TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, USA.
Eur Heart J Acute Cardiovasc Care. 2019 Sep;8(6):554-561. doi: 10.1177/2048872618796990. Epub 2018 Oct 15.
Patients with atrial fibrillation and concomitant coronary artery disease (CAD) are at higher risk for myocardial infarction or cardiovascular death, often require antiplatelet therapy and are therefore exposed to an increased risk of bleeding. This meta-analysis aimed to compare the efficacy and safety profile of non-vitamin K antagonist oral anticoagulants (NOACs) with warfarin in patients with atrial fibrillation and concomitant CAD.
We performed a trial-level meta-analysis of CAD subgroups from four trials of NOAC versus warfarin in patients with atrial fibrillation, comparing the primary trial endpoints (efficacy: stroke or systemic embolic event; safety: International Society on Thrombosis and Haemostasis major bleeding) in patients with versus those without CAD, and used interaction testing to assess for treatment effect modification.
In total, 58,606 patients with established CAD were included in this meta-analysis. NOACs reduced the risk of stroke/systemic embolic event irrespective of presence of CAD (CAD: 0.76 (0.56-1.04); no CAD: hazard ratio 0.77 (0.56-1.06); -INT 0.93). Similarly, there was no effect modification by presence of CAD for major bleeding (CAD: hazard ratio 0.92 (0.65-1.32), no CAD: 0.83 (0.61-1.12); -INT 0.46) or myocardial infarction (CAD: hazard ratio 0.95 (0.62-1.44); no CAD: hazard ratio 0.95 (0.60-1.50); -INT = 0.98). While NOACs reduced all-cause mortality in patients without CAD compared with warfarin (hazard ratio 0.85 (0.71-1.02)), there was no difference in mortality between NOACs and warfarin in the CAD group (hazard ratio 0.99 (0.82-1.20); -INT 0.01).
The present meta-analysis of four trials supports that NOACs are safe and at least as effective as warfarin in patients with atrial fibrillation and established CAD.
患有心房颤动和同时患有冠状动脉疾病 (CAD) 的患者发生心肌梗死或心血管死亡的风险较高,通常需要抗血小板治疗,因此出血风险增加。这项荟萃分析旨在比较非维生素 K 拮抗剂口服抗凝剂 (NOACs) 与华法林在患有心房颤动和同时患有 CAD 的患者中的疗效和安全性。
我们对四项比较 NOAC 与华法林治疗心房颤动患者的试验中的 CAD 亚组进行了试验水平的荟萃分析,比较了有 CAD 和无 CAD 的患者的主要试验终点(疗效:中风或全身性栓塞事件;安全性:国际血栓和止血协会大出血),并使用交互检验评估治疗效果的修饰。
共有 58606 例确诊 CAD 的患者纳入本荟萃分析。NOACs 降低了中风/全身性栓塞事件的风险,无论 CAD 存在与否(CAD:0.76(0.56-1.04);无 CAD:风险比 0.77(0.56-1.06);-INT 0.93)。同样,对于大出血(CAD:风险比 0.92(0.65-1.32),无 CAD:0.83(0.61-1.12);-INT 0.46)或心肌梗死(CAD:风险比 0.95(0.62-1.44);无 CAD:风险比 0.95(0.60-1.50);-INT = 0.98),CAD 的存在对治疗效果没有影响。虽然与华法林相比,NOACs降低了无 CAD 患者的全因死亡率(风险比 0.85(0.71-1.02)),但在 CAD 组中,NOACs 与华法林之间的死亡率无差异(风险比 0.99(0.82-1.20);-INT 0.01)。
四项试验的荟萃分析支持,在患有心房颤动和已确诊 CAD 的患者中,NOACs 是安全的,至少与华法林一样有效。