Efficacy of ivabradine in heart failure patients with a high-risk profile (analysis from the SHIFT trial)

Abdin, A., Komajda, M., Borer, J. S., Ford, I. , Tavazzi, L., Batailler, C., Swedberg, K., Rosano, G. M.C., Mahfoud, F. and Böhm, M. (2023) Efficacy of ivabradine in heart failure patients with a high-risk profile (analysis from the SHIFT trial). ESC Heart Failure, (doi: 10.1002/ehf2.14455) (Early Online Publication)

Abstract

Aims: Early start and patient profile‐oriented heart failure (HF) management has been recommended. In this post hoc analysis from the SHIFT trial, we analysed the treatment effects of ivabradine in HF patients with systolic blood pressure (SBP) < 110 mmHg, resting heart rate (RHR) ≥ 75 b.p.m., left ventricular ejection fraction (LVEF) ≤ 25%, New York Heart Association (NYHA) Class III/IV, and their combination. Methods and results: The SHIFT trial enrolled 6505 patients (LVEF ≤ 35% and RHR ≥ 70 b.p.m.), randomized to ivabradine or placebo on the background of guideline‐defined standard care. Compared with placebo, ivabradine was associated with a similar relative risk reduction of the primary endpoint (cardiovascular death or HF hospitalization) in patients with SBP < 110 and ≥110 mmHg [hazard ratio (HR) 0.89, 95% confidence interval (CI) 0.74–1.08 vs. HR 0.80, 95% CI 0.72–0.89, P interaction = 0.34], LVEF ≤ 25% and >25% (HR 0.85, 95% CI 0.72–1.01 vs. HR 0.80, 95% CI 0.71–0.90, P interaction = 0.53), and NYHA III–IV and II (HR 0.83, 95% CI 0.74–0.94 vs. HR 0.81, 95% CI 0.69–0.94, P interaction = 0.79). The effect was more pronounced in patients with RHR ≥ 75 compared with <75 (HR 0.76, 95% CI 0.68–0.85 vs. HR 0.97, 95% CI 0.81–0.1.16, P interaction = 0.02). When combining these profiling parameters, treatment with ivabradine was also associated with risk reductions comparable with patients with low‐risk profiles for the primary endpoint (relative risk reduction 29%), cardiovascular death (11%), HF death (49%), and HF hospitalization (38%; all P values for interaction: 0.40). No safety concerns were observed between study groups. Conclusions: Our analysis shows that RHR reduction with ivabradine is effective and improves clinical outcomes in HF patients across various risk indicators such as low SBP, high RHR, low LVEF, and high NYHA class to a similar extent and without safety concern.

• Item Type: Articles
• Additional Information: The SHIFT study was funded by Servier, France.
• Keywords: Heart failure, high risk, risk indicators, heart rate, ivabradine.
• Status: Early Online Publication
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Ford, Professor Ian
• Authors: Abdin, A., Komajda, M., Borer, J. S., Ford, I., Tavazzi, L., Batailler, C., Swedberg, K., Rosano, G. M.C., Mahfoud, F., and Böhm, M.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre
• Journal Name: ESC Heart Failure
• Publisher: Wiley
• ISSN: 2055-5822
• ISSN (Online): 2055-5822
• Published Online: 10 July 2023
• Copyright Holders: Copyright © 2023 The Authors
• First Published: First published in ESC Heart Failure 2023
• Publisher Policy: Reproduced under a Creative Commons License