Bivalirudin versus heparin in high and low bleeding risk patients undergoing primary PCI for STEMI: pre-specified analysis from the BRIGHT-4 trial
Y Han, C Yan, H Song, Y Li, M Qiu, Z Liang, G StoneAbstract
Background
In the BRIGHT-4 trial, among 6,016 patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) with a radial artery approach, procedural anticoagulation with bivalirudin plus a post-PCI high-dose infusion for 2-4 hours reduced the 30-day primary composite outcome of all-cause death or BARC (Bleeding Academic Research Consortium) types 3-5 bleeding, as well as death and bleeding individually, compared with heparin monotherapy.
Purpose
Whether the benefits of bivalirudin apply principally to patients who are at high bleeding risk (HBR) is unknown.
Methods
In a pre-specified analysis from BRIGHT-4, outcomes were examined by baseline bleeding risk, with HBR defined as a CRUSADE score ≥30.
Results
HBR was present in 1,435 (23.9%) randomized patients. HBR patients had higher rates of the 30-day primary endpoint (8.6% vs. 2.2%; hazard ratio [HR] 4.08, 95% CI 3.14-5.31), driven both by greater mortality and BARC types 3-5 bleeding. In HBR patients, the primary outcome occurred in 8.1% of patients randomized to bivalirudin vs. 9.2% randomized to heparin (difference -1.1%, 95% CI -4.0% to 1.8%; HR 0.88, 95% CI 0.62-1.26). In non-HBR patients, the primary outcome occurred in 1.4% of patients randomized to bivalirudin vs. 2.9% randomized to heparin (difference -1.5%, 95% CI -2.3% to -0.6%; HR 0.49, 95% CI 0.32-0.75) (Pinteraction=0.04).
Conclusions
Among these patients, procedural anticoagulation with bivalirudin plus a high-dose post-PCI infusion for 2-4 hours reduced the 30-day primary composite outcome and all-cause death compared with heparin monotherapy at least as strongly in non-HBR patients as in HBR patients.Central Illustration