Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden
Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
Open Heart. 2024 Jan 29;11(1):e002602. doi: 10.1136/openhrt-2024-002602.
To assess outcomes after cardiac surgery with biological valve replacement, valve repair or transcatheter aortic valve implantation (TAVI) in patients with atrial fibrillation (AF) in accordance with oral anticoagulant (OAC) treatment.
All patients in Sweden undergoing valvular intervention with AF were included. Associations between OAC exposure and cardiovascular (CV) events (composite of CV death, ischaemic stroke or systemic embolism) and major bleeding were investigated using Cox regression analysis. The analysis was separated in time periods of 0-3 and 3-12 months after discharge.
4730 patients were included in the first time period, 54.0% had received a surgical biological valve prosthesis, 23.8% valve repair and 22.2% TAVI. Exposure to warfarin (comparator) was 62.3%, to non-vitamin K antagonist oral anticoagulants (NOACs) 10.0% and to no OAC 27.7%. NOAC exposure was associated with similar risk of the composite CV outcome and major bleeding from 0 to 3 months. No OAC was associated with increased risk of the composite CV outcome (HR 1.71; 95% CI 1.26 to 2.32) and similar risk of major bleeding. Further analysis of the bioprosthetic valve replacement subgroup indicated increased risk of CV death when exposed to NOAC (HR 2.58; 95% CI 1.15 to 5.78) and no OAC (HR 2.82; 95% CI 1.65 to 4.82) compared with warfarin from 0 to 3 months. No differences were seen between 3 and 12 months.
In this registry-based cohort study of patients with AF with severe valvular heart disease undergoing various valvular interventions, NOAC appears to be comparable with warfarin regarding efficacy and safety. Patients not receiving OAC had higher risk of CV events. NOAC was associated with increased CV death compared with warfarin in the surgical bioprosthetic valve replacement subgroup, illustrating the importance of being cautious when extrapolating data from one patient group to another. Further studies comparing NOAC and warfarin in the early postoperative phase are warranted, especially following surgical bioprosthetic valve replacement.
评估心房颤动（AF）患者行心脏手术时行生物瓣置换、瓣膜修复或经导管主动脉瓣植入术（TAVI）后，根据口服抗凝剂（OAC）治疗的结果。
纳入所有在瑞典行瓣膜介入治疗并伴有 AF 的患者。采用 Cox 回归分析评估 OAC 暴露与心血管（CV）事件（CV 死亡、缺血性卒中和全身性栓塞的复合终点）和大出血之间的相关性。分析分为出院后 0-3 个月和 3-12 个月两个时间段。
纳入了 4730 例患者，其中 54.0%接受了外科生物瓣假体置换，23.8%行瓣膜修复，22.2%行 TAVI。华法林（对照组）暴露率为 62.3%，非维生素 K 拮抗剂口服抗凝剂（NOAC）暴露率为 10.0%，无 OAC 暴露率为 27.7%。NOAC 暴露 0-3 个月时与 CV 复合结局和大出血的风险相似。无 OAC 暴露与 CV 复合结局风险增加相关（HR 1.71；95%CI 1.26 至 2.32），但大出血风险相似。对生物瓣置换亚组的进一步分析表明，与华法林相比，NOAC（HR 2.58；95%CI 1.15 至 5.78）和无 OAC（HR 2.82；95%CI 1.65 至 4.82）暴露时 CV 死亡风险增加，0-3 个月时观察到差异。3-12 个月时未见差异。
在这项基于登记的 AF 伴严重瓣膜性心脏病患者队列研究中，行各种瓣膜介入治疗的患者中，NOAC 似乎在疗效和安全性方面与华法林相当。未接受 OAC 治疗的患者发生 CV 事件的风险更高。NOAC 与华法林相比，在外科生物瓣置换亚组中 CV 死亡风险增加，这表明从一组患者外推数据时需要谨慎。需要进一步研究比较 NOAC 和华法林在术后早期的效果，特别是在外科生物瓣置换后。
