Avendano Ricardo, Romero Jorge, Lupercio Florentino, Diaz Juan Carlos, Quispe Renato, Golive Anjani, Natale Andrea, Garcia Mario J, Krumerman Andrew K, Di Biase Luigi
Montefiore Medical Center, Albert Einstein College of Medicine, 111 East 210th Street, Bronx, NY, 10467, USA.
Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin, TX, USA.
J Interv Card Electrophysiol. 2019 Jan;54(1):73-80. doi: 10.1007/s10840-018-0427-y. Epub 2018 Aug 20.
Amiodarone is a potent inhibitor of the CYP450:3A4 and inhibitor of the P-glycoprotein, both of which metabolize new oral anticoagulants (NOACs). Patients who are on NOACs and are concomitantly treated with amiodarone may have a higher risk of major bleeding according to recent retrospective trials. Whether this increased risk outweighs the benefits of NOACs compared to warfarin is unknown. We aimed to compare clinical outcomes between NOACs and warfarin in patients with atrial fibrillation (AF) being treated with amiodarone.
We performed a systematic review of MEDLINE, Cochrane, and Embase for randomized controlled trials that compared NOACs to warfarin for prophylaxis of ischemic stroke/thromboembolic events (TEs) in patients with AF and reported outcomes on TE, major bleeding, and intracranial bleeding (ICB). Risk ratio (RR) and 95% confidence intervals were measured using the Mantel-Haenszel method. Fixed effects model was used, and if heterogeneity (I2) was > 25%, effects were analyzed using a random model.
A total of four studies comparing NOACs to warfarin were included in the analysis. The total number of patients on amiodarone was 6197. Mean follow up was 23 ± 5 months. No statistically significant difference for TE prevention (RR, 0.73; 95% CI 0.50-1.07), major bleeding (RR, 1.02; 95% CI 0.68-1.53), or ICB outcomes (RR, 0.58; 95% CI 0.22-1.51) between patients on NOACs + amiodarone when compared to patients on warfarin + amiodarone.
Among patients with AF taking amiodarone, there is no increased risk of stroke, major bleeding, or ICB with NOACs compared to warfarin.
胺碘酮是细胞色素P450 3A4的强效抑制剂和P-糖蛋白抑制剂，二者均可代谢新型口服抗凝药（NOACs）。根据近期的回顾性试验，正在服用NOACs且同时接受胺碘酮治疗的患者发生大出血的风险可能更高。与华法林相比，这种增加的风险是否超过了NOACs的获益尚不清楚。我们旨在比较在接受胺碘酮治疗的心房颤动（AF）患者中，使用NOACs和华法林的临床结局。
我们对MEDLINE、Cochrane和Embase进行了系统评价，纳入比较NOACs与华法林预防AF患者缺血性卒中/血栓栓塞事件（TEs）的随机对照试验，并报告TE、大出血和颅内出血（ICB）的结局。采用Mantel-Haenszel方法测量风险比（RR）和95%置信区间。使用固定效应模型，如果异质性（I2）>25%，则使用随机模型分析效应。
分析共纳入四项比较NOACs与华法林的研究。服用胺碘酮的患者总数为6197例。平均随访时间为23±5个月。与服用华法林+胺碘酮的患者相比，服用NOACs+胺碘酮的患者在预防TE（RR，0.73；95%CI 0.50-1.07）、大出血（RR，1.02；95%CI 0.68-1.53）或ICB结局（RR，0.58；95%CI 0.22-1.51）方面无统计学显著差异。
在服用胺碘酮的AF患者中，与华法林相比，使用NOACs不会增加卒中、大出血或ICB的风险。
