Browsing by Author "Wijns, William (7006420435)"

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Aims: To report the six-month angiographic and two-year clinical outcome data from the first-in-man study with the Ultimaster DES, a thin-strut cobalt-chromium sirolimus-eluting stent (SES) with an innovative abluminal-gradient-coated bioresorbable polymer. Methods and results: CENTURY is a multicentre, single-arm, prospective study that enrolled 105 patients (113 lesions) with coronary artery disease. All patients were scheduled to have an angiographic follow-up at six months, while 45 and 20 patients respectively had IVUS and OCT assessments. The primary endpoint was six-month in-stent late lumen loss. Secondary endpoints included clinical, IVUS and OCT outcomes. Clinical follow-up is available up to two years and will continue up to five years. Procedural success was 97.1% and device success was 100%. Angiographic late loss at six months was 0.04±0.35 mm, also reflected in a low binary restenosis rate of 0.9% and confirmed by IVUS-assessed neointimal volume obstruction of 1.02±1.62%. The mean strut coverage assessed by OCT was 96.2% with 1.66±4.02 malapposed stent struts. There were no deaths in the study, three (2.9%) periprocedural and one (0.9%) spontaneous myocardial infarction, not related to the target vessel. At one and two years, the target lesion failure rate was 3.8% and 5.7%, while the TLR rate was 1.9% and 2.8%, respectively. There was one acute definite stent thrombosis. Conclusions: The Ultimaster™ novel bioresorbable polymer sirolimus-eluting stent demonstrated good performance, including high procedural success and strong suppression of neointimal proliferation at six months. Good safety and effectiveness were shown up to two years in the studied population. © Europa Digital & Publishing 2015. All rights reserved.

Aims Cardiopoietic cells, produced through cardiogenic conditioning of patients' mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort. Methods and results This multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n= 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving> 24 million mesenchymal stem cells (n=315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n=157) or sham procedure (n= 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n= 151 sham). The primary efficacy endpoint was a Finkelstein Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann Whitney estimator 0.54, 95% confidence interval [CI] 0.47 0.61 [value> 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200-370mL (60% of patients) (Mann Whitney estimator 0.61, 95% CI 0.52-0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death. Conclusion The primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted. © The Author 2016.

Objectives This study sought to evaluate the feasibility and safety of autologous bone marrow-derived and cardiogenically oriented mesenchymal stem cell therapy and to probe for signs of efficacy in patients with chronic heart failure. Background In pre-clinical heart failure models, cardiopoietic stem cell therapy improves left ventricular function and blunts pathological remodeling. Methods The C-CURE (Cardiopoietic stem Cell therapy in heart failURE) trial, a prospective, multicenter, randomized trial, was conducted in patients with heart failure of ischemic origin who received standard of care or standard of care plus lineage-specified stem cells. In the cell therapy arm, bone marrow was harvested and isolated mesenchymal stem cells were exposed to a cardiogenic cocktail. Derived cardiopoietic stem cells, meeting release criteria under Good Manufacturing Practice, were delivered by endomyocardial injections guided by left ventricular electromechanical mapping. Data acquisition and analysis were performed in blinded fashion. The primary endpoint was feasibility/safety at 2-year follow-up. Secondary endpoints included cardiac structure/function and measures of global clinical performance 6 months post-therapy. Results Mesenchymal stem cell cocktail-based priming was achieved for each patient with the dose attained in 75% and delivery without complications in 100% of cases. There was no evidence of increased cardiac or systemic toxicity induced by cardiopoietic cell therapy. Left ventricular ejection fraction was improved by cell therapy (from 27.5 ± 1.0% to 34.5 ± 1.1%) versus standard of care alone (from 27.8 ± 2.0% to 28.0 ± 1.8%, p < 0.0001) and was associated with a reduction in left ventricular end-systolic volume (-24.8 ± 3.0 ml vs. -8.8 ± 3.9 ml, p < 0.001). Cell therapy also improved the 6-min walk distance (+62 ± 18 m vs. -15 ± 20 m, p < 0.01) and provided a superior composite clinical score encompassing cardiac parameters in tandem with New York Heart Association functional class, quality of life, physical performance, hospitalization, and event-free survival. Conclusions The C-CURE trial implements the paradigm of lineage guidance in cell therapy. Cardiopoietic stem cell therapy was found feasible and safe with signs of benefit in chronic heart failure, meriting definitive clinical evaluation. (C-Cure Clinical Trial; NCT00810238). © 2013 by the American College of Cardiology Foundation.

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

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.

Background: Two-stent techniques for percutaneous coronary intervention (PCI) on left main (LM) bifurcation (LMB) lesions are associated with an increased risk of in-stent restenosis (ISR) at left circumflex artery (LCx) ostium but the underlying mechanisms are incompletely understood. This study sought to investigate the association between cyclic change of LM-LCx bending angle (BALM-LCx) and the risk of ostial LCx ISR following two-stent techniques. Methods: In a retrospective cohort of patients undergoing two-stent PCI for LMB lesions, BALM-LCx and distal bifurcation angle (DBA) were computed with 3-dimensional angiographic reconstruction. The analysis was performed both at end-diastole and end-systole, and the angulation change throughout the cardiac cycle was defined as the cardiac motion-induced angulation change (∆CAngle). Results: A total of 101 patients were included. The mean pre-procedural BALM-LCx was 66.8 ± 16.1° at end-diastole and 54.1 ± 13.3° at end-systole with a range of 13.0 ± 7.7°. Pre-procedural ∆CBALM-LCx > 16.4° was the most relevant predictor of ostial LCx ISR (adjusted OR 11.58, 95% CI 4.04–33.19; p < 0.001). Post-procedural ∆CBALM-LCx > 9.8° and stent-induced diastolic BALM-LCx change > 11.6° were also related with ostial LCx ISR. DBA was positively correlated with BALM-LCx and showed a weaker association of pre-procedural ∆CDBA > 14.5° with ostial LCx ISR (adjusted OR 6.87, 95% CI 2.57–18.37; p < 0.001). Conclusions: Three-dimensional angiographic bending angle is a feasible and reproducible novel method for LMB angulation measurement. A large pre-procedural cyclic change of BALM-LCx was associated with an increased risk of ostial LCx ISR following two-stent techniques. © 2023 Elsevier B.V.

Aims: The aim of this study was to establish the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster) by comparison with an everolimus-eluting stent with permanent polymer (PP-EES; XIENCE). Methods and results: CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) is a large-scale, prospective, multicentre, randomised single-blind, controlled, non-inferiority trial conducted at 58 study sites globally, including Europe, Japan and Korea, powered to prove non-inferiority for freedom from target lesion failure (TLF: cardiac death, target vessel-related myocardial infarction [MI] and target lesion revascularisation) at nine months. Patients requiring a percutaneous coronary intervention (PCI) were randomised (1:1) to BP-SES (n=551) or PP-EES (n=550). Freedom from TLF at five years was 90.0% in the BP-SES and 91.1% in the PP-EES group (p=0.54). The patient-oriented composite endpoint (all death, any MI, any revascularisation) was 24.1 and 25.6% (p=0.57) with BP-SES and PP-EES, respectively. The very late stent thrombosis rate from one to five years was especially low at 0.2% in both arms. Conclusions: This randomised clinical trial showed that the BP-SES stent was non-inferior to the benchmark PP-EES stent for TLF. Safety and efficacy measures were comparable up to five-year follow-up after PCI. © Europa Digital & Publishing 2018.

As bifurcation PCI can often be resource-demanding due to the use of multiple guidewires, balloons and stents, different technical options are sometimes being explored, in different local settings, to meet the need of optimally treating a patient with a bifurcation lesion, while being confronted with limited material resources. Therefore, it seems important to keep a proper balance between what is recognised as the contemporary state of the art, and what is known to be potentially harmful and to be discouraged. Ultimately, the resource-tailored approach to bifurcation PCI may be characterised by the notion of minimum technical requirements for each step of a successful procedure. Hence, this paper describes the logical sequence of steps when performing bifurcation PCI with provisional SB stenting, starting with basic anatomy assessment and ending with the optimisation of MB stenting and the evaluation of the potential need to stent the SB, suggesting, for each step, the minimum technical requirement for a successful intervention. © Europa Digital & Publishing 2018. All rights reserved.