Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction-Outcomes at two years.
Cardiovasc Revasc Med
; 66: 43-50, 2024 Sep.
Article
em En
| MEDLINE
| ID: mdl-38575449
ABSTRACT
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Fragmentos de Peptídeos
/
Proteínas Recombinantes
/
Heparina
/
Sistema de Registros
/
Antitrombinas
/
Hirudinas
/
Intervenção Coronária Percutânea
/
Infarto do Miocárdio sem Supradesnível do Segmento ST
/
Infarto do Miocárdio com Supradesnível do Segmento ST
/
Hemorragia
País/Região como assunto:
Europa
Idioma:
En
Revista:
Cardiovasc Revasc Med
Assunto da revista:
ANGIOLOGIA
/
CARDIOLOGIA
Ano de publicação:
2024
Tipo de documento:
Article