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.

American Heart Journal
|April 10, 2025
PubMed

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.
Abstract

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