A new sirolimus-coated balloon (SCB) is noninferior to a paclitaxel-coated balloon (PCB) in patients with in-stent restenosis (ISR) at 9-month follow-up and similar 1-year clinical events, a new study shows. These data were reported by Haiwei Liu, MD, and Yi Li, MD, of the Sir Run Run Shaw Hospital, Hangzhou, China, and colleagues, in a manuscript published Wednesday online in JACC: Cardiovascular Interventions. Currently, limited data is available in the comparison of SCBs and PCBs. PCBs are a well-known treatment strategy for managing coronary vessels, and this randomized-controlled trial aimed to compare a novel SCB with a PCB for the treatment of ISR. In this prospective, assessor-blinded, controlled trial — SIBLINT-ISR (Sirolimus-Coated Balloon Versus Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis) — patients were randomized 1:1 to either an SCB (SeQuent SCB, B. Braun Melsungen; 4 µg/mm2 ) or PCB (SeQuent Please NEO, B. Braun Melsungen; 3 µg/mm2 ). Noninferiority for 9-month angiographic in-segment late lumen loss (LLL) was the primary endpoint of this study. Secondary endpoints included procedural success, target lesion restenosis rate and target lesion failure (cardiac death, target vessel myocardial infarction or revascularization) at 1-year. A total of 258 patients were randomized 1:1 to receive an SCB (n=130) or a PCB (n=128). At 9-month follow-up, the between-group difference in the primary endpoint was 0.07 mm (95% confidence interval [CI]: -0.05 to 0.19 mm; SCB=0.37 mm, PCB=0.30 mm). The noninferiority margin was 0.20 mm (pnoninferiority<0.0001). No significant differences were observed in the 1-year secondary clinical outcomes between the groups. Overall, the novel SCB was noninferior to a PCB, demonstrated by the similar in-segment LLL — measured at 9-months follow-up — and similar secondary clinical outcomes at 1-year. In an accompanying editorial, Antonio Colombo, MD, of Humanitas University, Pieve Emanuele-Milan, Italy, and Humanitas Research Hospital, Rozzano-Milan, Italy, and Pier Pasquale Leone, MD, MSc, of Montefiore Medical Center, New York, discussed the case of ISR in coronary artery disease and compared data across trial types for drug-eluting stents (DES) and drug-coated balloons (DCBs). The editorialists wrote that there was a larger number of patients in this present study compared with two other similar trials, but there are other factors to consider when deciding on treatment options for ISR. “The message we take home from this study is that the difference in outcomes in DES ISR is likely to be affected by the result following predilatation rather than the type of DCB used,” the editorialists wrote. Sources: Liu H, Li Y, Fu G, et al. Sirolimus- vs Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis: The SIBLINT-ISR Randomized Trial. JACC: Cardiovasc Interv. 2025 Feb 19 (Article in Press). Colombo A, Leone PP. Sirolimus- vs Paclitaxel-Coated Balloons for In-Stent Restenosis: Another Brick in the Wall. JACC: Cardiovasc Interv. 2025 Feb 19 (Article in Press). Image Credit: Peera – stock.adobe.com