Abstract 14362: Eligibility for Ivabradine in Heart Failure: Representativeness of SHIFT in a Broad Population
Background: Elevated resting heart rate is a risk factor for adverse outcomes in patients with chronic heart failure (HF). The sinus node inhibitor ivabradine was EMA and FDA approved in 2005 and 2015 respectively, with the SHIFT trial confirming its efficacy and safety. Our objective was to characterize proportions of patients eligible for ivabradine, and the representativeness of the SHIFT clinical trial enrolees as compared to those in the Swedish Heart Failure Registry (SwedeHF).
Methods: We examined 26,404 patients with an EF < 40% from SwedeHF and divided them by SHIFT-type and non-SHIFT-type. Both inpatients and outpatients were considered SHIFT-type if they met the following eligibility criteria: NYHA II-IV, HR > 70 bpm and baseline sinus rhythm. Baseline characteristics and medication use were compared between both groups and change in eligibility over time was reported at 6-months and 1-year in a subset of patients with follow-up registrations of eligibility variables.
Results: Overall, 14.2% (n=3741) of patients were SHIFT-type. These patients were more likely to be younger, male, have diabetes, ischemic heart disease, lower EF and more recent onset of HF (<6 months) (p<0.001; Table). Although the majority of patients in both groups were on beta-blocker therapy, only 58.8% of SHIFT-type patients were on >50% of the target dose compared to 67.3% in non-SHIFT-type patients (p<0.001). From initial registration to 6 months and 1 year respectively, 14.8% (n=555) and 19.3% (n=724) SHIFT-type patients became ineligible, 85.2% (n=3186) and 80.7% (n=3017) remained eligible, and 4.6% (n=249) and 4.9% (n=335) of non-SHIFT-type patients became eligible.
Conclusion: From SwedeHF, ~1 in 10 patients with chronic HF are eligible for ivabradine. These patients have a distinct clinical profile with a large percentage not meeting target beta-blocker dose. SHIFT-type patients who became ineligible over time did so due to lower subsequent heart rates.
Author Disclosures: D. Das: None. G. Savarese: None. U. Dahlström: Research Grant; Modest; AstraZeneca Inc.. Consultant/Advisory Board; Modest; Novartis Inc., Vifor Pharma. M. Fu: None. J.G. Howlett: None. J.A. Ezekowitz: Research Grant; Modest; Amgen, Merck, Novartis, Johnson & Johnson, Servier, Travena and Alere. Consultant/Advisory Board; Modest; Amgen, Pfizer, Novartis, Bristol-Myers Squibb. L.H. Lund: None.
- © 2016 by American Heart Association, Inc.