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European Heart Journal Advance Access published online on December 5, 2005

European Heart Journal, doi:10.1093/eurheartj/ehi667
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European Heart Journal © The European Society of Cardiology 2005; all rights reserved
Received May 16, 2005
Revised September 23, 2005
Accepted November 3, 2005

Clinical research

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

Francisco Pérez-Gómez 1 *, Antonio Salvador 2, Javier Zumalde 3, Jose A. Iriarte 4, Jesús Berjón 5, Eduardo Alegría 6, Carlos Almería 1, Ramón Bover 1, Dionisio Herrera 7, Cristina Fernández 1, and for the National Study for Prevention of Embolism in Atrial Fibrillation Investigators

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

* To whom correspondence should be addressed.
Francisco Pérez-Gómez, E-mail: fperezg.hcsc{at}salud.madrid.org


   Abstract

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.

Keywords: Atrial fibrillation; Stroke; Mitral stenosis; Anticoagulants; Antiplatelets; Severe bleeding.
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