Randomized Trial of Benznidazole for Chronic Chagas' Cardiomyopathy

MORILLO CA; MARIN-NETO JA; AVEZUM A; SOSA-ESTANI S; RASSI A JR; ROSAS F; VILLENA E; QUIROZ R; BONILLA R; BRITTO C; GUHL F; VELAZQUEZ E; BONILLA L; MEEKS B; RAO-MELACINI P; POGUE J; MATTOS A; LAZDINS J; RASSI A; CONNOLLY SJ; YUSUF S; BENEFIT INVESTIGATORS

NEW ENGLAND JOURNAL OF MEDICINE

MASSACHUSETTS MEDICAL SOC

Año: 2015 vol. 373 p. 1295 - 1306

0028-4793

BACKGROUND:The role of trypanocidal therapy in patients with established Chagas´ cardiomyopathy is unproven.METHODS:We conducted a prospective, multicenter, randomized study involving 2854 patients with Chagas´ cardiomyopathy who received benznidazole or placebo for up to 80 days and were followed for a mean of 5.4 years. The primary outcome in the time-to-event analysis was the first event of any of the components of the composite outcome of death, resuscitated cardiac arrest, sustained ventricular tachycardia, insertion of a pacemaker or implantable cardioverter-defibrillator, cardiac transplantation, new heart failure, stroke, or other thromboembolic event.RESULTS:The primary outcome occurred in 394 patients (27.5%) in the benznidazole group and in 414 (29.1%) in the placebo group (hazard ratio, 0.93; 95% confidence interval [CI], 0.81 to 1.07; P=0.31). At baseline, a polymerase-chain-reaction (PCR) assay was performed on blood samples obtained from 1896 patients; 60.5% had positive results for Trypanosoma cruzi on PCR. The rates of conversion to negative PCR results (PCR conversion) were 66.2% in the benznidazole group and 33.5% in the placebo group at the end of treatment, 55.4% and 35.3%, respectively, at 2 years, and 46.7% and 33.1%, respectively, at 5 years or more (P