在体重处于极端范围的房颤患者中，阿哌沙班与华法林的疗效和安全性。
Efficacy and Safety of Apixaban Versus Warfarin in Patients With Atrial Fibrillation and Extremes in Body Weight.
机构信息
Johann Wolfgang Goethe University, Frankfurt, Germany (S.G.G.).
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.H.A., D.M.W., S.M.A.-K., C.B.G., R.D.L.).
出版信息
Circulation. 2019 May 14;139(20):2292-2300. doi: 10.1161/CIRCULATIONAHA.118.037955.
BACKGROUND
Guidelines caution against the use of non-vitamin K antagonist oral anticoagulants in patients with extremely high (>120 kg) or low (≤60 kg) body weight because of a lack of data in these populations.
METHODS
In a post hoc analysis of ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation; n=18 201), a randomized trial comparing apixaban with warfarin for the prevention of stroke in patients with atrial fibrillation, we estimated the randomized treatment effect (apixaban versus warfarin) stratified by body weight (≤60, >60-120, >120 kg) using a Cox regression model and tested the interaction between body weight and randomized treatment. The primary efficacy and safety outcomes were stroke or systemic embolism and major bleeding.
RESULTS
Of the 18 139 patients with available weight and outcomes data, 1985 (10.9%) were in the low-weight group (≤60 kg), 15 172 (83.6%) were in the midrange weight group (>60-120 kg), and 982 (5.4%) were in the high-weight group (>120 kg). The treatment effect of apixaban versus warfarin for the efficacy outcomes of stroke/systemic embolism, all-cause death, or myocardial infarction was consistent across the weight spectrum (interaction P value>0.05). For major bleeding, apixaban had a better safety profile than warfarin in all weight categories and even showed a greater relative risk reduction in patients in the low (≤60 kg; HR, 0.55; 95% CI, 0.36-0.82) and midrange (>60-120 kg) weight groups (HR, 0.71; 95% CI, 0.61-0.83; interaction P value=0.016).
CONCLUSIONS
Our findings provide evidence that apixaban is efficacious and safe across the spectrum of weight, including in low- (≤60 kg) and high-weight patients (>120 kg). The superiority on efficacy and safety outcomes of apixaban compared with warfarin persists across weight groups, with even greater reductions in major bleeding in patients with atrial fibrillation with low to normal weight as compared with high weight. The superiority of apixaban over warfarin in regard to efficacy and safety for stroke prevention seems to be similar in patients with atrial fibrillation across the spectrum of weight, including in low- and very high-weight patients. Thus, apixaban appears to be appropriate for patients with atrial fibrillation irrespective of body weight.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov . Unique identifier: NCT00412984.
背景
指南警告称，由于缺乏这些人群的数据，不建议将非维生素 K 拮抗剂口服抗凝剂用于体重极高（＞120kg）或极低（≤60kg）的患者。
方法
在 ARISTOTLE（阿哌沙班用于预防心房颤动患者中风和其他血栓栓塞事件；n=18201）的事后分析中，这是一项比较阿哌沙班与华法林预防心房颤动患者中风的随机试验，我们使用 Cox 回归模型按体重（≤60kg、＞60-120kg、＞120kg）分层估计随机治疗效果（阿哌沙班与华法林），并检验体重与随机治疗之间的交互作用。主要疗效和安全性结局是中风或全身性栓塞以及大出血。
结果
在有体重和结局数据的 18139 名患者中，1985 名（10.9%）体重较轻（≤60kg），15172 名（83.6%）体重中等（＞60-120kg），982 名（5.4%）体重较重（＞120kg）。阿哌沙班与华法林在疗效结局（中风/全身性栓塞、全因死亡或心肌梗死）方面的治疗效果在整个体重范围内是一致的（交互 P 值＞0.05）。对于大出血，阿哌沙班在所有体重类别中的安全性均优于华法林，甚至在体重较轻（≤60kg；HR，0.55；95%CI，0.36-0.82）和体重中等（＞60-120kg）的患者中（HR，0.71；95%CI，0.61-0.83；交互 P 值=0.016）显示出更大的相对风险降低。
结论
我们的研究结果提供了证据，表明阿哌沙班在整个体重范围内（包括体重较轻（≤60kg）和较重（＞120kg）的患者）均有效且安全。与华法林相比，阿哌沙班在疗效和安全性结局方面的优势在体重组中持续存在，与体重较高的患者相比，房颤伴低至正常体重患者的大出血风险降低幅度更大。阿哌沙班在预防中风方面的疗效和安全性似乎与房颤患者的体重谱相似，包括体重较轻和非常重的患者。因此，阿哌沙班似乎适合体重不同的房颤患者。
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