Hiroshige Yamabe1, Koichi Kaikita2, Toshiyuki Matsumura3, Atsushi Iwasa4, Junjiro Koyama5, Takashi Uemura6, Yasuhiro Morikami7, Ryusuke Tsunoda8, Kenji Morihisa9, Kazuteru Fujimoto10, Ichiro Kajiwara11, Kunihiko Matsui12, Kenichi Tsujita2, Hisao Ogawa13. 1. Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto City, Kumamoto, Japan. Electronic address: yyamabe@kumamoto-u.ac.jp. 2. Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto City, Kumamoto, Japan. 3. Division of Cardiology, Japan Labor Health and Welfare Organization Kumamoto Rosai Hospital, Yatsushiro City, Kumamoto, Japan. 4. Department of Cardiology, New Tokyo Hospital, Matsudo City, Chiba, Japan. 5. Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto City, Kumamoto, Japan. 6. Division of Cardiology, Kumamoto General Hospital, Yatsushiro City, Kumamoto, Japan. 7. Division of Cardiology, Kumamoto City Hospital, Kumamoto City, Kumamoto, Japan. 8. Division of Cardiology, Japanese Red Cross Kumamoto Hospital, Kumamoto City, Kumamoto, Japan. 9. Division of Cardiology, Kumamoto Central Hospital, Kumamoto City, Kumamoto Japan. 10. Department of Cardiology, National Hospital Organization Kumamoto Medical Center, Kumamoto City, Kumamoto, Japan. 11. Cardiovascular Medicine, Arao City Hospital, Arao City, Kumamoto, Japan. 12. Department of Community Medicine, Kumamoto University Hospital, Kumamoto City, Kumamoto, Japan. 13. National Cerebral and Cardiovascular Center, Suita City, Osaka, Japan.
Abstract
BACKGROUND: Experimental studies suggest that angiotensin II-receptor blockers can influence atrial remodeling and may prevent atrial fibrillation (AF). Therefore, we hypothesized that irbesartan may prevent the recurrence of AF following either catheter ablation or electrical cardioversion of AF. METHODS: Study on the Effect of Irbesartan on Atrial Fibrillation Recurrence in Kumamoto (SILK study) is a prospective, multicenter, randomized, and open-label comparative evaluation of the effects of irbesartan and amlodipine on AF recurrence in hypertensive patients with AF who are scheduled to undergo catheter ablation or electrical cardioversion of AF. The primary end point was either AF or atrial tachycardia (AT) recurrence. AF/AT recurrence was evaluated for 6 months using 24-h Holter electrocardiogram and portable electrocardiogram. The secondary endpoints included the change in blood pressure, the interval from the procedure to the first AF/AT recurrence, cardiovascular events, left atrial diameter (LAD), left ventricular ejection fraction (LVEF), and changes in the biomarkers [brain natriuretic polypeptide (BNP), high-sensitivity C-reactive protein (hs-CRP), urinary albumin/creatinine]. RESULTS: The study enrolled 98 patients (irbesartan; n=47, amlodipine; n=51). The recurrence of AF/AT was observed in 8 patients (17.0%) in the irbesartan group and in 10 patients (19.6%) in the amlodipine group. There was no significant difference in the AF/AT recurrence between the irbesartan and amlodipine groups. Blood pressure decreased similarly in both groups. There were no significant differences between the two groups as regards to the interval from the procedure to the first AF/AT recurrence, occurrence of cardiovascular events, changes in LAD and LVEF. BNP and urinary albumin/creatinine significantly decreased similarly in both groups, but no significant difference was found in hs-CRP between the two groups. CONCLUSIONS: In hypertensive patients with AF, treatment with irbesartan did not have any advantage over amlodipine in the reduction of AF/AT recurrence after catheter ablation or electrical cardioversion.
RCT Entities:
BACKGROUND: Experimental studies suggest that angiotensin II-receptor blockers can influence atrial remodeling and may prevent atrial fibrillation (AF). Therefore, we hypothesized that irbesartan may prevent the recurrence of AF following either catheter ablation or electrical cardioversion of AF. METHODS: Study on the Effect of Irbesartan on Atrial Fibrillation Recurrence in Kumamoto (SILK study) is a prospective, multicenter, randomized, and open-label comparative evaluation of the effects of irbesartan and amlodipine on AF recurrence in hypertensivepatients with AF who are scheduled to undergo catheter ablation or electrical cardioversion of AF. The primary end point was either AF or atrial tachycardia (AT) recurrence. AF/AT recurrence was evaluated for 6 months using 24-h Holter electrocardiogram and portable electrocardiogram. The secondary endpoints included the change in blood pressure, the interval from the procedure to the first AF/AT recurrence, cardiovascular events, left atrial diameter (LAD), left ventricular ejection fraction (LVEF), and changes in the biomarkers [brain natriuretic polypeptide (BNP), high-sensitivity C-reactive protein (hs-CRP), urinary albumin/creatinine]. RESULTS: The study enrolled 98 patients (irbesartan; n=47, amlodipine; n=51). The recurrence of AF/AT was observed in 8 patients (17.0%) in the irbesartan group and in 10 patients (19.6%) in the amlodipine group. There was no significant difference in the AF/AT recurrence between the irbesartan and amlodipine groups. Blood pressure decreased similarly in both groups. There were no significant differences between the two groups as regards to the interval from the procedure to the first AF/AT recurrence, occurrence of cardiovascular events, changes in LAD and LVEF. BNP and urinary albumin/creatinine significantly decreased similarly in both groups, but no significant difference was found in hs-CRP between the two groups. CONCLUSIONS: In hypertensivepatients with AF, treatment with irbesartan did not have any advantage over amlodipine in the reduction of AF/AT recurrence after catheter ablation or electrical cardioversion.