Cardiovascular revascularization medicine : including molecular interventions · 2024
Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction-Outcomes at two years.
СтатьяСравнительное исследованиеМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Omerovic Elmir, James Stefan, Råmundal Truls, Fröbert Ole, Linder Rikard, Danielewicz Mikael, Hamid Mehmet, Pagonis Christos, Henareh Loghman, Wagner Henrik, Stewart Jason, Jensen Jens, Lindros Pontus, Robertsson Lotta, Wikström Helena, Ulvenstam Anders, Bhiladval Pallonji, Tödt Tim, Ioanes Dan, Kellerth Thomas, Zagozdzon Leszek, Götberg Matthias, Andersson Jonas, Angerås Oskar, Östlund Ollie, Held Claes, Koul Sasha, Erlinge David
Аннотация
BACKGROUND: The registry-based randomized VALIDATE-SWEDEHEART trial (NCT02311231) compared bivalirudin vs. heparin in patients undergoing percutaneous coronary intervention (PCI) for myocardial infarction (MI). It showed no difference in the composite primary endpoint of death, MI, or major bleeding at 180 days. Here, we report outcomes at two years.
METHODS: Analysis of primary and secondary endpoints at two years of follow-up was prespecified in the study protocol. We report the study results for the extended follow-up time here.
RESULTS: In total, 6006 patients were enrolled, 3005 with ST-segment elevation MI (STEMI) and 3001 with Non-STEMI (NSTEMI), representing 70 % of all eligible patients with these diagnoses during the study. The primary endpoint occurred in 14.0 % (421 of 3004) in the bivalirudin group compared with 14.3 % (429 of 3002) in the heparin group (hazard ratio [HR] 0.97; 95 % confidence interval [CI], 0.85-1.11; P = 0.70) at one year and in 16.7 % (503 of 3004) compared with 17.1 % (514 of 3002), (HR 0.97; 95 % CI, 0.96-1.10; P = 0.66) at two years. The results were consistent in patients with STEMI and NSTEMI and across major subgroups.
CONCLUSIONS: Until the two-year follow-up, there were no differences in endpoints between patients with MI undergoing PCI and allocated to bivalirudin compared with those allocated to heparin.
REGISTRATION: URL: https://www.
CLINICALTRIALS: gov; Unique identifier: NCT02311231.
METHODS: Analysis of primary and secondary endpoints at two years of follow-up was prespecified in the study protocol. We report the study results for the extended follow-up time here.
RESULTS: In total, 6006 patients were enrolled, 3005 with ST-segment elevation MI (STEMI) and 3001 with Non-STEMI (NSTEMI), representing 70 % of all eligible patients with these diagnoses during the study. The primary endpoint occurred in 14.0 % (421 of 3004) in the bivalirudin group compared with 14.3 % (429 of 3002) in the heparin group (hazard ratio [HR] 0.97; 95 % confidence interval [CI], 0.85-1.11; P = 0.70) at one year and in 16.7 % (503 of 3004) compared with 17.1 % (514 of 3002), (HR 0.97; 95 % CI, 0.96-1.10; P = 0.66) at two years. The results were consistent in patients with STEMI and NSTEMI and across major subgroups.
CONCLUSIONS: Until the two-year follow-up, there were no differences in endpoints between patients with MI undergoing PCI and allocated to bivalirudin compared with those allocated to heparin.
REGISTRATION: URL: https://www.
CLINICALTRIALS: gov; Unique identifier: NCT02311231.