A randomized comparison of two paclitaxel‐coated balloons for the treatment of in‐stent restenosis: The LONGTY ISR China randomized trial (LONGTY DCB vs SeQuent Please DCB)
Catheterization and Cardiovascular Interventions Mar 23, 2021
Hu P, Sun Y, Li CL, et al. - This prospective, multicenter, randomized, noninferiority trial was conducted to compare LONGTY drug‐coated balloon (DCB) vs SeQuent Please DCB, in terms of efficacy and clinical safety, in patients with in‐stent restenosis (ISR). In this study including 211 patients with ISR from 13 Chinese sites, target lesion late lumen loss at 9 months' follow‐up was the primary endpoint. In all cases, device success was attained. At the 9 month angiographic follow‐up, target lesion late lumen loss with LONGTY and with SeQuent Please was identified to be 0.35 ± 0.42 mm and 0.38 ± 0.45 mm, respectively, ( p for noninferiority <.001). An extended observation for 2 years revealed extremely low and similar clinical endpoints, including cardiac death, myocardial infarction, and thrombus rate, in both groups. Findings demonstrated the noninferiority of new‐generation LONGTY DCB to the SeQuent Please DCB for target lesion late lumen loss at 9 months (primary endpoint).
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