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.
Importantly, there were no significant differences in the 30-day rates of reinfarction, stroke, or ischemia-driven target vessel revascularisation between the two groups. However, stent thrombosis occurred in 0.37% of bivalirudin-assigned patients and 1.10% of heparin-assigned patients.
The findings of this trial suggest that bivalirudin with a post-PCI high-dose infusion may be a safer and more effective treatment option than heparin monotherapy for patients with STEMI undergoing primary PCI. This is especially important given the conflicting results of previous randomized trials examining the use of bivalirudin versus heparin in these patients.
BRIGHT-4 trial provides important evidence supporting the use of bivalirudin with a post-PCI high-dose infusion as a safe and effective treatment option for patients with STEMI undergoing primary PCI. It is important for healthcare providers to consider these findings when making treatment decisions for these patients.