Kim Hyo-Soo, Kang Jeehoon, Hwang Doyeon, Han Jung-Kyu, Yang Han-Mo, Kang Hyun-Jae, Koo Bon-Kwon, Kim Seok Yeon, Park Keun-Ho, Rha Seung-Woon, Shin Won-Yong, Lim Hong-Seok, Park Kyungil, Park Kyung Woo
Seoul National University Hospital, Korea (H-S.K., J.K., D.H., J-K.H., H-M.Y., H-J.K., B-K.K., K.W.P.).
Seoul Medical Center, Korea (S.Y.K.).
Circulation. 2021 Mar 16;143(11):1081-1091. doi: 10.1161/CIRCULATIONAHA.120.051700. Epub 2020 Nov 18.
Large-scale randomized comparison of drug-eluting stents (DES) based on durable polymer versus biodegradable polymer technology is currently insufficient in patients with acute coronary syndrome (ACS). The present study aimed to prove the noninferiority of the durable polymer DES (DP-DES) compared with the biodegradable polymer DES (BP-DES) in such patients.
The HOST-REDUCE-POLYTECH-ACS (Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases-Comparison of Reduction of Prasugrel Dose or Polymer Technology in ACS Patients) trial is an investigator-initiated, randomized, open-label, adjudicator-blinded, multicenter, noninferiority trial comparing the efficacy and safety of DP-DES and BP-DES in patients with ACS. The primary end point was a patient-oriented composite outcome (a composite of all-cause death, nonfatal myocardial infarction, and any repeat revascularization) at 12 months. The key secondary end point was device-oriented composite outcome (a composite of cardiac death, target-vessel myocardial infarction, or target lesion revascularization) at 12 months.
A total of 3413 patients were randomized to receive the DP-DES (1713 patients) and BP-DES (1700 patients). At 12 months, patient-oriented composite outcome occurred in 5.2% in the DP-DES group and 6.4% in the BP-DES group (absolute risk difference, -1.2%; <0.001). The key secondary end point, device-oriented composite outcome, occurred less frequently in the DP-DES group (DP-DES vs BP-DES, 2.6% vs 3.9%; hazard ratio, 0.67 [95% CI, 0.46-0.98]; =0.038), mostly because of a reduction in target lesion revascularization. The rate of spontaneous nonfatal myocardial infarction and stent thrombosis were extremely low, with no significant difference between the 2 groups (0.6% versus 0.8%; =0.513 and 0.1% versus 0.4%; =0.174, respectively).
In ACS patients receiving percutaneous coronary intervention, DP-DES was noninferior to BP-DES with regard to patient-oriented composite outcomes at 12 months after index percutaneous coronary intervention. Registration: URL: https://wwwclinicaltrials.gov; Unique identifier: NCT02193971.
对于急性冠状动脉综合征（ACS）患者，基于耐用聚合物与可生物降解聚合物技术的药物洗脱支架（DES）的大规模随机比较目前尚不充分。本研究旨在证明在这类患者中，耐用聚合物DES（DP-DES）与可生物降解聚合物DES（BP-DES）相比具有非劣效性。
HOST-REDUCE-POLYTECH-ACS（冠状动脉疾病治疗的优化策略——ACS患者中普拉格雷剂量降低或聚合物技术比较）试验是一项由研究者发起的、随机、开放标签、裁决者设盲、多中心、非劣效性试验，比较DP-DES和BP-DES在ACS患者中的疗效和安全性。主要终点是12个月时以患者为导向的复合结局（全因死亡、非致命性心肌梗死和任何再次血运重建的复合）。关键次要终点是12个月时以器械为导向的复合结局（心源性死亡、靶血管心肌梗死或靶病变血运重建的复合）。
共有3413例患者被随机分配接受DP-DES（1713例患者）和BP-DES（1700例患者）。12个月时，DP-DES组以患者为导向的复合结局发生率为5.2%，BP-DES组为6.4%（绝对风险差异，-1.2%；P<0.001）。关键次要终点，即以器械为导向的复合结局，在DP-DES组中发生频率较低（DP-DES组与BP-DES组，2.6%对3.9%；风险比，0.67[95%CI，0.46 - 0.98]；P = 0.038），主要是由于靶病变血运重建减少。自发性非致命性心肌梗死和支架血栓形成的发生率极低，两组之间无显著差异（分别为0.6%对0.8%；P = 0.513和0.1%对0.4%；P = 0.174）。
在接受经皮冠状动脉介入治疗的ACS患者中，在首次经皮冠状动脉介入治疗后12个月时，DP-DES在以患者为导向的复合结局方面不劣于BP-DES。注册信息：网址：https://wwwclinicaltrials.gov；唯一标识符：NCT02193971。
