Author + information
- Edimar Alcides Bocchi and
- Guilherme Guimarães
Background: Ivabradine reduces heart rate (HR) and significantly reduced cardiovascular risk in the SHIFT trial. There are concerns limiting the generalization of efficacy and safety for chagasic etiology (CH)-HF due to persistent myocarditis, fibrosis; sinus node dysfunction, conduction disorders, and worse prognosis in CH-HF. We investigated whether ivabradine could be effective in reducing heart rate (HR) with an acceptable safety profile in CH-HF.
Methods: SHIFT was a randomized, double-blind, placebo-controlled trial in symptomatic systolic stable HF, HR ≥70 b.p.m., and in sinus rhythm. Patients treated with guideline-recommended therapy were randomized to placebo or ivabradine (starting dose 5 mg b.i.d., titrated to 7.5 mg or 2.5 mg b.i.d., according to HR and tolerability). Ivabradine significantly reduced the composite primary endpoint of cardiovascular mortality or hospitalization for worsening HF.
Results: The baseline characteristics of 38 CH-HF patients versus SHIFT trial showed more prevalence of female sex, more patients in use of diuretics, cardiac glycosides, and antialdosterone agents, and fewer patients under ACEI/ARB and target daily dose of β-blocker. In the CH-HF group 20 received ivabradine and 18 placebo. Ivabradine was effective in reducing mean HR from 78±4 to 66±8 b.p.pm. (p<0.0001) versus placebo from 78.8±11 to 70±13 (p=0.03). No clinically severe bradycardia was reported with ivabradine in CH-HF patients. The primary composite end-point was reported in 50% and 56% of ivabradine and placebo group respectively (ns) (10 events in each arm). The cardiovascular mortality at 1 and 2 year follow-up was in the ivabradine group 15% and 30%, and 23% and 46% in placebo group. In the ivabradine group 90% of patients improved or persisted with the same functional class in comparison with 67% in the placebo group.
Conclusions: CH-HF patients presented a high incidence of primary end-point. Ivabradine was effective in reducing HR in CH-HF patients without adverse events of severe bradycardia. Although our results are based on a very limited sample and should be interpreted with caution, they suggest that ivabradine may have a favorable benefit-risk profile in CH-HF patients.
Poster Hall, Hall C
Sunday, March 19, 2017, 9:45 a.m.-10:30 a.m.
Session Title: Heart Failure and Cardiomyopathies: Heart Failure Is Just a Revolving Door
Abstract Category: 14. Heart Failure and Cardiomyopathies: Therapy
Presentation Number: 1293-255
- 2017 American College of Cardiology Foundation