Abstract：
OBJECTIVE: To evaluate whether the effectiveness and safety of low (81 mg daily) versus high-dose (325 mg daily) aspirin is consistent across races among patients with established atherosclerotic cardiovascular disease (ASCVD).
METHODS: A secondary analysis of the randomised controlled trial ADAPTABLE was performed.
METHODS: The study was conducted in 40 centres and one health plan participating in the National Patient-Centred Clinical Research Network (PCORnet) in the USA.
METHODS: Among 15 076 participants with established ASCVD, 14 096 had self-reported race available and were included in the analysis. Participants were divided according to self-reported race as Black (n=1311, 9.3%), White (n=11 990, 85.1%) or other race (n=795, 5.6%).
METHODS: Participants were randomised to open-label daily aspirin doses of 81 mg versus 325 mg in a 1:1 ratio for a median of 26.2 months.
METHODS: The primary effectiveness endpoint was a composite of death from any cause, hospitalisation for myocardial infarction or hospitalisation for stroke. The primary safety endpoint was hospitalisation for bleeding requiring blood product transfusion.
RESULTS: Estimated cumulative incidence of the primary effectiveness endpoint at median follow-up with the 81 mg and the 325 mg daily doses were 6.70% and 7.12% in White participants (adjusted HR: 1.00 [95% CI: 0.88 to 1.15]); 12.27% and 10.69% in Black participants (adjusted HR: 1.40 [95% CI: 1.02 to 1.93]); and 6.88% and 7.69% in other participants (adjusted HR: 0.86 [95% CI: 0.54 to 1.39]) (p-interaction=0.12), respectively. There was no significant interaction between self-reported race and assigned aspirin dose regarding the secondary effectiveness and the primary safety endpoints.
CONCLUSIONS: Race is not an effect modifier on the impact of aspirin dosing on effectiveness and safety in patients with established ASCVD. In clinical practice, treatment decisions regarding aspirin dose in secondary prevention of ASCVD should not be influenced by race.
BACKGROUND: NCT02697916.
METHODS: A secondary analysis of the randomised controlled trial ADAPTABLE was performed.
METHODS: The study was conducted in 40 centres and one health plan participating in the National Patient-Centred Clinical Research Network (PCORnet) in the USA.
METHODS: Among 15 076 participants with established ASCVD, 14 096 had self-reported race available and were included in the analysis. Participants were divided according to self-reported race as Black (n=1311, 9.3%), White (n=11 990, 85.1%) or other race (n=795, 5.6%).
METHODS: Participants were randomised to open-label daily aspirin doses of 81 mg versus 325 mg in a 1:1 ratio for a median of 26.2 months.
METHODS: The primary effectiveness endpoint was a composite of death from any cause, hospitalisation for myocardial infarction or hospitalisation for stroke. The primary safety endpoint was hospitalisation for bleeding requiring blood product transfusion.
RESULTS: Estimated cumulative incidence of the primary effectiveness endpoint at median follow-up with the 81 mg and the 325 mg daily doses were 6.70% and 7.12% in White participants (adjusted HR: 1.00 [95% CI: 0.88 to 1.15]); 12.27% and 10.69% in Black participants (adjusted HR: 1.40 [95% CI: 1.02 to 1.93]); and 6.88% and 7.69% in other participants (adjusted HR: 0.86 [95% CI: 0.54 to 1.39]) (p-interaction=0.12), respectively. There was no significant interaction between self-reported race and assigned aspirin dose regarding the secondary effectiveness and the primary safety endpoints.
CONCLUSIONS: Race is not an effect modifier on the impact of aspirin dosing on effectiveness and safety in patients with established ASCVD. In clinical practice, treatment decisions regarding aspirin dose in secondary prevention of ASCVD should not be influenced by race.
BACKGROUND: NCT02697916.
摘要：
目的：评估低剂量（每日81毫克）与高剂量（每日325毫克）阿司匹林的有效性和安全性是否在已确定的动脉粥样硬化性心血管疾病（ASCVD）患者中的种族之间一致。
方法：对ADAPTABLE随机对照试验进行二次分析。
方法：本研究在美国国家以患者为中心的临床研究网络（PCRnet）的40个中心和一个健康计划中进行。
方法：在15,076名已建立ASCVD的参与者中，14096有自我报告的种族可用，并包括在分析中。参与者根据自我报告的种族分为黑人（n=1311，9.3％），白人（n=11990，85.1%）或其他种族（n=795，5.6%）。
方法：参与者以1：1的比例随机分配给开放标签的每日阿司匹林剂量为81mg和325mg，中位数为26.2个月。
方法：主要有效性终点是由任何原因导致的死亡，因心肌梗死或中风住院。主要安全终点是因需要输血的出血而住院。
结果：在白人参与者中，每日剂量为81mg和325mg的中位随访时，主要有效性终点的估计累积发生率分别为6.70％和7.12％（调整后的HR：1.00[95％CI：0.88至1.15]）；黑人参与者中的12.27％和10.69％（调整后的HR：1.40[95％CI：1.02至1.93]），其他参与者分别。在次要有效性和主要安全性终点方面，自我报告的种族和分配的阿司匹林剂量之间没有显著的相互作用。
结论：Race不是阿司匹林给药对ASCVD患者有效性和安全性影响的效应调节剂。在临床实践中,ASCVD二级预防中阿司匹林剂量的治疗决定不应受到种族的影响.
背景：NCT02697916。
方法：对ADAPTABLE随机对照试验进行二次分析。
方法：本研究在美国国家以患者为中心的临床研究网络（PCRnet）的40个中心和一个健康计划中进行。
方法：在15,076名已建立ASCVD的参与者中，14096有自我报告的种族可用，并包括在分析中。参与者根据自我报告的种族分为黑人（n=1311，9.3％），白人（n=11990，85.1%）或其他种族（n=795，5.6%）。
方法：参与者以1：1的比例随机分配给开放标签的每日阿司匹林剂量为81mg和325mg，中位数为26.2个月。
方法：主要有效性终点是由任何原因导致的死亡，因心肌梗死或中风住院。主要安全终点是因需要输血的出血而住院。
结果：在白人参与者中，每日剂量为81mg和325mg的中位随访时，主要有效性终点的估计累积发生率分别为6.70％和7.12％（调整后的HR：1.00[95％CI：0.88至1.15]）；黑人参与者中的12.27％和10.69％（调整后的HR：1.40[95％CI：1.02至1.93]），其他参与者分别。在次要有效性和主要安全性终点方面，自我报告的种族和分配的阿司匹林剂量之间没有显著的相互作用。
结论：Race不是阿司匹林给药对ASCVD患者有效性和安全性影响的效应调节剂。在临床实践中,ASCVD二级预防中阿司匹林剂量的治疗决定不应受到种族的影响.
背景：NCT02697916。
