St-Jan Hospital, Brugge, Belgium.
AOU Maggiore della Carità, Eastern Piedmont University, Novara, Italy.
Atherosclerosis. 2021 Mar;321:39-44. doi: 10.1016/j.atherosclerosis.2021.02.006. Epub 2021 Feb 16.
BACKGROUND AND AIMS: The impact of advanced age on the optimal duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary revascularization (PCI) is still greatly debated. Therefore, the aim of the present sub-analysis of the REDUCE trial was to assess the impact of age on the comparison between a short 3 months vs standard 12 months DAPT in ACS patients treated with the COMBO Dual Stent Therapy. METHODS: The REDUCE trial is a prospective, multicenter, investigator-initiated study that randomized ACS patients undergoing PCI with the COMBO drug eluting stent to either 3 or 12 months of DAPT. The study population was divided according to age (<or ≥ 75 years). Primary study endpoint was a composite of all-cause mortality, myocardial infarction, definite/probable stent thrombosis (ST), stroke, target-vessel revascularization (TVR) and bleeding (BARC II, III, V) at 12 months. Secondary endpoints were cardiovascular mortality and the individual components of the primary endpoint within 24 months. RESULTS: From June 2014 to May 2016, 1496 patients were included in the study, of whom 205 (13.7%) ≥75 years of age. Among them, 50.7% of the elderly and 50.2% of younger patients were assigned to the 3-month DAPT treatment. Baseline characteristics were well matched between the two arms, except for a higher rate of males (p=0.02) and a reduced number of lesions on the right coronary artery (p=0.02) in elderly patients treated for the short DAPT duration. Median follow-up was 682.5 days [IQR:667-731]. At 12 months, no difference in the primary endpoint was observed according to DAPT duration in both patients aged ≥75 years (22.1% vs 18.8%, HR [95%CI] = 1.6 [0.73-3.5], p=0.24) and younger ones (9.7% vs 10.9%, HR [95%CI] = 0.85 [0.59-1.27], p=0.44; p INT = 0.15). Results were confirmed after correction for baseline differences among the elderly (adjusted HR [95%CI] = 1.7 [0.75-3.9], p=0.21). Comparable rates of survival, thrombotic (MI, stent thrombosis, TVR, stroke) and bleeding events were observed with the two DAPT strategies, with no impact of age. CONCLUSIONS: The present study shows that among ACS patients randomized in the REDUCE trial, a 3-month DAPT strategy was comparable to a standard 12-month DAPT at a 2-year follow-up for both ischemic and bleeding endpoints, in elderly and younger patients. Thus, despite presenting the limitations of a subgroup analysis, our study strengthens the feasibility of a shorter DAPT duration even among high-risk subsets of ACS patients.
背景和目的：年龄对接受经皮冠状动脉血运重建术（PCI）的急性冠状动脉综合征（ACS）患者双联抗血小板治疗（DAPT）最佳持续时间的影响仍存在很大争议。因此，本研究旨在评估年龄对 COMBO 双重支架治疗的 ACS 患者短期 3 个月与标准 12 个月 DAPT 比较的影响，该研究是 REDUCE 试验的亚组分析。
方法：REDUCE 试验是一项前瞻性、多中心、由研究者发起的研究，该研究将接受 PCI 的 ACS 患者随机分为 3 个月或 12 个月 DAPT 组。根据年龄（<或≥75 岁）将研究人群进行分组。主要研究终点是所有原因死亡、心肌梗死、确定/可能的支架血栓形成（ST）、卒中和靶血管血运重建（TVR）和出血（BARC II、III、V）的复合终点在 12 个月时。次要终点是心血管死亡和 24 个月内的主要终点的各个组成部分。
结果：从 2014 年 6 月至 2016 年 5 月，共纳入 1496 例患者，其中 205 例（13.7%）年龄≥75 岁。其中，老年组中 50.7%和年轻组中 50.2%的患者接受了 3 个月 DAPT 治疗。两组间的基线特征匹配良好，除了老年组的男性比例较高（p=0.02）和右冠状动脉病变数量较少（p=0.02）。中位随访时间为 682.5 天[IQR：667-731]。在 12 个月时，根据 DAPT 持续时间，≥75 岁的患者（22.1%比 18.8%，HR[95%CI]为 1.6[0.73-3.5]，p=0.24）和年轻患者（9.7%比 10.9%，HR[95%CI]为 0.85[0.59-1.27]，p=0.44；p INT=0.15）的主要终点无差异。在对老年患者的基线差异进行校正后，结果仍然一致（校正 HR[95%CI]为 1.7[0.75-3.9]，p=0.21）。两种 DAPT 策略均观察到缺血性和出血性终点的生存率、血栓性（心肌梗死、支架血栓形成、TVR、卒中等）和出血事件相似，且与年龄无关。
结论：本研究表明，在 REDUCE 试验中随机分组的 ACS 患者中，与标准 12 个月 DAPT 相比，3 个月 DAPT 策略在 2 年随访时，无论是缺血性还是出血性终点，在老年患者和年轻患者中均具有可比性。因此，尽管存在亚组分析的局限性，但我们的研究加强了即使在 ACS 患者的高危亚组中也可以进行较短的 DAPT 持续时间的可行性。
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