Aspirin Dosing for Secondary Prevention of Atherosclerotic Cardiovascular Disease in Patients Treated With P2Y12 Inhibitors.
Aspirin Dosing for Secondary Prevention of Atherosclerotic Cardiovascular Disease in Patients Treated With P2Y12 Inhibitors.
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DOI：
10.1161/jaha.123.030385
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发表时间：
2023-10-17
影响因子：
5.4
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适应性试验(阿司匹林剂量：一项评估益处和长期有效性的以患者为中心的试验)是一项大型、务实的随机对照试验，发现高剂量和低剂量阿司匹林对动脉粥样硬化性心血管疾病的二级预防没有差异。目前尚不清楚伴随的P2Y12抑制剂治疗是否改变了阿司匹林剂量对临床事件的影响。适应性组的参与者根据氯吡格雷或普拉格雷的基线使用情况进行分层(P2Y12组)。主要有效终点是死亡、心肌梗死或中风；主要安全终点是需要输血的大出血。我们使用多变量COX回归来比较P2Y12组和非P2Y12组阿司匹林剂量的相对有效性和安全性。在13名有数据的 815(91.6%)参与者中，3051(22.1%)在基线时服用氯吡格雷(2849[93.4%])或普拉格雷(203[6.7%])。使用P2Y12抑制剂与较高的主要有效终点风险(10.86%比6.31%；调整后的风险比，1.40[95%可信区间，1.22-1.62])相关，但与出血无关(0.95%比0.53%；调整后的风险比，1.42[95%可信区间，0.91-2.22])。我们发现通过使用P2Y12抑制剂，高剂量阿司匹林与低剂量阿司匹林的相对有效性和安全性没有相互作用。总体而言，与小剂量阿司匹林组相比，大剂量阿司匹林组更常见的是剂量转换或停药，但这种模式并未因使用P2Y12抑制剂而改变。在这项适应性的预先指定分析中，我们发现高剂量阿司匹林与低剂量阿司匹林的相对有效性和安全性不会因P2Y12抑制剂的基线使用而改变。Https://www.clinical.trials.gov.唯一标识：NCT02697916。
The ADAPTABLE (Aspirin Dosing: A Patient‐Centric Trial Assessing Benefits and Long‐Term Effectiveness) was a large, pragmatic, randomized controlled trial that found no difference between high‐ versus low‐dose aspirin for secondary prevention of atherosclerotic cardiovascular disease. Whether concomitant P2Y12 inhibitor therapy modifies the effect of aspirin dose on clinical events remains unclear. Participants in ADAPTABLE were stratified according to baseline use of clopidogrel or prasugrel (P2Y12 group). The primary effectiveness end point was a composite of death, myocardial infarction, or stroke; and the primary safety end point was major bleeding requiring blood transfusions. We used multivariable Cox regression to compare the relative effectiveness and safety of aspirin dose within P2Y12 and non‐P2Y12 groups. Of 13 815 (91.6%) participants with available data, 3051 (22.1%) were receiving clopidogrel (2849 [93.4%]) or prasugrel (203 [6.7%]) at baseline. P2Y12 inhibitor use was associated with higher risk of the primary effectiveness end point (10.86% versus 6.31%; adjusted hazard ratio [HR], 1.40 [95% CI, 1.22–1.62]) but was not associated with bleeding (0.95% versus 0.53%; adjusted HR, 1.42 [95% CI, 0.91–2.22]). We found no interaction in the relative effectiveness and safety of high‐ versus low‐dose aspirin by P2Y12 inhibitor use. Overall, dose switching or discontinuation was more common in the high‐dose compared with low‐dose aspirin group, but the pattern was not modified by P2Y12 inhibitor use. In this prespecified analysis of ADAPTABLE, we found that the relative effectiveness and safety of high‐ versus low‐dose aspirin was not modified by baseline P2Y12 inhibitor use. https://www.clinical.trials.gov. Unique identifier: NCT02697916.