替格瑞洛-阿司匹林与氯吡格雷-阿司匹林在肾功能相关的小卒中或短暂性脑缺血发作的功能丧失型载体中的比较：CHANCE-2 试验的事后分析。
Ticagrelor-Aspirin Versus Clopidogrel-Aspirin Among Loss-of-Function Carriers With Minor Stroke or Transient Ischemic Attack in Relation to Renal Function: A Post Hoc Analysis of the CHANCE-2 Trial.
机构信息
Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, and China National Clinical Research Center for Neurological Diseases, Beijing, China (A.W., X.X., H.L., J.J., J.L., Y.W., X.Z., Z.L., Y.J., L.L., X.M.).
Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China National Clinical Research Center for Neurological Diseases, Beijing, Department of Epidemiology and Health Statistics, School of Public Health, Capital Medical University, Beijing, and Beijing Municipal Key Laboratory of Clinical Epidemiology, Beijing, China (X.T., Y.Z.).
出版信息
Ann Intern Med. 2022 Nov;175(11):1534-1542. doi: 10.7326/M22-1667. Epub 2022 Nov 1.
BACKGROUND
Evidence on the risk-benefit ratio of dual antiplatelet therapies among patients with stroke and impaired renal function is limited and inconsistent.
OBJECTIVE
To investigate the effect of renal function on the efficacy and safety of ticagrelor-aspirin versus clopidogrel-aspirin treatment.
DESIGN
Post hoc analysis of a multicenter, randomized, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT04078737).
SETTING
202 centers in China.
PATIENTS
loss-of-function allele carriers with minor stroke or transient ischemic attack.
INTERVENTION
Ticagrelor-aspirin and clopidogrel-aspirin.
MEASUREMENTS
Renal function was evaluated by estimated glomerular filtration rate (eGFR) levels. The primary efficacy and safety outcomes were recurrent stroke and severe or moderate bleeding within 90 days, respectively.
RESULTS
Among 6378 patients, 4050 (63.5%) had normal (eGFR ≥90 mL/min/1.73 m), 2010 (31.5%) had mildly decreased (eGFR 60 to 89 mL/min/1.73 m), and 318 (5.0%) had moderately to severely decreased (eGFR <60 mL/min/1.73 m) renal function. The corresponding differences in recurrent stroke between ticagrelor-aspirin and clopidogrel-aspirin for normal, mildly decreased, and moderately to severely decreased renal function was -2.8 percentage points (95% CI, -4.4 to -1.3 percentage points) (hazard ratio [HR], 0.63 [CI, 0.49 to 0.81]), -0.2 percentage point (CI, -2.4 to 2.0 percentage points) (HR, 0.98 [CI, 0.69 to 1.39]), and 3.7 percentage points (CI, -2.3 to 10.1 percentage points) (HR, 1.31 [CI, 0.48 to 3.55]), respectively. Rates of severe or moderate bleeding did not substantially differ by treatment assignments across eGFR categories.
LIMITATION
Renal function was only evaluated by using eGFR, and the proportion of patients with severely decreased renal function was low.
CONCLUSION
Patients with normal, rather than impaired, renal function received greater benefit from ticagrelor-aspirin versus clopidogrel-aspirin.
PRIMARY FUNDING SOURCE
Ministry of Science and Technology of the People's Republic of China.
背景
关于肾功能受损的卒中患者双联抗血小板治疗的风险-获益比的证据有限且不一致。
目的
研究肾功能对替格瑞洛-阿司匹林与氯吡格雷-阿司匹林治疗疗效和安全性的影响。
设计
多中心、随机、双盲、安慰剂对照试验的事后分析。（ClinicalTrials.gov：NCT04078737）。
地点
中国 202 个中心。
患者
携带功能丧失等位基因的小卒中或短暂性脑缺血发作患者。
干预措施
替格瑞洛-阿司匹林和氯吡格雷-阿司匹林。
测量
通过估算肾小球滤过率（eGFR）水平评估肾功能。主要疗效和安全性结局分别为 90 天内复发卒中以及严重或中度出血。
结果
在 6378 例患者中，4050 例（63.5%）肾功能正常（eGFR≥90 mL/min/1.73 m），2010 例（31.5%）肾功能轻度下降（eGFR 60 至 89 mL/min/1.73 m），318 例（5.0%）肾功能中度至重度下降（eGFR＜60 mL/min/1.73 m）。替格瑞洛-阿司匹林与氯吡格雷-阿司匹林相比，正常、轻度下降和中度至重度下降肾功能患者的复发性卒中差异分别为-2.8 个百分点（95%CI，-4.4 至-1.3 个百分点）（风险比[HR]，0.63[CI，0.49 至 0.81]）、-0.2 个百分点（CI，-2.4 至 2.0 个百分点）（HR，0.98[CI，0.69 至 1.39]）和 3.7 个百分点（CI，-2.3 至 10.1 个百分点）（HR，1.31[CI，0.48 至 3.55]）。不同 eGFR 类别之间，严重或中度出血的发生率与治疗分配没有显著差异。
局限性
仅通过 eGFR 评估肾功能，且肾功能严重下降患者的比例较低。
结论
与氯吡格雷-阿司匹林相比，替格瑞洛-阿司匹林在肾功能正常而非受损的患者中获益更大。
主要资金来源
中华人民共和国科学技术部。
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