Spinoni Enrico Guido, Ghiglieno Chiara, Costantino Simona, Battistini Eleonora, Dell'Era Gabriele, Porcellini Stefano, Santagostino Matteo, De Vecchi Federica, Renda Giulia, Patti Giuseppe
Department of Translational Medicine, University of Eastern Piedmont, 28100 Novara, Italy.
Department of Thoracic, Heart and Vascular Diseases, Maggiore della Carità Hospital, 28100 Novara, Italy.
J Clin Med. 2022 Feb 14;11(4):986. doi: 10.3390/jcm11040986.
There are no data on procedure-related bleeding outcome with non-vitamin K antagonist anticoagulants (NOACs) versus vitamin K antagonist anticoagulants (VKAs) in patients with atrial fibrillation (AF) undergoing cardiac implantable electronic device (CIED) intervention. Our aim was to evaluate whether NOACs have a safety benefit even in terms of fewer hemorrhagic complications at the site of CIED implant. Consecutive AF patients receiving NOACs or VKAs at the time of CIED procedure were included in this observational, retrospective, and monocentric investigation. Primary endpoint was the incidence of post-intervention pocket hematoma. A total of 311 patients were enrolled, 146 on NOACs, and 165 on VKAs. The incidence of pocket hematoma was 3.4% in the NOAC versus 13.3% in the VKA group ( = 0.002). Primary outcome-free survival at 30-days was 96.6% in patients on NOACs and 86.0% in those on VKAs ( = 0.019). Multivariate analysis, adjusted by propensity-score calculation of inverse-probability-weighting, showed a significantly lower occurrence of pocket hematoma in patients receiving NOACs versus VKAs (HR 0.35, 95% CI 0.13-0.96, = 0.042). Such NOACs benefit was confirmed versus patients on VKAs without peri-procedural bridging with low-molecular-weight heparin (HR 0.34, 95% CI 0.11-0.99, = 0.048). The incidence of pocket infection, surgical pocket evacuation, ischemic events, and major bleeding complications at 30 days (secondary endpoints) was similar in the two groups. In conclusion, our data suggest that, among patients with AF undergoing implantable cardiac defibrillator or pacemaker intervention, the use of NOACs versus VKAs may be associated with significant reduction of post-procedural pocket hematoma, regardless of bridging with low-molecular-weight heparin in the VKA group. These results are hypothesis generating and need to be confirmed in a specific randomized study.
在接受心脏植入式电子设备（CIED）干预的心房颤动（AF）患者中，尚无关于非维生素K拮抗剂抗凝剂（NOACs）与维生素K拮抗剂抗凝剂（VKAs）在与手术相关的出血结局方面的对比数据。我们的目的是评估即使在CIED植入部位出血并发症较少的情况下，NOACs是否具有安全性优势。在这项观察性、回顾性、单中心研究中，纳入了在CIED手术时接受NOACs或VKAs治疗的连续性AF患者。主要终点是干预后囊袋血肿的发生率。总共纳入了311例患者，其中146例使用NOACs，165例使用VKAs。NOAC组囊袋血肿的发生率为3.4%，而VKA组为13.3%（P = 0.002）。使用NOACs的患者30天无主要结局生存率为96.6%，使用VKAs的患者为86.0%（P = 0.019）。通过倾向评分计算的逆概率加权进行调整的多变量分析显示，与使用VKAs的患者相比，接受NOACs的患者囊袋血肿的发生率显著更低（风险比0.35，95%置信区间0.13 - 0.96，P = 0.042）。与未在围手术期使用低分子肝素进行桥接的使用VKAs的患者相比，这种NOACs的优势得到了证实（风险比0.34，95%置信区间0.11 - 0.99，P = 0.048）。两组在30天时的囊袋感染、手术囊袋引流、缺血事件和大出血并发症的发生率（次要终点）相似。总之，我们的数据表明，在接受植入式心脏除颤器或起搏器干预的AF患者中，与VKAs相比，使用NOACs可能与显著降低术后囊袋血肿有关，无论VKA组是否使用低分子肝素进行桥接。这些结果只是提出了假设，需要在一项特定的随机研究中得到证实。
