Landmark trial shows drug-eluting balloon as effective option for in-stent restenosis
www.news-medical.net
Nov. 3, 2025, 9:05 a.m.
Results from the first randomized clinical trial in the United States to compare a sirolimus-eluting balloon (DEB) to control group consisting of drug-eluting stent (DES) and balloon angioplasty (BA) for the treatment of bare-metal and DES in-stent restenosis (ISR) deemed DEB to be noninferior to conventional therapies. ISR after DES implantation occurs in 4-8% of patients within one year and continues in over 1% of patients annually. In addition, more than 10% of PCI is due to ISR. The approach to treatment of ISR includes the use of DES, DEB, BA, or coronary artery bypass surgery. However, there are limited randomized data examining the use of drug-coated balloons compared with other conventional approaches for ISR, and no approved sirolimus-eluting balloons in the United States.