替格瑞洛联合或不联合阿司匹林用于 PCI 术后高危患者。
Ticagrelor with or without Aspirin in High-Risk Patients after PCI.
机构信息
From the Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital (R.M., U.B., J.Y.C., G.D., S.S.), Mount Sinai Health System (S.K.S.), Columbia University Medical Center (S.O.M.), Icahn School of Medicine at Mount Sinai (S.S.), and Montefiore Medical Center (G.W.), New York, and St. Francis Hospital, Roslyn (R.S.) - all in New York; Kansas City, Missouri (D.J.C.); the University of Florida-Shands, Jacksonville (D.J.A.); Clinica Mediterranea, Naples (C.B.), and Policlinico Umberto I University, Rome (G.S.) - both in Italy; the London School of Hygiene and Tropical Medicine, London (T.C., S.P.), Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, and Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (V.K.), and the West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow (K.O.) - all in the United Kingdom; the 2nd Department of Cardiology Jagiellonian University Medical College, Krakow (D.D.), and the Department of Invasive Cardiology, Center of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw (R.G.) - both in Poland; Research and Innovation in Interventional Cardiology and Cardiac Intensive Care, Peter Munk Cardiac Centre, University Health Network, Toronto (V.D.), and Hamilton Health Sciences, Hamilton, ON (S.R.M.) - both in Canada; Instituto de Investigación Sanitaria del Hospital Clínico San Carlos and Complutense University, Madrid (J.E.); Sinai Hospital of Baltimore System, Baltimore (P.G.); Kerckhoff Clinic, Bad Nauheim (C.W.H.), Deutsches Herzzentrum München, Munich (A.K.), and Helios Amper-Klinikum, Dachau (B.W.) - all in Germany; the Carl and Edyth Lindner Center for Research and Education at the Christ Hospital, Cincinnati (T.H.); Wilhelminenhospital, Vienna (K.H.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Rabin Medical Center, Petach Tikva, Israel (R.K.); Duke University Medical Center-Duke Clinical Research Institute, Durham, NC (M.K., E.M.O.); the University of Kentucky, Lexington (D.M.); Groupe Hospitalier Bichat-Claude-Bernard, Paris (P.G.S.); Shenyang North Hospital, Shenyang, China (Y.H.); and Beth Israel Deaconess Medical Center, Boston (C.M.G.).
出版信息
N Engl J Med. 2019 Nov 21;381(21):2032-2042. doi: 10.1056/NEJMoa1908419. Epub 2019 Sep 26.
BACKGROUND
Monotherapy with a P2Y 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.).
背景
在双联抗血小板治疗结束后的最短时间内，使用 P2Y 抑制剂单药治疗是一种降低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，我们比较了替格瑞洛单药治疗与替格瑞洛加阿司匹林治疗在高出血风险或缺血事件风险的患者中的效果，这些患者已经接受了 PCI。在替格瑞洛加阿司匹林治疗 3 个月后，未发生重大出血事件或缺血事件的患者继续服用替格瑞洛，并随机分为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联合会（BARC）类型 2、3 或 5 出血。我们还使用非劣效性假设和 1.6 个百分点的绝对差值评估了任何原因导致的死亡、非致死性心肌梗死或非致死性卒中的复合终点。
结果
我们纳入了 9006 例患者，其中 7119 例在 3 个月后进行了随机分组。随机分组至 1 年时，随机接受替格瑞洛加安慰剂的患者中主要终点的发生率为 4.0%，而随机接受替格瑞洛加阿司匹林的患者中发生率为 7.1%（风险比，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在 BARC 类型 3 或 5 出血方面相似（发生率分别为接受替格瑞洛加安慰剂的患者 1.0%和接受替格瑞洛加阿司匹林的患者 2.0%；风险比，0.49；95%CI，0.33 至 0.74）。两组的任何原因导致的死亡、非致死性心肌梗死或非致死性卒中发生率均为 3.9%（差异，-0.06 个百分点；95%CI，-0.97 至 0.84；风险比，0.99；95%CI，0.78 至 1.25；非劣效性 P<0.001）。
结论
在接受 PCI 且完成 3 个月双联抗血小板治疗的高危患者中，替格瑞洛单药治疗与替格瑞洛加阿司匹林治疗相比，出血相关的临床重要事件发生率更低，且无死亡、心肌梗死或卒中风险增加。（由 AstraZeneca 资助；TWILIGHT 临床试验.gov 编号，NCT02270242.）
Zotero 插件