A new and experimental anti-clotting drug, cangrelor, proved better than the commonly used clopidogrel and was significantly more effective at preventing blood clots in a large trial of patients who underwent coronary stent procedures. These data, from the phase III CHAMPION PHOENIX study, were presented at the American College of Cardiology's 62nd Annual Scientific Session and published simultaneously in the New England Journal of Medicine.
Researchers report that the new drug, which is administered intravenously, reduced the odds of complications from stenting procedures. Specifically, those who received cangrelor had a lower combined incidence of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 hours after randomization.
"We are very excited about the potential for this new medication to reduce complications in patients receiving coronary stents for a wide variety of indications. In addition to being much quicker to take effect and more potent than currently available treatment options, this intravenous drug is reversible and has a fast offset of action, which could be an advantage if emergency surgery is needed." said Deepak L. Bhatt, MD, MPH, lead author of the study, director of the Integrated Interventional Cardiovascular Program at Brigham and Women's Hospital (BWH) and chief of cardiology at VA Boston Healthcare System, as well as professor of medicine at Harvard Medical School.
In this randomized double-blind trial, researchers compared the novel IV drug cangrelor against the oral clopidogrel standard of care in approximately 11,000 patients at 153 centers around the world. The study included a wide selection of patients with different types of heart attack, angina, and other conditions for which people undergo percutaneous coronary intervention (PCI), as long as they did not have high risk for bleeding or recent exposure to other anti-clotting drugs.
Researchers report significantly better performance by cangrelor compared with clopidogrel:
- A 22 percent reduction in the odds of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 hours after randomization: 4.7 percent vs. 5.9 percent
- A 38 percent reduction in the odds of stent thrombosis at 48 hours: 0.8 percent vs. 1.4 percent
- Both treatment arms showed a quite low, statistically comparable incidence in severe bleeding at 48 hours: 0.16 percent vs. 0.11 percent.
Coronary artery stents are used in the majority of patients who undergo percutaneous coronary intervention (PCI), a common medical procedure used to treat arteries in the heart that have become narrowed or blocked due to coronary artery disease, which affects an estimated 14 million Americans. During this procedure, patients are regularly given oral doses of an anti-clotting agent to prevent blood clotting. Both cangrelor and clopidogrel interfere with the P2Y12 receptor, a platelet-surface protein that helps regulate blood clotting.
"We are encouraged by these compelling results, especially as it relates to the safety data, and believe that this drug has the potential to offer dramatic benefits to our patients" said Robert A. Harrington, M.D., chairman of medicine at Stanford University School of Medicine and co-chair of the study.
The company plans to file for approval with the Food and Drug Administration using data from CHAMPION PHOENIX and the earlier BRIDGE trial.
The Medicines Company sponsored the CHAMPION PHOENIX trial and provided a research grant to the Duke Clinical Research Institute for the statistical analyses and event adjudication. Both Bhatt and Harrington reported receiving institutional grants from The Medicines Company. Harrington reported receiving grants and travel support to attend meetings for the trial from the company.
Brigham and Women's Hospital (BWH) is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. BWH has more than 3.5 million annual patient visits, is the largest birthing center in New England and employs more than 15,000 people. The Brigham's medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in patient care, quality improvement and patient safety initiatives, and its dedication to research, innovation, community engagement and educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving nearly 1,000 physician-investigators and renowned biomedical scientists and faculty supported by $640 million in funding. For the last 19 years, BWH ranked second in research funding from the National Institutes of Health (NIH) among independent hospitals. BWH continually pushes the boundaries of medicine, including building on its legacy in organ transplantation by performing the first face transplants in the U.S. in 2011. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies, OurGenes and the Women's Health Initiative. For more information and resources, please visit BWH's online newsroom.
Journal
New England Journal of Medicine