医学
再狭窄
心肌梗塞
临床终点
靶病变
药物洗脱支架
内科学
支架
心脏病学
随机对照试验
血管成形术
外科
经皮冠状动脉介入治疗
作者
Xingxuan Cai,Shanshan Zhou,Xiaoqing Cai,Lei Gao,Feng Tian,Jing Jing,Yundai Chen
标识
DOI:10.1016/j.jjcc.2022.08.014
摘要
BackgroundThis head-to-head, multicenter, randomized trial investigated the safety and efficacy of Restore (Cardionovum, Bonn, Germany) drug-coated balloon (DCB) angioplasty in an Asian patient population with coronary drug-eluting stent in-stent restenosis (DES-ISR).MethodsA total of 240 patients with coronary DES-ISR were treated with Restore DCB or with SeQuent® Please (Braun, Melsungen, Germany) DCB. This trial used nine-month in-segment late lumen loss (LL) as the primary endpoint. Secondary endpoints included two-year clinical event rates.ResultsPatient, lesion, and procedural characteristics in both treatment groups were similar. Nine-month in-segment LL was 0.38 ± 0.50 mm with Restore vs. 0.35 ± 0.47 mm with SeQuent® Please (p for non-inferiority = 0.02). The two-year follow-up rates were 95.8 % (115/120) in the Restore group and 94.2 % (113/120) in the SeQuent® Please group. Both groups had similar one- and two-year target lesion failure (TLF) rates (13.3 % vs. 12.6 %; p = 0.87 at one year, 14.8 % vs. 15.0 %; p = 1.0 at two years). Moreover, the all-cause mortality and myocardial infarction rates were 0 and 3.5 % (4/120) in the Restore group and 0.9 % (1/120) and 3.5 % (4/120) in the SeQuent® Please group, respectively. Additional analyzing of vessel quantitative flow ratio (QFR) did also show noninferior outcomes for one explicit treatment bunch.ConclusionsThe two-year follow-up indicated sustained long-term clinical safety and efficacy for both devices on the basis of QFR value.
科研通智能强力驱动
Strongly Powered by AbleSci AI