Comparing the efficacy and safety of two different drug-coated balloons in in-stent restenosis: Two-year clinical outcomes of the RESTORE ISR China randomized trial

作者：Cai, Xingxuan; Zhou, Shanshan; Cai, Xiaoqing; Gao, Lei; Tian, Feng; Jing, Jing; Chen, Yundai^*

来源：Journal of Cardiology, 2023, 81(1): 76-82.

DOI：10.1016/j?cc.2022.08.014

• Drug -coated balloon
• In-stent restenosis
• Late lumen loss
• Major adverse cardiac events
• Target lesion failure

Background: This 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 cor-onary drug-eluting stent in-stent restenosis (DES-ISR).Methods: A total of 240 patients with coronary DES-ISR were treated with Restore DCB or with SeQuent (R) 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.Results: Patient, 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 (R) 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 (R) 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 myocar-dial 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 (R) Please group, respectively. Additional analyzing of vessel quantitative flow ratio (QFR) did also show noninferior outcomes for one explicit treatment bunch.Conclusions: The two-year follow-up indicated sustained long-term clinical safety and efficacy for both devices on the basis of QFR value.

• 单位
  南方医科大学; 6