Department of Cardiology, The Second Affiliated Hospital, Army Medical University, Chongqing, China.
Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.
Cardiovasc Ther. 2021 Oct 15;2021:5546260. doi: 10.1155/2021/5546260. eCollection 2021.
The increased thrombotic risk in patients with acute coronary syndrome (ACS) and diabetes highlights the need for adequate antithrombotic protection. We aimed to compare the 6-month clinical outcomes between ticagrelor and clopidogrel in patients with ACS and diabetes.
The study was a single-center, prospective, randomized, open-label, blinded endpoint, and controlled registry trial. A total of 270 ACS patients with diabetes were randomly assigned in a 1 : 1 ratio to either the ticagrelor group or the clopidogrel group. Follow-up was performed for 6 months, and the data on efficacy outcomes and bleeding events were collected. At 6 months, complete follow-up data were available for 266 (98.5%) of 270 patients, and 4 were lost to follow-up. There was no significant difference in the survival rate of the effective endpoints between the ticagrelor group ( = 133) and the clopidogrel group ( = 133) (HR 0.83, 95% CI 0.44-1.56, = 0.561), but the incidence of bleeding events in the ticagrelor group was higher than that in the clopidogrel group (HR 1.76, 95% CI 1.00-3.10, = 0.049).
Ticagrelor did not improve the composite of nonfatal MI, target vessel revascularization, rehospitalization, stroke, and death from any cause; however, it significantly increased the incidence of bleeding events defined by the Bleeding Academic Research Consortium (BARC) criteria in Chinese patients with ACS and diabetes during the 6-month follow-up compared with clopidogrel.
急性冠脉综合征(ACS)和糖尿病患者的血栓形成风险增加,突出了充分的抗血栓保护的必要性。我们旨在比较替格瑞洛和氯吡格雷在 ACS 和糖尿病患者中的 6 个月临床结局。
这是一项单中心、前瞻性、随机、开放标签、盲终点、对照登记研究。共纳入 270 例 ACS 合并糖尿病患者,按 1:1 比例随机分配至替格瑞洛组或氯吡格雷组。随访 6 个月,收集疗效结局和出血事件的数据。在 6 个月时,270 例患者中的 266 例(98.5%)获得了完整的随访数据,4 例失访。替格瑞洛组(n=133)和氯吡格雷组(n=133)的有效终点生存率无显著差异(HR 0.83,95%CI 0.44-1.56,=0.561),但替格瑞洛组出血事件的发生率高于氯吡格雷组(HR 1.76,95%CI 1.00-3.10,=0.049)。
替格瑞洛并未改善非致命性 MI、靶血管血运重建、再住院、卒中和任何原因导致的死亡的复合终点;然而,与氯吡格雷相比,它在 6 个月随访期间显著增加了中国 ACS 和糖尿病患者中根据 Bleeding Academic Research Consortium(BARC)标准定义的出血事件的发生率。