Russo Vincenzo, Attena Emilio, Baroni Matteo, Trotta Roberta, Manu Marius Constantin, Kirchhof Paulus, De Caterina Raffaele
Cardiology Unit, Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli"-Monaldi Hospital, 80131 Naples, Italy.
Cardiologia 3-A. De Gasperis Cardio Center, ASST GOM Niguarda Ca'Granda, Piazza dell'Ospedale Maggiore 3, 20162 Milan, Italy.
J Clin Med. 2022 Jun 28;11(13):3751. doi: 10.3390/jcm11133751.
Background: Elderly patients are at high risk of both ischaemic and bleeding events, and the low body weight is considered a risk factor for major bleeding in atrial fibrillation (AF) patients on anticoagulation therapy. The aim of our study was to compare the safety and effectiveness of non-vitamin K antagonist oral anticoagulants (NOACs) versus well-controlled vitamin-K antagonists (VKA) therapy among AF patients aged >75 years and with a body weight <60 kg in a prospective registry setting. Methods: Data for this study were sourced from the Italian cohorts of PREFER in AF and PREFER in AF PROLONGATION registries. The occurrence of a composite of stroke, transient ischemic attack and systemic embolism (thromboembolic events) was the primary effectiveness endpoint. The occurrence of major bleeding was the primary safety endpoint. All-cause hospitalizations and all-cause death were the secondary endpoints. The net clinical benefit (NCB) was calculated in order to obtain an integrated assessment of the anti-thromboembolic and pro-haemorrhagic effects of NOACs vs. VKA. Results: Overall, 522 patients were included; 225 were on treatment with NOACs and 317 patients with VKA. The NOAC group more frequently featured a higher BMI and a higher prevalence of history of stroke/TIA and insulin-requiring diabetes; conversely, heart failure and chronic liver disease were less frequent in the NAOC group. In the unmatched study population, 18 patients (3.6% in the NOAC vs. 3.2% in the VKA group, p = 0.79) experienced thromboembolic events; 19 patients (1.78% in the NOAC vs. 4.73% in the VKA group, p = 0.06) experienced major bleeding events; and 68 patients were hospitalized during the follow-up (9.3% vs. 14.8%, p = 0.06). After balancing for potential confounders by using the 1:1 propensity score matching technique, 426 patients (213 on NOAC and 213 on VKA) were selected. We found no significant differences in terms of thromboembolic events (3.76% vs. 4.69%, p = 0.63), major bleeding events (n: 1.88% vs. 4.22%, p = 0.15) and hospitalizations (9.9% vs. 16.9%, p = 0.06) between NOAC vs. VKA matched population. Based on these incidences, we found a positive net clinical benefit (+1.6) of NOACs vs. VKAs. Conclusions: These real-world data suggest the safety and effectiveness of using NOACs in elderly patients with low body weight.
老年患者发生缺血性和出血性事件的风险都很高，低体重被认为是接受抗凝治疗的心房颤动（AF）患者发生大出血的一个危险因素。我们研究的目的是在前瞻性登记研究中，比较非维生素K拮抗剂口服抗凝药（NOACs）与良好控制的维生素K拮抗剂（VKA）治疗在年龄>75岁且体重<60kg的AF患者中的安全性和有效性。方法：本研究的数据来源于意大利AF-PREFER队列研究和AF-PROLONGATION登记研究。卒中、短暂性脑缺血发作和系统性栓塞（血栓栓塞事件）的复合发生情况是主要有效性终点。大出血的发生情况是主要安全性终点。全因住院和全因死亡是次要终点。计算净临床获益（NCB）以综合评估NOACs与VKA的抗血栓栓塞和促出血效应。结果：总体上，纳入了522例患者；225例接受NOACs治疗，317例接受VKA治疗。NOAC组的BMI更高，卒中/TIA病史和需要胰岛素治疗的糖尿病患病率更高；相反，NAOC组心力衰竭和慢性肝病的发生率较低。在未匹配的研究人群中，18例患者（NOAC组为3.6%，VKA组为3.2%，p = 0.79）发生了血栓栓塞事件；19例患者（NOAC组为1.78%，VKA组为4.73%，p = 0.06）发生了大出血事件；68例患者在随访期间住院（9.3%对14.8%，p = 0.06）。通过使用1:1倾向评分匹配技术平衡潜在混杂因素后，选择了426例患者（213例接受NOAC治疗，213例接受VKA治疗）。我们发现在匹配人群中，NOAC组与VKA组在血栓栓塞事件（3.76%对4.69%，p = 0.63）、大出血事件（n：1.88%对4.22%，p = 0.15）和住院情况（9.9%对16.9%，p = 0.06）方面无显著差异。基于这些发生率，我们发现NOACs相对于VKAs有正向的净临床获益（+1.6）。结论：这些真实世界数据表明在低体重老年患者中使用NOACs的安全性和有效性。
