New Drug-Eluting Balloon May Be as Safe and Effective as Conventional Metal Stents for Repeat Percutaneous Coronary Interventions
Trial led by Mount Sinai researcher could lead to safer and easier treatment for patients with coronary in-stent restenosis
A new drug-eluting balloon can perform just as well as the standard treatment for patients with coronary in-stent restenosis (ISR) undergoing repeated percutaneous coronary intervention (PCI). These breakthrough findings of an international clinical trial led by a Mount Sinai researcher could transform the way this patient population is treated.
This is the first U.S.-regulated, and largest randomized, trial to compare a balloon coated with the drug sirolimus against the current standard of care for ISR, which includes both repeat stenting and balloon angioplasty. It could lead to a safer and simpler alternative for patients who need repeat PCI.
Significant results from the “SELUTION4ISR Trial” were presented during a Late Breaking Clinical Trial session at the Transcatheter Cardiovascular Therapeutics conference in San Francisco on October 26.
“For the first time, we’ve shown that a sirolimus-eluting balloon can match the outcomes of standard care for in-stent restenosis while avoiding yet another metal layer. This opens the door to treating restenosis in a simpler, safer way,” says co-Principal Investigator Roxana Mehran, MD, Director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Wiener Cardiovascular Institute at the Icahn School of Medicine at Mount Sinai. “This study represents an important advance in how we manage restenosis. Patients with multiple stent layers have long faced limited options. A drug-eluting balloon that performs as well as a new stent could be a true paradigm shift.”
ISR occurs when a coronary artery becomes narrow again after a successful PCI procedure is performed to open that blocked artery. PCI is a non-surgical procedure in which interventional cardiologists use a catheter to place stents in the blocked coronary arteries to restore blood floor.
The standard treatment for initial and repeated PCI involves implanting a metallic drug-eluting stent, a permanent metallic implant that effectively opens the artery. Patients are also put on an antiplatelet therapy. ISR patients require additional stents, and repeated use of these metallic stents remains a persistent problem. For those who cannot tolerate another stent or prolonged antiplatelet therapy, interventional cardiologists use a balloon that is not drug-coated to expand the artery. Roughly 1 in 10 PCI procedures are performed in the United States to treat ISR every year, which translates into thousands of cases. Each time a new stent is added, more metal layers build up inside the artery, which can make future procedures harder and increase the risk of recurrent ischemic events including heart attack and stent restenosis.
Drug-coated balloons using the medication paclitaxel, which are approved by the Food and Drug Administration, are another treatment option to reopen the artery in patients with diabetes or high bleeding risk.
In this trial, researchers analyzed a new drug-eluting balloon called the Selution Sustained Limus Release Balloon. It uses sirolimus, also known as rapamycin, which is a potent immunosuppressive medication. This inhibits the growth and migration of smooth muscle cells and inflammatory cells that contribute to restenosis.
Investigators enrolled 418 patients with coronary ISR who had either one or two previous stents in this multicenter, single-blind, randomized trial. Of the participants, 197 were treated with the sirolimus balloon, while 193 received standard care (80 percent of these received new drug-eluting stents and 20 percent had plain balloon angioplasty using balloons not coated with a drug). The primary outcome was target lesion failure at the one-year mark following the procedure.They tested to see if results from the sirolimus balloon were within an acceptable margin of standard care.
One-year results showed that target lesion failure was similar between the groups, with 16.2 percent in patients treated with the sirolimus balloon compared to 13.5 percent who received standard care, a difference that is not statistically significant. The proportion of patients who needed clinically indicated repeat procedures at the treated site was nearly identical in both groups, 12.7 percent for sirolimus balloons versus 12.4 percent for standard care. The new balloon performed similarly overall to standard treatments. However, repeat stenting for patients with only one previous stent layer performed somewhat better than the balloon. Additionally, among patients treated with balloon angioplasty alone, the sirolimus balloon outperformed plain balloons.
“Patients who develop in-stent restenosis may now have a metal-free treatment option that works about as well as another stent in many cases. This may be particularly valuable for those who already have multiple stent layers, where adding more metal may increase risk or complicate future procedures,” adds Dr. Mehran. “For interventional cardiologists, this study provides evidence supporting sirolimus-eluting balloons as a viable alternative for patients with complex or multilayer ISR, where repeat stenting may not be ideal. It also reinforces the importance of tailoring therapy to the number of stent layers and lesion characteristics.”
Researchers are conducting long-term follow-up through five years to evaluate durability of these results. Further studies will test the device in broader populations, including those with more than two stent layers or in smaller vessels. Also, comparative cost-effectiveness and quality-of-life analyses are warranted.
This trial was funded by M.A. Med Alliance SA (a Cordis Company).
Mount Sinai Is a World Leader in Cardiology and Heart Surgery
Mount Sinai Fuster Heart Hospital at The Mount Sinai Hospital ranks No. 2 nationally for cardiology, heart, and vascular surgery, according to U.S. News & World Report®. It also ranks No. 1 in New York and No. 6 globally according to Newsweek’s “The World’s Best Specialized Hospitals.”
It is part of Mount Sinai Health System, which is New York City's largest academic medical system, encompassing seven hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. We advance medicine and health through unrivaled education and translational research and discovery to deliver care that is the safest, highest-quality, most accessible and equitable, and the best value of any health system in the nation. The Health System includes approximately 9,000 primary and specialty care physicians; 10 free-standing joint-venture centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 48 multidisciplinary research, educational, and clinical institutes. Hospitals within the Health System are consistently ranked by Newsweek’s® “The World’s Best Smart Hospitals” and by U.S. News & World Report's® “Best Hospitals” and “Best Children’s Hospitals.” The Mount Sinai Hospital is on the U.S. News & World Report's® “Best Hospitals” Honor Roll for 2025-2026.
For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Instagram, LinkedIn, X, and YouTube.
About the Mount Sinai Health System
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with 48,000 employees working across seven hospitals, more than 400 outpatient practices, more than 600 research and clinical labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time—discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.
Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes approximately 9,000 primary and specialty care physicians and 10 free-standing joint-venture centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida. Hospitals within the System are consistently ranked by Newsweek’s® “The World’s Best Smart Hospitals, Best in State Hospitals, World Best Hospitals and Best Specialty Hospitals” and by U.S. News & World Report's® “Best Hospitals” and “Best Children’s Hospitals.” The Mount Sinai Hospital is on the U.S. News & World Report® “Best Hospitals” Honor Roll for 2025-2026.
For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Instagram, LinkedIn, X, and YouTube.
