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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 )
Author(s) -
Hu Po,
Sun Yong,
Li ChangLing,
Jin Rui,
Xie Qiang,
Jiang XueJun,
Wu LianPin,
Jiang JianJun,
Qiu XinBiao,
Cao Yu,
Ji Guang,
Wang Hua,
Yao ZhuHua,
Li Bin,
Xia Yong,
Wang JianAn,
Jiang Jun
Publication year - 2021
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.29589
Subject(s) - medicine , clinical endpoint , restenosis , target lesion , randomized controlled trial , myocardial infarction , stent , surgery , lesion , radiology , percutaneous coronary intervention
Objectives This study sought to compare the efficacy and clinical safety of the LONGTY drug‐coated balloon (DCB) with those of SeQuent Please DCB in patients with in‐stent restenosis (ISR). Background Although DCB technologies have evolved, little is known about the clinical efficacy of the new‐generation LONGTY DCB. Methods This was a prospective, multicenter, randomized, noninferiority trial comparing LONGTY DCB with SeQuent Please DCB in patients with ISR. The primary endpoint was target lesion late lumen loss at 9 months' follow‐up. Results A total of 211 patients with ISR from 13 Chinese sites were included (LONGTY DCB, n = 105; SeQuent Please DCB, n = 106). Device success was achieved in all patients. At the 9 month angiographic follow‐up, target lesion late lumen loss was 0.35 ± 0.42 mm with LONGTY and 0.38 ± 0.45 mm with SeQuent Please ( p for noninferiority <.001). The target lesion revascularization rates at 1 year were similar in both DCB groups (15.24 vs. 13.21%; p = .673). Over an extended follow‐up of 2 years, the clinical endpoints, including cardiac death, myocardial infarction, and thrombus rate, were extremely low and similar in both groups. Conclusions In this multicenter, head‐to‐head, randomized trial, the new‐generation LONGTY DCB was noninferior to the SeQuent Please DCB for the primary endpoint of target lesion late lumen loss at 9 months.