Feistritzer, Hans-Josef and Jobs, Alexander and Zeymer, Uwe and Schneider, Steffen and Lauten, Philipp and Ferenc, Miroslaw and Weferling, Maren and Brinkmann, Regine and Winkler, Sebastian and Landmesser, Ulf and Trippel, Tobias and Stellbrink, Christoph and Wienbergen, Harm and Fuernau, Georg and Moellmann, Helge and Linke, Axel and Jung, Christian and Lauten, Alexander and Achenbach, Stephan and Rassaf, Tienush and Schmitz, Thomas and Cremer, Sebastian and Olivier, Christoph and Schaechinger, Volker and Sossalla, Samuel and Toischer, Karl and Templin, Christian and Sedding, Daniel and Clemmensen, Peter and Tigges, Eike and Meincke, Felix and Abu Sharar, Haitham and Kulenthiran, Saarraaken and Schulze, P. Christian and Jacobshagen, Claudius and Frank, Derk and Baldus, Stephan and Lehmann, Ralf and Spies, Christian and Klein, Norbert and Eitel, Ingo and Zahn, Ralf and Schmeisser, Alexander and Gori, Tommaso and Lurz, Philipp and Akin, Ibrahim and Chatzis, Georgios and Rizas, Konstantinos and Kessler, Thorsten and Ademaj, Fadil and Elsaesser, Albrecht and Maier, Lars and Oener, Alper and Staudt, Alexander and Werner, Nikos and Geisler, Tobias and Kessler, Mirjam and Ferrari, Markus Wolfgang and Seyfarth, Melchior and Nordbeck, Peter and Ewen, Sebastian and Bietau, Christian and Haghikia, Arash and Reinstadler, Sebastian J. and Geppert, Alexander and Hoesler, Nadine and Toth-Gayor, Gabor and Billmann, Bjoern and Tschierschke, Ramon and Schmidt, Christian and Fichtlscherer, Stephan and Thiele, Holger (2025) Complete revascularization versus culprit-lesion only PCI in patients with NSTEMI and multivessel disease-Design and rationale of the randomized COMPLETE-NSTEMI trial. AMERICAN HEART JOURNAL, 287. pp. 94-106. ISSN 0002-8703, 1097-6744
Full text not available from this repository. (Request a copy)Abstract
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
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | ELEVATION MYOCARDIAL-INFARCTION; PERCUTANEOUS CORONARY INTERVENTION; DELAYED INVASIVE INTERVENTION; ST-ELEVATION; ARTERY-DISEASE; ANGIOGRAPHY; OUTCOMES; STEMI; ANGIOPLASTY; MANAGEMENT; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 23 Mar 2026 10:52 |
| Last Modified: | 23 Mar 2026 10:52 |
| URI: | https://pred.uni-regensburg.de/id/eprint/68109 |
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