Fox, K., Ford, I. , Steg, P. G., Tardif, J.-C., Tendera, M. and Ferrari, R. (2015) Bradycardia and atrial fibrillation in patients with stable coronary artery disease treated with ivabradine: an analysis from the SIGNIFY study. European Heart Journal, 36(46), pp. 3291-3296. (doi: 10.1093/eurheartj/ehv451) (PMID:26385957)
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Abstract
Aim: The aim of this study was to determine the impact of emergent bradycardia and atrial fibrillation (AF) on cardiovascular outcomes in 19 083 patients with stable coronary artery disease (CAD) receiving ivabradine or placebo (SIGNIFY, Study assessInG the morbidity–mortality beNefits of the If inhibitor ivabradine in patients with coronarY artery disease). Methods and results: Emergent bradycardia (resting heart rate <50 b.p.m. on 12-lead electrocardiogram) with ivabradine was reported in 3572 patients (37.4%) overall, and in 2242 (37.2%) patients with Canadian Cardiovascular Society (CCS) class ≥2 angina. There was no difference in outcomes over the course of the study in ivabradine-treated patients with and without emergent bradycardia in the whole population (2.5 vs. 2.9% per year, respectively, for primary composite endpoint of cardiovascular death or non-fatal myocardial infarction) or in the angina subgroup (2.5 vs. 3.2% per year). Neither was there an increase in the rate of primary endpoint after emergent bradycardia was recorded compared with those without emergent bradycardia. There were 754 cases of emergent AF on treatment (2.2% per year ivabradine vs. 1.5% per year placebo) and 469 in the patients with angina (2.2 vs. 1.5% per year). While outcomes occurred more frequently in patients in whom emergent AF had been recorded, there was no treatment–placebo difference in outcomes, including stroke, and no difference in treatment effect in patients with limiting angina. Conclusion: Both in the overall population as well as in the angina subset, bradycardia was common in ivabradine-treated patients, but did not appear to impact outcomes. Emergent AF was relatively rare and did not appear to have an impact on outcomes relative to placebo.
| Item Type: | Articles |
|---|---|
| Status: | Published |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | Ford, Professor Ian |
| Authors: | Fox, K., Ford, I., Steg, P. G., Tardif, J.-C., Tendera, M., and Ferrari, R. |
| College/School: | College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre |
| Journal Name: | European Heart Journal |
| Publisher: | Oxford University Press |
| ISSN: | 0195-668X |
| ISSN (Online): | 1522-9645 |
| Copyright Holders: | Copyright © 2015 The Authors |
| First Published: | First published in European Heart Journal 36(46):3291-3296 |
| Publisher Policy: | Reproduced in accordance with the copyright policy of the publisher |
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