Complete revascularization versus culprit-lesion only PCI in patients with NSTEMI and multivessel disease – Design and rationale of the randomized COMPLETE-NSTEMI trial - 23/05/25
Doi : 10.1016/j.ahj.2025.04.007
Hans-Josef Feistritzer, MD, PhD 1, †, Alexander Jobs, MD 1, †, Uwe Zeymer, MD 2, 3, Steffen Schneider, PhD 2, Philipp Lauten, MD 4, Miroslaw Ferenc, MD 5, Maren Weferling, MD 6, Regine Brinkmann, MD 7, Sebastian Winkler, MD 8, Ulf Landmesser, MD 9, Tobias Trippel, MD 10, Christoph Stellbrink, MD 11, Harm Wienbergen, MD 12, Georg Fürnau, MD 13, Helge Möllmann, MD 14, Axel Linke, MD 15, Christian Jung, MD 16, Alexander Lauten, MD 17, Stephan Achenbach, MD 18, Tienush Rassaf, MD 19, Thomas Schmitz, MD 20, Sebastian Cremer, MD 21, Christoph Olivier, MD 22, Volker Schächinger, MD 23, Samuel Sossalla, MD 6, 24, Karl Toischer, MD 25, Christian Templin, MD 26, Daniel Sedding, MD 27, Peter Clemmensen, MD 28, Eike Tigges, MD 29, Felix Meincke, MD 30, Haitham Abu Sharar, MD 31, Saarraaken Kulenthiran, MD 32, P. Christian Schulze, MD 33, Claudius Jacobshagen, MD 34, 35, Derk Frank, MD 36, Stephan Baldus, MD 37, Ralf Lehmann, MD 38, Christian Spies, MD 39, Norbert Klein, MD 40, Ingo Eitel, MD 41, Ralf Zahn, MD 3, Alexander Schmeisser, MD 42, Tommaso Gori, MD 43, Philipp Lurz, MD 43, Ibrahim Akin, MD 44, Georgios Chatzis, MD 45, Konstantinos Rizas, MD 46, Thorsten Kessler, MD 47, Fadil Ademaj, MD 48, Albrecht Elsässer, MD 49, Lars Maier, MD 50, Alper Öner, MD 51, Alexander Staudt, MD 52, Nikos Werner, MD 53, Tobias Geisler, MD 54, Mirjam Keßler, MD 55, Markus Wolfgang Ferrari, MD 56, Melchior Seyfarth, MD 57, Peter Nordbeck, MD 58, Sebastian Ewen, MD 59, Christian Bietau, MD 60, Arash Haghikia, MD 61, Sebastian J. Reinstadler, MD, PhD 62, Alexander Geppert, MD 63, Nadine Hösler, PhD 64, Gabor Toth-Gayor, MD 65, Björn Billmann, MD 66, Ramon Tschierschke, MD 67, Christian Schmidt, MD 68, Stephan Fichtlscherer, MD 69, Holger Thiele, MD 1, ⁎ 
on behalf of the
on behalf of the
COMPLETE-NSTEMI Investigators
1 Department of Internal Medicine/Cardiology, Heart Center Leipzig at Leipzig University and Leipzig Heart Science, Leipzig, Germany
2 Institut für Herzinfarktforschung, Ludwigshafen, Germany
3 Klinikum Ludwigshafen, Ludwigshafen, Germany
4 Zentralklinik Bad Berka, Bad Berka, Germany
5 Division of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany
6 Kerckhoff-Klinik, Department of Cardiology, Bad Nauheim, Germany
7 Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum Nordrhein-Westfalen, Ruhr-Universität Bochum, Bad Oeynhausen, Germany
8 Clinic for Internal Medicine and Cardiology, Unfallkrankenhaus Berlin, Berlin, Germany
9 Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Benjamin Franklin, Berlin, Germany
10 Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Virchow Klinikum, Berlin, Germany
11 Department of Cardiology, Klinikum Bielefeld, Bielefeld, Germany
12 Klinikum Links der Weser Bremen, Bremen, Germany
13 Clinic for Internal Medicine II, Staedtisches Klinikum Dessau, Brandenburg Medical School Theodor Fontane and Faculty of Health Sciences Brandenburg, Dessau-Rosslau, Germany
14 Department of Internal Medicine, St. Johannes-Hospital, Dortmund, Germany
15 Technische Universität Dresden, Heart Centre, Dresden, Germany
16 Department of Cardiology, Pulmonology and Vascular Medicine, University Hospital and Medical Faculty, Heinrich-Heine University, Duesseldorf, Germany
17 Department of General and Interventional Cardiology and Rhythmology, Helios Klinikum Erfurt, Erfurt, Germany
18 Department of Cardiology, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany
19 Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen, Essen, Germany
20 Department of Cardiology, Elisabeth Krankenhaus Essen, Essen, Germany
21 Cardiopulmonary Institute, Goethe University, Frankfurt, Germany
22 Department of Cardiology and Angiology, University Heart Center Freiburg-Bad Krozingen, University of Freiburg, Freiburg, Germany
23 Medizinische Klinik I, Herz-Thorax Zentrum, Klinikum Fulda, Fulda, Germany
24 Department of Cardiology and Angiology, Medical Clinic I, University Clinic of Giessen, Giessen, Germany
25 Department of Cardiology and Pneumology, University Medical Center Göttingen, Germany
26 Department of Internal Medicine B, University Medicine Greifswald, Greifswald, Germany
27 Department of Internal Medicine III, University Hospital Halle (Saale), Halle (Saale), Germany
28 Department of Cardiology, University Heart & Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany and Department of Medicine, Cardiology, Zealand University Hospital, Roskilde and Nykøbing Falster, Denmark
29 Department of Cardiology and Critical Care, Asklepios Clinic St. Georg, Hamburg, Germany
30 Department of Cardiology, Asklepios Klinik Altona, Hamburg, Germany
31 Department of Cardiology, Angiology and Pneumology, Heidelberg University Hospital, Heidelberg, Germany
32 Internal Medicine Clinic III, Cardiology, Angiology and Intensive Care Medicine, Saarland University Hospital, Homburg, Germany
33 Department of Medicine, Division of Cardiology, Angiology and Intensive Care Medicine, University Hospital Jena, Jena, Germany
34 Clinic for Cardiology and Pneumology, Georg August University Göttingen, Göttingen, Germany
35 Vincentius-Diakonissen Hospital, Karlsruhe, Germany
36 Department of Internal Medicine III, Cardiology and Critical Care, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
37 Clinic III for Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany
38 Asklepios Clinic Langen, Langen, Germany
39 Clinic and Policlinic for Cardiology, Leipzig University Clinic, Leipzig, Germany
40 Department of Cardiology, Angiology and Internal Intensive-Care Medicine, Klinikum St. Georg Leipzig, Leipzig, Germany
41 Medical Clinic II, Cardiology, Angiology, Intensive Care Medicine, University Heart Center Lübeck, Lübeck, Germany
42 Department of Internal Medicine, Division of Cardiology and Angiology, Magdeburg University, Magdeburg, Germany
43 Department of Cardiology, University Clinic Mainz, Mainz, Germany
44 Department of Cardiology, University of Mannheim, Mannheim, Germany
45 Department of Cardiology, Angiology, and Intensive Care Medicine, University Hospital, Philipps University of Marburg, Marburg, Germany
46 Department Internal Medicine, University Hospital Munich, Campus Grosshadern, Ludwig-Maximilians-University Munich (LMU Munich), Munich, Germany
47 Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany
48 Department of Cardiology, Paracelsus Medical University, Nuremberg, Germany
49 University Clinic for Internal Medicine, Cardiology, Oldenburg, Germany
50 Department of Internal Medicine II, University Hospital Regensburg, Regensburg, Germany
51 Department of Cardiology, Rostock University Medical Centre, Rostock, Germany
52 Department of Cardiology and Angiology, Hospital Schwerin, Schwerin, Germany
53 Department of Cardiology, Heart Centre Trier, Barmherzige Brueder Hospital, Trier, Germany
54 Department of Cardiology and Angiology, University Hospital Tübingen, Germany
55 Department of Cardiology, Angiology, Pneumology and Intensive Care, Ulm University Heart Center, Ulm, Germany
56 Division of Interventional Cardiology, Helios Dr. Horst Schmidt Kliniken Wiesbaden, Wiesbaden, Germany
57 Department of Cardiology, Heart Center Wuppertal, Witten/Herdecke University, Wuppertal, Germany
58 Department of Internal Medicine I, University Hospital Würzburg, Würzburg, Germany
59 Schwarzwald-Baar Klinikum, Villingen-Schwenningen, Germany
60 Vogtland-Klinikum Plauen, Plauen, Germany
61 Department of Cardiology and Rhythmology, University Hospital St. Josef-Hospital Bochum, Cardiology and Rhythmology, Ruhr University Bochum, Bochum, Germany
62 University Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck, Innsbruck, Austria
63 3rd Department of Medicine, Cardiology and Intensive Care Medicine, Clinic Ottakring, Vienna, Austria
64 Leipzig Heart Science Institute, Leipzig, Germany
65 Division of Cardiology, Department of Internal Medicine, Medical University Graz, Graz, Austria
66 Clinic for Internal Medicine – Cardiology, Städtisches Klinikum Wolfenbüttel, Wolfenbüttel, Germany
67 Department of Cardiology, Angiology and Intensive Care Medicine, Brüderklinikum Julia Lanz, Mannheim, Germany
68 Medizinische Klinik I, Klinikum Neumarkt, Neumarkt, Germany
69 Heart and Vascular Center Bad Segeberg, Cardiology and Angiology, Segeberger Kliniken, Bad Segeberg, Germany
⁎Reprint requests: Holger Thiele, MD, Department of Internal Medicine/Cardiology, Heart Center Leipzig at Leipzig University and Leipzig Heart Science, Strümpellstr. 39 04289 Leipzig, Germany.Department of Internal Medicine/CardiologyHeart Center Leipzig at Leipzig University and Leipzig Heart Science, StrümpellstrLeipzig39 04289Germany
Highlights |
• | Randomized evidence regarding the optimal revascularization strategey in NSTEMI patients with multivessel coronary artery disease is limited. |
• | The COMPLETE-NSTEMI trail aims to investigate whether complete revascularization is superior over culprit-lesion only PCI in these patients. |
• | This trial will enroll 3390 NSTEMI patients at 65 to 70 in Germany and Austria. |
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
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Elsevier Inc. Tous droits réservés.
Vol 287
P. 94-106 - septembre 2025 Retour au numéro
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