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心房颤动患者机械主动脉瓣置换术后的抗凝质量与结局:一项全国性队列研究。

Quality of anticoagulation and outcomes after mechanical aortic valve replacement in patients with atrial fibrillation: a nationwide cohort study.

作者信息

Lehto Joonas, Björn Rikhard, Halminen Olli, Linna Miika, Haukka Jari, Putaala Jukka, Mustonen Pirjo, Kinnunen Janne, Hartikainen Juha, Airaksinen Juhani K E, Kiviniemi Tuomas O, Lehto Mika

机构信息

Heart Center, Turku University Hospital and University of Turku, POB 52, Turku FI-20521, Finland.

Department of Industrial Engineering and Management, Aalto University, Espoo, Finland.

出版信息

Eur Heart J Qual Care Clin Outcomes. 2025 Aug 11;11(5):654-664. doi: 10.1093/ehjqcco/qcaf028.

Abstract

AIMS

Mechanical aortic valve replacement (AVR) remains the primary treatment for younger patients with severe aortic valve disease. However, limited information is available regarding the quality of the required lifelong vitamin K antagonist (VKA) therapy, atrial fibrillation (AF), and their relationship with adverse events after AVR. This study assessed the quality of VKA therapy prior to bleeding and ischaemic events following mechanical AVR in patients with AF.

METHODS AND RESULTS

The registry-based Finnish AntiCoagulation in Atrial Fibrillation study combining data from several Finnish healthcare registers covers all patients diagnosed with AF during 2007-18 in Finland. This analysis included patients undergoing mechanical AVR before or after the AF diagnosis. A total of 1086 patients with mechanical AVR and AF either before (41.2%) or after (58.8%) the operation were identified. Cumulative incidence estimates at 10 years after AVR were 27.9% for significant bleeding, 5.8% for intracranial haemorrhage, 12.8% for ischaemic stroke, and 7.2% for myocardial infarction. Time in therapeutic range (TTR) < 80% with international normalized ratio (INR) target 2.0-3.5 was associated with higher bleeding occurrence [adjusted hazard ratio (aHR) 1.97, 1.39-2.79, P < 0.001]. Time in therapeutic range with INR target ≥2.0 was associated with higher stroke occurrence (aHR/standard deviation 1.22, 1.01-1.46, P = 0.035). Mortality was high (28.9%/10 years), and TTR <80% was associated with higher mortality (aHR 2.74, 2.00-3.76, P < 0.001).

CONCLUSION

Adverse events, particularly major bleeding, are common in patients with AF following mechanical AVR, and mortality is high. Suboptimal TTR appears to predict bleeding episodes, ischaemic stroke, and death, and it could be useful in high-risk patient identification and targeting of preventive strategies.

TRIAL REGISTRATION

Finnish AntiCoagulation in Atrial Fibrillation study, ClinicalTrials Identifier: NCT04645537, https://clinicaltrials.gov/ct2/show/NCT04645537.

摘要

目的

机械主动脉瓣置换术(AVR)仍是年轻重度主动脉瓣疾病患者的主要治疗方法。然而,关于所需终身维生素K拮抗剂(VKA)治疗的质量、心房颤动(AF)及其与AVR术后不良事件的关系,目前可用信息有限。本研究评估了房颤患者机械AVR术后出血和缺血事件前VKA治疗的质量。

方法与结果

基于登记处的芬兰房颤抗凝研究结合了来自芬兰多个医疗保健登记处的数据,涵盖了2007年至2018年期间在芬兰所有被诊断为房颤的患者。该分析包括在房颤诊断之前或之后接受机械AVR的患者。共识别出1086例在手术前(41.2%)或手术后(58.8%)患有机械性AVR和房颤的患者。AVR术后10年的累积发病率估计为:严重出血27.9%,颅内出血5.8%,缺血性卒中12.8%,心肌梗死7.2%。国际标准化比值(INR)目标为2.0 - 3.5时,治疗范围内时间(TTR)< 80%与更高的出血发生率相关[调整后风险比(aHR)1.97,1.39 - 2.79,P < 0.001]。INR目标≥2.0时的治疗范围内时间与更高的卒中发生率相关(aHR/标准差1.22,1.01 - 1.46,P = 0.035)。死亡率较高(28.9%/10年),TTR < 80%与更高的死亡率相关(aHR 2.74,2.00 - 3.76,P < 0.001)。

结论

机械AVR术后房颤患者不良事件常见,尤其是大出血,死亡率高。次优的TTR似乎可预测出血事件、缺血性卒中和死亡,有助于识别高危患者并制定预防策略。

试验注册

芬兰房颤抗凝研究,临床试验标识符:NCT04645537,https://clinicaltrials.gov/ct2/show/NCT04645537

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5abb/12342859/616580677b32/qcaf028_ga.jpg

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