Dehghani Payam, Cao Davide, Baber Usman, Nicolas Johny, Sartori Samantha, Pivato Carlo A, Zhang Zhongjie, Dangas George, Angiolillo Dominick J, Briguori Carlo, Cohen David J, Collier Timothy, Dudek Dariusz, Gibson Michael, Gil Robert, Huber Kurt, Kaul Upendra, Kornowski Ran, Krucoff Mitchell W, Kunadian Vijay, Mehta Shamir, Moliterno David J, Ohman E Magnus, Escaned Javier, Sardella Gennaro, Sharma Samin K, Shlofmitz Richard, Weisz Giora, Witzenbichler Bernhard, Pocock Stuart, Mehran Roxana
Department of Cardiology, Prairie Vascular Research, Regina, Saskatchewan, Canada.
Center for Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY 10029-6574, USA.
Eur Heart J Cardiovasc Pharmacother. 2022 Sep 29;8(7):707-716. doi: 10.1093/ehjcvp/pvac016.
We aimed to evaluate the treatment effects of ticagrelor monotherapy in the very high risk cohort of patients with concomitant diabetes mellitus (DM) and chronic kidney disease (CKD) undergoing percutaneous coronary intervention (PCI).
In the TWILIGHT (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial, after 3-month dual antiplatelet therapy with ticagrelor and aspirin post-PCI, event-free patients were randomized to either aspirin or placebo in addition to ticagrelor for 12 months. Those with available information on DM and CKD status were included in this subanalysis and were stratified by the presence or absence of either condition: 3391 (54.1%) had neither DM nor CKD (DM-/CKD-), 1822 (29.0%) had DM only (DM+/CKD-), 561 (8.9%) had CKD only (DM-/CKD+), and 8.0% had both DM and CKD (DM+/CKD+). The incidence of the primary endpoint of Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding did not differ according to DM/CKD status (P-trend = 0.13), but there was a significant increase in BARC 3 or 5 bleeding (P-trend < 0.001) as well as the key secondary endpoint of death, myocardial infarction, or stroke (P-trend < 0.001). Ticagrelor plus placebo reduced bleeding events compared with ticagrelor plus aspirin across all four groups, including DM+/CKD+ patients with respect to BARC 2-5 [4.5% vs. 8.7%; hazard ratio (HR) 0.49, 95% confidence interval (CI) 0.24-1.01] as well as BARC 3-5 (0.8% vs. 5.3%; HR 0.15, 95% CI 0.03-0.53) bleeding, with no evidence of heterogeneity. The risk of death, myocardial infarction, or stroke was similar between treatment arms across all groups.
Irrespective of the presence of DM, CKD, and their combination, ticagrelor monotherapy reduced the risk of bleeding without a significant increase in ischaemic events compared with ticagrelor plus aspirin.
我们旨在评估替格瑞洛单药治疗对接受经皮冠状动脉介入治疗（PCI）的伴有糖尿病（DM）和慢性肾脏病（CKD）的极高危患者队列的治疗效果。
在TWILIGHT（冠状动脉介入治疗后高危患者使用替格瑞洛联合阿司匹林或单用替格瑞洛）试验中，PCI术后接受替格瑞洛和阿司匹林3个月的双联抗血小板治疗后，无事件患者被随机分为在替格瑞洛基础上加用阿司匹林或安慰剂，持续12个月。本亚组分析纳入了有DM和CKD状态可用信息的患者，并根据是否存在这两种情况进行分层：3391例（54.1%）既无DM也无CKD（DM-/CKD-），1822例（29.0%）仅有DM（DM+/CKD-），561例（8.9%）仅有CKD（DM-/CKD+），8.0%同时有DM和CKD（DM+/CKD+）。出血学术研究联盟（BARC）2、3或5型出血的主要终点发生率根据DM/CKD状态无差异（P趋势=0.13），但BARC 3或5型出血（P趋势<0.001）以及死亡、心肌梗死或卒中的关键次要终点（P趋势<0.001）有显著增加。与替格瑞洛加阿司匹林相比，替格瑞洛加安慰剂在所有四组中均减少了出血事件，包括DM+/CKD+患者的BARC 2 - 5型出血[4.5%对8.7%；风险比（HR）0.49，95%置信区间（CI）0.24 - 1.01]以及BARC 3 - 5型出血（0.8%对5.3%；HR 0.15，95%CI 0.03 - 0.53），且无异质性证据。各治疗组间所有组的死亡、心肌梗死或卒中风险相似。
无论是否存在DM、CKD及其组合，与替格瑞洛加阿司匹林相比，替格瑞洛单药治疗降低了出血风险，且缺血事件无显著增加。
