Lip Gregory Y H, Lanitis Tereza, Mardekian Jack, Kongnakorn Thitima, Phatak Hemant, Dorian Paul
From the Centre for Cardiovascular Science, City Hospital, University of Birmingham, Birmingham, United Kingdom (G.Y.H.L.); Thrombosis Research Unit, Aalborg University, Aalborg, Denmark (G.Y.H.L.); Modeling and Simulation, Evidera, London, United Kingdom (T.L., T.K.); Statistics, Pfizer, New York, NY (J.M.); US Health Economics & Outcomes Research, EMD Serono, Rockland, MA (H.P.); and Division of Cardiology, University of Toronto, St. Michael's Hospital, Toronto, Ontario, Canada (P.D.).
Stroke. 2015 Oct;46(10):2830-7. doi: 10.1161/STROKEAHA.115.009995. Epub 2015 Aug 27.
Although recommended by guidelines, the benefits of treating patients with atrial fibrillation with a low-stroke risk score, with aspirin or anticoagulants, have not been clearly established. With advent of safer non-vitamin K antagonist oral anticoagulant, we assessed the clinical and economic implications of 5 mg BID of apixaban versus aspirin among patients with a relative low risk of stroke as assessed using the CHADS2 (congestive heart failure, hypertension, age>75, diabetes mellitus, stroke/transient ischemic attack) and CHA2DS2-VASc (congestive heart failure, hypertension, age, diabetes mellitus, stroke/transient ischemic attack, vascular disease) stroke risk classification.
A previously developed and validated Markov model was adapted. A secondary analysis of the Apixaban Versus Acetylsalicylic Acid to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment (AVERROES) study was conducted to estimate event rates in different low-risk cohorts by treatment. Three cohorts (n=1000) with a CHADS2 score of 1, CHA2DS2-VASc score of 1, and CHA2DS2-VASc of score 2 to 4 were simulated to assess the number of clinical events avoided in terms of strokes and major bleeds, as well as life years gained, quality-adjusted life years gained, costs, and incremental costs per quality-adjusted life year gained.
Apixaban was associated with fewer strokes and systemic embolism versus aspirin across all subgroups; however, it caused more major bleeding events. The reduction in systemic embolism offset the increase in major bleeding events leading to increased life expectancy and quality-adjusted life year gains, achieved at an increased cost that was lower than the UK threshold of $44,400 (ie, £30,000) per quality-adjusted life year gained across the 3 cohorts examined.
Anticoagulant treatment with apixaban versus aspirin in low-risk patients, as identified using CHADS2 or CHA2DS2-VASc, is projected to increase life expectancy and provide clinical benefits that are cost effective.
尽管指南有所推荐,但对于卒中风险评分较低的房颤患者使用阿司匹林或抗凝剂治疗的益处尚未明确确立。随着更安全的非维生素K拮抗剂口服抗凝剂的出现,我们评估了使用CHADS2(充血性心力衰竭、高血压、年龄>75岁、糖尿病、卒中/短暂性脑缺血发作)和CHA2DS2-VASc(充血性心力衰竭、高血压、年龄、糖尿病、卒中/短暂性脑缺血发作、血管疾病)卒中风险分类评估的卒中风险相对较低的患者中,每日两次服用5mg阿哌沙班与阿司匹林相比的临床和经济影响。
采用先前开发并验证的马尔可夫模型。对阿哌沙班与乙酰水杨酸预防房颤患者卒中的研究(AVERROES)进行二次分析,该研究纳入了对维生素K拮抗剂治疗无效或不适用的患者,以按治疗方式估计不同低风险队列中的事件发生率。模拟了三个队列(n = 1000),其CHADS2评分为1、CHA2DS2-VASc评分为1以及CHA2DS2-VASc评分为2至4,以评估在卒中、大出血方面避免的临床事件数量,以及获得的生命年数、质量调整生命年数、成本和每获得一个质量调整生命年的增量成本。
在所有亚组中,与阿司匹林相比,阿哌沙班与较少的卒中和全身性栓塞相关;然而,它导致了更多的大出血事件。全身性栓塞的减少抵消了大出血事件的增加,从而导致预期寿命延长和质量调整生命年增加,所增加的成本低于英国每获得一个质量调整生命年44,400美元(即30,000英镑)的阈值,该阈值是在研究的三个队列中计算得出的。
对于使用CHADS2或CHA2DS2-VASc确定的低风险患者,与阿司匹林相比,使用阿哌沙班进行抗凝治疗预计会延长预期寿命,并提供具有成本效益的临床益处。