Key result
Bivalirudin shows no benefit over heparin for death, MI, or major bleeding during primary PCI.
Why the study?
Does bivalirudin reduce the composite of all-cause death, MI, or major bleeding in patients with ST-segment-elevation MI undergoing primary percutaneous coronary intervention compared to heparin?
RCT (n=3,005)
Yes
Does bivalirudin reduce the composite of all-cause death, MI, or major bleeding in patients with ST-segment-elevation MI undergoing primary percutaneous coronary intervention compared to heparin?
In patients with STEMI undergoing primary PCI with modern antiplatelet therapy and radial access, bivalirudin was not superior to heparin in reducing the composite of death, MI, or major bleeding.
Answers are grounded in this paper and cite their sources.
Bivalirudin not superior to heparin in MI PCI without planned GPI; challenges routine bivalirudin preference and extends evidence to radial/potent P2Y12 era.
Background: Bivalirudin was not superior to unfractionated heparin in patients with myocardial infarction (MI) treated with percutaneous coronary intervention and no planned use of GPI (glycoprotein IIb/IIIa inhibitors) in contemporary clinical practice of radial access and potent P2Y 12 -inhibitors in the VALIDATE-SWEDEHEART randomized clinical trial (Bivalirudin Versus Heparin in STEMI and NSTEMI Patients on Modern Antiplatelet Therapy–Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies Registry). Methods: In this prespecified separately powered subgroup analysis, we included patients with ST-segment–elevation MI undergoing primary percutaneous coronary intervention with the primary composite end point of all-cause death, MI, or major bleeding event within 180 days. Results: Among the 6006 patients enrolled in the trial, 3005 patients with ST-segment–elevation MI were randomized to receive bivalirudin or heparin. The mean age was 66.8 years. According to protocol recommendations, 87% were treated with potent oral P2Y 12 -inhibitors before start of angiography and radial access was used in 90%. GPI was used in 51 (3.4%) and 74 (4.9%) of patients randomized to receive bivalirudin and heparin, respectively. The primary end point occurred in 12.5% (187 of 1501) and 13.0% (196 of 1504; hazard ratio [HR], 0.95 [95% CI, 0.78–1.17], P =0.64) with consistent results in all major subgroups. All-cause death occurred in 3.9% versus 3.9% (HR, 1.00 [0.70–1.45], P =0.98), MI in 1.7% versus 2.2% (HR, 0.76 [0.45–1.28], P =0.30), major bleeding in 8.3% versus 8.0% (HR, 1.04 [0.81–1.33], P =0.78), and definite stent thrombosis in 0.5% versus 1.3% (HR, 0.42 [0.18–0.96], P =0.04). Conclusions: In patients with ST-segment–elevation MI undergoing primary percutaneous coronary intervention with radial access and receiving current recommended treatments with potent P2Y 12 -inhibitors rate of the composite of all-cause death, MI, or major bleeding was not lower in those randomized to receive bivalirudin as compared with heparin. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02311231.
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A 2021 study conducted an RCT in ST-segment-elevation myocardial infarction (n=3,005). Bivalirudin vs. Heparin was evaluated on composite of all-cause death, MI, or major bleeding event within 180 days (HR 0.95, 95% CI 0.78-1.17, p=0.64). Bivalirudin did not lower the rate of all-cause death, MI, or major bleeding compared with heparin in patients with STEMI undergoing primary PCI (12.5% vs 13.0%; HR 0.95; 95% CI 0.78-1.17; P=0.64).
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