Bivalirudin is a safer and more effective anticoagulant than heparin for the treatment of patients with the most severe type of heart attack undergoing urgent percutaneous coronary intervention (PCI), and it can reduce the risk of death or severe bleeding by 31%.
These are the results of a new study led by researchers from the Icahn School of Medicine at Mount Sinai. This is the first large-scale clinical trial to compare the most widely used anticoagulant after CPI, and shows that administration of bivalirudin at a high dose of two to four hours significantly reduces death, heavy bleeding and thrombosis when compared to heparin.
The results were announced Sunday, November 6, in a presentation of the delayed clinical trial at the American Heart Association (AHA 22) Scientific Sessions in Chicago, and are published in scalpel; This work could have wide-ranging implications, changing the course of treatment for hundreds of thousands of patients around the world who have a large blockage of the heart artery, a condition known as ST-segment elevation myocardial infarction, or STEMI. It is the most dangerous type of heart attack.
“For the first time, this study identifies the best and safest course of treatment for patients undergoing stenting to treat a heart attack STEMI,” says co-principal investigator Greg W. Stone, MD, director of academic affairs for Mount Sinai Health System. Professor of Medicine (cardiology) and Population Health Science and Policy at Icahn Mount Sinai. “Compared with heparin, bivalirudin plus a short infusion significantly improved the likelihood of surviving ST-segment elevation myocardial infarction and reduced the two most terrifying complications – severe bleeding and stent thrombosis.”
In the BRIGHT-4 trial, patients with a heart attack caused by a myocardial infarction underwent STEMI – a “primary PCI” – an emergency stenting procedure to preserve heart muscle function. Patients need anticoagulant therapy during this minimally invasive procedure to successfully open a blocked cardiac artery and prevent future blood clots from forming and causing another heart attack.
The most common anticoagulant used during primary coronary intervention is heparin. However, its effects can be somewhat unpredictable, resulting in higher than desirable rates of bleeding and blood clots. Bivalirudin is a newer anticoagulant with predictable ‘blood-thinning’ effects. Heparin and bivalirudin have been compared in six previous large randomized trials in STEMI patients, but in those studies, they were given different regimens and base therapies. This new research evaluates the two most widely used regimens of heparin and bivalirudin, which have not been directly compared with each other in a suitable-sized trial.
Dr. Stone with Yaling Han, MD, PhD at North Shenyang Hospital in Shenyang, China led a team of researchers to analyze 6106 patients enrolled in the study across 87 sites in China between February 2019 and April 2022. All of them underwent initial PCI for the treatment of myocardial infarction. Caused by ST segment elevation, in almost all cases a procedure is performed that uses the radial artery at the wrist to target the blocked heart artery. Patients were randomized to receive the most frequently used regimens of heparin and bivaludine, which previous studies have shown to be the safest and most effective. One group received heparin alone, and it was administered intravenously. The other group received bivalirudin intravenously, followed by a high-dose intravenous infusion two to four hours after the procedure.
Investigators followed patients for 30 days after the procedure, which is the time frame in which ST-segment elevation myocardial infarction patients are most at risk of adverse events. The primary objective of the study was to compare the incidence of all-cause mortality or the incidence of major bleeding. The researchers found that 4.4 percent of patients treated with heparin died or had severe bleeding within 30 days, compared with 3.1 percent of patients treated with bivalirudin. Overall, the bivalirudin group had a 31 percent reduction in mortality or heavy bleeding compared to patients in the heparin group—a statistically significant reduction.
The researchers then looked at the specific incidence of death alone and major bleeding alone between the groups. They found that deaths decreased from 3.9 percent in patients treated with heparin to 3.0 percent in patients treated with biviludine. Severe bleeding also decreased from 0.8% in the heparin group to 0.2% in the bivalirudin group. Both of these differences were statistically significant.
They also analyzed the rate of blood clotting in the stent – a complication that occurs when a blood vessel suddenly closes due to a blood clot that usually leads to a second heart attack or death. This was also 0.4 percent lower in the bivalirudin group compared to 1.1 in the heparin group, again a statistically significant decrease.
“These results are tragic,” said Dr. Stone. “The simple decision to use bivalirudin during primary coronary intervention in patients with heart attacks, which is now generic and therefore inexpensive, could save hundreds of thousands of lives annually and prevent significant bleeding and stent thrombosis compared to heparin.”
The Bright-4 trial was an investigator sponsored and organized trial. The trial was funded by the China Society of Cardiology Foundation (CSCF2019A01) with a research grant from Jiangsu Hengrui Pharmaceuticals Co., Ltd.
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Randomized controlled/clinical trial
Bivalirudin plus high-dose infusion versus heparin monotherapy in patients with ST-section elevation myocardial infarction undergoing primary percutaneous coronary intervention: a randomized trial.
The date the article was published
November 6, 2022
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