Shah Rohan, Hellkamp Anne, Lokhnygina Yuliya, Becker Richard C, Berkowitz Scott D, Breithardt Günter, Hacke Werner, Halperin Jonathan L, Hankey Graeme J, Fox Keith A A, Nessel Christopher C, Mahaffey Kenneth W, Piccini Jonathan P, Singer Daniel E, Patel Manesh R
Duke Clinical Research Institute, Durham, NC.
University of Cincinnati College of Medicine, Cincinnati, OH.
Am Heart J. 2016 Sep;179:77-86. doi: 10.1016/j.ahj.2016.05.019. Epub 2016 Jun 22.
We aimed to investigate the relationship between aspirin use and clinical outcomes in patients enrolled in Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF), in particular, those with known coronary artery disease (CAD).
Patients in ROCKET AF, comparing rivaroxaban and warfarin, were analyzed. Aspirin use was assessed at baseline. Stroke and systemic embolism, myocardial infarction, death, and major or nonmajor clinically relevant (NMCR) bleeding were compared between groups. Multivariable modeling was done adjusting for baseline risk factors.
A total of 5,205 (36.5%) patients were receiving aspirin at baseline (mean dose 99.2mg); 30.6% of those had known CAD. Patients receiving aspirin were more likely to have prior myocardial infarction (22% vs 14%; P<.001) and heart failure (68% vs 59%; P<.001). Relative efficacy of rivaroxaban versus warfarin was similar with and without aspirin use for both stroke/systemic embolism (P=.95 for interaction), and major or NMCR bleeding (P=.76 for interaction). After adjustment, aspirin use was associated with similar rates of stroke/systemic embolism (hazard ratio [HR] 1.16, 95% CI 0.98-1.37; P=.094) but higher rates of all-cause death (HR 1.27, 95% CI 1.13-1.42; P<.0001) and major or NMCR bleeding (HR 1.32, 95% CI 1.21-1.43; P<.0001). There was a significant interaction between no CAD at baseline and aspirin for all-cause death (P=.009).
Aspirin use at baseline was associated with an increased risk for bleeding and all-cause death in ROCKET AF, a risk most pronounced in patients without known CAD. Although these findings may reflect unmeasured clinical factors, further investigation is warranted to determine optimal aspirin use in patients with AF.
我们旨在研究在房颤患者中使用利伐沙班每日一次口服直接抑制Xa因子与使用维生素K拮抗剂预防卒中及栓塞试验（ROCKET AF）中阿司匹林的使用与临床结局之间的关系，尤其是在已知患有冠状动脉疾病（CAD）的患者中。
对ROCKET AF中比较利伐沙班和华法林的患者进行分析。在基线时评估阿司匹林的使用情况。比较两组之间的卒中、全身性栓塞、心肌梗死、死亡以及主要或非主要临床相关（NMCR）出血情况。进行多变量建模以调整基线风险因素。
共有5205名（36.5%）患者在基线时接受阿司匹林治疗（平均剂量99.2mg）；其中30.6%患有已知CAD。接受阿司匹林治疗的患者更有可能有既往心肌梗死（22%对14%；P<0.001）和心力衰竭（68%对59%；P<0.001）。在使用和未使用阿司匹林的情况下，利伐沙班相对于华法林的相对疗效在卒中/全身性栓塞（交互作用P = 0.95）和主要或NMCR出血（交互作用P = 0.76）方面相似。调整后，阿司匹林的使用与卒中/全身性栓塞发生率相似（风险比[HR] 1.16，95%置信区间0.98 - 1.37；P = 0.094），但全因死亡率更高（HR 1.27，95%置信区间1.13 - 1.42；P<0.0001）以及主要或NMCR出血发生率更高（HR 1.32，95%置信区间1.21 - 1.43；P<0.0001）。在基线时无CAD和阿司匹林之间对于全因死亡存在显著交互作用（P = 0.009）。
在ROCKET AF中，基线时使用阿司匹林与出血和全因死亡风险增加相关，这种风险在无已知CAD的患者中最为明显。尽管这些发现可能反映了未测量的临床因素，但仍有必要进一步研究以确定房颤患者中阿司匹林的最佳使用方法。
