Section of Geriatrics, Department of Medical Sciences, University of Turin, AOU Città della Salute e della Scienza, Molinette, Turin, Italy.
Department of Experimental and Clinical Medicine, University of Florence, Largo G. Brambilla 3, Florence 50134, Italy.
Eur J Intern Med. 2024 Mar;121:88-94. doi: 10.1016/j.ejim.2023.10.010. Epub 2023 Oct 23.
In a large nationwide administrative database including ∼35 % of Italian population, we analyzed the impact of oral anticoagulant treatment (OAT) in patients with a hospital diagnosis of non-valvular atrial fibrillation (NVAF).
Of 170404 OAT-naïve patients (mean age 78.7 years; 49.4 % women), only 61.1 % were prescribed direct oral anticoagulants, DOACs, or vitamin-K antagonists, VKAs; 14.2 % were given aspirin (ASA), and 24.8 % no anti-thrombotic drugs (No Tx). We compared ischemic stroke (IS), IS and systemic embolism (IS/SE), intracranial hemorrhage (ICH), major bleeding (MB), major gastro-intestinal bleeding, all-cause deaths and the composite outcome, across four propensity-score matched treatment cohorts with >15400 patients each. Over 2.9±1.5 years, the incidence of IS and IS/SE was slightly less with VKAs than with DOACs (1.62 and 1.84 vs 1.81 and 1.99 events.100 person-years; HR=0.85, 95%CI=0.76-0.95 and HR=0.87, 95%CI=0.78-0.97). This difference disappeared in a sensitivity analysis which excluded those patients treated with low-dose of apixaban, edoxaban, or rivaroxaban (41.7% of DOACs cohort). Compared with DOACs, VKAs were associated with greater incidence of ICH (1.09 vs 0.81; HR=1.38, 95%CI=1.17-1.62), MB (3.78 vs 3.31; HR=1.14, 95%CI=1.02-1.28), all-cause mortality (9.66 vs 10.10; HR=1.07, 95%CI=1.02-1.11), and composite outcome (13.72 vs 13.32; HR=1.04, 95%CI=1.01-1.08). IS, IS/SE, and mortality were more frequent with ASA or No Tx than with VKAs or DOACs (p<0.001 for all comparisons).
Beyond confirming the association with a better net clinical benefit of DOACs over VKAs, our findings substantiate the large proportion of NVAF patients still inappropriately anticoagulated, thereby reinforcing the need for educational programs.
在一个包括约 35%意大利人口的大型全国性行政数据库中，我们分析了口服抗凝治疗（OAT）对非瓣膜性心房颤动（NVAF）住院诊断患者的影响。
在 170404 名 OAT 初治患者（平均年龄 78.7 岁；49.4%为女性）中，仅 61.1%接受了直接口服抗凝剂（DOACs）、维生素 K 拮抗剂（VKAs）；14.2%给予阿司匹林（ASA），24.8%未给予抗血栓药物（No Tx）。我们比较了四个倾向评分匹配的治疗队列中（每个队列超过 15400 名患者）的缺血性卒中（IS）、IS 和全身性栓塞（IS/SE）、颅内出血（ICH）、大出血（MB）、主要胃肠出血、全因死亡和复合结局。在 2.9±1.5 年期间，与 VKA 相比，DOACs 治疗的 IS 和 IS/SE 发生率略低（1.62 和 1.84 比 1.81 和 1.99 事件。100 人年；HR=0.85，95%CI=0.76-0.95 和 HR=0.87，95%CI=0.78-0.97）。这一差异在排除了接受低剂量阿哌沙班、依度沙班或利伐沙班治疗的患者（DOACs 队列的 41.7%）的敏感性分析中消失了。与 DOACs 相比，VKA 与更高的 ICH 发生率相关（1.09 比 0.81；HR=1.38，95%CI=1.17-1.62）、MB（3.78 比 3.31；HR=1.14，95%CI=1.02-1.28）、全因死亡率（9.66 比 10.10；HR=1.07，95%CI=1.02-1.11）和复合结局（13.72 比 13.32；HR=1.04，95%CI=1.01-1.08）。与 VKA 或 DOACs 相比，ASA 或 No Tx 的 IS、IS/SE 和死亡率更高（所有比较的 p<0.001）。
除了证实 DOACs 相对于 VKA 具有更好的净临床获益外，我们的研究结果证实了仍有大量 NVAF 患者接受不适当的抗凝治疗，因此需要加强教育计划。
