Clinical Epidemiology and Statistical Unit, Orono Group. Rosario, Argentina.
Clin Cardiol. 2013 Feb;36(2):61-7. doi: 10.1002/clc.22081. Epub 2013 Jan 21.
Warfarin reduces ischemic stroke in atrial fibrillation, but has numerous limitations. Novel oral anticoagulants provide more predictable anticoagulation with fewer shortcomings.
Novel oral anticoagulants are superior to warfarin to prevent stroke or systemic embolism.
Phase III randomized warfarin-controlled trials enrolling >3000 patients that reported clinical efficacy and safety of novel oral anticoagulants in patients with atrial fibrillation were identified from MEDLINE, Embase, and Cochrane Central Register of Controlled Trials through October 2012. Two reviewers extracted data; differences were resolved by consensus. The end points analyzed were stroke or systemic embolism (primary efficacy composite); all-cause mortality, ischemic stroke, systemic embolism (individually, secondary efficacy); and hemorrhagic stroke, major bleeding (individually, safety). The Mantel-Haenszel method was used to calculate pooled relative risk (RR) and 95% confidence intervals (CI) from fixed-effects (if homogenous) or random-effects models (if heterogeneous).
In 5 studies of 51895 patients, the composite of stroke or systemic embolism (RR: 0.82; 95% CI: 0.69-0.98; P = 0.03) and all-cause mortality (RR: 0.91; 95% CI: 0.85-0.96; P = 0.0026, respectively) were reduced with the novel agents. Factor Xa inhibitors significantly reduced the primary composite (RR: 0.84; 95% CI: 0.74-0.94; P = 0.004) and all-cause mortality (RR: 0.91; 95% CI: 0.84 - 0.98; P = 0.01). Direct thrombin inhibitor achieved results similar to the overall meta-analysis (drug class-outcome interactions P = 0.47 for primary outcome, P = 1.00 for mortality). Compared with warfarin, novel anticoagulants markedly reduced hemorrhagic stroke (RR: 0.51; 95% CI: 0.41-0.64; P < 0.0001).
Novel oral anticoagulants may be superior to warfarin in patients with atrial fibrillation, reducing the composite of stroke or systemic embolism and lowering all-cause mortality. The benefit is largely due to fewer hemorrhagic strokes.
华法林可降低房颤患者的缺血性卒中风险，但存在诸多局限性。新型口服抗凝剂可提供更可预测的抗凝效果，且缺点更少。
新型口服抗凝剂在预防卒中或全身性栓塞方面优于华法林。
我们从 MEDLINE、Embase 和 Cochrane 对照试验中心注册库中检索了截至 2012 年 10 月发表的 3000 多例患者参与的 III 期随机华法林对照试验，以评估新型口服抗凝剂在房颤患者中的临床疗效和安全性。两名审查员提取数据；通过协商解决分歧。分析的终点包括卒中或全身性栓塞（主要疗效复合终点）、全因死亡率、缺血性卒中和全身性栓塞（分别为次要疗效终点）以及出血性卒中和大出血（分别为安全性终点）。采用固定效应（同质性）或随机效应（异质性）模型计算来自 5 项研究（51895 例患者）的卒中或全身性栓塞（RR：0.82；95%CI：0.69-0.98；P=0.03）和全因死亡率（RR：0.91；95%CI：0.85-0.96；P=0.0026）的合并相对风险（RR）和 95%置信区间（CI）。
在 5 项研究（51895 例患者）中，新型抗凝剂可降低卒中或全身性栓塞（RR：0.84；95%CI：0.74-0.94；P=0.004）和全因死亡率（RR：0.91；95%CI：0.84-0.98；P=0.01）的发生率。Xa 因子抑制剂可显著降低主要复合终点（RR：0.84；95%CI：0.74-0.94；P=0.004）和全因死亡率（RR：0.91；95%CI：0.84-0.98；P=0.01）的发生率。直接凝血酶抑制剂的结果与总体荟萃分析相似（药物类别-结局交互作用 P=0.47 用于主要结局，P=1.00 用于死亡率）。与华法林相比，新型抗凝剂可显著降低出血性卒中的发生率（RR：0.51；95%CI：0.41-0.64；P<0.0001）。
新型口服抗凝剂在房颤患者中可能优于华法林，可降低卒中或全身性栓塞的发生率，降低全因死亡率。其获益主要归因于出血性卒中发生率降低。
