非维生素K拮抗剂口服抗凝药与华法林相比在房颤患者中的疗效和安全性

Efficacy and safety of non-vitamin K antagonist oral anticoagulants compared with warfarin in patients with atrial fibrillation.

作者信息

Friberg Leif, Oldgren Jonas

机构信息

Department of Clinical Sciences at Danderyd Hospital, Karolinska Institute, Stockholm, Sweden.

Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.

出版信息

Open Heart. 2017 Sep 23;4(2):e000682. doi: 10.1136/openhrt-2017-000682. eCollection 2017.

AIMS

Non-vitamin K antagonist oral anticoagulants (NOACs) were in pivotal randomised controlled trials at least non-inferior to warfarin for stroke prevention in atrial fibrillation, but time in therapeutic range (TTR) for warfarin was lower (mean 55%-65%) than in Swedish general care where TTR is >70%. We compared efficacy and safety of NOACs and warfarin treatment for stroke prevention in Sweden.

METHODS

Retrospective cohort study of all non-selected oral anticoagulation naïve atrial fibrillation patients with first prescription for NOACs or warfarin between December 2011 and December 2014, excluding patients with mitral stenosis or mechanical valvular prosthesis. Data were obtained from cross-linked national registers, propensity scores were used as continuous covariates, and associations between treatment and outcomes were evaluated by multivariable Cox regressions.

RESULTS

The study comprised 18 638 patients on NOAC and 49 418 on warfarin treatment, with 90 204 patient-years follow-up. Age (mean) was 73.4 vs 73.7 years, p<0.001, and CHADS-VASc points (mean) 3.38 vs 3.24, p<0.001, in NOAC and warfarin groups, respectively. HRs (95% CI) for NOACs versus warfarin were 1.04 (0.91-1.19) for all-cause stroke or systemic embolism, 1.16 (1.00-1.35) for ischaemic stroke, 0.85 (0.76-0.96) for major bleeding, 1.22 (1.01-1.46) for gastrointestinal bleeding, 0.60 (0.47-0.76) for intracranial haemorrhage and 0.89 (0.81-0.96) for all-cause mortality.

CONCLUSION

In this large non-selected anticoagulation naïve Swedish atrial fibrillation cohort, the risks for all-cause stroke or systemic embolism were similar with NOACs and warfarin, but NOACs were associated with significantly lower risks of all-cause mortality, major bleeding and intracranial haemorrhage but higher risk of gastrointestinal bleeding. Better safety suggests NOACs as preferred treatment for patients with atrial fibrillation starting oral anticoagulation.

目的

在关键随机对照试验中，非维生素K拮抗剂口服抗凝药（NOACs）在预防房颤患者中风方面至少不劣于华法林，但华法林的治疗范围内时间（TTR）低于瑞典普通护理中的情况（瑞典普通护理中TTR>70%）。我们比较了在瑞典使用NOACs和华法林预防中风的疗效和安全性。

方法

对2011年12月至2014年12月期间首次处方使用NOACs或华法林的所有未选择的初治口服抗凝房颤患者进行回顾性队列研究，排除二尖瓣狭窄或机械瓣膜置换患者。数据来自交联的国家登记处，倾向评分用作连续协变量，通过多变量Cox回归评估治疗与结局之间的关联。

结果

该研究纳入了18638例接受NOAC治疗的患者和49418例接受华法林治疗的患者，随访90204患者年。NOAC组和华法林组的年龄（均值）分别为73.4岁和73.7岁，p<0.001，CHADS-VASc评分（均值）分别为3.38和3.24，p<0.001。NOACs与华法林相比，全因中风或全身性栓塞的风险比（HR，95%CI）为1.04（0.91-1.19），缺血性中风为1.16（1.00-1.35），大出血为0.85（0.76-0.96），胃肠道出血为1.22（1.01-1.46），颅内出血为0.60（0.47-0.76），全因死亡率为0.89（0.81-0.96）。