For heart attack patients undergoing procedure such as stent placement, anticoagulant bivalirudin may improve outcomes compared to heparin

Among patients who experienced a heart attack and underwent a percutaneous coronary intervention (PCI; a procedure used to open narrowed coronary arteries, such as stent placement), the use of the anticoagulant bivalirudin following the procedure resulted in a decrease in adverse clinical events, primarily due to a reduction in bleeding events, compared with heparin alone or heparin plus the antiplatelet agent tirofiban, according to a study appearing in JAMA.

Antithrombotic therapy is essential to prevent adverse ischemic events, especially stent thrombosis (formation of a blood clot) and the occurrence of a subsequent heart attack during and after primary PCI in patients who had a heart attack (acute myocardial infarction; AMI). The benefits of antithrombotic (anticlotting) agents must be weighed against their risk of hemorrhagic (bleeding) complications, which have been associated with subsequent death. Anticoagulation during primary PCI is most commonly achieved with heparin or with bivalirudin. Because of mixed results in trials involving these drugs, the safety and efficacy of bivalirudin in patients with AMI undergoing PCI is still uncertain, especially compared with heparin alone, according to background information in the article.

Yaling Han, M.D., Ph.D., of the General Hospital of Shenyang Military Region, Shenyang Liaoning Province, China, and colleagues randomly assigned 2,194 patients with AMI undergoing primary PCI at 82 centers in China to receive bivalirudin with a post-PCI infusion (n = 735), heparin alone (n = 729), or heparin plus tirofiban with a post-PCI infusion (n = 730).

Net adverse clinical events at 30 days (a composite of major adverse cardiac or cerebral events [all-cause death, subsequent heart attack, ischemia-driven target vessel revascularization, or stroke] or bleeding) occurred in 8.8 percent of patients treated with bivalirudin, compared with 13.2 percent of patients treated with heparin, and 17 percent of patients treated with heparin plus tirofiban.

Bleeding at 30 days was reduced by bivalirudin compared with heparin and heparin plus tirofiban (4.1 percent vs 7.5 percent vs 12.3 percent, respectively). Bivalirudin also reduced bleeding requiring medical intervention.

There were no statistically significant differences between treatments in the 30-day rates of major adverse cardiac or cerebral events, stent thrombosis, acquired thrombocytopenia (decrease in platelets in the blood), or in acute (<24-hour) stent thrombosis. At the 1-year follow-up, the results remained similar.

"In this multicenter randomized trial [the BRIGHT trial], by reducing bleeding with comparable rates of major adverse cardiac or cerebral events and stent thrombosis, bivalirudin significantly reduced 30-day and 1-year rates of net adverse clinical events compared with both heparin alone and heparin plus tirofiban in patients with AMI undergoing primary PCI. The reduction in net adverse clinical events was consistent across multiple subgroups," the authors write.

Editorial: Can BRIGHT Restore The Glow of Bivalirudin?

Patients undergoing PCI should have a tailored approach with regards to their antithrombotic regimen, write Matthew A. Cavender, M.D., M.P.H., and David P. Faxon, M.D., of Brigham and Women's Hospital, Harvard Medical School, Boston, in an accompanying editorial.

"Patients in whom the risk of bleeding is high such as women, patients with renal dysfunction, or patients for whom femoral access is needed may benefit from an antithrombotic regimen that decreases the risk of bleeding. In contrast, patients at high risk of thrombotic complications may benefit from regimens that reduce the risk of thrombosis while conceding that the risk of bleeding may increase. Understanding how to optimize outcomes for each individual patient remains the ultimate goal - a goal that is only achieved with the help of more studies like BRIGHT."