Yun Kyeong Ho, Cho Jae Young, Lee Seung Yul, Rhee Sang Jae, Kim Byeong Keuk, Hong Myeong Ki, Jang Yangsoo, Oh Seok Kyu
Departments of Cardiovascular Medicine, Regional Cardiocerebrovascular Center, Wonkwang University Hospital, Iksan, South Korea.
Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Front Pharmacol. 2021 Jan 14;11:620906. doi: 10.3389/fphar.2020.620906. eCollection 2020.
: Ticagrelor monotherapy after 3 months dual antiplatelet therapy (DAPT) with aspirin and ticagrelor can reduce bleeding without increasing ischemic events after percutaneous coronary intervention (PCI). However, the impact of this approach among the patient with diabetes remains unknown. : This was a sub-analysis of the Ticagrelor Monotherapy after 3 months in the Patients Treated with New Generation Sirolimus Eluting Stent for Acute Coronary Syndrome (TICO) trial. After successful PCI, the patients were randomly assigned to ticagrelor monotherapy after 3-months DPAT or to ticagrelor-based 12-months DAPT. We compared ischemic events and bleeding events between the patients with diabetes and without diabetes for 12 months. Ischemic events were defined as death, myocardial infarction, ischemic stroke, transient ischemic attack, stent thrombosis, and any revascularizations. Bleeding events were defined according to the Thrombolysis in Myocardial Infarction (TIMI) criteria and Bleeding Academic Research Consortium (BARC) definition. : Between August 2015 and October 2018, 3,056 patients were enrolled in the TICO trial, of which 835 (27.3%) had diabetes mellitus. Diabetes mellitus was associated with all evaluated ischemic and bleeding events. No significant differences in any ischemic events were observed in patients with diabetes between ticagrelor monotherapy after 3-months DAPT and ticagrelor-based 12-months DAPT (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.45-1.52, p = 0.540). In patients with diabetes, the overall incidence of bleeding complications during the 12-months follow-up period did not differ between the two treatment groups (HR 0.83, 95% CI 1.48-1.43, p = 0.505). However, ticagrelor monotherapy was significantly reduced both any TIMI bleeding and BARC three or five bleeding events in diabetes patients in the 3-months landmark analysis, after 3-months DAPT period (HR 0.20, 95% CI 0.07-0.59, p = 0.003). : In diabetic patients, ticagrelor monotherapy showed a lower incidence of bleeding complications after 3-months DAPT period, without increasing ischemic complications, compared with ticagrelor-based 12-months DAPT (ClinicalTrials.gov Identifier: NCT02494895).
在经皮冠状动脉介入治疗（PCI）后，使用阿司匹林和替格瑞洛进行3个月的双联抗血小板治疗（DAPT）后，改用替格瑞洛单药治疗可减少出血，且不增加缺血事件。然而，这种方法在糖尿病患者中的影响尚不清楚。
这是对新一代西罗莫司洗脱支架治疗急性冠状动脉综合征患者3个月后替格瑞洛单药治疗（TICO）试验的一项亚分析。PCI成功后，患者被随机分配至3个月DAPT后改用替格瑞洛单药治疗组或接受基于替格瑞洛的12个月DAPT组。我们比较了糖尿病患者和非糖尿病患者12个月内的缺血事件和出血事件。缺血事件定义为死亡、心肌梗死、缺血性中风、短暂性脑缺血发作、支架血栓形成以及任何血管重建。出血事件根据心肌梗死溶栓（TIMI）标准和出血学术研究联盟（BARC）定义进行定义。
2015年8月至2018年10月期间，3056例患者纳入TICO试验，其中835例（27.3%）患有糖尿病。糖尿病与所有评估的缺血和出血事件相关。在糖尿病患者中，3个月DAPT后改用替格瑞洛单药治疗与基于替格瑞洛的12个月DAPT相比，在任何缺血事件方面未观察到显著差异（风险比[HR]0.83，95%置信区间[CI]0.45 - 1.52，p = 0.540）。在糖尿病患者中，两个治疗组在12个月随访期内出血并发症的总体发生率无差异（HR 0.83，95% CI 1.48 - 1.43，p = 0.505）。然而，在3个月的标志性分析中，即3个月DAPT期后，替格瑞洛单药治疗显著降低了糖尿病患者的任何TIMI出血以及BARC 3型或5型出血事件（HR 0.20，95% CI 0.07 - 0.59，p = 0.003）。
在糖尿病患者中，与基于替格瑞洛的12个月DAPT相比，3个月DAPT期后改用替格瑞洛单药治疗出血并发症发生率更低，且不增加缺血并发症（ClinicalTrials.gov标识符：NCT02494895）。
