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European Heart Journal Advance Access originally published online on December 5, 2005
European Heart Journal 2006 27(8):960-967; doi:10.1093/eurheartj/ehi667
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© The European Society of Cardiology 2006. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Effect of antithrombotic therapy in patients with mitral stenosis and atrial fibrillation: a sub-analysis of NASPEAF randomized trial

Francisco Pérez-Gómez1,*, Antonio Salvador2, Javier Zumalde3, Jose A. Iriarte4, Jesús Berjón5, Eduardo Alegría6, Carlos Almería1, Ramón Bover1, Dionisio Herrera7, Cristina Fernández1 for the National Study for Prevention of Embolism in Atrial Fibrillation Investigators{dagger}

1Servicio de Cardiología, Hospital Clinico San Carlos, Prof. Martín Lagos s/n., 28040 Madrid, Spain
2Hospital Dr Peset, Valencia, Spain
3Hospital Galdakao, Bilbao, Spain
4Hospital Basurto, Bilbao, Spain
5Hospital de Navarra, Pamplona, Spain
6Clinica Universitaria de Navarra, Pamplona, Spain
7Centro Medico Avenida Portugal, Madrid, Spain

Received 16 May 2005; revised 23 September 2005; accepted 3 November 2005; online publish-ahead-of-print 5 December 2005.

* Corresponding author. Tel: +34 91 330 31 43; fax: +34 91 330 31 42. E-mail address: fperezg.hcsc{at}salud.madrid.org

Aims The randomized NASPEAF study included non-valvular with prior embolism and mitral stenosis patients in the same group. This is a sub-study to specially focus on the antithrombotic therapy in mitral stenosis.

Methods and results We analysed 311 patients with mitral stenosis, compared with 175 non-valvular atrial fibrillation patients with prior embolism, stratified by a history of previous embolism and assigned to anticoagulant therapy [target international normalized ratio (INR)=2.0–3.0] or combined antiplatelet plus moderate intensity anticoagulant therapy. Median follow-up was 2.9 years. Outcomes were fatal and non-fatal embolism, stroke and myocardial infarction, sudden death, and death from bleeding. Combined therapy in mitral stenosis patients, compared with anticoagulant alone therapy, reduced the risk of vascular events by 58.3%. During equal therapy, the outcome annual rates were essentially the same in non-valvular and valvular patients [hazard ratio 0.90 (95% confidence interval 0.37–2.16), P=0.81]. During anticoagulant alone therapy, the annual event rate in mitral stenosis patients without prior embolism was low (2.5%) and it was very high in patients with prior embolism (6.6%).

Conclusion Combined therapy was effective in mitral stenosis patients. Prior embolism patients are not efficiently protected with anticoagulant alone therapy for an INR of 2.0–3.0.

Key Words: Atrial fibrillation • Stroke • Mitral stenosis • Anticoagulants • Antiplatelets • Severe bleeding


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