西京医院陶凌小组近日取得一项新成果。他们提出，药物涂层球囊血管成形术（REC-CAGEFREE II）后患者的逐步双联抗血小板治疗降级：多中心、随机、开放标签、评估者盲、非劣效性试验。相关论文于2025年3月31日发表在《英国医学杂志》上。

目的：探讨是否可以对接受药物包覆气球治疗的患者采用较低强度的抗血小板治疗方案。

设计：多中心、随机、开放标签、评估盲、非劣效性试验（REC-CAGEFREE II）。

设置：2021年11月27日至2023年1月21日期间在中国的41家医院。

参与者：1948例（18-80岁）急性冠状动脉综合征患者，根据国际药物包被球囊共识，仅接受紫杉醇包被球囊治疗。

干预措施参与者：随机分配（1:1）到逐步双重抗血小板治疗（DAPT）降级组（n=975），由阿司匹林加替格瑞洛治疗1个月，随后5个月的替格瑞洛单药治疗，然后6个月的阿司匹林单药治疗，或标准DAPT组（n=973），由阿司匹林加替格瑞洛治疗12个月。

主要结果测量：主要终点是意向治疗人群12个月的净不良临床事件（全因死亡、卒中、心肌梗死、血运重建和出血，学术研究联盟（BARC） 3型或5型出血）。如果绝对风险差异的单侧95%置信区间（CI）的上限小于3.2%，则确定非劣效性。

结果：参与者的平均年龄为59.2岁，男性74.9%，糖尿病30.5%，高危出血20.6%。60.9%为小血管病变，17.8%为支架内再狭窄。药物包被球囊平均直径2.72 mm（标准差0.49）。12个月时，主要终点发生在87例（8.9%）参与者：逐步降级组84例（8.6%），标准组84例(差异0.36%；单侧95% CI上边界2.47%；P_{non-inferiority} = 0.013)。在逐步降级组与标准组相比，BARC 3型或5型出血发生率为4比16参与者:（0.4% vs 1.6%，差异为1.19% (95% CI为2.07% ~ 0.31%)，P=0.008）， 84例发生全因死亡、卒中、心肌梗死和血运重建，74例发生全因死亡参与者：(8.6% v 7.6%,差异1.05% (95% CI 1.37%到3.47%),P = 0.396)。通过胜率方法将其视为具有分级临床重要性，在预定义的全因死亡、卒中、心肌梗死、BARC 3型出血、血运重建和BARC 2型出血的分级复合终点上，与标准组（10.1%）相比，逐步降级组（14.4%）的胜率更高（胜率1.43 (95% CI 1.12至1.83)，P=0.004）。按照方案和意向治疗分析的结果相似。

研究结果表明，在可以仅用药物涂层球囊治疗的急性冠状动脉综合征参与者中，对于净不良临床事件，逐步降低DAPT并不亚于12个月的DAPT。

附：英文原文

Title: Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial

Author: Chao Gao, Bin Zhu, Fan Ouyang, Shangyu Wen, Yanmin Xu, Wenxia Jia, Ping Yang, Yuquan He, Yiming Zhong, Yimeng Zhou, Zhifu Guo, Guidong Shen, Likun Ma, Liang Xu, Yuzeng Xue, Tao Hu, Qiong Wang, Yi Liu, Ruining Zhang, Jianzheng Liu, Zhiwei Jiang, Jielai Xia, Scot Garg, Robert-Jan van Geuns, Davide Capodanno, Yoshinobu Onuma, Duolao Wang, Patrick Serruys, Ling Tao

Issue&Volume: 2025/03/31

Abstract: Objectives To investigate whether a less intense antiplatelet regimen could be used for people receiving drug coated balloons.

Design Multicentre, randomised, open label, assessor blind, non-inferiority trial (REC-CAGEFREE II).

Setting 41 hospitals in China between 27 November 2021 and 21 January 2023.

Participants 1948 adults (18-80 years) with acute coronary syndrome who received treatment exclusively with paclitaxel-coated balloons according to the international drug coated balloon consensus.

Interventions Participants were randomly assigned (1:1) to either the stepwise dual antiplatelet therapy (DAPT) de-escalation group (n=975) consisting of aspirin plus ticagrelor for one month, followed by five months of ticagrelor monotherapy, and then six months of aspirin monotherapy, or to the standard DAPT group (n=973) consisting of aspirin plus ticagrelor for 12 months.

Main outcome measures The primary endpoint was net adverse clinical events (all cause death, stroke, myocardial infarction, revascularisation, and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding) at 12 months in the intention-to-treat population. Non-inferiority was established if the upper limit of the one sided 95% confidence interval (CI) for the absolute risk difference was smaller than 3.2%.

Results The mean age of participants was 59.2 years, 74.9% were men, 30.5% had diabetes, and 20.6% were at high bleeding risk. 60.9% of treated lesions were in small vessels, and 17.8% were in-stent restenosis. The mean drug coated balloon diameter was 2.72 mm (standard deviation 0.49). At 12 months, the primary endpoint occurred in 87 (8.9%) participants in the stepwise de-escalation group and 84 (8.6%) in the standard group (difference 0.36%; upper boundary of the one sided 95% CI 2.47%; P_{non-inferiority}=0.013). In the stepwise de-escalation versus standard groups, BARC type 3 or 5 bleeding occurred in four versus 16 participants (0.4% v 1.6%, difference 1.19% (95% CI 2.07% to 0.31%), P=0.008), and all cause death, stroke, myocardial infarction, and revascularisation occurred in 84 versus 74 participants (8.6% v 7.6%, difference 1.05% (95% CI 1.37% to 3.47%), P=0.396). Treated as having hierarchical clinical importance by the win ratio method, more wins were noted with the stepwise de-escalation group (14.4% wins) compared with the standard group (10.1% wins) for the predefined hierarchical composite endpoint of all cause death, stroke, myocardial infarction, BARC type 3 bleeding, revascularisation, and BARC type 2 bleeding (win ratio 1.43 (95% CI 1.12 to 1.83), P=0.004). Results from the per-protocol and the intention-to-treat analysis were similar.

Conclusions Among participants with acute coronary syndrome who could be treated by drug coated balloons exclusively, a stepwise DAPT de-escalation was non-inferior to 12 month DAPT for net adverse clinical events.

DOI: 10.1136/bmj-2024-082945

Source: https://www.bmj.com/content/388/bmj-2024-082945