JAMA · 2025
Fractional Flow Reserve-Guided Complete vs Culprit-Only Revascularization in Non-ST-Elevation Myocardial Infarction and Multivessel Disease: The SLIM Randomized Clinical Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Pustjens Tobias F S, Veenstra Leo, Camaro Cyril, Ruiters Alexander W, Lux Árpad, Ruzsa Zoltán, Piroth Zsolt, Ilhan Mustafa, Vainer Jindrich, Gho Ben, Winkler Patty J C, Stein Mera, Theunissen Ralph A L J, Kala Petr, Polad Jawed, Berta Balázs, Gabrio Andrea, van Royen Niels, van 't Hof Arnoud W J, Rasoul Saman
Аннотация
IMPORTANCE: The benefits of fractional flow reserve (FFR)-guided complete coronary revascularization in patients with non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel disease remain unclear.
OBJECTIVE: To compare FFR-guided complete revascularization of nonculprit lesions vs culprit-only revascularization in patients with NSTEMI and multivessel disease.
DESIGN, SETTING, AND PARTICIPANTS: This prospective, investigator-initiated, multicenter, international randomized clinical trial was conducted at 9 hospitals in Europe. Patients with NSTEMI and multivessel disease who had successful revascularization of the culprit lesion were enrolled between June 2018 and July 2024, and final follow-up was completed on July 21, 2025. The analysis was conducted on July 28, 2025. Eligibility criteria included the presence of at least 1 stenosis of at least 50% in a nonculprit lesion amendable for revascularization.
INTERVENTION: Patients were randomized to receive either FFR-guided complete or culprit-only revascularization during the index procedure. Staged revascularization within 6 weeks after the index procedure was allowed in the culprit-only group.
MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of all-cause death, nonfatal myocardial infarction, any revascularization, and stroke at 1 year. Key secondary outcomes included individual components of the primary outcome, net adverse clinical events, all-cause death or nonfatal myocardial infarction, cardiac rehospitalization, and bleeding events.
RESULTS: Among 478 randomized patients (mean [SD] age, 65.9 [10.6] years; 347 [72.9%] males), 240 were randomized to receive FFR-guided complete revascularization and 238 were randomized to receive culprit-only revascularization, with crossover occurring in 7 patients in the culprit-only group. The primary outcome occurred in 13 patients (5.5%) in the FFR-guided complete revascularization group vs 32 patients (13.6%) in the culprit-only group (hazard ratio [HR], 0.38 [95% CI, 0.20-0.72]; P = .003). Rates of any revascularization (3.0% vs 11.5%; HR, 0.24 [95% CI, 0.11-0.56]; P < .001) and net adverse clinical events (6.3% vs 15.3%; HR, 0.39 [95% CI, 0.21-0.70]; P = .002) were also significantly lower in the complete revascularization group, while there were no significant differences in the remaining secondary outcomes.
CONCLUSION AND RELEVANCE: FFR-guided complete revascularization during the index procedure resulted in a significant reduction in the composite of all-cause death, nonfatal myocardial infarction, any revascularization, and stroke at 1 year. This was mainly driven by reduced repeat revascularization.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03562572.
OBJECTIVE: To compare FFR-guided complete revascularization of nonculprit lesions vs culprit-only revascularization in patients with NSTEMI and multivessel disease.
DESIGN, SETTING, AND PARTICIPANTS: This prospective, investigator-initiated, multicenter, international randomized clinical trial was conducted at 9 hospitals in Europe. Patients with NSTEMI and multivessel disease who had successful revascularization of the culprit lesion were enrolled between June 2018 and July 2024, and final follow-up was completed on July 21, 2025. The analysis was conducted on July 28, 2025. Eligibility criteria included the presence of at least 1 stenosis of at least 50% in a nonculprit lesion amendable for revascularization.
INTERVENTION: Patients were randomized to receive either FFR-guided complete or culprit-only revascularization during the index procedure. Staged revascularization within 6 weeks after the index procedure was allowed in the culprit-only group.
MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of all-cause death, nonfatal myocardial infarction, any revascularization, and stroke at 1 year. Key secondary outcomes included individual components of the primary outcome, net adverse clinical events, all-cause death or nonfatal myocardial infarction, cardiac rehospitalization, and bleeding events.
RESULTS: Among 478 randomized patients (mean [SD] age, 65.9 [10.6] years; 347 [72.9%] males), 240 were randomized to receive FFR-guided complete revascularization and 238 were randomized to receive culprit-only revascularization, with crossover occurring in 7 patients in the culprit-only group. The primary outcome occurred in 13 patients (5.5%) in the FFR-guided complete revascularization group vs 32 patients (13.6%) in the culprit-only group (hazard ratio [HR], 0.38 [95% CI, 0.20-0.72]; P = .003). Rates of any revascularization (3.0% vs 11.5%; HR, 0.24 [95% CI, 0.11-0.56]; P < .001) and net adverse clinical events (6.3% vs 15.3%; HR, 0.39 [95% CI, 0.21-0.70]; P = .002) were also significantly lower in the complete revascularization group, while there were no significant differences in the remaining secondary outcomes.
CONCLUSION AND RELEVANCE: FFR-guided complete revascularization during the index procedure resulted in a significant reduction in the composite of all-cause death, nonfatal myocardial infarction, any revascularization, and stroke at 1 year. This was mainly driven by reduced repeat revascularization.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03562572.