Complete revascularization versus culprit-lesion only PCI in patients with NSTEMI and multivessel disease – Design and rationale of the randomized COMPLETE-NSTEMI trial

Feistritzer HJ, Jobs A, Zeymer U, Schneider S, Lauten P, Ferenc M, Weferling M, Brinkmann R, Winkler S, Landmesser U, Trippel T, Stellbrink C, Wienbergen H, Fürnau G, Möllmann H, Linke A, Jung C, Lauten A, Achenbach S, Rassaf T, Schmitz T, Cremer S, Olivier C, Schächinger V, Sossalla S, Toischer K, Templin C, Sedding D, Clemmensen P, Tigges E, Meincke F, Sharar HA, Kulenthiran S, Schulze PC, Jacobshagen C, Frank D, Baldus S, Lehmann R, Spies C, Klein N, Eitel I, Zahn R, Schmeisser A, Gori T, Lurz P, Akin I, Chatzis G, Rizas K, Kessler T, Ademaj F, Elsässer A, Maier L, Öner A, Staudt A, Werner N, Geisler T, Keßler M, Ferrari MW, Seyfarth M, Nordbeck P, Ewen S, Bietau C, Haghikia A, Reinstadler SJ, Geppert A, Hösler N, Toth-Gayor G, Billmann B, Tschierschke R, Schmidt C, Fichtlscherer S, Thiele H (2025)

Publication Type: Journal article

Publication year: 2025

Journal

Book Volume: 287

Pages Range: 94-106

DOI: 10.1016/j.ahj.2025.04.007

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

Authors with CRIS profile

Involved external institutions

Wiener Gesundheitsverbund Kliniken Austria (AT) Leipzig Heart Institute GmbH Germany (DE) Medizinische Universität Graz Austria (AT) Städtisches Klinikum Wolfenbüttel Germany (DE) Brüderklinikum Julia Lanz Germany (DE) Kliniken des Landkreises Neumarkt i.d.OPf. Germany (DE) Segeberger Kliniken Germany (DE) Herzzentrum Leipzig Germany (DE) IHF GmbH Institut für Herzinfarktforschung Germany (DE) Zentralklinikum Bad Berka Germany (DE) Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH Germany (DE) Kerckhoff-Klinik Germany (DE) Herz- und Diabeteszentrum Nordrhein-Westfalen Germany (DE) Unfallkrankenhaus Berlin Germany (DE) Charité - Universitätsmedizin Berlin Germany (DE) Klinikum Bielefeld Germany (DE) Klinikum Links der Weser Germany (DE) Medizinische Hochschule Brandenburg "Theodor Fontane" / Brandenburg Medical School "Theodor Fontane" Germany (DE) St.-Johannes-Hospital Germany (DE) Technische Universität Dresden Germany (DE) Universitätsklinikum Düsseldorf Germany (DE) HELIOS Kliniken Germany (DE) Universitätsklinikum Essen Germany (DE) Elisabeth-Krankenhaus Essen Germany (DE) Goethe-Universität Frankfurt am Main Germany (DE) Klinikum Fulda Germany (DE) Universitätsklinikum Göttingen Germany (DE) Universitätsmedizin Greifswald / Universitätsklinikum Greifswald Germany (DE) Universitätsklinikum Halle (Saale) Germany (DE) Universitätsklinikum Hamburg-Eppendorf (UKE) Germany (DE) Asklepios Kliniken Germany (DE) Asklepios Klinik Altona Germany (DE) Universitätsklinikum Heidelberg Germany (DE) Universitätsklinikum des Saarlandes (UKS) Germany (DE) Universitätsklinikum Jena Germany (DE) Georg-August-Universität Göttingen Germany (DE) Universitätsklinikum Schleswig-Holstein (UKSH) Germany (DE) Universität Leipzig Germany (DE) Klinikum St. Georg Germany (DE) Katholisches Klinikum Bochum (St. Josef- und St. Elisabeth-Hospital gGmbH) Germany (DE) Medizinische Universität Innsbruck Austria (AT) Klinikum der Stadt Ludwigshafen am Rhein gGmbH Germany (DE) Otto-von-Guericke-Universität Magdeburg Germany (DE) Universitätsmedizin der Johannes Gutenberg-Universität Mainz Germany (DE) Universität Mannheim Germany (DE) Universitätsklinikum Gießen und Marburg (UKGM) Germany (DE) Klinikum der Universität München Germany (DE) Technische Universität München (TUM) Germany (DE) Paracelsus Medizinische Privatuniversität, Nürnberg Germany (DE) Carl von Ossietzky Universität Oldenburg Germany (DE) Universitätsklinikum Regensburg Germany (DE) Universitätsmedizin Rostock Germany (DE) Helios Hospital Schwerin Germany (DE) Universitätsklinikum Tübingen Germany (DE) Universität Ulm Germany (DE) Horst-Schmidt-Kliniken Germany (DE) Universität Witten/Herdecke Germany (DE) Universitätsklinikum Würzburg Germany (DE) Schwarzwald-Baar Klinikum Germany (DE)

How to cite

APA:

Feistritzer, H.J., Jobs, A., Zeymer, U., Schneider, S., Lauten, P., Ferenc, M.,... Thiele, H. (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, 94-106. https://doi.org/10.1016/j.ahj.2025.04.007

MLA:

Feistritzer, Hans Josef, et al. "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 (2025): 94-106.

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