利伐沙班治疗从维生素 K 拮抗剂治疗中转换过来的患者的临床结局：一项随机试验的亚组分析。

Clinical outcomes with rivaroxaban in patients transitioned from vitamin K antagonist therapy: a subgroup analysis of a randomized trial.

机构信息

Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27705, USA.

出版信息

Ann Intern Med. 2013 Jun 18;158(12):861-8. doi: 10.7326/0003-4819-158-12-201306180-00003.

DOI:10.7326/0003-4819-158-12-201306180-00003

PMID:23778903

Abstract

BACKGROUND

In ROCKET AF (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation), a large randomized, clinical trial, rivaroxaban was noninferior to warfarin in preventing stroke or systemic embolism in patients with atrial fibrillation.

OBJECTIVE

To determine the efficacy and safety of rivaroxaban compared with warfarin among vitamin K antagonist (VKA)-naive and VKA-experienced patients.

DESIGN

Prespecified subgroup analysis. (ClinicalTrials.gov: NCT00403767).

SETTING

Global.

PATIENTS

14,264 persons with atrial fibrillation.

MEASUREMENTS

Interaction of the relative treatment effect of rivaroxaban and warfarin on stroke or systemic embolism among VKA-naive and VKA-experienced patients.

RESULTS

Overall, 7897 (55.4%) patients were VKA-experienced and 6367 (44.6%) were VKA-naive. The effect of rivaroxaban versus warfarin on stroke or systemic embolism was consistent: Rates per 100 patient-years of follow-up were 2.32 versus 2.87 for VKA-naive patients (hazard ratio [HR], 0.81 [95% CI, 0.64 to 1.03]) and 1.98 versus 2.09 for VKA-experienced patients (HR, 0.94 [CI, 0.75 to 1.18]; interaction P = 0.36). During the first 7 days, rivaroxaban was associated with more bleeding than warfarin (HR in VKA-naive patients, 5.83 [CI, 3.25 to 10.44], and in VKA-experienced patients, 6.66 [CI, 3.83 to 11.58]; interaction P = 0.53). After 30 days, rivaroxaban was associated with less bleeding than warfarin in VKA-naive patients (HR, 0.84 [CI, 0.74 to 0.95]) and similar bleeding in VKA-experienced patients (HR, 1.06 [CI, 0.96 to 1.17]; interaction P = 0.003).

LIMITATION

The trial was not designed to detect differences in these subgroups.

CONCLUSION

The efficacy of rivaroxaban in VKA-experienced and VKA-naive patients was similar to that of the overall trial. There were more bleeding events within 7 days of study drug initiation with rivaroxaban, but after 30 days, rivaroxaban was associated with less bleeding in VKA-naive patients and similar bleeding in VKA-experienced patients. This information may be useful to clinicians considering a transition to rivaroxaban for patients receiving VKA therapy.

PRIMARY FUNDING SOURCE

Johnson & Johnson and Bayer HealthCare.

摘要

背景

在 ROCKET AF（利伐沙班每日一次、口服、直接 Xa 因子抑制与维生素 K 拮抗剂用于预防心房颤动中的中风和栓塞试验）中，一项大型随机临床试验表明，利伐沙班在预防中风或全身性栓塞方面不劣于华法林，用于房颤患者。

目的

确定利伐沙班在维生素 K 拮抗剂（VKA）初治和 VKA 经验丰富的患者中的疗效和安全性。

设计

预先设定的亚组分析。（ClinicalTrials.gov：NCT00403767）。

地点

全球。

患者

14264 名房颤患者。

测量

利伐沙班和华法林对 VKA 初治和 VKA 经验丰富患者中风或全身性栓塞的相对治疗效果的相互作用。

结果

总体而言，7897 名（55.4%）患者为 VKA 经验丰富，6367 名（44.6%）为 VKA 初治。利伐沙班与华法林对中风或全身性栓塞的疗效一致：随访期间每 100 患者年的发生率分别为 VKA 初治患者 2.32 与 2.87（危险比[HR]，0.81 [95%CI，0.64 至 1.03]）和 VKA 经验丰富患者 1.98 与 2.09（HR，0.94 [CI，0.75 至 1.18]；交互 P=0.36）。在前 7 天，利伐沙班比华法林更容易引起出血（VKA 初治患者的 HR，5.83 [CI，3.25 至 10.44]，VKA 经验丰富患者的 HR，6.66 [CI，3.83 至 11.58]；交互 P=0.53）。30 天后，利伐沙班在 VKA 初治患者中比华法林出血更少（HR，0.84 [CI，0.74 至 0.95]），在 VKA 经验丰富患者中出血相似（HR，1.06 [CI，0.96 至 1.17]；交互 P=0.003）。