Complete revascularization versus culprit-lesion only PCI in patients with NSTEMI and multivessel disease - Design
Hans-Josef Feistritzer1, Alexander Jobs1, Uwe Zeymer2
1Department of Internal Medicine/Cardiology, Heart Center Leipzig at Leipzig University and Leipzig Heart Science, Leipzig, Germany.
Insights
The COMPLETE-NSTEMI trial compares complete versus culprit-lesion only percutaneous coronary intervention (PCI) in non-ST-segment elevation myocardial infarction (NSTEMI) patients with multivessel coronary artery disease (CAD). This study will determine the optimal revascularization strategy for improved patient outcomes.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Multivessel coronary artery disease (CAD) affects 30-70% of non-ST-segment elevation myocardial infarction (NSTEMI) patients.
- Limited randomized controlled trial (RCT) evidence exists for complete revascularization strategies in NSTEMI patients with multivessel CAD.
Purpose of the Study:
- To investigate if multivessel percutaneous coronary intervention (PCI) is superior to culprit-lesion only PCI in NSTEMI patients with multivessel CAD.
- To establish the optimal revascularization strategy for this patient population.
Main Methods:
- Prospective, randomized, controlled, multicenter, open-label trial (COMPLETE-NSTEMI).
- Enrollment of 3390 NSTEMI patients with multivessel CAD.
- Randomization of patients 1:1 to either complete PCI or culprit-lesion only PCI.
Main Results:
- The primary efficacy endpoint is a composite of cardiovascular death or rehospitalization for nonfatal myocardial infarction.
- The trial is event-driven, aiming for 578 primary endpoint events with a minimum 12-month follow-up.
- Recruitment completion is expected in the first half of 2027, with final results anticipated in 2028.
Conclusions:
- The COMPLETE-NSTEMI trial is the first dedicated study to address the optimal revascularization strategy in NSTEMI patients with multivessel CAD.
- Findings will provide crucial evidence to guide clinical decision-making for this patient group.
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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