替格瑞洛单药治疗与替格瑞洛联合阿司匹林用于非ST段抬高型急性冠状动脉综合征患者经皮冠状动脉介入治疗后：TWILIGHT-ACS研究
Ticagrelor alone vs. ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: TWILIGHT-ACS.
作者信息
Baber Usman, Dangas George, Angiolillo Dominick Joseph, Cohen David Joel, Sharma Samin Kumar, Nicolas Johny, Briguori Carlo, Cha Jin Yu, Collier Timothy, Dudek Dariusz, Džavik Vladimir, Escaned Javier, Gil Robert, Gurbel Paul, Hamm Christian W, Henry Timothy, Huber Kurt, Kastrati Adnan, Kaul Upendra, Kornowski Ran, Krucoff Mitchell, Kunadian Vijay, Marx Steven Owen, Mehta Shamir, Moliterno David, Ohman Erik Magnus, Oldroyd Keith, Sardella Gennaro, Sartori Samantha, Shlofmitz Richard, Steg Philippe Gabriel, Weisz Giora, Witzenbichler Bernhard, Han Ya-Ling, Pocock Stuart, Gibson Charles Michael, Mehran Roxana
机构信息
Department of Cardiology, The University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.
Department of Cardiology, The Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, One Gustave L. Levy Place, Box 1030, New York, NY 10029-6574, USA.
出版信息
Eur Heart J. 2020 Oct 1;41(37):3533-3545. doi: 10.1093/eurheartj/ehaa670.
AIMS
The aim of this study was to determine the effect of ticagrelor monotherapy on clinically relevant bleeding and major ischaemic events in relation to clinical presentation with and without non-ST elevation acute coronary syndromes (NSTE-ACS) among patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES).
METHODS AND RESULTS
We conducted a pre-specified subgroup analysis of The Ticagrelor With Aspirin or Alone in High Risk Patients After Coronary Intervention (TWILIGHT) trial, which enrolled 9006 patients with high-risk features undergoing PCI with DES. After 3 months of dual antiplatelet therapy (DAPT) with ticagrelor plus aspirin, 7119 adherent and event-free patients were randomized in a double-blind manner to ticagrelor plus placebo versus ticagrelor plus aspirin for 12 months. The primary outcome was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding while the composite of all-cause death, myocardial infarction (MI), or stroke was the key secondary outcome. Among patients with NSTE-ACS (n = 4614), ticagrelor monotherapy reduced BARC 2, 3, or 5 bleeding by 53% [3.6% vs. 7.6%; hazard ratio (HR) 0.47; 95% confidence interval (CI) 0.36-0.61; P < 0.001) and in stable patients (n = 2503) by 24% (4.8% vs. 6.2%; HR 0.76; 95% CI 0.54-1.06; P = 0.11; nominal Pint = 0.03). Rates of all-cause death, MI, or stroke among those with (4.3% vs. 4.4%; HR 0.97; 95% CI 0.74-1.28; P = 0.84) and without (3.1% vs. 3.2%; HR 0.96; 95% CI 0.61-1.49; P = 0.85) NSTE-ACS were similar between treatment arms irrespective of clinical presentation (Pint = 0.96).
CONCLUSION
Among patients with or without NSTE-ACS who have completed an initial 3-month course of DAPT following PCI with DES, ticagrelor monotherapy reduced clinically meaningful bleeding events without increasing ischaemic risk as compared with ticagrelor plus aspirin. The benefits of ticagrelor monotherapy with respect to bleeding events were more pronounced in patients with NSTE-ACS.
TRIAL REGISTRATION
Clinicaltrials.gov identifier: NCT02270242.
目的
本研究旨在确定在接受药物洗脱支架（DES）经皮冠状动脉介入治疗（PCI）的患者中，替格瑞洛单药治疗对伴有和不伴有非ST段抬高急性冠状动脉综合征（NSTE-ACS）临床表现的临床相关出血和主要缺血事件的影响。
方法与结果
我们对冠状动脉介入治疗后替格瑞洛联合阿司匹林或单用在高危患者中的应用（TWILIGHT）试验进行了预先指定的亚组分析，该试验纳入了9006例具有高危特征且接受DES PCI的患者。在接受替格瑞洛加阿司匹林的双联抗血小板治疗（DAPT）3个月后，7119例依从且无事件的患者以双盲方式随机分为替格瑞洛加安慰剂组与替格瑞洛加阿司匹林组，治疗12个月。主要结局是出血学术研究联盟（BARC）2、3或5型出血，而全因死亡、心肌梗死（MI）或卒中的复合结局是关键次要结局。在NSTE-ACS患者（n = 4614）中，替格瑞洛单药治疗使BARC 2、3或5型出血减少了53%[3.6%对7.6%；风险比（HR）0.47；95%置信区间（CI）0.36 - 0.61；P < 0.001]，在稳定患者（n = 2503）中减少了24%（4.8%对6.2%；HR 0.76；95% CI 0.54 - 1.06；P = 0.11；名义P交互作用 = 0.03）。无论临床表现如何，治疗组中伴有（4.3%对4.4%；HR 0.97；95% CI 0.74 - 1.28；P = 0.84）和不伴有（3.1%对3.2%；HR 0.96；95% CI 0.61 - 1.49；P = 0.85）NSTE-ACS的患者的全因死亡、MI或卒中发生率相似（P交互作用 = 0.96）。
结论
在接受DES PCI后完成初始3个月DAPT疗程的伴有或不伴有NSTE-ACS的患者中，与替格瑞洛加阿司匹林相比，替格瑞洛单药治疗减少了具有临床意义的出血事件，且未增加缺血风险。替格瑞洛单药治疗在出血事件方面带来的益处，在NSTE-ACS患者中更为显著。
试验注册
Clinicaltrials.gov标识符：NCT02270242。
Zotero 插件