Department of Advanced Biomedical Sciences, Federico II University, Naples, Italy; Cardiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
JACC Heart Fail. 2016 Nov;4(11):870-880. doi: 10.1016/j.jchf.2016.07.012. Epub 2016 Sep 7.
This study investigated the efficacy and safety of novel oral anticoagulants (NOACs) in patients with atrial fibrillation (AF) and heart failure (HF) by a meta-analysis.
AF is quite prevalent in patients with HF.
Four phase III clinical trials comparing NOACs to warfarin in patients with AF were included. Each patient was defined as affected by HF according to the criteria of the trial in which the patient was enrolled. Pre-specified outcomes were the composite of stroke/systemic embolism (SSE); major, intracranial, and any bleeding; and cardiovascular (CV) and all-cause death.
A total of 55,011 patients were enrolled, 26,384 (48%) with HF, and 28,627 (52%) without HF; 27,518 receiving NOACs and 27,493 receiving warfarin (median, 70 years of age; 36% females; follow-up: 1.5 to 2.8 years). Rates of SSE (relative risk [RR]: 0.98; 95% confidence interval [CI]: 0.90 to 1.07]; p = 0.68) and major bleeding (RR: 0.95; 95% CI: 0.88 to 1.03; p = 0.21) were comparable in patients with and without HF. HF patients had reduced rates of any (RR: 0.86; 95% CI: 0.81 to 0.91; p < 0.01) and intracranial (RR: 0.74 95% CI: 0.63 to 0.88; p < 0.01) bleeding but increased rates of all-cause (RR: 1.70 95% CI: 1.31 to 2.19; p < 0.01) and CV death (RR: 2.05 95% CI: 1.66 to 2.55; p < 0.01). NOACs, compared with warfarin significantly reduced SSE and major, intracranial, and any bleeding, regardless of the presence or absence of HF (p > 0.05 for each).
Patients with AF and HF had increased mortality but reduced rates of intracranial and any bleeding compared with the no-HF patients, with no differences in rates of SSE and major bleeding. NOACs significantly reduced SSE, major bleeding, and intracranial hemorrhage in HF patients. No interactions in efficacy and safety of NOACs were observed between AF patients with and without HF.
通过荟萃分析研究新型口服抗凝剂（NOACs）在伴有心房颤动（AF）和心力衰竭（HF）的患者中的疗效和安全性。
AF 在伴有 HF 的患者中非常普遍。
纳入了四项比较 AF 患者中 NOACs 与华法林的 III 期临床试验。根据患者入组试验的标准，每位患者均被定义为 HF 患者。预先设定的结局是卒中/全身性栓塞（SSE）的复合结局；大出血；主要、颅内和任何部位出血；心血管（CV）和全因死亡。
共纳入 55011 例患者，26384 例（48%）为 HF 患者，28627 例（52%）为非 HF 患者；27518 例接受 NOACs，27493 例接受华法林（中位年龄 70 岁；36%为女性；随访：1.5 至 2.8 年）。HF 患者 SSE（风险比 [RR]：0.98；95%置信区间 [CI]：0.90 至 1.07]；p=0.68）和大出血（RR：0.95；95%CI：0.88 至 1.03；p=0.21）的发生率与非 HF 患者相当。HF 患者任何部位（RR：0.86；95%CI：0.81 至 0.91；p<0.01）和颅内（RR：0.74；95%CI：0.63 至 0.88；p<0.01）出血的发生率较低，但全因（RR：1.70；95%CI：1.31 至 2.19；p<0.01）和 CV 死亡（RR：2.05；95%CI：1.66 至 2.55；p<0.01）的发生率较高。与华法林相比，无论是否存在 HF，NOACs 均显著降低了 SSE 以及大出血、颅内和任何部位出血的发生率（p>0.05）。
与非 HF 患者相比，伴有 AF 和 HF 的患者死亡率更高，但颅内和任何部位出血的发生率更低，SSE 和大出血的发生率无差异。NOACs 可显著降低 HF 患者的 SSE、大出血和颅内出血发生率。在伴有和不伴有 HF 的 AF 患者中，NOACs 的疗效和安全性没有观察到交互作用。
