Real-world effectiveness and safety of oral anticoagulation strategies in atrial fibrillation: a cohort study based on a German claims dataset.

IF 2.3 Q2 MEDICINE, GENERAL & INTERNAL

Pragmatic and Observational Research Pub Date : 2018-05-01 eCollection Date: 2018-01-01 DOI:10.2147/POR.S156521

Sabrina Mueller, Antje Groth, Stefan G Spitzer, Anja Schramm, Andreas Pfaff, Ulf Maywald

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引用次数: 12

Abstract

Objective: To compare the real-world effectiveness and safety of non-vitamin-K-antagonist oral anticoagulant (NOAC) treatment in atrial fibrillation (AF) patients with a vitamin-K-antagonist (VKA)-based treatment.

Methods: This was a retrospective analysis of an anonymized claims dataset from 3 German health insurance funds covering the period from January 01, 2010 to June 30, 2014, with a minimum observation time of 12 months. All continuously insured patients with at least 2 outpatient AF diagnoses and/or 1 inpatient respective diagnosis who received at least 1 outpatient prescription of a NOAC or VKA were included.

Outcomes and measures: Death, ischemic strokes (IS), non-specified strokes, transient ischemic attacks (TIAs), myocardial infarctions (MIs), arterial embolism (AE), hemorrhagic strokes, severe bleedings, and composite outcomes. Main comparisons were done based on propensity score-matched (PSM) cohorts. Results were reported as incidence rate ratios and hazard ratios (HRs).

Results: We assigned 37,439 AF patients to each PSM cohort (NOAC cohort: mean age 78.2 years, mean CHA₂DS₂VASc score 2.96, mean follow-up 348.5 days; VKA cohort: mean age 78.2 years, mean CHA₂DS₂VASc 2.95, mean follow-up 365.5 days). NOAC exposure was associated with significantly higher incidence rate ratios; 95% CI/HRs; 95% CI for the following outcomes: death (1.22; 1.17-1.28/1.22; 1.17-1.28), IS (1.90; 1.69-2.15/1.92; 1.69-2.19), non-specified strokes (2.04; 1.16-3.70/1.93; 1.13-3.32), TIAs (1.52; 1.29-1.79/1.44; 1.21-1.70), MIs (1.26; 1.10-1.15/1.31; 1.13-1.52), AE (1.75; 1.32-2.32/1.81; 1.36-2.34) and severe bleeding (1.92; 1.71-2.15/1.95; 1.74-2.20). Multivariable Cox regression analyses and additional sensitivity analysis, including analysis of PSM-matched NOAC/VKA treatment-naive patients, only confirmed the above results. The study was documented under clinicaltrials.gov (NCT02657616).

Conclusion and relevance: A VKA therapy seems to be more effective and safer than a NOAC therapy in a real-world cohort of German AF patients.

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房颤口服抗凝策略的实际有效性和安全性:基于德国索赔数据集的队列研究。

目的:比较非维生素k拮抗剂口服抗凝剂(NOAC)与维生素k拮抗剂(VKA)治疗心房颤动(AF)患者的实际疗效和安全性。方法:回顾性分析来自3个德国健康保险基金的匿名索赔数据集，时间跨度为2010年1月1日至2014年6月30日，最小观察时间为12个月。所有连续参保的至少2例门诊房颤诊断和/或1例住院分别诊断且至少1例门诊NOAC或VKA处方的患者均被纳入研究。结果和指标:死亡、缺血性中风(IS)、非特异性中风、短暂性脑缺血发作(tia)、心肌梗死(MIs)、动脉栓塞(AE)、出血性中风、严重出血和综合结果。主要比较基于倾向评分匹配(PSM)队列。结果以发生率比和危险比(hr)报告。结果:我们将37,439例房颤患者分配到每个PSM队列(NOAC队列:平均年龄78.2岁，平均CHA2DS2VASc评分2.96，平均随访348.5天;VKA队列:平均年龄78.2岁，平均CHA2DS2VASc 2.95，平均随访365.5天)。NOAC暴露与显著较高的发病率相关;95%可信区间/小时;以下结局的95% CI:死亡(1.22;1.17 -1.28/1.22;1.17-1.28)，为(1.90;1.69 -2.15/1.92;1.69-2.19)，非指定笔画(2.04;1.16 -3.70/1.93;1.13-3.32)， TIAs (1.52;1.29 -1.79/1.44;1.21-1.70)， MIs (1.26;1.10 -1.15/1.31;1.13-1.52)， ae (1.75;1.32 -2.32/1.81;1.36-2.34)和严重出血(1.92;1.71 -2.15/1.95;1.74 - -2.20)。多变量Cox回归分析和附加的敏感性分析，包括对psm匹配的NOAC/VKA治疗初治患者的分析，仅证实了上述结果。该研究记录在clinicaltrials.gov (NCT02657616)上。结论和相关性:在现实世界的德国房颤患者队列中，VKA治疗似乎比NOAC治疗更有效和更安全。

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Pragmatic and Observational Research MEDICINE, GENERAL & INTERNAL-

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期刊介绍： Pragmatic and Observational Research is an international, peer-reviewed, open-access journal that publishes data from studies designed to closely reflect medical interventions in real-world clinical practice, providing insights beyond classical randomized controlled trials (RCTs). While RCTs maximize internal validity for cause-and-effect relationships, they often represent only specific patient groups. This journal aims to complement such studies by providing data that better mirrors real-world patients and the usage of medicines, thus informing guidelines and enhancing the applicability of research findings across diverse patient populations encountered in everyday clinical practice.