BACKGROUND Monotherapy with a P2Y12 inhibitor after a minimum period of dual antiplatelet therapy is an emerging approach to reduce the risk of bleeding after percutaneous coronary intervention (PCI). METHODS In a double-blind trial, we examined the effect of ticagrelor alone as compared with ticagrelor plus aspirin with regard to clinically relevant bleeding among patients who were at high risk for bleeding or an ischemic event and had undergone PCI. After 3 months of treatment with ticagrelor plus aspirin, patients who had not had a major bleeding event or ischemic event continued to take ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. We also evaluated the composite end point of death from any cause, nonfatal myocardial infarction, or nonfatal stroke, using a noninferiority hypothesis with an absolute margin of 1.6 percentage points. RESULTS We enrolled 9006 patients, and 7119 underwent randomization after 3 months. Between randomization and 1 year, the incidence of the primary end point was 4.0% among patients randomly assigned to receive ticagrelor plus placebo and 7.1% among patients assigned to receive ticagrelor plus aspirin (hazard ratio, 0.56; 95% confidence interval [CI], 0.45 to 0.68; P<0.001). The difference in risk between the groups was similar for BARC type 3 or 5 bleeding (incidence, 1.0% among patients receiving ticagrelor plus placebo and 2.0% among patients receiving ticagrelor plus aspirin; hazard ratio, 0.49; 95% CI, 0.33 to 0.74). The incidence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke was 3.9% in both groups (difference, -0.06 percentage points; 95% CI, -0.97 to 0.84; hazard ratio, 0.99; 95% CI, 0.78 to 1.25; P<0.001 for noninferiority). CONCLUSIONS Among high-risk patients who underwent PCI and completed 3 months of dual antiplatelet therapy, ticagrelor monotherapy was associated with a lower incidence of clinically relevant bleeding than ticagrelor plus aspirin, with no higher risk of death, myocardial infarction, or stroke. (Funded by AstraZeneca; TWILIGHT ClinicalTrials.gov number, NCT02270242.).

中文翻译：

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PCI术后高危患者使用替卡格雷或加或不加阿司匹林。

背景技术在最小限度的双重抗血小板治疗后，用P2Y12抑制剂进行单药治疗是一种减少经皮冠状动脉介入治疗（PCI）后出血风险的新兴方法。方法在一项双盲试验中，我们对出血风险高或缺血性事件并接受PCI的患者，在临床相关出血方面检查了单独使用替卡格雷与阿司匹林相比的疗效。用替卡格雷或阿司匹林治疗3个月后，未发生大出血或局部缺血事件的患者继续服用替卡格雷，并被随机分配接受阿司匹林或安慰剂治疗1年。主要终点是出血学术研究协会（BARC）2、3或5型出血。我们还评估了任何原因导致的复合死亡终点，非致命性心肌梗塞或非致命性中风，使用非劣效性假设，绝对差值为1.6个百分点。结果我们招募了9006例患者，其中7119例在3个月后进行了随机分组。在随机分组至1年之间，随机分组接受替卡格雷或安慰剂治疗的患者的主要终点发生率为4.0％，接受替卡格雷或阿司匹林治疗的患者的主要终点发生率为7.1％（危险比，0.56； 95％置信区间[CI]， 0.45至0.68； P <0.001）。两组之间的风险差异与BARC 3型或5型出血相似（发生率，接受替卡格雷或安慰剂治疗的患者为1.0％，接受替卡格雷或阿司匹林治疗的患者为2.0％；危险比为0.49； 95％CI为0.33至0.74） 。非致命性心肌梗死，任何原因导致的死亡发生率，两组的非致命性卒中发生率为3.9％（差异为-0.06个百分点； 95％CI为-0.97至0.84；危险比为0.99； 95％CI为0.78至1.25；非劣效性为P <0.001）。结论在接受PCI并完成3个月双重抗血小板治疗的高危患者中，与替卡格雷或阿司匹林相比，替加格雷单药治疗与临床相关出血的发生率较低，且无更高的死亡，心肌梗塞或中风风险。（由阿斯利康（AstraZeneca）资助；暮光之城ClinicalTrials.gov编号，NCT02270242。）。与替加格雷或阿司匹林相比，替加格雷单药治疗的临床相关出血发生率较低，并且没有更高的死亡，心肌梗塞或中风风险。（由阿斯利康（AstraZeneca）资助；暮光之城ClinicalTrials.gov编号，NCT02270242。）。与替加格雷或阿司匹林相比，替加格雷单药治疗的临床相关出血发生率较低，并且没有更高的死亡，心肌梗塞或中风风险。（由阿斯利康（AstraZeneca）资助；暮光之城ClinicalTrials.gov编号，NCT02270242。）。