BACKGROUND Whether a regimen of ticagrelor monotherapy attenuates bleeding complications without increasing ischemic risk in patients undergoing complex percutaneous coronary intervention (PCI) is unknown. OBJECTIVES To evaluate the effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients undergoing complex PCI from the randomized, double-blind, placebo-controlled TWILIGHT trial. METHODS In the TWILIGHT trial, after 3 months of ticagrelor plus aspirin, event-free patients remained on ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. Complex PCI was defined as any of the following: 3 vessels treated, ≥3 lesions treated, total stent length >60 mm, bifurcation with 2 stents implanted, atherectomy device use, left main PCI, surgical bypass graft or chronic total occlusion as target lesions. Bleeding and ischemic endpoints were evaluated at 1 year after randomization. RESULTS Among 7,119 patients randomized in the main trial, complex PCI was performed in 2,342 patients. Compared to ticagrelor plus aspirin, ticagrelor plus placebo resulted in significantly lower rates of BARC type 2, 3 or 5 bleeding (4.2% vs. 7.7%; hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.38-0.76). BARC type 3 or 5 bleeding was also significantly reduced (1.1% vs. 2.6%; HR: 0.41; 95% CI: 0.21-0.80). There were no significant between-group differences in death, myocardial infarction or stroke (3.8% vs. 4.9%; HR: 0.77; 95% CI: 0.52-1.15), nor in stent thrombosis. CONCLUSIONS Among patients undergoing complex PCI who initially completed 3 months of ticagrelor plus aspirin, continuation of ticagrelor monotherapy was associated with lower incidence of bleeding without increasing the risk of ischemic events compared to continuing ticagrelor plus aspirin.

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复杂 PCI 后与阿司匹林或单独使用替格瑞洛：暮光复杂分析

背景 在接受复杂经皮冠状动脉介入治疗 (PCI) 的患者中，替格瑞洛单药治疗方案是否能减轻出血并发症而不增加缺血风险尚不清楚。目的 在随机、双盲、安慰剂对照 TWILIGHT 试验中评估替格瑞洛单药治疗与替格瑞洛加阿司匹林联合治疗对接受复杂 PCI 的患者的影响。方法在 TWILIGHT 试验中，替格瑞洛加阿司匹林 3 个月后，无事件患者继续使用替格瑞洛，并被随机分配接受阿司匹林或安慰剂治疗 1 年。复杂 PCI 定义为以下任何一种：治疗 3 条血管，治疗≥3 个病灶，支架总长度 >60 mm，分叉处植入 2 个支架，使用旋切设备，左主干 PCI，手术旁路移植或慢性完全闭塞作为目标病灶. 在随机化后 1 年评估出血和缺血终点。结果 在主要试验中随机分配的 7,119 名患者中，2,342 名患者进行了复杂 PCI。与替格瑞洛加阿司匹林相比，替格瑞洛加安慰剂显着降低了 BARC 2、3 或 5 型出血的发生率（4.2% 对 7.7%；风险比 [HR]：0.54；95% 置信区间 [CI]：0.38-0.76 ）。BARC 3 型或 5 型出血也显着减少（1.1% 对 2.6%；HR：0.41；95% CI：0.21-0.80）。死亡、心肌梗塞或中风（3.8% 对 4.9%；HR：0.77；95% CI：0.52-1.15）和支架血栓形成没有显着的组间差异。结论 在最初完成 3 个月的替格瑞洛加阿司匹林的复杂 PCI 患者中，