Bivalirudin not superior to heparin in STEMI patients undergoing PCI: Circulation
Sweden: A recent study showed no benefit of Bivalirudin versus heparin in patients with STEMI undergoing primary percutaneous coronary intervention (PCI) with radial access and currently recommended treatments. The rate of the composite of all-cause death, myocardial infarction (MI), or major bleeding was not lower in those who received bivalirudin compared with heparin. The results of the study were published in the journal Circulation: Cardiovascular Interventions.
Previously, 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), bivalirudin was not found to be superior to unfractionated heparin in patients with MI treated with PCI and no planned use of GPI (glycoprotein IIb/IIIa inhibitors) in contemporary clinical practice of radial access and potent P2Y12-inhibitors.
Stefan James, Department of Medical Sciences (S.J., G.S.), Uppsala University, Sweden, and colleagues included patients with ST-segment–elevation MI (STEMI) undergoing PCI in this recently conducted prespecified separately powered subgroup analysis of the VALIDATE-SWEDEHEART trial. The primary composite endpoint of all-cause death, MI, or major bleeding event within 180 days.
Out of 6006 patients enrolled in the trial, 305 patients with STEMI were randomized to receive bivalirudin or heparin. The mean age was 66.8 years.
Based on the study, the researchers found the following:
- According to protocol recommendations, 87% were treated with potent oral P2Y12-inhibitors before the 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) with consistent results in all major subgroups.
- All-cause death occurred in 3.9% versus 3.9% (HR, 1.00), MI in 1.7% versus 2.2% (HR, 0.76), major bleeding in 8.3% versus 8.0% (HR, 1.04), and definite stent thrombosis in 0.5% versus 1.3% (HR, 0.42).
"In this subgroup analysis of the VALIDATE-SWEDEHEART trial, no incremental benefit of bivalirudin over heparin in patients undergoing PCI for MI," wrote the authors. "There was no difference in major adverse cardiac events or bleeding."
Reference:
The study titled, "Bivalirudin Versus Heparin Monotherapy in ST-Segment–Elevation Myocardial Infarction," was published in the journal Circulation: Cardiovascular Interventions.
