Complete revascularization versus culprit-lesion only PCI in patients with NSTEMI and multivessel disease: design and rationale of the randomized COMPLETE-NSTEMI trial
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 rand...
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
September 2025
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| In: |
American heart journal
Year: 2025, Volume: 287, Pages: 94-106 |
| ISSN: | 1097-6744 |
| DOI: | 10.1016/j.ahj.2025.04.007 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.ahj.2025.04.007 Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S0002870325001218 
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| Author Notes: | Hans-Josef Feistritzer, MD, PhD, Alexander Jobs, MD, Uwe Zeymer, MD, Steffen Schneider, PhD, Philipp Lauten, MD, Miroslaw Ferenc, MD, Maren Weferling, MD, Regine Brinkmann, MD, Sebastian Winkler, MD, Ulf Landmesser, MD, Tobias Trippel, MD, Christoph Stellbrink, MD, Harm Wienbergen, MD, Georg Fürnau, MD, Helge Möllmann, MD, Axel Linke, MD, Christian Jung, MD, Alexander Lauten, MD, Stephan Achenbach, MD, Tienush Rassaf, MD, Thomas Schmitz, MD, Sebastian Cremer, MD, Christoph Olivier, MD, Volker Schächinger, MD, Samuel Sossalla, MD, Karl Toischer, MD, Christian Templin, MD, Daniel Sedding, MD, Peter Clemmensen, MD, Eike Tigges, MD, Felix Meincke, MD, Haitham Abu Sharar, MD, Saarraaken Kulenthiran, MD, P. Christian Schulze, MD, Claudius Jacobshagen, MD, Derk Frank, MD, Stephan Baldus, MD, Ralf Lehmann, MD, Christian Spies, MD, Norbert Klein, MD, Ingo Eitel, MD, Ralf Zahn, MD, Alexander Schmeisser, MD, Tommaso Gori, MD, Philipp Lurz, MD,Ibrahim Akin, MD, Georgios Chatzis, MD, Konstantinos Rizas, MD, Thorsten Kessler, MD, Fadil Ademaj, MD, Albrecht Elsässer, MD, Lars Maier, MD, Alper Öner, MD, Alexander Staudt, MD, Nikos Werner, MD, Tobias Geisler, MD,Mirjam Keßler, MD, Markus Wolfgang Ferrari, MD, Melchior Seyfarth, MD, Peter Nordbeck, MD, Sebastian Ewen, MD, Christian Bietau, MD, Arash Haghikia, MD, Sebastian J. Reinstadler, MD, PhD, Alexander Geppert, MD, Nadine Hösler, PhD,Gabor Toth-Gayor, MD, Björn Billmann, MD, Ramon Tschierschke, MD, Christian Schmidt, MD, Stephan Fichtlscherer, MD, and Holger Thiele, MD, on behalf of the COMPLETE-NSTEMI Investigators |
| Summary: | 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 |
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| Item Description: | Online verfügbar: 8. April 2025, Artikelversion: 1. Mai 2025 Gesehen am 19.08.2025 |
| Physical Description: | Online Resource |
| ISSN: | 1097-6744 |
| DOI: | 10.1016/j.ahj.2025.04.007 |