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非体外循环冠状动脉旁路移植术后氯吡格雷与替格瑞洛的随机试验。

A Randomized Trial of Clopidogrel vs Ticagrelor After Off-Pump Coronary Bypass.

机构信息

Division of Cardiovascular Surgery, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Yonsei University Health System, Seoul, Republic of Korea.

Division of Cardiovascular Surgery, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Yonsei University Health System, Seoul, Republic of Korea.

出版信息

Ann Thorac Surg. 2023 May;115(5):1127-1134. doi: 10.1016/j.athoracsur.2022.10.040. Epub 2022 Nov 14.

Abstract

BACKGROUND

This study aimed to compare the outcomes of aspirin in combination with either ticagrelor or clopidogrel after off-pump coronary artery bypass (OPCAB) in patients with clopidogrel resistance.

METHODS

Between November 2014 and November 2020, 1739 patients underwent OPCAB. Aspirin and clopidogrel treatment was initiated the day after surgery. On postoperative days 7 to 9, clopidogrel resistance was evaluated using a point-of-care assay. A total of 278 (18.9%) patients had clopidogrel resistance ( platelet reaction unit >208) and were enrolled in the study. The study investigators excluded patients with coresistance to aspirin (n = 74) and divided the remaining patients (mean age, 67.4 ± 8.5 years) into 2 groups (an aspirin and ticagrelor group [AT group; n = 102] and an aspirin and clopidogrel group [AC group; n = 102]), randomly assigned using a 1:1 ratio block table. The primary end point was graft patency and major adverse cardiovascular events (MACEs; defined as the composite of cardiovascular mortality, myocardial infarction, and repeat revascularization at 1 year after OPCAB), and the coprimary end point was the graft patency rate. The data were analyzed using the intent-to-treat method.

RESULTS

The graft occlusion rates in the AT and AC groups were 3.9% and 5.9%, respectively (P = .52). Neither death from cardiovascular causes (1.0% vs 2.9%; P = .32) nor myocardial infarction showed significant differences (1.0% vs 3.9%; P = .18). No significant difference in the rates of major bleeding were found between the 2 groups (P = .75). However, the AT group was associated with a lower rate of MACEs after OPCAB (hazard ratio, 0.77; 95% CI, 0.684-0.891; P = .01).

CONCLUSIONS

These results suggest that ticagrelor may be associated with reducing MACEs in patients with clopidogrel resistance after OPCAB.

摘要

背景

本研究旨在比较氯吡格雷抵抗患者行非体外循环冠状动脉旁路移植术(OPCAB)后,阿司匹林联合替格瑞洛或氯吡格雷的治疗效果。

方法

2014 年 11 月至 2020 年 11 月,共 1739 例行 OPCAB 的患者纳入本研究。术后第 1 天开始给予阿司匹林和氯吡格雷治疗。术后第 7-9 天,使用即时检测法评估氯吡格雷抵抗情况。共有 278 例(18.9%)患者发生氯吡格雷抵抗(血小板反应单位>208)并被纳入研究。研究人员排除了阿司匹林共抵抗患者(n=74),并将其余患者(平均年龄 67.4±8.5 岁)随机分为两组(阿司匹林和替格瑞洛组[AT 组;n=102]和阿司匹林和氯吡格雷组[AC 组;n=102]),使用 1:1 区组随机化方法。主要终点是移植物通畅率和主要不良心血管事件(MACE;定义为 OPCAB 术后 1 年时心血管死亡、心肌梗死和再次血运重建的复合终点),共同主要终点是移植物通畅率。采用意向治疗方法分析数据。

结果

AT 组和 AC 组的移植物闭塞率分别为 3.9%和 5.9%(P=0.52)。心血管原因死亡(1.0% vs 2.9%;P=0.32)和心肌梗死均无显著差异(1.0% vs 3.9%;P=0.18)。两组间大出血发生率无显著差异(P=0.75)。然而,OPCAB 后 AT 组的 MACE 发生率较低(风险比,0.77;95%CI,0.684-0.891;P=0.01)。

结论

这些结果表明,替格瑞洛可能与降低 OPCAB 后氯吡格雷抵抗患者的 MACE 发生率相关。

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