New findings that assess the real-world usage of the Prevail drug coated balloon (DCB) compared to other contemporary DCBs point to a device that offers comparable clinical outcomes over a two-year period. Presenting at a late-breaking clinical trial session on Saturday at the Cardiovascular Research Technologies (CRT) 2025 meeting, Sacharias von Koch, MD, from Skåne University Hospital in Lund, Sweden, revealed that in a two-year follow-up, all-cause mortality for Prevail DCB was 7.2% compared to other DCBs at 8.2%. Other event rates calculated from the retrospective observational study, which enrolled 6,488 patients undergoing PCI with DCB treatment, included myocardial infarction (6.1% vs. 8.0%); new PCI revascularization (14.6% vs. 14.9%) and target lesion definite thrombosis (0.8% vs. 1.3%). SCAAR data The study authors, who utilized data from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) also noted a target lesion revascularization rate of 7.4% for the Prevail (Medtronic) DCB vs. 8.7% for other DCBs as well as a target vessel revascularization rate of 10.5% vs. 11.3%. The Prevail DCV was approved for use in Sweden in 2021. “This is decidedly the largest study to date investigating the use of Prevail DCB,” said Dr. von Koch during his presentation. “In this analysis evaluating 2-year results, the Prevail DCB had comparable outcomes with other contemporary DCB, suggesting that the Prevail DCB is a suitable option when considering DCB during PCI.” Further testing involving a separate sensitivity analysis that compared the Prevail DCB with other paclitaxel- and sirolimus-coated DCBs, found that results remained consistent, with Prevail demonstrating similar or slightly lower event rates in most categories. The study’s authors emphasized that while the study provided robust real-world data, additional research was required to reach firmer conclusions of DCB’s effectiveness. Study methodology The study included 6,488 patients who underwent PCI with DCB treatment. The study population was divided into two groups: those treated with the Prevail DCB (n=1,797 procedures; n=2,289 devices; mean age: 70.1 years; 22.2% female). The other group was treated with other DCBs (n=4,694 procedures; n=5,765 devices; mean age: 72.2 years; 21.9% were female). Researchers assessed patient-level outcomes (all-cause mortality, new myocardial infarction and new revascularization with PCI) and device-level outcomes (target lesion thrombosis, target lesion revascularization and target vessel revascularization). Image Credit: Bailey G. Salimes Image Caption: Sacharias von Koch, MD, presents his late-breaking clinical trial Saturday, March 8, 2025, at Cardiovascular Research Technologies (CRT).