Algazzar Alaa S, Aljondi Raghad M, Metwalli Eilaf Majdi, Dhaher Ghazal Y, Mushaeb Hanan H, Aljadani Renad H, Balahmar Rahaf S, Hafiz Awatif, Qutub Mohamed A
Department of Cardiology, Ahmed Maher Teaching Hospital, Cairo, Egypt.
Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
Anatol J Cardiol. 2025 Jan 7;29(2):95-103. doi: 10.14744/AnatolJCardiol.2024.4603.
Type 2 diabetes mellitus (T2DM) patients with small-diameter stents (SDS), that are equal to or less than 2.5 mm in diameter, face increased risks of restenosis and complications. This study aimed to evaluate the 1-year follow-up to assess the rate of major adverse cardiac events (MACE) and bleeding risk between ticagrelor and clopidogrel in T2DM patients after SDS implantation.
The study was a single-center, prospective controlled registry trial, which included 332 T2DM patients who underwent percutaneous coronary intervention with SDS implantation. Follow-up was conducted for 1 year.
Following propensity score matching, the 1-year analysis revealed no significant difference in the risk of the composite MACE between clopidogrel and ticagrelor groups (P = .295). Male gender, history of ischemic heart disease, ejection fraction (EF), coronary lesion type, and chronic kidney disease (CKD) were identified as potential predictors for the composite endpoint. In a subanalysis of CKD patients, the 12-month rates of composites of cardiac death (CD), myocardial infarction (MI), stroke, and target vessel revascularization (TVR) were lower in the ticagrelor group than in the clopidogrel group (P = .024). However, the ticagrelor group was associated with a higher rate of bleeding compared to the clopidogrel group (20% vs. 9%) (P = .041).
Our study demonstrated that ticagrelor did not show improvement in the composite of CD, MI, stroke, TVR, or the risk of bleeding events defined by the BARC criteria in patients with T2DM and SDS compared with clopidogrel emphasizing the importance of individualized treatment decisions based on patient characteristics. However, the results may not be representative of the entire population.
直径小于或等于2.5毫米的小直径支架（SDS）植入2型糖尿病（T2DM）患者体内，会增加再狭窄和并发症风险。本研究旨在评估T2DM患者植入SDS后，替格瑞洛和氯吡格雷在1年随访期内主要不良心脏事件（MACE）发生率及出血风险。
本研究为单中心前瞻性对照注册试验，纳入332例行SDS植入经皮冠状动脉介入治疗的T2DM患者。随访1年。
倾向评分匹配后，1年分析显示氯吡格雷组和替格瑞洛组的复合MACE风险无显著差异（P = 0.295）。男性、缺血性心脏病史、射血分数（EF）、冠状动脉病变类型和慢性肾脏病（CKD）被确定为复合终点的潜在预测因素。在CKD患者亚组分析中，替格瑞洛组心脏死亡（CD）、心肌梗死（MI）、卒中及靶血管血运重建（TVR）复合事件的12个月发生率低于氯吡格雷组（P = 0.024）。然而，与氯吡格雷组相比，替格瑞洛组出血发生率更高（20%对9%）（P = 0.041）。
我们的研究表明，与氯吡格雷相比，替格瑞洛在T2DM和SDS患者中，在CD、MI、卒中、TVR复合事件或BARC标准定义的出血事件风险方面未显示出改善，强调了基于患者特征进行个体化治疗决策的重要性。然而，结果可能不代表整个人群。
