Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction—Outcomes at two years

• Published in: Cardiovascular revascularization medicine 2024, Vol.66, p.43-50
• Main Authors: 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
• Format: Article
• Language: English
• Subjects: Aged; Anticoagulants - adverse effects; Anticoagulants - therapeutic use; Antithrombins - administration & dosage; Antithrombins - adverse effects; Antithrombins - therapeutic use; Bivalirudin; Cardiac and Cardiovascular Systems; Clinical Medicine; Female; Hemorrhage - chemically induced; Heparin - administration & dosage; Heparin - adverse effects; Heparin - therapeutic use; Hirudins - administration & dosage; Hirudins - adverse effects; Humans; Kardiologi; Klinisk medicin; Male; Medical and Health Sciences; Medicin och hälsovetenskap; Middle Aged; Myocardial infarction; Non-ST Elevated Myocardial Infarction - diagnosis; Non-ST Elevated Myocardial Infarction - diagnostic imaging; Non-ST Elevated Myocardial Infarction - mortality; Non-ST Elevated Myocardial Infarction - therapy; PCI; Peptide Fragments - adverse effects; Peptide Fragments - therapeutic use; Percutaneous Coronary Intervention - adverse effects; Percutaneous Coronary Intervention - mortality; Recombinant Proteins - administration & dosage; Recombinant Proteins - adverse effects; Recombinant Proteins - therapeutic use; Registries; Risk Factors; ST Elevation Myocardial Infarction - diagnosis; ST Elevation Myocardial Infarction - mortality; ST Elevation Myocardial Infarction - therapy; Sweden; Time Factors; Treatment Outcome; Unfractionated heparin
• ISSN: 1553-8389; 1878-0938; 1878-0938
• DOI: 10.1016/j.carrev.2024.03.025

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. 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. 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. 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. •A large-scale trial involving 6006 MI patients compared the outcomes of bivalirudin and heparin.•Two-year outcomes show no significant difference in MI patients treated with bivalirudin vs. heparin.•Consistent results were observed in both STEMI and NSTEMI patient groups.•Long-term follow-up confirmed similar safety and efficacy profiles for both drugs.