Clinical trials are an important tool used in medical research to evaluate the safety and effectiveness of new treatments. A clinical trial, called BRIGHT-4, examined the use of bivalirudin versus heparin in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The results of this trial showed that bivalirudin, when given with a post-PCI high-dose infusion, was more effective at reducing the risk of major bleeding and all-cause mortality compared to heparin alone.
Bivalirudin is a type of anticoagulant medication that is used in patients with certain heart conditions, specifically those undergoing a procedure called percutaneous coronary intervention (PCI). It works by preventing blood clots from forming during the procedure, reducing the risk of complications such as heart attack or stroke.
BRIGHT-4 was conducted at 87 clinical centers in 63 cities and included a total of 6,016 patients with STEMI undergoing primary PCI. Patients were randomly assigned to receive either bivalirudin with a post-PCI high-dose infusion or unfractionated heparin monotherapy. The primary endpoint of the trial was a composite of all-cause mortality or Bleeding Academic Research Consortium (BARC) types 3–5 bleeding at 30 days.
The results of the trial showed that bivalirudin with a post-PCI high-dose infusion significantly reduced the 30-day composite rate of all-cause mortality or BARC types 3–5 major bleeding compared to heparin monotherapy. Specifically, the 30-day rate of the primary endpoint was 4.39% in the heparin group versus 3.06% in the bivalirudin group. Additionally, all-cause mortality within 30 days occurred in 3.92% of heparin-assigned patients and 2.96% of bivalirudin-assigned patients, and BARC types 3–5 bleeding occurred in 0.80% of heparin-assigned patients and 0.17% of bivalirudin-assigned patients.