CLINICAL RESEARCH: CLINICAL TRIALS
Comparative effects of antiplatelet, anticoagulant, or combined therapy in patients with valvular and nonvalvular atrial fibrillation
A randomized multicenter study
Francisco Pérez-Gómez, PhD, FESC*,*,
Eduardo Alegría, MD, PhD ,
Jesus Berjón, MD, PhD ,
Jose A. Iriarte, MD, PhD ,
Javier Zumalde, MD||,
Antonio Salvador, MD, PhD¶,
Luis Mataix, MD#
NASPEAF Investigators
* Hospital Clínico San Carlos, Madrid, Spain
Clínica Universitaria de Navarra, Pamplona, Spain
Hospital de Navarra, Pamplona, Spain
Hospital de Basurto, Bilbao, Spain
|| Hospital Galdakao, Bilbao, Spain
¶ Hospital Dr. Peset, Valencia, Spain
# Centro Especialidades Avenida de Portugal, Madrid, Spain
Manuscript received February 18, 2004;
revised manuscript received May 3, 2004,
accepted May 11, 2004.
* Reprint requests and correspondence: Dr. Francisco Pérez-Gómez, Servicio de Cardiología, Hospital Clínico San Carlos, Prof. Martín Lagos s/n, 28040 Madrid, Spainfperezg.hcsc@salud.madrid.org
OBJECTIVES: This trial evaluated the efficacy and safety of the combination of antiplatelet and moderate-intensity anticoagulation therapy in patients with atrial fibrillation associated with recognized risk factors or mitral stenosis.
BACKGROUND: Warfarin was more effective than aspirin in preventing stroke in these patients; combined therapy with low anticoagulant intensity was ineffective. Mitral stenosis patients were not investigated.
METHODS: We performed a multicenter randomized trial in 1,209 patients at risk. The intermediate-risk group included patients with risk factors or age >60 years: 242 received the cyclooxygenase inhibitor triflusal, 237 received acenocumarol, and 235 received a combination of both. The high-risk group included patients with prior embolism or mitral stenosis: 259 received anticoagulants and 236 received the combined therapy. Median follow-up was 2.76 years. Primary outcome was a composite of vascular death and nonfatal stroke or systemic embolism.
RESULTS: Primary outcome was lower in the combined therapy than in the anticoagulant arm in both the intermediate- (hazard ratio [HR] 0.33 [95% confidence interval (CI)0.12 to 0.91]; p = 0.02) and the high-risk group (HR 0.51 [95% CI 0.27 to 0.96]; p = 0.03). Primary outcome plus severe bleeding was lower with combined therapy in the intermediate-risk group. Nonvalvular and mitral stenosis patients had similar embolic event rates during anticoagulant therapy.
CONCLUSIONS: The combined antiplatelet plus moderate-intensity anticoagulation therapy significantly decreased the vascular events compared with anticoagulation alone and proved to be safe in atrial fibrillation patients.
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Abbreviations and Acronyms
| | AF = atrial fibrillation | | AFASAK = Copenhagen Study on Atrial Fibrillation | | CI = confidence interval | | EAFT = European Atrial Fibrillation Trial | | HR = hazard ratio | | INR = international normalized ratio | | MI = myocardial infarction | | NASPEAF = National Study for Prevention of Embolism in Atrial Fibrillation | | SPAF = Stroke Prevention in Atrial Fibrillation | | TIA = transient ischemic attack | | WARIS = Warfarin Aspirin Re-Infarction Study |
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