比较两种剂量阿司匹林在慢性肾脏病患者二级预防心血管结局中的有效性和安全性：ADAPTABLE 的亚组分析。
Comparison of the effectiveness and safety of 2 aspirin doses in secondary prevention of cardiovascular outcomes in patients with chronic kidney disease: A subgroup analysis of ADAPTABLE.
机构信息
Department of Cardiology, The University of Kansas Medical Center, Kansas City, KS.
Department of Cardiology, The University of Kansas Medical Center, Kansas City, KS.
出版信息
Am Heart J. 2023 Oct;264:31-39. doi: 10.1016/j.ahj.2023.06.001. Epub 2023 Jun 7.
BACKGROUND
Among patients with established cardiovascular disease, the ADAPTABLE trial found no significant differences in cardiovascular events and bleeding rates between 81 mg and 325 mg of aspirin (ASA) daily. In this secondary analysis from the ADAPTABLE trial, we studied the effectiveness and safety of ASA dosing in patients with a history of chronic kidney disease (CKD).
METHODS
ADAPTABLE participants were stratified based on the presence or absence of CKD, defined using ICD-9/10-CM codes. Within the CKD group, we compared outcomes between patients taking ASA 81 mg and 325 mg. The primary effectiveness outcome was defined as a composite of all cause death, myocardial infarction, or stroke and the primary safety outcome was hospitalization for major bleeding. Adjusted Cox proportional hazard models were utilized to report differences between the groups.
RESULTS
After excluding 414 (2.7%) patients due to missing medical history, a total of 14,662 patients were included from the ADAPTABLE cohort, of whom 2,648 (18%) patients had CKD. Patients with CKD were older (median age 69.4 vs 67.1 years; P < .0001) and less likely to be white (71.5% vs 81.7%; P < .0001) when compared to those without CKD. At a median follow-up of 26.2 months, CKD was associated with an increased risk of both the primary effectiveness outcome (adjusted HR 1.79 [1.57, 2.05] P < .001 and the primary safety outcome (adjusted HR 4.64 (2.98, 7.21), P < .001 and P < .05, respectively) regardless of ASA dose. There was no significant difference in effectiveness (adjusted HR 1.01 95% CI 0.82, 1.23; P = .95) or safety (adjusted HR 0.93; 95% CI 0.52, 1.64; P = .79) between ASA groups.
CONCLUSIONS
Patients with CKD were more likely than those without CKD to have adverse cardiovascular events or death and were also more likely to have major bleeding requiring hospitalization. However, there was no association between ASA dose and study outcomes among these patients with CKD.
背景
在已患有心血管疾病的患者中，ADAPTABLE 试验发现每日服用 81 毫克和 325 毫克阿司匹林（ASA）在心血管事件和出血率方面没有显著差异。在 ADAPTABLE 试验的这项二次分析中，我们研究了 ASA 剂量在慢性肾脏病（CKD）病史患者中的有效性和安全性。
方法
根据 ICD-9/10-CM 代码，将 ADAPTABLE 参与者分为存在或不存在 CKD。在 CKD 组中，我们比较了服用 ASA 81 毫克和 325 毫克的患者之间的结局。主要有效性结局定义为全因死亡、心肌梗死或中风的复合结局，主要安全性结局定义为因大出血而住院的事件。采用调整后的 Cox 比例风险模型报告组间差异。
结果
排除因缺少病史而缺失的 414 例患者（2.7%）后，从 ADAPTABLE 队列中共纳入 14662 例患者，其中 2648 例（18%）患者患有 CKD。与无 CKD 患者相比，CKD 患者年龄更大（中位数 69.4 岁 vs 67.1 岁；P<0.0001）且白人比例更低（71.5% vs 81.7%；P<0.0001）。在中位随访 26.2 个月时，无论 ASA 剂量如何，CKD 均与主要有效性结局（调整后的 HR 1.79[1.57，2.05]，P<0.001）和主要安全性结局（调整后的 HR 4.64[2.98，7.21]，P<0.001 和 P<0.05）的风险增加相关。在 CKD 患者中，ASA 剂量与有效性（调整后的 HR 1.01，95%CI 0.82，1.23；P=0.95）或安全性（调整后的 HR 0.93，95%CI 0.52，1.64；P=0.79）之间均无显著差异。
结论
与无 CKD 患者相比，CKD 患者更有可能发生不良心血管事件或死亡，且更有可能因大出血需要住院治疗。然而，在这些 CKD 患者中，ASA 剂量与研究结局之间没有关联。
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