Dual antiplatelet therapy (DAPT) for 12 months is the standard of care after coronary stenting in patients with acute coronary syndrome (ACS). The aim of this individual patient-level meta-analysis was to summarise the evidence comparing DAPT de-escalation to ticagrelor monotherapy versus continuing DAPT for 12 months after coronary drug-eluting stent implantation. A systematic review and individual patient data (IPD)-level meta-analysis of randomised trials with centrally adjudicated endpoints was performed to evaluate the comparative efficacy and safety of ticagrelor monotherapy (90 mg twice a day) after short-term DAPT (from 2 weeks to 3 months) versus 12-month DAPT in patients undergoing percutaneous coronary intervention with a coronary drug-eluting stent. Randomised trials comparing P2Y inhibitor monotherapy with DAPT after coronary revascularisation were searched in Ovid MEDLINE, Embase, and two websites ( and ) from database inception up to May 20, 2024. Trials that included patients with an indication for long-term oral anticoagulants were excluded. The risk of bias was assessed using the revised Cochrane risk-of-bias tool. The principal investigators of the eligible trials provided IPD by means of an anonymised electronic dataset. The three ranked coprimary endpoints were major adverse cardiovascular or cerebrovascular events (MACCE; a composite of all-cause death, myocardial infarction, or stroke) tested for non-inferiority in the per-protocol population; and Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding and all-cause death tested for superiority in the intention-to-treat population. All outcomes are reported as Kaplan–Meier estimates. The non-inferiority was tested using a one-sided α of 0·025 with the prespecified non-inferiority margin of 1·15 (hazard ratio [HR] scale), followed by the ranked superiority testing at a two-sided α of 0·05. This study is registered with PROSPERO (CRD42024506083). A total of 8361 unique citations were screened, of which 610 records were considered potentially eligible during the screening of titles and abstracts. Of these, six trials that randomly assigned patients to ticagrelor monotherapy or DAPT were identified. De-escalation took place a median of 78 days (IQR 31–92) after intervention, with a median duration of treatment of 334 days (329−365). Among 23 256 patients in the per-protocol population, MACCE occurred in 297 (Kaplan–Meier estimate 2·8%) with ticagrelor monotherapy and 332 (Kaplan–Meier estimate 3·2%) with DAPT (HR 0·91 [95% CI 0·78–1·07]; p=0·0039 for non-inferiority; τ<0·0001). Among 24 407 patients in the intention-to-treat population, the risks of BARC 3 or 5 bleeding (Kaplan–Meier estimate 0·9% 2·1%; HR 0·43 [95% CI 0·34–0·54]; p<0·0001 for superiority; τ=0·079) and all-cause death (Kaplan–Meier estimate 0·9% 1·2%; 0·76 [0·59–0·98]; p=0·034 for superiority; τ<0·0001) were lower with ticagrelor monotherapy. Trial sequential analysis showed strong evidence of non-inferiority for MACCE and superiority for bleeding among the overall and ACS populations (the z-curve crossed the monitoring boundaries or the required information size without crossing the futility boundaries or approaching the null). The treatment effects were heterogeneous by sex for MACCE (p interaction=0·041) and all-cause death (p interaction=0·050), indicating a possible benefit in women with ticagrelor monotherapy, and by clinical presentation for bleeding (p interaction=0·022), indicating a benefit in ACS with ticagrelor monotherapy. Our study found robust evidence that, compared with 12 months of DAPT, de-escalation to ticagrelor monotherapy does not increase ischaemic risk and reduces the risk of major bleeding, especially in patients with ACS. Ticagrelor monotherapy might also be associated with a mortality benefit, particularly among women, which warrants further investigation. Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale.

中文翻译：

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有或没有急性冠脉综合征患者降级至替格瑞洛单药治疗与 12 个月双联抗血小板治疗：随机试验的系统评价和个体患者水平荟萃分析


12 个月的双联抗血小板治疗 (DAPT) 是急性冠状动脉综合征 (ACS) 患者冠状动脉支架置入术后的标准治疗方法。这项个体患者水平荟萃分析的目的是总结比较 DAPT 降阶梯治疗替格瑞洛单药治疗与冠状动脉药物洗脱支架植入后继续 DAPT 12 个月的证据。对具有集中判定终点的随机试验进行系统评价和个体患者数据 (IPD) 水平荟萃分析，以评估短期 DAPT（从 2 周起）后替格瑞洛单药治疗（90 毫克，每天两次）的比较疗效和安全性接受冠状动脉药物洗脱支架经皮冠状动脉介入治疗的患者接受为期 12 个月的 DAPT 治疗（3 个月至 3 个月）。从数据库建立到 2024 年 5 月 20 日，在 Ovid MEDLINE、Embase 和两个网站 ( 和 ) 中检索了比较冠状动脉血运重建后 P2Y 抑制剂单药治疗与 DAPT 的随机试验。排除了包括有长期口服抗凝剂指征的患者的试验。使用修订后的 Cochrane 偏倚风险工具评估偏倚风险。符合条件的试验的主要研究人员通过匿名电子数据集提供了 IPD。排名前三的共同主要终点是主要不良心血管或脑血管事件（MACCE；全因死亡、心肌梗塞或中风的综合结果），在符合方案的人群中测试非劣效性；出血学术研究联盟 (BARC) 在意向治疗人群中测试了 3 或 5 次出血和全因死亡的优越性。所有结果均按 Kaplan-Meier 估计值报告。 使用单侧 α 0·025 和预先指定的非劣效性边际 1·15（风险比 [HR] 量表）测试非劣效性，然后使用两侧 α 0 进行排名优效性测试·05.本研究已在 PROSPERO 注册（CRD42024506083）。总共筛选了 8361 条独特的引文，其中 610 条记录在标题和摘要筛选过程中被认为可能符合条件。其中，有 6 项试验将患者随机分配至替格瑞洛单药治疗或 DAPT。干预后中位降级发生在 78 天（IQR 31-92），中位治疗持续时间为 334 天（329-365）。在符合方案人群的 23 256 名患者中，替格瑞洛单药治疗组中 297 例（Kaplan-Meier 估计为 2·8%）发生 MACCE，DAPT 组中 332 例（Kaplan-Meier 估计为 3·2%）发生 MACCE（HR 0·91 [95%） CI 0·78–1·07]；p=0·0039 为非劣效性；τ<0·0001)。在意向治疗人群中的 24 407 名患者中，BARC 3 或 5 级出血的风险（Kaplan-Meier 估计 0·9% 2·1%；HR 0·43 [95% CI 0·34–0·54] ]；p<0·0001 的优越性；τ=0·079）和全因死亡（Kaplan-Meier 估计 0·9% 1·2%；0·76 [0·59–0·98]；p= 0·034 的优越性；τ<0·0001) 替格瑞洛单药治疗较低。试验序贯分析显示了在总体人群和 ACS 人群中 MACCE 的非劣效性和出血的优越性的有力证据（z 曲线跨越了监测边界或所需的信息大小，但未跨越无效边界或接近零值）。 MACCE 的治疗效果（p 相互作用 = 0·041）和全因死亡（p 相互作用 = 0·050）的治疗效果存在异质性，表明接受替格瑞洛单药治疗的女性可能受益，并且出血的临床表现也不同（p 相互作用） =0·022)，表明替格瑞洛单药治疗对 ACS 有益。我们的研究发现强有力的证据表明，与 12 个月的 DAPT 相比，降级至替格瑞洛单药治疗不会增加缺血风险并降低大出血风险，特别是对于 ACS 患者。替格瑞洛单一疗法也可能与死亡率获益相关，特别是在女性中，这值得进一步研究。提契诺州心脏中心研究所，Ente Ospedaliero Cantonale。