Key result
Bivalirudin cuts 30-day death or major bleeding ~51% vs heparin in non-HBR patients.
Why the study?
In the BRIGHT-4 trial, procedural bivalirudin plus a post-PCI high-dose infusion reduced 30-day death or BARC types 3-5 bleeding compared with heparin monotherapy in STEMI patients undergoing radial primary PCI. Whether the benefits of bivalirudin apply principally to patients at high bleeding risk was unknown.
Does procedural anticoagulation with bivalirudin plus a post-PCI high-dose infusion for 2-4 hours reduce the 30-day composite of all-cause death or BARC types 3-5 bleeding compared with heparin monotherapy differently in high bleeding risk versus non-high bleeding risk patients with STEMI undergoing radial primary PCI?
RCT (n=6,016)
Randomized
Does procedural anticoagulation with bivalirudin plus a post-PCI high-dose infusion for 2-4 hours reduce the 30-day composite of all-cause death or BARC types 3-5 bleeding compared with heparin monotherapy differently in high bleeding risk versus non-high bleeding risk patients with STEMI undergoing radial primary PCI?
Procedural anticoagulation with bivalirudin plus a 2-4 hour high-dose post-PCI infusion reduced 30-day all-cause death or major bleeding compared with heparin monotherapy at least as strongly in non-high bleeding risk patients as in high bleeding risk patients undergoing radial primary PCI for STEMI.
Greater bivalirudin benefit in non-HBR patients supports targeted use; extends BRIGHT-4 by showing bleeding risk modifies anticoagulation effect in STEMI PCI.
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.
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Han et al. (2026) conducted an RCT in ST-segment elevation myocardial infarction (STEMI) (n=6,016). Bivalirudin plus post-PCI high-dose infusion vs. Heparin monotherapy was evaluated on 30-day composite of all-cause death or BARC types 3-5 bleeding (in HBR subgroup) (HR 0.88, 95% CI 0.62-1.26, p=0.04 for interaction). Bivalirudin vs heparin reduced 30-day death or BARC 3-5 bleeding more strongly in non-HBR (1.4% vs 2.9%; HR 0.49, 95% CI 0.32-0.75) than HBR patients (8.1% vs 9.2%; HR 0.88; Pinteraction=0.04).
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