小柯机器人

北京天坛医院王拥军教授比较了替卡格雷与氯吡格雷在CYP2C19功能丧失携带者卒中或短暂性脑缺血发作中的疗效和安全性。这一研究成果发表在2021年10月28日出版的《新英格兰医学杂志》上。

替卡格雷与氯吡格雷在CYP2C19功能丧失携带者卒中二级预防方面的比较尚未广泛开展。

研究组在中国的202个中心进行了一项随机、双盲、安慰剂对照试验，招募携带CYP2C19功能缺失等位基因的轻度缺血性中风或短暂性脑缺血发作（TIA）患者。在症状出现后24小时内按1:1的比例随机分组，分别接受替卡格雷和氯吡格雷安慰剂，或接受氯吡格雷和替卡格雷安慰剂治疗；两组均服用阿司匹林21天。主要疗效结局为新发脑卒中，主要安全性结局为90天内的严重或中度出血。

研究组共筛查了11255名患者，纳入6412名，其中3205名患者被分配到替卡格雷组，3207名患者被分配到氯吡格雷组。患者年龄中位数为64.8岁，女性占33.8%；98.0%为汉族。

替卡格雷组中有191名患者（6.0%）在90天内发生卒中，显著低于氯吡格雷组的243名患者（7.6%），风险比为0.77。次要结局通常与主要结局的方向相同。替卡格雷组中有9例（0.3%）患者发生严重或中度出血，氯吡格雷组中有11例（0.3%）；替卡格雷组中有170例（5.3%）患者发生全因出血，氯吡格雷组中有80例（2.5%）。

研究结果表明，在携带CYP2C19功能丧失等位基因的中国轻度缺血性卒中或TIA患者中，替卡格雷在90天时发生卒中的风险略低于氯吡格雷。两个治疗组之间发生严重或中度出血的风险没有差异，但替卡格雷与总出血事件的相关性高于氯吡格雷。

附：英文原文

Title: Ticagrelor versus Clopidogrel in CYP2C19 Loss-of-Function Carriers with Stroke or TIA | NEJM

Author: Yongjun Wang, M.D.,, Xia Meng, M.D., Ph.D.,, Anxin Wang, Ph.D.,, Xuewei Xie, M.D., Ph.D.,, Yuesong Pan, Ph.D.,, S. Claiborne Johnston, M.D., Ph.D.,, Hao Li, Ph.D.,, Philip M. Bath, D.Sc., F.Med.Sci.,, Qiang Dong, M.D., Ph.D.,, Anding Xu, M.D., Ph.D.,, Jing Jing, M.D., Ph.D.,, Jinxi Lin, M.D., Ph.D.,, Siying Niu, M.D.,, Yilong Wang, M.D., Ph.D.,, Xingquan Zhao, M.D., Ph.D.,, Zixiao Li, M.D., Ph.D.,, Yong Jiang, Ph.D.,, Wei Li, M.D., Ph.D.,, Liping Liu, M.D., Ph.D.,, Jie Xu, M.D., Ph.D.,, Liguo Chang, M.D.,, Lihua Wang, M.D., Ph.D.,, Xianbo Zhuang, M.D., Ph.D.,, Jinguo Zhao, M.D.,, Yefang Feng, M.D.,, Honghao Man, M.D.,, Guozhong Li, M.D., Ph.D.,, and Baojun Wang, M.D., Ph.D.

Issue&Volume: 2021-10-28

Abstract:

Background

Comparisons between ticagrelor and clopidogrel for the secondary prevention of stroke in CYP2C19 loss-of-function carriers have not been extensively performed.

Methods

We conducted a randomized, double-blind, placebo-controlled trial at 202 centers in China involving patients with a minor ischemic stroke or transient ischemic attack (TIA) who carried CYP2C19 loss-of-function alleles. Patients were assigned within 24 hours after symptom onset, in a 1:1 ratio, to receive ticagrelor (180 mg on day 1 followed by 90 mg twice daily on days 2 through 90) and placebo clopidogrel or to receive clopidogrel (300 mg on day 1 followed by 75 mg once daily on days 2 through 90) and placebo ticagrelor; both groups received aspirin for 21 days. The primary efficacy outcome was new stroke, and the primary safety outcome was severe or moderate bleeding, both within 90 days.

Results

A total of 11,255 patients were screened and 6412 patients were enrolled, with 3205 assigned to the ticagrelor group and 3207 to the clopidogrel group. The median age of the patients was 64.8 years, and 33.8% were women; 98.0% belonged to the Han Chinese ethnic group. Stroke occurred within 90 days in 191 patients (6.0%) in the ticagrelor group and 243 patients (7.6%) in the clopidogrel group (hazard ratio, 0.77; 95% confidence interval, 0.64 to 0.94; P=0.008). Secondary outcomes were generally in the same direction as the primary outcome. Severe or moderate bleeding occurred in 9 patients (0.3%) in the ticagrelor group and in 11 patients (0.3%) in the clopidogrel group; any bleeding occurred in 170 patients (5.3%) and 80 patients (2.5%), respectively.

Conclusions

Among Chinese patients with minor ischemic stroke or TIA who were carriers of CYP2C19 loss-of-function alleles, the risk of stroke at 90 days was modestly lower with ticagrelor than with clopidogrel. The risk of severe or moderate bleeding did not differ between the two treatment groups, but ticagrelor was associated with more total bleeding events than clopidogrel.

DOI: 10.1056/NEJMoa2111749

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2111749

The New England Journal of Medicine：《新英格兰医学杂志》，创刊于1812年。隶属于美国麻省医学协会，最新IF：176.079
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