Researchers have found that bivalirudin is a safer and more effective anticoagulant than heparin for treating percutaneous coronary intervention patients.
The researchers found that heart attack patients who underwent urgent percutaneous coronary intervention had a 31% lower risk of death or major bleeding if they were treated with bivalirudin. Bivalirudin also led to a lower risk of thrombosis.
These findings are from a new study led by the Icahn School of Medicine at Mount Sinai. It is the first large-scale clinical trial to compare bivalirudin and heparin, which are the most widely used anticoagulants after urgent percutaneous coronary intervention.
The results have been published in The Lancet.
The findings could save thousands of lives
The findings could have broad implications for heart attack treatment courses, affecting hundreds of thousands of patients across the world. These medications are used in patients who have had a major heart artery blockage, a condition known as ST-segment elevation myocardial infarction or STEMI. This is the most serious kind of heart attack.
“For the first time, this study identifies the best and safest treatment course for patients undergoing stenting to treat a STEMI heart attack,” said co-principal investigator Gregg Stone, MD, Professor of Medicine at Icahn Mount Sinai.
“Compared with heparin, bivalirudin plus a short infusion substantially improved the likelihood of surviving a STEMI and reduced the two most feared complications—major bleeding and stent thrombosis.”
Percutaneous coronary intervention can lead to dangerous blood clots
The trial examined patients with STEMI heart attacks who underwent “primary percutaneous coronary intervention”. This is an emergency stenting procedure to preserve heart muscle function. Patients require anticoagulant therapy during the procedure to successfully open the blocked heart arteries. The drugs also prevent blood clots from forming, preventing another heart attack.
Heparin is the most common anticoagulant used after percutaneous coronary intervention. However, heparin can be unpredictable and can lead to bleeding and blood clots. Bivalirudin has more predictable blood thinning effects.
The researchers to analysed 6,106 patients in the study across 87 sites in China between February 2019 and April 2022. All the patients underwent primary percutaneous coronary intervention. The patients were randomly assigned either heparin or bivalirudin.
The researchers followed the patients for 30 days following the procedure, the timeframe in which STEMI patients are at the highest risk of adverse effects. They found that 4.4% of patients treated with heparin died or had a major bleed within 30 days, compared to 3.1% of patients treated with bivalirudin. Overall, the bivalirudin group had a 31% reduction in the rate of death or major bleeding compared with patients in the heparin group.
The researchers then examined specific incidences of death alone and major bleeding alone between the groups. Deaths were reduced from 3.9% in heparin-treated patients compared to 3% in bivalirudin-treated patients. Severe bleeding was reduced from 0.8% in the heparin group to 0.2% in the bivalirudin group. Rates of stent thrombosis were also analysed. This was also lower in the bivalirudin group at 0.4% compared to 1.1% in the heparin group.
“These results are dramatic. The simple decision to use bivalirudin during primary percutaneous coronary intervention in patients with heart attacks, which is now generic and thus inexpensive, can save hundreds of thousands of lives per year and prevent major bleeding and stent thrombosis compared with heparin,” said Dr Stone