Browsing by Author "Jüni, Peter (7004263326)"

[No abstract available]

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.

Aims: Selective use of DES only in patients at higher risk of MACE is common practice, particularly in healthcare systems with a large premium payable for DES. We aimed to identify subgroups of patients in which the use of BMS in primary percutaneous coronary intervention (PPCI) for STEMI can still be justified. Methods and results: We performed a patient-level pooled analysis of COMFORTABLE AMI and EXAMINATION comparing contemporary DES with BMS in PPCI. A risk score was applied using three parameters: lesion length >15mm, vessel size <3 mm, and diabetes mellitus. Individual data were available for 2,655 patients. The incidence of MACE at one year was incrementally higher in patients with risk scores of 1 or 2/3. MACE rates were lower in patients with a risk score 0 or 1 who were treated with DES (p=0.0073 and p=0.008). No difference in death or reinfarction was seen between DES and BMS in any group. There was a significant reduction in TLR with DES in all three groups. Conclusions: A score comprising vessel size, lesion length, and diabetes did not identify patients at low risk with equivalent or better results from BMS use. The results suggest that the practice of only selective use of DES in primary PCI should be discouraged. © Europa Digital & Publishing 2017. All rights reserved.