Department of Cardiology, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai.
Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing.
Coron Artery Dis. 2021 Sep 1;32(6):526-533. doi: 10.1097/MCA.0000000000000994.
Treatment of coronary in-stent restenosis (ISR) remains challenging in contemporary clinical applications. Drug-coated balloon (DCB) angioplasty offers an effective treatment for ISR. Shenqi is a novel iopromide-based paclitaxel-coated balloon and its clinical safety, effectiveness and angiographic efficacy in patients with ISR have not been investigated.
A total of 216 subjects with the first occurrence of ISR at 11 investigational sites in China were randomly allocated in a 1:1 fashion to treatment with DCB SeQuent Please or Shenqi. Clinical follow-up was planned at 1, 6, 9 and 12 months, and angiographic follow-up was planned at 9 months. The study was powered for the primary endpoint of 9-month in-segment late loss.
At 9-month follow-up, the in-segment late loss was 0.29 ± 0.43 mm with Shenqi versus 0.30 ± 0.46 mm with SeQuent Please, and the one-sided 97.5% upper confidence limit of the difference was 0.14 mm, achieving noninferiority of Shenqi compared with SeQuent Please (P = 0.002). In total, 12 patients developed target lesion failure (TLF) in the Shenqi group compared with 16 patients in the SeQuent Please group (10.91% versus 15.09%; P = 0.42) within 1 year. TLF was mainly driven by target lesion revascularization (9.09%) followed by target vessel-related myocardial infarction (1.82%) and cardiovascular death (0.91%) in the Shenqi group.
Shenqi DCB was noninferior to SeQuent Please DCB for the primary endpoint of 9-month in-segment late loss. Shenqi DCB may become an attractive alternative treatment for patients with coronary ISR, withholding the need for additional stent implantation.
在当代临床应用中，治疗冠状动脉支架内再狭窄（ISR）仍然具有挑战性。药物涂层球囊（DCB）血管成形术为 ISR 提供了一种有效的治疗方法。深奇是一种新型的碘普罗胺基紫杉醇涂层球囊，其在 ISR 患者中的临床安全性、有效性和血管造影疗效尚未得到研究。
在中国的 11 个研究地点，共有 216 名首次发生 ISR 的患者以 1:1 的比例随机分配至 DCB SeQuent Please 或深奇治疗组。临床随访计划在 1、6、9 和 12 个月进行，血管造影随访计划在 9 个月进行。该研究的主要终点为 9 个月时的节段内晚期管腔丢失。
在 9 个月的随访中，深奇组的节段内晚期管腔丢失为 0.29±0.43mm，而 SeQuent Please 组为 0.30±0.46mm，差异的单侧 97.5%置信上限为 0.14mm，深奇与 SeQuent Please 相比达到了非劣效性（P=0.002）。共有 12 名患者在深奇组发生了目标病变失败（TLF），而在 SeQuent Please 组为 16 名（10.91%比 15.09%；P=0.42），在 1 年内。深奇组的 TLF 主要由靶病变血运重建（9.09%）驱动，其次是靶血管相关心肌梗死（1.82%）和心血管死亡（0.91%）。
深奇 DCB 在 9 个月时的节段内晚期管腔丢失主要终点方面不劣于 SeQuent Please DCB。深奇 DCB 可能成为冠状动脉 ISR 患者的一种有吸引力的治疗选择，可以避免再次植入支架。
