Department of Cardiovascular Sciences, Campus Bio-Medico University of Rome, Italy.
Medical Faculty Pilsen of Charles University, Prague, Czech Republic.
Am J Med. 2019 Jun;132(6):749-757.e5. doi: 10.1016/j.amjmed.2018.12.036. Epub 2019 Jan 19.
The risks of thromboembolic and hemorrhagic events in patients with atrial fibrillation both increase with age; therefore, net clinical benefit analyses of anticoagulant treatments in the elderly population are crucial to guide treatment. We evaluated the 1-year clinical outcomes with non-vitamin-K antagonist and vitamin K antagonist oral anticoagulants (NOACs vs VKAs) in elderly (≥75 years) patients with atrial fibrillation in a prospective registry setting.
Data on 3825 elderly patients were pooled from the PREFER in AF and PREFER in AF PROLONGATION registries. The primary outcome was the incidence of the net composite endpoint, including major bleeding and ischemic cardiovascular events on NOACs (n = 1556) compared with VKAs (n = 2269).
The rates of the net composite endpoint were 6.6%/year with NOACs vs 9.1%/year with VKAs (odds ratio [OR] 0.71; 95% confidence interval [CI], 0.51-0.99; P = .042). NOAC therapy was associated with a lower rate of major bleeding compared with VKA use (OR 0.58; 95% CI, 0.38-0.90; P = .013). Ischemic events were nominally reduced too (OR 0.71; 95% CI, 0.51-1.00; P = .050). Major bleeding with NOACs was numerically lower in higher-risk patients with low body mass index (BMI; OR 0.50; 95% CI, 0.22-1.12; P = .07) or with age ≥85 years (OR 0.44; 95% CI, 0.13-1.49; P = .17).
Our real-world data indicate that, compared with VKAs, NOAC use is associated with a better net clinical benefit in elderly patients with atrial fibrillation, primarily due to lower rates of major bleeding. Major bleeding with NOACs was numerically lower also in higher-risk patients with low BMI or age ≥85 years.
房颤患者的血栓栓塞和出血风险均随年龄增长而增加；因此，评估抗凝治疗在老年人群中的净临床获益对于指导治疗至关重要。我们在一项前瞻性注册研究中评估了非维生素 K 拮抗剂和维生素 K 拮抗剂口服抗凝剂（NOACs 与 VKA）在老年（≥75 岁）房颤患者中的 1 年临床结局。
从 PREFER in AF 和 PREFER in AF PROLONGATION 登记研究中汇总了 3825 例老年患者的数据。主要结局是包括使用 NOACs（n=1556）与 VKA（n=2269）的主要出血和缺血性心血管事件的净复合终点发生率。
NOACs 的净复合终点发生率为 6.6%/年，VKA 为 9.1%/年（比值比[OR] 0.71；95%置信区间[CI]，0.51-0.99；P=0.042）。NOAC 治疗与 VKA 相比，大出血发生率较低（OR 0.58；95%CI，0.38-0.90；P=0.013）。缺血性事件也略有减少（OR 0.71；95%CI，0.51-1.00；P=0.050）。NOAC 大出血的风险在低体重指数（BMI）（OR 0.50；95%CI，0.22-1.12；P=0.07）或年龄≥85 岁（OR 0.44；95%CI，0.13-1.49；P=0.17）的高危患者中也较低。
我们的真实世界数据表明，与 VKA 相比，NOAC 治疗在老年房颤患者中具有更好的净临床获益，主要是由于大出血发生率较低。NOAC 大出血的风险在 BMI 较低或年龄≥85 岁的高危患者中也较低。
