side branch diameter ≥2.5 mm and side branch lesion length >5 mm. Five-year follow-up was completed for 197 patients. The primary endpoint was the composite of all-cause mortality, myocardial infarction, or target vessel revascularisation. Results: The mean side branch stent diameter was 2.7±0.3 mm and mean side branch lesion length was 10.3±7.2 mm. At 5-year follow-up, the primary endpoint occurred in 18.4% of provisional and 23.7% of systematic culotte patients (hazard ratio [HR] 0.75, 95% confidence interval [CI]: 0.41-1.38). No significant differences were identified individually for all-cause mortality (7.8% vs 7.2%, HR 1.11, 95% CI: 0.40-3.05), myocardial infarction (8.7% vs 13.4%, HR 0.64, 95% CI: 0.27-1.50) or target vessel revascularisation (6.8% vs 9.3%, HR 1.12, 95% CI: 0.37-3.34). Stent thrombosis rates were also similar (1.9% vs 3.1%, HR 0.63, 95% CI: 0.11-3.75). There was no significant interaction between the extent of side branch disease and the primary outcome (p=0.34). Conclusions: In large non-left main true bifurcation lesions, the use of a systematic culotte strategy showed no benefit over provisional stenting for the composite outcome of all-cause mortality, myocardial infarction, or target vessel revascularisation at 5 years. The stepwise provisional approach may be considered preferable for the majority of true coronary bifurcation lesions. © Europa Digital & Publishing 2023. All rights reserved.
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    The 17th expert consensus document of the European Bifurcation Club - techniques to preserve access to the side branch during stepwise provisional stenting
    (2023)
    Pan, Manuel (7202544866)
    ;
    Lassen, Jens Flensted (57189389659)
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    Burzotta, Francesco (7003405739)
    ;
    Ojeda, Soledad (8654250900)
    ;
    Albiero, Remo (7003819431)
    ;
    Lefèvre, Thierry (13608617100)
    ;
    Hildick-Smith, David (8089365300)
    ;
    Johnson, Thomas W. (56418917800)
    ;
    Chieffo, Alaide (57202041611)
    ;
    Banning, Adrian P. (57957647700)
    ;
    Ferenc, Miroslaw (8933716300)
    ;
    Darremont, Olivier (23666794700)
    ;
    Chatzizisis, Yiannis S. (13907765800)
    ;
    Louvard, Yves (7004523655)
    ;
    Stankovic, Goran (59150945500)
    Provisional stenting has become the default technique for the treatment of most coronary bifurcation lesions. However, the side branch (SB) can become compromised after main vessel (MV) stenting and restoring SB patency can be difficult in challenging anatomies. Angiographic and intracoronary imaging criteria can predict the risk of side branch closure and may encourage use of side branch protection strategies. These protective approaches provide strategies to avoid SB closure or overcome compromise following MV stenting, minimising periprocedural injury. In this article, we analyse the strategies of SB preservation discussed and developed during the most recent European Bifurcation Club (EBC) meetings.
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