Bivalirudin during Primary PCI in Acute Myocardial Infarction

TLDR

Bivalirudin, a direct thrombin inhibitor, offers similar ischemia suppression to heparin plus glycoprotein IIb/IIIa inhibitors while reducing hemorrhagic complications in patients with stable angina and NSTEMI undergoing PCI. This study aimed to determine the safety and efficacy of bivalirudin alone versus heparin plus glycoprotein IIb/IIIa inhibitors in high‑risk patients with ST‑segment elevation myocardial infarction undergoing primary PCI. A randomized trial of 3,602 STEMI patients within 12 hours of symptom onset compared the two anticoagulation strategies, with primary endpoints of major bleeding and net adverse clinical events assessed at 30 days. Bivalirudin alone lowered 30‑day net adverse clinical events (9.2% vs 12.1%) and major bleeding (4.9% vs 8.3%), reduced cardiac and all‑cause mortality, but increased early stent thrombosis within 24 hours without a 30‑day rise. ClinicalTrials.gov identifier NCT00433966.

Abstract

Treatment with the direct thrombin inhibitor bivalirudin, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, results in similar suppression of ischemia while reducing hemorrhagic complications in patients with stable angina and non-ST-segment elevation acute coronary syndromes who are undergoing percutaneous coronary intervention (PCI). The safety and efficacy of bivalirudin in high-risk patients are unknown.We randomly assigned 3602 patients with ST-segment elevation myocardial infarction who presented within 12 hours after the onset of symptoms and who were undergoing primary PCI to treatment with heparin plus a glycoprotein IIb/IIIa inhibitor or to treatment with bivalirudin alone. The two primary end points of the study were major bleeding and combined adverse clinical events, defined as the combination of major bleeding or major adverse cardiovascular events, including death, reinfarction, target-vessel revascularization for ischemia, and stroke (hereinafter referred to as net adverse clinical events) within 30 days.Anticoagulation with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, resulted in a reduced 30-day rate of net adverse clinical events (9.2% vs. 12.1%; relative risk, 0.76; 95% confidence interval [CI] 0.63 to 0.92; P=0.005), owing to a lower rate of major bleeding (4.9% vs. 8.3%; relative risk, 0.60; 95% CI, 0.46 to 0.77; P<0.001). There was an increased risk of acute stent thrombosis within 24 hours in the bivalirudin group, but no significant increase was present by 30 days. Treatment with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, resulted in significantly lower 30-day rates of death from cardiac causes (1.8% vs. 2.9%; relative risk, 0.62; 95% CI, 0.40 to 0.95; P=0.03) and death from all causes (2.1% vs. 3.1%; relative risk, 0.66; 95% CI, 0.44 to 1.00; P=0.047).In patients with ST-segment elevation myocardial infarction who are undergoing primary PCI, anticoagulation with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, results in significantly reduced 30-day rates of major bleeding and net adverse clinical events. (ClinicalTrials.gov number, NCT00433966 [ClinicalTrials.gov]. ).