The researchers think that switching to bivalirudin might conserve numerous thousands of lives each year.
Bivalirudin was discovered to be both safer and more efficient than heparin in the treatment of cardiovascular disease patients undergoing percutaneous coronary intervention.
Current research suggests that bivalirudin is a much safer and more reliable anticoagulant than heparin for dealing with clients with the most extreme type of heart attack who undergo urgent percutaneous coronary intervention (PCI), with a 31% reduction in the danger of mortality or significant bleeding.
These are the outcomes of a brand-new research study led by Mount Sinais Icahn School of Medicine scientists. This is the first large-scale medical trial to analyze the 2 anticoagulants frequently utilized after PCI, and it shows that bivalirudin provided with a two- to four-hour high-dose infusion dramatically reduces apoplexy, significant bleeding, and death when compared to heparin.
Dr. Stone along with Yaling Han, MD, Ph.D., of Shenyang Northern Hospital in Shenyang, China led a team of scientists to evaluate 6,106 patients enrolled in the research study across 87 sites in China in between February 2019 and April 2022. Investigators followed clients for 30 days following the treatment, the timeframe in which STEMI patients are at the highest danger for negative events. Scientists found that 4.4 percent of clients treated with heparin died or had a significant bleed within 30 days, compared to 3.1 percent of patients treated with bivalirudin. Overall, the bivalirudin group had a 31 percent decrease in the rate of death or major bleeding compared with clients in the heparin group– an extremely statistically considerable decrease.
They discovered that deaths were minimized from 3.9 percent in heparin-treated patients to 3.0 percent in bivalirudin-treated patients.
The outcomes were just recently announced in a Late Breaking Clinical Trial presentation at the American Heart Associations Scientific Sessions (AHA 22) in Chicago and were released in The Lancet. This research may have significant implications, modifying the treatment of hundreds of thousands of patients worldwide who suffer a significant obstruction in a heart artery, a condition called ST-segment elevation myocardial infarction, or STEMI. It is the most extreme type of heart attack.
Reduction in the danger of death or significant bleeding after primary PCI in patients with STEMI treated with heparin monotherapy (blue curve) or bivalirudin with a post-procedure infusion (red curve). The threat ratio of 0.69 symbolizes a 31% decrease in risk. The ARR (outright risk decrease) was 1.3%. The NNT (number of patients needed to deal with to prevent one death or big bleed) was 76. Credit: Mount Sinai Health System
” For the very first time, this research study determines the very best and safest treatment course for clients undergoing stenting to treat a STEMI heart attack,” says co-Principal Investigator Gregg W. Stone, MD, Director of Academic Affairs for the Mount Sinai Health System and Professor of Medicine (Cardiology), and Population Health Science and Policy, at Icahn Mount Sinai. “Compared with heparin, bivalirudin plus a brief infusion considerably improved the likelihood of making it through a STEMI and lowered the two most feared issues– major bleeding and stent apoplexy.”
Clients suffering STEMI heart attacks were included in the “BRIGHT-4” trial and got “primary PCI”– an emergency stenting treatment to maintain heart muscle function. Throughout this minimally intrusive operation, patients will need anticoagulant therapy to effectively open the obstructed heart artery and prevent future blood embolisms from establishing and activating another heart attack.
Bivalirudin is a more recent anticoagulant that has more predictable “blood thinning” effects. Heparin and bivalirudin have been compared in 6 prior big randomized trials in clients with STEMI, but in those research studies, they were administered with varying regimens and background treatments.
Dr. Stone along with Yaling Han, MD, Ph.D., of Shenyang Northern Hospital in Shenyang, China led a group of scientists to analyze 6,106 patients enrolled in the research study throughout 87 sites in China between February 2019 and April 2022. Clients were randomized to receive the 2 most commonly utilized regimens of heparin and bivalirudin, which prior research studies have shown to be the safest and most efficient.
Private investigators followed clients for 30 days following the treatment, the timeframe in which STEMI patients are at the highest danger for adverse events. Researchers found that 4.4 percent of patients treated with heparin passed away or had a major bleed within 30 days, compared to 3.1 percent of clients treated with bivalirudin.
They discovered that deaths were reduced from 3.9 percent in heparin-treated patients to 3.0 percent in bivalirudin-treated clients. Serious bleeding also was decreased from 0.8 percent in the heparin group to 0.2 percent in the bivalirudin group.
They likewise analyzed the rate of stent thrombosis– a problem that occurs when the vessel abruptly closes as the outcome of a blood embolisms that usually results in a 2nd heart attack or death. This was likewise lower in the bivalirudin group at 0.4 percent compared to 1.1 in the heparin group, again a statistically significant decrease.
” These results are remarkable,” Dr. Stone said. “The basic choice to utilize bivalirudin during primary PCI in clients with cardiac arrest, which is now generic and therefore affordable, can save hundreds of thousands of lives per year and prevent significant bleeding and stent apoplexy compared with heparin.”
Reference: “Bivalirudin plus a high-dose infusion versus heparin monotherapy in clients with ST-segment elevation myocardial infarction undergoing main percutaneous coronary intervention: a randomised trial” by Yi Li, MD, Zhenyang Liang, MD, Lei Qin, MD, Professor Mian Wang, MD, Xianzhao Wang, MD, Huanyi Zhang, MD, Yin Liu, MD, Professor Yan Li, MD, Zhisheng Jia, MD, Professor Limin Liu, MD, Professor Hongyan Zhang, MD, Jun Luo, MD, Songwu Dong, MD, Professor Jincheng Guo, MD, Hengqing Zhu, MD, Shengli Li, MD, Haijun Zheng, MD, Professor Lijun Liu, MD, Professor Yanqing Wu, MD, Professor Yiming Zhong, MD, Miaohan Qiu, MD, Professor Yaling Han, MD and Professor Gregg W Stone, MD, 6 November 2022, The Lancet.DOI: 10.1016/ S0140-6736( 22 )01999-7.
The BRIGHT-4 trial was an investigator-sponsored and organized trial. The trial was funded by the Chinese Society of Cardiology Foundation with a research grant from Jiangsu Hengrui Pharmaceuticals Co., Ltd