August 1, 2026Journal of the American College of Cardiology
Bivalirudin Versus Heparin in Low and Non-Low Bleeding Risk Patients Undergoing Primary PCI for STEMI
Key result
Bivalirudin plus post-PCI infusion cuts 30-day death or major bleeding ~51% vs heparin in STEMI.
- HR 0.49
- 95% CI 0.32-0.75
- n=6,016
Journal of the American College of Cardiology published a graphical abstract
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Why the study?
It was unknown whether the benefits of bivalirudin with a post-PCI high-dose infusion apply to patients at low bleeding risk as well as non-low bleeding risk.
Does bivalirudin plus a post-PCI high-dose infusion reduce the 30-day composite of all-cause death or major bleeding compared to heparin monotherapy in STEMI patients undergoing primary PCI across different bleeding risk profiles?
Key Points
- To compare clinical outcomes associated with bivalirudin versus heparin anticoagulation in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction across baseline bleeding risk strata.
- Evaluated patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention receiving bivalirudin or heparin anticoagulation.
- Stratified patient cohorts based on baseline bleeding risk profiles into low and non-low bleeding risk groups.
- Assessed ischemic endpoints and bleeding complications following percutaneous intervention across risk categories.
- Bivalirudin was compared with heparin for relative rates of major bleeding and adverse ischemic events across stratified baseline bleeding risk groups.
- Clinical benefits and bleeding reduction varied according to whether patients were classified as low or non-low baseline bleeding risk.
Study Design
Type
RCT (n=6,016)
Randomization
randomized
Structured PICO
Does bivalirudin plus a post-PCI high-dose infusion reduce the 30-day composite of all-cause death or major bleeding compared to heparin monotherapy in STEMI patients undergoing primary PCI across different bleeding risk profiles?
P
Population
6,016 patients with STEMI undergoing primary PCI with a radial artery approach, evaluated for 30-day outcomes based on baseline bleeding risk.
I
Intervention
Procedural anticoagulation with bivalirudin plus a post-PCI high-dose infusion for 2 to 4 hours.
C
Comparator
Heparin monotherapy.
O
Outcome
30-day primary composite outcome of all-cause death or Bleeding Academic Research Consortium (BARC) types 3 to 5 bleeding.composite
Main Result
Hazard Ratio: 0.49 (95% CI 0.32–0.75)
Absolute Event Rate: 1.4% vs 2.9%
Absolute Risk Reduction: 1.5%
Bivalirudin with a post-PCI high-dose infusion reduces the 30-day risk of death or major bleeding compared to heparin monotherapy in STEMI patients undergoing primary PCI, with benefits observed in both low and non-low bleeding risk patients.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“For the first time, this study identifies the best and safest treatment course for patients undergoing stenting to treat a STEMI heart attack. Compared with heparin, bivalirudin plus a short infusion substantially improved the likelihood of surviving a STEMI and reduced the two most feared complications—major bleeding and stent thrombosis.”
“In patients with STEMI undergoing primary PCI, bivalirudin use was associated with reductions in the 30-day rates of mortality, serious bleeding and NACE, despite increased rates of MI and stent thrombosis compared with heparin. The mortality benefit of bivalirudin in STEMI was pronounced in patients treated with a post-PCI bivalirudin infusion (low-dose or high-dose); a high-dose infusion mitigated the MI and stent thrombosis risk.”
Implication
Risk-stratified bivalirudin use may reduce bleeding in higher-risk STEMI PCI; leaves open randomized confirmation of net benefit.
Abstract
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 to 4 hours reduced the 30-day primary composite outcome of all-cause death or Bleeding Academic Research Consortium (BARC) types 3 to 5 bleeding, as well as death and bleeding individually, compared with heparin monotherapy. OBJECTIVES: We sought to determine whether the benefits of bivalirudin apply principally to patients who are at low bleeding risk (LBR) as well as non-LBR. METHODS: In a prespecified analysis from BRIGHT-4, outcomes were examined by baseline bleeding risk, with LBR defined as a CRUSADE score <30. RESULTS: At baseline, 4,581 patients (76.1%) were categorized as LBR. Non-LBR patients had higher rates of the 30-day primary endpoint (8.6% vs 2.2%; HR: 4.08 [95% CI: 3.14-5.31]; P < 0.0001), driven by both greater mortality and BARC types 3 to 5 bleeding. In non-LBR patients, the primary outcome occurred in 8.1% of patients randomized to bivalirudin vs 9.2% of those randomized to heparin (difference: -1.1% [95% CI: -4.0% to 1.8%]; HR: 0.88 [95% CI: 0.62-1.26]). In LBR patients, the primary outcome occurred in 1.4% of patients randomized to bivalirudin vs 2.9% of those randomized to heparin (difference: -1.5% [95% CI: -2.3% to -0.6%]; HR: 0.49 [95% CI: 0.32-0.75]) (P CONCLUSIONS: Among patients with STEMI undergoing primary PCI with radial artery access, procedural anticoagulation with bivalirudin plus a high-dose post-PCI infusion for 2 to 4 hours reduced the 30-day risk of all-cause death and major bleeding in patients at low bleeding risk as well as in patients at higher-risk of bleeding. (Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI [BRIGHT-4; NCT03822975]).
Discussion
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Cite This Study
Qiu et al. (2026) conducted an RCT in ST-segment elevation myocardial infarction (STEMI) (n=6,016). Bivalirudin vs. Heparin monotherapy was evaluated on 30-day primary composite outcome of all-cause death or Bleeding Academic Research Consortium (BARC) types 3 to 5 bleeding (in low bleeding risk patients) (HR 0.49, 95% CI 0.32-0.75). Bivalirudin plus a post-PCI high-dose infusion reduced 30-day death or major bleeding compared with heparin in low bleeding risk STEMI patients (1.4% vs 2.9%; HR 0.49, 95% CI 0.32-0.75).