FROMLINE: Written by: Jacqueline Mitchell
Newswise – BOSTON – In the largest randomized clinical trial and first of its kind in the United States to date, a team led by researchers at Beth Israel Deaconess Medical Center (BIDMC) evaluated the effectiveness and safety of using a drug-eluting balloon in patients undergoing coronary angioplasty. In an original research presented at the Cardiology Research Technology conference in Washington, DC and published concurrently JAMAThe team reports that patients treated with a balloon coated with paclitaxel, a drug used to prevent restenosis, experienced lower failure rates compared to patients treated with an uncoated balloon.
The results of the study, designed and conducted in consultation with the U.S. Food and Drug Administration (FDA) and sponsored by Boston Scientific Corp. funded suggest that the drug-coated balloon offers an effective treatment strategy for the treatment of heart attacks. Stent restenosis or recurrent blockages within previously placed stents. On March 1, the FDA approved the paclitaxel-coated balloon, which was evaluated by the BIDMC-led team. It is the first balloon of its kind approved in the United States for the treatment of coronary disease.
“Drug-coated balloons have emerged internationally as an alternative treatment option, but despite promising international data, they have not yet been evaluated or approved for use in the United States,” said lead researcher Robert W. Yeh, MD, MSc, MBA, director of the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology and Head of Department of Interventional Cardiology at BIDMC. “Even with advances in stent technology, patients with coronary in-stent restenosis continue to account for approximately 10 percent of individuals undergoing angioplasty each year. In particular, patients with multiple previous stents have very poor long-term outcomes. There is growing opinion that drug-coated balloons may address an unmet clinical need in patients with coronary artery disease in the United States.”
Every year, millions of people around the world undergo coronary angioplasty, a non-surgical procedure to treat blockages in the arteries that supply blood to the heart. In a variation of the procedure known as balloon angioplasty, a deflated balloon attached to a catheter is inserted into a narrowed artery. Once the balloon is positioned, it is inflated, opening the narrowed blood vessel and restoring blood flow to the heart. While balloon angioplasty is very effective, in-stent restenosis – a re-narrowing of the treated artery and a recurrence of symptoms requiring additional repair – occurs within a year of the procedure.
The multicenter, randomized trial called AGENT IDE included participants with in-stent restenosis, all of whom had high rates of coronary risk factors; more than half had diabetes and nearly 80 percent previously had two or more large coronary arteries that were partially or completely blocked. Of the 600 participants, 406 were randomly assigned to receive the paclitaxel-coated balloon catheter and 194 received an uncoated balloon catheter. Clinical follow-up was conducted in the hospital at 30 days, six months and 12 months after the procedure and will continue for five years.
Participants were monitored for three primary endpoints: a relapse requiring revascularization or another procedure to restore blood flow to the blocked artery; myocardial infarction or heart attack caused by lack of blood flow to the heart; and sudden cardiac death.
After a year, Yeh and colleagues showed that the drug-coated balloon was superior to an uncoated balloon in the likelihood of patients experiencing one or more of these endpoints. Eighteen percent of participants in the experimental group experienced one or more of the primary endpoints, compared to 29 percent in the control group. Likewise, those who received the drug-coated balloon were statistically significantly less likely to experience revascularization (13 percent versus 25 percent) or myocardial infarction (6 percent versus 11) than those who received an uncoated balloon. The scientists saw no statistically significant difference in the rate of cardiac death between the two groups (3 percent versus 1.6 percent).
“The participants in this study represented a population of patients at very high risk for recurrent restenosis,” said Yeh, who is also the Katz Silver Family Professor of Medicine in Outcomes Research in Cardiology at Harvard Medical School. “More than 40 percent of participants had previously had multiple stents. Nevertheless, treatment with the drug-coated balloon resulted in a consistent relative risk reduction and a numerically greater absolute risk reduction in events. A drug-eluting balloon may be particularly useful when additional stenting would result in three or more stent layers, which would limit future therapeutic options.”
Co-authors included Richard Schlofmiz, MD, of Saint Francis Hospital; Jeffrey Moses, MD, and Ajay J. Kirtane, MD, SM, of Columbia University Irving Medical Center/New York Presbyterian Hospital and the Cardiocular Research Foundation; William Bachinsky, MD, of the University of Pittsburgh Medical Center; Suhail Dohad, MD, of Cedars Sinai Medical Center; Steven Rudick, MD, of the Lindner Center for Research and Education at Christ Hospital; Robert Stoler, MD, at Baylor Scott & White Heart and Vascular Hospital; Brian K. Jefferson, MD, at HCA Tristar Centennial Medical Center; William Nicholson, MD, at Emory University Hospital; John Altman, MD, at Saint Anthony Hospital; Cinthia Bateman, MD, of South Denver Cardiology; Amar Krishnaswamy, MD, of the Cleveland Clinic Foundation; J. Aaron Grantham, MD, at Saint Lukes Hospital in Kansas City; Frank J. Zidar, MD, at Austin Hart; Steven P. Marso, MD, at Overland Park Regional Medical Center; Jennifer A. Tremmel, MD, MS, at Stanford University Medical Center; Cindy Grines of Northside Hospital Cardiocular Institute; Mustafa I. Ahmed, MD, at the University of Alabama at Birmingham; Azeem Latib, MD, at Montefiore Medical Center Albert Einstein College of Medicine; Benham Tehrani, MD, and Wayne Batchelor, MD, at the Innova Schar Heart and Vascular Institute; J. Dawn Abbott, MD, at Lifespan Cardiovascular Institute, Rhode Island Hospital; Paul Underwood, MD, and Dominic J. Allocco, MD, Boston Scientific Corporation. This study was sponsored by Boston Scientific Corp. supports. Quantitative coronary angiography was performed by the Baim Institute for Clinical Research, Inc., an independent angiography core laboratory.
Yeh reported receiving personal fees and grants from Boston Scientific during the conduct of this study; and grants and personal fees from Boston Scientific, Abbott, Vascular, and Medtronic, and personal fees from the U.S. Food and Drug Administration, Elixir Medical, Shockwave Medical, and Infrared X outside the submitted work. Please see… publication A complete list of conflict of interest disclosures can be found here.
About BIDMC
Beth Israel Deaconess Medical Center is a leading academic medical center where exceptional care is supported by quality education and research. BIDMC is a teaching institution of Harvard Medical School and consistently ranks among the nation’s top independent hospitals in funding from the National Institutes of Health. BIDMC is the official hospital of the Boston Red Sox.
Beth Israel Deaconess Medical Center is part of Beth Israel Lahey Health, a health system that brings together academic medical centers and teaching hospitals, community and specialty hospitals, more than 4,800 physicians and 38,000 employees in a shared mission to improve access to great care and advance the science and practice of medicine through groundbreaking research and education.
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