Department of Pharmacy Practice, University of Connecticut School of Pharmacy, Storrs; Evidence-Based Practice Center, Hartford Hospital, Hartford, Conn.
Institute of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin Berlin, Germany.
Am J Med. 2019 Sep;132(9):1078-1083. doi: 10.1016/j.amjmed.2019.04.013. Epub 2019 May 2.
BACKGROUND: Patients with nonvalvular atrial fibrillation with stage 4 or 5 chronic kidney disease or undergoing hemodialysis were excluded from phase III randomized trials of nonvitamin K antagonist oral anticoagulants (NOACs). We sought to evaluate the effectiveness and safety of rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation and stage 4 or 5 chronic kidney disease or undergoing hemodialysis in routine practice. METHODS: Using MarketScan data from January 2012 to December 2017, we identified patients on oral anticoagulant (OAC) with naïve nonvalvular atrial fibrillation and stage 4 or 5 chronic kidney disease or undergoing hemodialysis and with ≥12 months of insurance coverage before OAC initiation. Differences in baseline covariates between the rivaroxaban and warfarin cohorts were adjusted using inverse probability-of-treatment weights based on propensity scores calculated using generalized boosted models and 10,000 regression trees (absolute standardized differences <0.1 achieved for all covariates after adjustment). Patients were followed until a stroke/systemic embolism or major bleeding event, OAC discontinuation/switch, insurance disenrollment, or end of data availability. Hazard ratios (HRs) and 95% confidence intervals (CIs) comparing the OAC cohorts were calculated using Cox regression. RESULTS: We identified 1896 rivaroxaban (38.7% received a dose <20 mg/d) and 4848 warfarin users. Eighty-eight percent of included patients had stage 5 chronic kidney disease or were undergoing hemodialysis. Rivaroxaban did not significantly reduce stroke or systemic embolism (HR = 0.55, 95% CI = 0.27-1.10) or ischemic stroke (HR = 0.67, 95% CI = 0.30-1.50) alone, but it was associated with a significant 32% (95% CI = 1-53%) reduction in major bleeding risk compared with warfarin. CONCLUSION: Among patients with nonvalvular atrial fibrillation and stage 4 or 5 chronic kidney disease or undergoing hemodialysis, rivaroxaban appears associated with significantly less major bleeding compared to warfarin.
背景：在非维生素 K 拮抗剂口服抗凝剂（NOAC）的 III 期随机试验中，排除了伴有 4 或 5 期慢性肾脏病或正在接受血液透析的非瓣膜性心房颤动患者。我们旨在评估利伐沙班与华法林在常规实践中伴有 4 或 5 期慢性肾脏病或正在接受血液透析的非瓣膜性心房颤动患者中的有效性和安全性。
方法：利用 2012 年 1 月至 2017 年 12 月 MarketScan 数据，我们确定了开始使用口服抗凝剂（OAC）前有非瓣膜性心房颤动且无 4 或 5 期慢性肾脏病或正在接受血液透析病史、OAC 开始前至少 12 个月保险覆盖的患者。使用广义增强模型和 10000 个回归树计算的倾向评分来基于逆概率治疗权重调整利伐沙班组和华法林组之间的基线协变量差异（所有协变量调整后的绝对标准化差异<0.1）。直至卒中/全身性栓塞或大出血事件、OAC 停药/转换、保险退保或数据可用性结束，对患者进行随访。使用 Cox 回归计算比较 OAC 组的风险比（HR）和 95%置信区间（CI）。
结果：我们确定了 1896 名利伐沙班组（38.7%接受的剂量<20mg/d）和 4848 名利伐沙班组。88%的纳入患者有 5 期慢性肾脏病或正在接受血液透析。利伐沙班并未显著降低卒中或全身性栓塞（HR=0.55，95%CI=0.27-1.10）或缺血性卒中（HR=0.67，95%CI=0.30-1.50）风险，但与华法林相比，大出血风险显著降低 32%（95%CI=1-53%）。
结论：在伴有非瓣膜性心房颤动且有 4 或 5 期慢性肾脏病或正在接受血液透析的患者中，与华法林相比，利伐沙班似乎与显著减少大出血相关。
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