Department of Pharmacy Practice, University of Connecticut School of Pharmacy, Storrs; Evidence-Based Practice Center, Hartford Hospital, Conn.
Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
Am J Med. 2018 Aug;131(8):933-938.e1. doi: 10.1016/j.amjmed.2018.02.015. Epub 2018 Mar 8.
Frailty predicts poorer outcomes in patients receiving anticoagulation. We assessed the effectiveness and safety of rivaroxaban vs warfarin in frail patients experiencing venous thromboembolism.
Using US MarketScan claims data from January 2012-December 2016, we identified frail patients (using the Johns Hopkins Claims-Based Frailty Indicator score) who had ≥1 primary hospitalization/emergency department visit diagnosis codes for venous thromboembolism, received rivaroxaban or warfarin as their first outpatient oral anticoagulant within 30 days of the index event, and had ≥12 months of insurance prior to the index venous thromboembolism. Differences in baseline covariates between cohorts were adjusted using inverse probability of treatment weights based on propensity scores. The primary endpoint was the composite of recurrent venous thromboembolism or major bleeding. Patient claims were tracked for up to 12 months after the index venous thromboembolism or until endpoint occurrence oral anticoagulant discontinuation/switch, insurance disenrollment, or end of follow-up. Cox regression was used to calculate hazard ratios (HRs) with 95% confidence intervals (CIs).
Of 58,089 incident venous thromboembolism patients identified, 6869 (1365 rivaroxaban and 5504 warfarin users) were classified as frail. Rivaroxaban reduced patients' hazard of the composite of recurrent venous thromboembolism or major bleeding (HR 0.75; 95% CI, 0.57-0.98) and recurrent venous thromboembolism alone (HR 0.65; 95% CI, 0.44-0.97) compared with warfarin. No significant difference in major bleeding was observed between cohorts (HR 0.88; 95% CI, 0.61-1.27).
Frail patients experiencing a venous thromboembolism and given rivaroxaban experience less recurrent venous thromboembolism, with at least as good bleeding outcomes, as patients prescribed warfarin.
衰弱预测接受抗凝治疗的患者预后较差。我们评估了利伐沙班与华法林在患有静脉血栓栓塞症的虚弱患者中的有效性和安全性。
使用 2012 年 1 月至 2016 年 12 月美国 MarketScan 理赔数据，我们确定了虚弱患者（使用约翰霍普金斯基于索赔的衰弱指标评分），他们在静脉血栓栓塞症的首次主要住院/急诊就诊诊断代码后 30 天内接受利伐沙班或华法林作为其首次门诊口服抗凝剂，并且在索引静脉血栓栓塞症之前有至少 12 个月的保险。使用基于倾向评分的逆概率治疗权重对队列之间的基线协变量差异进行调整。主要终点是复发性静脉血栓栓塞症或大出血的复合终点。患者理赔记录在索引静脉血栓栓塞症后最长 12 个月或直至终点发生（口服抗凝剂停药/转换、保险退保或随访结束）进行跟踪。使用 Cox 回归计算风险比（HR）和 95%置信区间（CI）。
在确定的 58089 例首发静脉血栓栓塞症患者中，有 6869 例（1365 例利伐沙班组和 5504 例华法林组）被归类为虚弱。与华法林相比，利伐沙班降低了患者复发性静脉血栓栓塞症或大出血（HR 0.75；95%CI，0.57-0.98）和单纯复发性静脉血栓栓塞症（HR 0.65；95%CI，0.44-0.97）的复合终点发生风险。两组间大出血无显著差异（HR 0.88；95%CI，0.61-1.27）。
患有静脉血栓栓塞症并接受利伐沙班治疗的虚弱患者发生复发性静脉血栓栓塞症的风险较低，出血结局至少与接受华法林治疗的患者一样好。
