Faculty of Medicine, Department III for Internal Medicine, Heart Center, University Hospital of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.
InGef - Institute for Applied Health Research Berlin GmbH, Berlin, Germany.
Clin Res Cardiol. 2022 Aug;111(8):889-899. doi: 10.1007/s00392-022-01988-2. Epub 2022 Feb 26.
This study sought to investigate current anticoagulatory treatment patterns and clinical outcome in patients undergoing transcatheter mitral valve repair (MitraClip).
In a retrospective study of a German claims database (InGef research database), anticoagulatory treatment regimens were assessed using any drug prescription post discharge within the first 90 days after MitraClip procedure. Clinical events between 30 days and 6 months were examined by treatment regime. The study population comprised 1342 patients undergoing MitraClip procedure between 2014 and 2018. 22.4% received antiplatelet monotherapy, 20.8% oral anticoagulation (OAC) plus antiplatelet therapy, 19.4% OAC monotherapy, 11.7% dual antiplatelet therapy, 2.8% triple therapy and 21.0% did not receive any anticoagulatory drugs. 63% of patients with OAC received non-vitamin-K antagonist oral anticoagulants (NOAC). A total of 168 patients were newly prescribed OAC after MitraClip, of whom 12 patients (7.1%) had no diagnosis of atrial fibrillation or venous thromboembolism. 40% of patients with OAC prior to MitraClip did not have any OAC after MitraClip. The adjusted risk of all-cause mortality was significantly increased in patients with no anticoagulatory treatment (HR 3.84, 95% CI 2.33-6.33, p < 0.0001) when compared to antiplatelet monotherapy whereas the other regimes were not significantly different.
This large real-world data analysis demonstrates a heterogeneous spectrum of prescriptions for anticoagulant therapies after MitraClip. Considering relevant differences in clinical outcome across treatment groups, major effort is warranted for controlled trials in order to establish evidence-based recommendations on anticoagulatory treatment after percutaneous mitral valve repair.
本研究旨在调查行经导管二尖瓣修复术（MitraClip）患者的当前抗凝治疗模式和临床结局。
在一项德国索赔数据库（InGef 研究数据库）的回顾性研究中，通过出院后 90 天内的任何药物处方评估 MitraClip 术后的抗凝治疗方案。通过治疗方案检查 30 天至 6 个月之间的临床事件。研究人群包括 2014 年至 2018 年间接受 MitraClip 手术的 1342 名患者。22.4%接受抗血小板单药治疗，20.8%口服抗凝剂（OAC）加抗血小板治疗，19.4% OAC 单药治疗，11.7%双联抗血小板治疗，2.8%三联治疗，21.0%未接受任何抗凝药物。63%接受 OAC 的患者使用非维生素 K 拮抗剂口服抗凝剂（NOAC）。MitraClip 后共有 168 名患者新处方 OAC，其中 12 名（7.1%）无房颤或静脉血栓栓塞症诊断。MitraClip 前接受 OAC 的 40%患者在 MitraClip 后不再接受任何 OAC。与抗血小板单药治疗相比，未接受抗凝治疗的患者全因死亡率的调整风险显著增加（HR 3.84，95%CI 2.33-6.33，p<0.0001），而其他方案则无显著差异。
这项大型真实世界数据分析表明，MitraClip 后抗凝治疗的处方存在广泛的异质性。考虑到不同治疗组之间临床结局的差异，需要进行对照试验，以制定经皮二尖瓣修复术后抗凝治疗的循证建议。
