FFR-Guided Complete or Culprit-Only PCI in Patients with Myocardial Infarction

N Engl J Med. 2024 Apr 25;390(16):1481-1492. doi: 10.1056/NEJMoa2314149. Epub 2024 Apr 8.

Abstract

Background: The benefit of fractional flow reserve (FFR)-guided complete revascularization in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease remains unclear.

Methods: In this multinational, registry-based, randomized trial, we assigned patients with STEMI or very-high-risk non-STEMI (NSTEMI) and multivessel disease who were undergoing primary percutaneous coronary intervention (PCI) of the culprit lesion to receive either FFR-guided complete revascularization of nonculprit lesions or no further revascularization. The primary outcome was a composite of death from any cause, myocardial infarction, or unplanned revascularization. The two key secondary outcomes were a composite of death from any cause or myocardial infarction and unplanned revascularization.

Results: A total of 1542 patients underwent randomization, with 764 assigned to receive FFR-guided complete revascularization and 778 assigned to receive culprit-lesion-only PCI. At a median follow-up of 4.8 years (interquartile range, 4.3 to 5.2), a primary-outcome event had occurred in 145 patients (19.0%) in the complete-revascularization group and in 159 patients (20.4%) in the culprit-lesion-only group (hazard ratio, 0.93; 95% confidence interval [CI], 0.74 to 1.17; P = 0.53). With respect to the secondary outcomes, no apparent between-group differences were observed in the composite of death from any cause or myocardial infarction (hazard ratio, 1.12; 95% CI, 0.87 to 1.44) or unplanned revascularization (hazard ratio, 0.76; 95% CI, 0.56 to 1.04). There were no apparent between-group differences in safety outcomes.

Conclusions: Among patients with STEMI or very-high-risk NSTEMI and multivessel coronary artery disease, FFR-guided complete revascularization was not shown to result in a lower risk of a composite of death from any cause, myocardial infarction, or unplanned revascularization than culprit-lesion-only PCI at 4.8 years. (Funded by the Swedish Research Council and others; FULL REVASC ClinicalTrials.gov number, NCT02862119.).

Publication types

  • Randomized Controlled Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't
  • Comparative Study

MeSH terms

  • Aged
  • Australasia
  • Coronary Artery Disease* / complications
  • Coronary Artery Disease* / mortality
  • Coronary Artery Disease* / therapy
  • Coronary Vessels / diagnostic imaging
  • Coronary Vessels / surgery
  • Europe
  • Female
  • Follow-Up Studies
  • Fractional Flow Reserve, Myocardial*
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Myocardial Infarction / mortality
  • Myocardial Infarction / therapy
  • Myocardial Revascularization* / methods
  • Percutaneous Coronary Intervention* / methods
  • Registries
  • Reoperation
  • ST Elevation Myocardial Infarction* / etiology
  • ST Elevation Myocardial Infarction* / mortality
  • ST Elevation Myocardial Infarction* / physiopathology
  • ST Elevation Myocardial Infarction* / therapy

Associated data

  • ClinicalTrials.gov/NCT02862119