Beyer-Westendorf Jan, Förster Kati, Ebertz Franziska, Gelbricht Vera, Schreier Thomas, Göbelt Maria, Michalski Franziska, Endig Heike, Sahin Kurtulus, Tittl Luise, Weiss Norbert
Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital 'Carl Gustav Carus' Dresden, Technical University Dresden, Fetscherstrasse 74, Dresden D-01307, Germany
Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital 'Carl Gustav Carus' Dresden, Technical University Dresden, Fetscherstrasse 74, Dresden D-01307, Germany.
Europace. 2015 Apr;17(4):530-8. doi: 10.1093/europace/euu319. Epub 2015 Feb 17.
Worldwide, rivaroxaban is increasingly used for stroke prevention in atrial fibrillation (SPAF) but little is known about the rates of or reasons for rivaroxaban discontinuations in daily care. Using data from a prospective, non-interventional oral anticoagulation (NOAC) registry, we analysed rivaroxaban treatment persistence.
Persistence with rivaroxaban in SPAF was assessed in an ongoing, prospective, non-interventional registry of >2600 NOAC patients from daily care using the Kaplan-Meier time-to-first-event analysis. Reasons for and management of rivaroxaban discontinuation were assessed. Potential baseline risk factors for treatment discontinuation were evaluated using Cox regression analysis. Between October 2011 and April 2014, 1204 rivaroxaban SPAF patients were enrolled [39.3% switched from vitamin K antagonists (VKAs) and 60.7% newly treated patients]. Of these, 223 patients (18.5%) stopped rivaroxaban during follow-up (median 544 days), which translates into a discontinuation rate of 13.6 (95% CI 11.8-15.4) per 100 patient-years. Most common reasons for treatment discontinuations were bleeding complications (30% of all discontinuations), followed by other side-effects (24.2%) and diagnosis of stable sinus rhythm (9.9%). A history of chronic heart failure (HR 1.43; 95% CI 1.09-1.87; P = 0.009) or diabetes (HR 1.39; 95% CI 1.06-1.82; P = 0.018) were the only statistically significant baseline risk factors for rivaroxaban discontinuation. After discontinuation of rivaroxaban, patients received antiplatelet therapy (31.8%), VKA (24.2%), another NOAC (18.4%), heparin (9.9%), or nothing (15.7%).
Our data indicate that overall persistence with rivaroxaban therapy is high, with a discontinuation rate of ∼15% in the first year of treatment and few additional discontinuations thereafter.
在全球范围内，利伐沙班越来越多地用于心房颤动（AF）的卒中预防，但在日常医疗中，关于利伐沙班停药率及停药原因知之甚少。我们利用一项前瞻性、非干预性口服抗凝药（NOAC）登记研究的数据，分析了利伐沙班治疗的持续性。
在一项正在进行的、前瞻性、非干预性登记研究中，纳入来自日常医疗的2600多名NOAC患者，采用Kaplan-Meier首次事件时间分析评估AF患者中利伐沙班的持续性。评估了利伐沙班停药的原因及处理情况。采用Cox回归分析评估治疗停药的潜在基线危险因素。2011年10月至2014年4月期间，纳入1204例利伐沙班治疗的AF患者[39.3%由维生素K拮抗剂（VKA）转换而来，60.7%为新治疗患者]。其中，223例患者（18.5%）在随访期间（中位时间544天）停用利伐沙班，相当于每100患者年停药率为13.6（95%CI 11.8-15.4）。治疗停药的最常见原因是出血并发症（占所有停药的30%），其次是其他副作用（24.2%）和诊断为稳定窦性心律（9.9%）。慢性心力衰竭病史（HR 1.43；95%CI 1.09-1.87；P = 0.009）或糖尿病病史（HR 1.39；95%CI 1.06-1.82；P = 0.018）是利伐沙班停药仅有的具有统计学意义的基线危险因素。利伐沙班停药后，患者接受抗血小板治疗（31.8%）、VKA（24.2%）、另一种NOAC（18.4%）、肝素（9.9%）或未接受任何治疗（15.7%）。
我们的数据表明，利伐沙班治疗的总体持续性较高，治疗第一年停药率约为15%，此后停药情况较少。
