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Ivabradine in Stable Coronary Artery Disease without Clinical Heart Failure
Open accessAbstract
BACKGROUND: An elevated heart rate is an established marker of cardiovascular risk. Previous analyses have suggested that ivabradine, a heart-rate-reducing agent, may improve outcomes in patients with stable coronary artery disease, left ventricular dysfunction, and a heart rate of 70 beats per minute or more. METHODS: We conducted a randomized, double-blind, placebo-controlled trial of ivabradine, added to standard background therapy, in 19,102 patients who had both stable coronary artery disease without clinical heart failure and a heart rate of 70 beats per minute or more (including 12,049 patients with activity-limiting angina [class ≥II on the Canadian Cardiovascular Society scale, which ranges from I to IV, with higher classes indicating greater limitations on physical activity owing to angina]). We randomly assigned patients to placebo or ivabradine, at a dose of up to 10 mg twice daily, with the dose adjusted to achieve a target heart rate of 55 to 60 beats per minute. The primary end point was a composite of death from cardiovascular causes or nonfatal myocardial infarction. RESULTS: At 3 months, the mean (±SD) heart rate of the patients was 60.7±9.0 beats per minute in the ivabradine group versus 70.6±10.1 beats per minute in the placebo group. After a median follow-up of 27.8 months, there was no significant difference between the ivabradine group and the placebo group in the incidence of the primary end point (6.8% and 6.4%, respectively; hazard ratio, 1.08; 95% confidence interval, 0.96 to 1.20; P=0.20), nor were there significant differences in the incidences of death from cardiovascular causes and nonfatal myocardial infarction. Ivabradine was associated with an increase in the incidence of the primary end point among patients with activity-limiting angina but not among those without activity-limiting angina (P=0.02 for interaction). The incidence of bradycardia was higher with ivabradine than with placebo (18.0% vs. 2.3%, P<0.001). CONCLUSIONS: Among patients who had stable coronary artery disease without clinical heart failure, the addition of ivabradine to standard background therapy to reduce the heart rate did not improve outcomes. (Funded by Servier; SIGNIFY Current Controlled Trials number, ISRCTN61576291.).
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“For the indication of stable coronary disease, none of these medications have been shown to reduce the risk of mortality or myocardial infarction.”
From Clinical management of stable coronary artery disease in patients with type 2 diabetes mellitus: a scientific statement from the American Heart Association (2020) · cites this paper as [249]
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Metadata
- Authors
- Fox, K., Ford, I., Steg, P. G., Tardif, J.-C., Tendera, M., & Ferrari, R.
- Affiliations
- Inserm (FR)
- University of Glasgow (GB)
- Montreal Heart Institute (CA)
- University of Ferrara (IT)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2014-09-18
- Volume
- 371
- Issue
- 12
- Pages
- 1091-1099
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2153622558
- Cited by
- 486
- References
- 19
- Citations by year
- 2026: 10 · 2025: 16 · 2024: 30 · 2023: 34 · 2022: 29 · 2021: 29 · 2020: 27 · 2019: 44 · 2018: 35 · 2017: 49 · 2016: 95 · 2015: 68 · 2014: 18
- FWCI
- 52.69
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, other-oa)
- Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, other-oa)
- HAL (submittedVersion)
- Institutional Research Information System University of Ferrara (University of Ferrara) (submittedVersion)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich)
- Funders
- National Institute for Health and Care Research (NF-SI-0611-10149)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart rate and cardiovascular health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Rate Variability and Autonomic Control
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Health and Mental Health
- Keywords
- ivabradine, stable coronary artery disease, heart rate reduction, cardiovascular mortality, myocardial infarction, bradycardia, non-inferiority, left ventricular dysfunction, target heart rate, drug safety and efficacy, atrial fibrillation
- MeSH terms
- Ivabradine, Adrenergic beta-Antagonists, Aged, Angiotensin-Converting Enzyme Inhibitors, Benzazepines, Cardiovascular Diseases, Coronary Artery Disease, Double-Blind Method, Drug Therapy, Combination, Female, Heart Failure, Heart Rate, Humans, Male, Middle Aged, Risk, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Kaplan-Meier Estimate, Intention to Treat Analysis, Angina, Stable
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