Spyridon Deftereos1, Georgios Giannopoulos2, Michael Efremidis3, Charalampos Kossyvakis4, Apostolos Katsivas5, Vasiliki Panagopoulou4, Charalampos Papadimitriou4, Sofia Karageorgiou4, Konstantinos Doudoumis4, Konstantinos Raisakis4, Andreas Kaoukis4, Dimitrios Alexopoulos6, Antonis S Manolis7, Christodoulos Stefanadis7, Michael W Cleman8. 1. Department of Cardiology, Athens General Hospital "G. Gennimatas," Athens, Greece; Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut. 2. Department of Cardiology, Athens General Hospital "G. Gennimatas," Athens, Greece; Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut. Electronic address: ggiann@med.uoa.gr. 3. 2nd Department of Cardiology, Evaggelismos General Hospital, Athens, Greece. 4. Department of Cardiology, Athens General Hospital "G. Gennimatas," Athens, Greece. 5. 1st Department of Cardiology, Red Cross Hospital, Athens, Greece. 6. Department of Cardiology, University of Patras, Patras, Greece. 7. 1st Department of Cardiology, University of Athens Medical School, Athens, Greece. 8. Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.
Abstract
BACKGROUND: Our group previously showed that colchicine treatment is associated with decreased early recurrence rate after ablation for atrial fibrillation (AF). OBJECTIVE: The purpose of this study was to test the mid-term efficacy of colchicine in reducing AF recurrences after a single procedure of pulmonary vein isolation in patients with paroxysmal AF. Assessment of quality-of-life (QOL) changes was a secondary objective. METHODS:Patients with paroxysmal AF who were scheduled for ablation were randomized to a 3-month course of colchicine 0.5 mg twice daily or placebo and were followed for a median of 15 months (with a 3-month blanking period). QOL was assessed with a general-purpose health-related QOL tool (26-item World Health Organization QOL questionnaire) at baseline and after 3 and 12 months. RESULTS:Two hundred twenty-three randomized patients underwent ablation, and 206 patients were available for analysis (144 male, age 62.2 ± 5.8 years). AF recurrence rate in the colchicine group was 31.1% (32/103) vs 49.5% (51/103) in the control group (P = .010), translated in a relative risk reduction of 37% (odds ratio 0.46, 95% confidence interval 0.26-0.81). The number needed to treat was 6 (95% confidence interval 3.2-19.8). Physical domain QOL scores at 12 months were 63.6 ± 13.8 in the colchicine group and 52.5 ± 18.1 in controls, whereas psychological domain scores were 56.1 ± 13.7 vs 44.7 ± 17.3, respectively (P <.001, for both). CONCLUSION:Colchicine treatment after pulmonary vein isolation for paroxysmal AF is associated with lower AF recurrence rates after a single procedure. This reduction is accompanied by corresponding improvements in physical and psychological health-related QOL scores.
RCT Entities:
BACKGROUND: Our group previously showed that colchicine treatment is associated with decreased early recurrence rate after ablation for atrial fibrillation (AF). OBJECTIVE: The purpose of this study was to test the mid-term efficacy of colchicine in reducing AF recurrences after a single procedure of pulmonary vein isolation in patients with paroxysmal AF. Assessment of quality-of-life (QOL) changes was a secondary objective. METHODS:Patients with paroxysmal AF who were scheduled for ablation were randomized to a 3-month course of colchicine 0.5 mg twice daily or placebo and were followed for a median of 15 months (with a 3-month blanking period). QOL was assessed with a general-purpose health-related QOL tool (26-item World Health Organization QOL questionnaire) at baseline and after 3 and 12 months. RESULTS: Two hundred twenty-three randomized patients underwent ablation, and 206 patients were available for analysis (144 male, age 62.2 ± 5.8 years). AF recurrence rate in the colchicine group was 31.1% (32/103) vs 49.5% (51/103) in the control group (P = .010), translated in a relative risk reduction of 37% (odds ratio 0.46, 95% confidence interval 0.26-0.81). The number needed to treat was 6 (95% confidence interval 3.2-19.8). Physical domain QOL scores at 12 months were 63.6 ± 13.8 in the colchicine group and 52.5 ± 18.1 in controls, whereas psychological domain scores were 56.1 ± 13.7 vs 44.7 ± 17.3, respectively (P <.001, for both). CONCLUSION:Colchicine treatment after pulmonary vein isolation for paroxysmal AF is associated with lower AF recurrence rates after a single procedure. This reduction is accompanied by corresponding improvements in physical and psychological health-related QOL scores.
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