TY - JOUR
T1 - Complete revascularization versus culprit-lesion only PCI in patients with NSTEMI and multivessel disease - Design and rationale of the randomized COMPLETE-NSTEMI trial
T2 - The COMPLETE-NSTEMI trial
AU - COMPLETE-NSTEMI Investigators
AU - Feistritzer, Hans-Josef
AU - Jobs, Alexander
AU - Zeymer, Uwe
AU - Schneider, Steffen
AU - Lauten, Philipp
AU - Ferenc, Miroslaw
AU - Weferling, Maren
AU - Brinkmann, Regine
AU - Winkler, Sebastian
AU - Landmesser, Ulf
AU - Trippel, Tobias
AU - Stellbrink, Christoph
AU - Wienbergen, Harm
AU - Fürnau, Georg
AU - Möllmann, Helge
AU - Linke, Axel
AU - Jung, Christian
AU - Lauten, Alexander
AU - Achenbach, Stephan
AU - Rassaf, Tienush
AU - Schmitz, Thomas
AU - Cremer, Sebastian
AU - Olivier, Christoph
AU - Schächinger, Volker
AU - Sossalla, Samuel
AU - Toischer, Karl
AU - Templin, Christian
AU - Sedding, Daniel
AU - Clemmensen, Peter
AU - Tigges, Eike
AU - Meincke, Felix
AU - Sharar, Haitham Abu
AU - Kulenthiran, Saarraaken
AU - Schulze, P Christian
AU - Jacobshagen, Claudius
AU - Frank, Derk
AU - Baldus, Stephan
AU - Lehmann, Ralf
AU - Spies, Christian
AU - Klein, Norbert
AU - Eitel, Ingo
AU - Zahn, Ralf
AU - Schmeisser, Alexander
AU - Gori, Tommaso
AU - Lurz, Philipp
AU - Akin, Ibrahim
AU - Chatzis, Georgios
AU - Rizas, Konstantinos
AU - Kessler, Thorsten
AU - Ademaj, Fadil
AU - Thiele, Holger
N1 - Copyright © 2025 Elsevier Inc. All rights reserved.
PY - 2025/9
Y1 - 2025/9
N2 - BACKGROUND: Multivessel coronary artery disease (CAD) is present in 30-70% 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 non-fatal 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.
AB - BACKGROUND: Multivessel coronary artery disease (CAD) is present in 30-70% 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 non-fatal 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.
KW - Elevation myocardial-infarction
KW - Percutaneous coronary intervention
KW - Delayed invasive intervention
KW - St-elevation
KW - Artery-disease
KW - Angiography
KW - Outcomes
KW - Stemi
KW - Angioplasty
KW - Management
KW - Prospective Studies
KW - Humans
KW - Middle Aged
KW - Male
KW - Myocardial Revascularization/methods
KW - Randomized Controlled Trials as Topic
KW - Non-ST Elevated Myocardial Infarction/surgery
KW - Coronary Angiography
KW - Multicenter Studies as Topic
KW - Female
KW - Percutaneous Coronary Intervention/methods
KW - Aged
KW - Coronary Artery Disease/surgery
U2 - 10.1016/j.ahj.2025.04.007
DO - 10.1016/j.ahj.2025.04.007
M3 - Protocol
C2 - 40209841
SN - 0002-8703
VL - 287
SP - 94
EP - 106
JO - American heart journal
JF - American heart journal
ER -