Georgios Giannopoulos1, Charalampos Kossyvakis2, Michael Efremidis2, Apostolos Katsivas2, Vasiliki Panagopoulou2, Konstantinos Doudoumis2, Konstantinos Raisakis2, Konstantinos Letsas2, Ilias Rentoukas2, Vlasios Pyrgakis2, Antonis S Manolis2, Dimitrios Tousoulis2, Christodoulos Stefanadis2, Spyridon Deftereos2. 1. From the Department of Cardiology, Athens General Hospital "G. Gennimatas," Athens, Greece (G.G., C.K., K.D., K.R., I.R., V.P., S.D.); 2nd Department of Cardiology, Evangelismos General Hospital, Athens, Greece (M.E., K.L.); 1st Department of Cardiology, Red Cross Hospital, Athens, Greece (A.K.); 1st Department of Cardiology, University of Athens Medical School, Hippokration Hospital, Athens, Greece (V.P., A.S.M., D.T., C.S.). ggiann@med.uoa.gr georgios.giannopolous@yale.edu. 2. From the Department of Cardiology, Athens General Hospital "G. Gennimatas," Athens, Greece (G.G., C.K., K.D., K.R., I.R., V.P., S.D.); 2nd Department of Cardiology, Evangelismos General Hospital, Athens, Greece (M.E., K.L.); 1st Department of Cardiology, Red Cross Hospital, Athens, Greece (A.K.); 1st Department of Cardiology, University of Athens Medical School, Hippokration Hospital, Athens, Greece (V.P., A.S.M., D.T., C.S.).
Abstract
BACKGROUND: The autonomic system is an important determinant of atrial arrhythmogenesis. Current evidence indicates that a combined sympathovagal drive is most commonly responsible for eliciting atrial fibrillation (AF) episodes. The purpose of this study was to test whether moxonidine, a centrally acting sympathoinhibitory agent, can lead to a reduction in postablation AF recurrence. METHODS AND RESULTS: This was a prospective, double-blinded, randomized study of 291 hypertensive patients with symptomatic paroxysmal AF who were scheduled to undergo pulmonary vein isolation. Patients were randomly assigned to receive either moxonidine (0.2-0.4 mg daily) or placebo, along with standard antihypertensive treatment. No significant differences in blood pressure levels were observed between the 2 groups. In the primary outcome analysis, mean recurrence-free survival was 467 days (95% CI, 445-489 days) in the moxonidine group as compared with 409 days (95% CI, 381-437 days) in control subjects (log rank test, P=0.006). The calculated 12-month recurrence rate estimates were 36.9% in the control group and 20.0% in the moxonidine group (P=0.007). Moxonidine treatment was associated with lower recurrence risk after adjustment for age, body mass index, number of AF episodes in the previous year, and left atrial diameter (adjusted hazard ratio, 0.35 [95% CI, 0.22-0.55]; P<0.001). CONCLUSIONS: Treatment with moxonidine is associated with less AF recurrences after ablation treatment for drug-refractory AF in patients with hypertension. The observed effect does not appear to depend on the antihypertensive action of this agent. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01791699.
RCT Entities:
BACKGROUND: The autonomic system is an important determinant of atrial arrhythmogenesis. Current evidence indicates that a combined sympathovagal drive is most commonly responsible for eliciting atrial fibrillation (AF) episodes. The purpose of this study was to test whether moxonidine, a centrally acting sympathoinhibitory agent, can lead to a reduction in postablation AF recurrence. METHODS AND RESULTS: This was a prospective, double-blinded, randomized study of 291 hypertensivepatients with symptomatic paroxysmal AF who were scheduled to undergo pulmonary vein isolation. Patients were randomly assigned to receive either moxonidine (0.2-0.4 mg daily) or placebo, along with standard antihypertensive treatment. No significant differences in blood pressure levels were observed between the 2 groups. In the primary outcome analysis, mean recurrence-free survival was 467 days (95% CI, 445-489 days) in the moxonidine group as compared with 409 days (95% CI, 381-437 days) in control subjects (log rank test, P=0.006). The calculated 12-month recurrence rate estimates were 36.9% in the control group and 20.0% in the moxonidine group (P=0.007). Moxonidine treatment was associated with lower recurrence risk after adjustment for age, body mass index, number of AF episodes in the previous year, and left atrial diameter (adjusted hazard ratio, 0.35 [95% CI, 0.22-0.55]; P<0.001). CONCLUSIONS: Treatment with moxonidine is associated with less AF recurrences after ablation treatment for drug-refractory AF in patients with hypertension. The observed effect does not appear to depend on the antihypertensive action of this agent. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01791699.
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