von Hans-Josef Feistritzer ; Alexander Jobs ; Uwe Zeymer ; Steffen Schneider ; Philipp Lauten ; Miroslaw Ferenc ; Maren Weferling ; Regine Brinkmann ; Sebastian Winkler ; Ulf Landmesser ; Tobias Daniel Trippel ; Christoph Stellbrink ; Harm Wienbergen ; Georg Fürnau ; Helge Möllmann ; Axel Linke ; Christian Jung ; Alexander Lauten ; Stephan Achenbach ; Tienush Rassaf ; Thomas Schmitz ; Sebastian Cremer ; Christoph Olivier ; Volker Schächinger ; Samuel Tobias Sossalla ; Karl Toischer ; Christian Templin ; Daniel Sedding ; Peter Clemmensen ; Eike Philipp Tigges ; Felix Meincke ; Haitham Abu Sharar ; Saarraaken Kulenthiran ; Paul Christian Schulze ; Claudius Jacobshagen ; Derk Frank ; Stephan Baldus ; Ralf Lehmann ; Christian Spies ; Norbert Klein ; Ingo Eitel ; Ralf Zahn ; Alexander Schmeisser ; Tommaso Gori ; Philipp Lurz ; Ibrahim Akın ; Georgios Chatzis ; Konstantinos Rizas ; Thorsten Keßler ; Fadil Ademaj ; Albrecht Elsässer ; Lars Siegfried Maier ; Alper Öner ; Alexander Staudt ; Nikos Werner ; Tobias Geisler ; Mirjam Keßler ; Markus Ferrari ; Melchior Seyfarth ; Peter Johann Nordbeck ; Sebastian Ewen ; Christian Bietau ; Arash Haghikia ; Sebastian J. Reinstadler ; Alexander Geppert ; Nadine Hösler ; Gabor Toth-Gayor ; Björn Ulrich Nicolas Billmann ; Ramon Tschierschke ; Christian Schmidt ; Stephan Fichtlscherer ; Holger Thiele
Online verfügbar: 8. April 2025, Artikelversion: 1. Mai 2025 ; Gesehen am 19.08.2025
Background - Multivessel coronary artery disease (CAD) is present in 30% to 70% of patients presenting with non-ST-segment elevation myocardial infarction (NSTEMI) depending on varying age and risk profiles. In contrast to the STEMI cohort, there is only limited scientific evidence derived from randomized controlled trials directing the general decision for or against complete revascularization in the NSTEMI population. - Primary hypothesis - The COMPLETE-NSTEMI trial aims to investigate whether multivessel percutaneous coronary intervention (PCI) is superior over culprit-lesion only PCI in patients with NSTEMI and multivessel CAD. - Design - COMPLETE-NSTEMI is a prospective, randomized, controlled, multicenter, parallel group, open-label trial. It will enroll 3390 NSTEMI patients with multivessel CAD at 65 to 70 sites in Germany and Austria. Patients will be randomized 1:1 to either complete revascularization with PCI or culprit lesion-only PCI. - Endpoints - The primary efficacy endpoint is a composite of cardiovascular death or rehospitalization for nonfatal myocardial infarction during follow-up. The trial is event-driven and will be stopped as soon as 578 primary endpoint events and a minimal follow-up duration of 12 months for each patient are reached. - Current status - The first patient was enrolled at October 27, 2023. By April 2025, 51 sites have been activated and >500 patients have been randomized. Completion of recruitment is expected for the first half of 2027. The final results of the primary endpoint are expected in 2028. - Outlook - COMPLETE NSTEMI will be the first dedicated trial to answer the question about the optimal revascularization strategy in patients with NSTEMI and multivessel CAD. - Trial registration: ClinicalTrials.gov - NCT05786131
American heart journal Amsterdam [u.a.] : Elsevier, 1925 287(2025), Seite 94-106 Online-Ressource
