Browsing by Author "Richardt, Gert (7006414918)"

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.

Monotherapy with a potent P2Y12 receptor antagonist after 1 month of dual antiplatelet therapy (DAPT) may reduce bleeding in the absence of increased ischaemic events compared to 12-month DAPT in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI). PCI guidance with optical coherence tomography (OCT) may enhance stent expansion. COMPARE STEMI ONE is an international, multicentre, open-label, randomised controlled trial. In 1,656 ST-segment elevation myocardial infarction (STEMI) patients, prasugrel monotherapy after 1 month of DAPT, as compared to standard 12-month prasugrel-based DAPT, will be tested for non-inferiority for the primary composite endpoint of net adverse clinical events - defined as all-cause death, myocardial infarction, stroke, or Bleeding Academic Research Consortium Type 3 or 5 bleeding events - at 11 months after randomisation. Furthermore, an ancillary substudy will test the superiority of OCT-guided versus angiography-guided staged complete revascularisation in achieving a larger minimal stent area (MSA) in non-culprit lesions during staged procedures. COMPARE STEMI ONE is the first randomised controlled trial assessing an abbreviated 1-month DAPT regimen followed by prasugrel monotherapy in the context of STEMI. The trial will also study the value of OCT-guided PCI in terms of the MSA of non-culprit lesions and may elucidate potential synergies between intravascular imaging-guided PCI and abbreviated DAPT regimens. (ClinicalTrials.gov: NCT05491200).