MD Conference Express ESC 2012 - (Page 26)
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recurrent hospitalizations for worsening HF throughout the entire duration of SHIFT [Borer JS et al. Eur Heart J 2012]. The endpoints were the effect of ivabradine on total heart failure hospitalizations (incidence rate ratio [IRR] vs placebo) and repeated HF hospitalizations (total-time approach: time from randomization to first, second, and third hospitalizations), as well as total CV hospitalizations and total hospitalizations for any cause. The analyses, which were post hoc, were adjusted for protocol-specified prognostic factors present prior to randomization, including b-blocker intake, New York Heart Association (NYHA) class, ischemic cause of HF, LVEF, age, systolic blood pressure (BP), heart rate, and creatinine clearance. Prior to randomization, patients with ≥3 hospitalizations were older, had a higher heart rate, lower systolic BP, diastolic BP, and LVEF, higher NYHA class, longer duration of HF, higher incidence of diabetes, and more were taking mineralocorticoid receptor antagonists, diuretics, and digitalis, though fewer were able to tolerate b-blockers, compared with patients with <3 hospitalizations. At 30 months, the cumulative incidence of HF hospitalizations was 25% lower in the ivabradine group (n=3241) versus the placebo group (n=3264). Patients in the ivabradine group versus the placebo group had significantly fewer total hospitalizations for HF (902 vs 1211; IRR, 0.75; 95% CI, 0.65% to 0.87%; p=0.0002), hospitalizations for any cause (2661 vs 3110; IRR, 0.85; 95% CI, 0.78% to 0.94%; p=0.001), and CV hospitalizations (1909 vs 2272; IRR, 0.84; 95% CI, 0.76% to 0.94%; p=0.002). Using the total-time approach, during the total follow-up interval, significantly fewer ivabradine patients versus placebo patients had a second hospitalization (6% vs 9%; HR, 0.66; 95% CI, 0.55% to 0.79%; p<0.001) and third hospitalization (3% vs 4%; HR, 0.71; 95% CI, 0.54% to 0.93%; p=0.012; Figure 1). Figure 1. Recurrence of HF Hospitalization.
Ivabradine (n=3241) First hospitalization Second hospitalization 514 (16%) Placebo (n=3264) 672 (21%) Hazard Ratio 0.75 p value
and already receiving guideline-suggested therapies substantially decreased the risk of clinical deterioration as reflected by the reduction in total hospitalizations for worsening HF, reduction in the incidence of recurrent HF hospitalizations, and increase in time to first and subsequent hospitalizations. This benefit reduces the total burden of HF for the patient and can be expected to substantially reduce healthcare costs. These findings are consistent with the 2012 European Society of Cardiolgy heart failure guidelines that recommend ivabradine for the reduction of HF hospitalization in patients who meet the SHIFT trial’s eligibility criteria, and who are treated with maximal HF therapy, including an ACEI or ARB, maximized b-blockade, and mineralocorticoid receptor antagonist.
CLARIFY: Similar 1-Year Outcomes for Men and Women with Stable CAD
Written by Lori Alexander
Despite substantial differences in the risk profiles of men and women with stable coronary artery disease (CAD), outcomes at 1 year appear to be similar, according to an analysis of data from the international Prospective Observational Longitudinal Registry of Patients with Stable Coronary Artery Disease [CLARIFY; Steg PG et al. Eur Heart J 2012] registry. The study adds new insights into gender differences in stable CAD, as relatively few studies have compared outcomes in this patient population. However, results should be interpreted in the context of an observational registry data set. The study included data for 30,977 outpatients with stable CAD, defined as prior myocardial infarction (MI), angiographic coronary disease (>50% lesion), ischemic symptoms and a positive stress test, or prior coronary revascularization from 45 countries; 23,975 (77.4%) of the patients were men. The main outcome was a composite of cardiovascular (CV) death, MI, or stroke. Analyses were time to first event, and comparisons by gender were adjusted for differences in patient baseline characteristics. At 1 year, the rate of the primary outcome was similar for men and women (adjusted rates, 1.7% vs 1.8%, respectively; OR, 0.93; 95% CI, 0.75 to 1.15; p=0.5), reported Philippe Gabriel Steg, MD, Hôpital Bichat, Paris, France, who presented the findings of the study. Women were at similar risk as men for major CV outcomes (Figure 1). Prof. Steg added that there was an interaction between gender and age, with younger women having slightly better outcomes than younger men; however, the same was not true for middle-aged or older women (p-interaction=0.0077).
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p<0.001
189 (6%)
283 (9%)
0.66
p<0.001
Third hospitalization
90 (3%)
128 (4%)
0.71
p=0.012
0.4
0.6
0.8
1.0
1.2
Favors Ivabradine
Favors Placebo
HF=heart failure. Reproduced with permission from JS Borer, MD.
Heart rate reduction with ivabradine in patients with chronic HF in sinus rhythm with a heart rate ≥70 bpm
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October 2012
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Table of Contents for the Digital Edition of MD Conference Express ESC 2012
MD Conference Express ESC 2012
Contents
ESC 2012 Clinical Practice Guidelines
TAVI: 10 Years After the First Case
PARAMOUNT Trial Results
TRILOGY ACS Outcomes
Results from the ALTITUDE Trial
Results of the WOEST Trial
Results from the Aldo-DHF Trial
FAME 2 Results
Results from the IABP-SHOCK II Trial
STEMI Mortality Decreases in France While Some Key Risk Factors Increase
Results from the PURE Study
PURE: Treatment and Control of Hypertension
Genetic Determinants of Variability in Dabigatran Exposure
The RE-LY AF Registry
TRA 2°P-TIMI 50 Results
Rivaroxaban of Benefit in STEMI: ATLAS ACS 2-TIMI 51
Ivabradine Effect on Recurrent Hospitalization for HF
CLARIFY: Similar 1-Year Outcomes for Men and Women with Stable CAD
HPS2-THRIVE Study Results
PRoFESS Study Results
Outcomes from the CARDia Trial
Hypertension
Atrial Fibrillation
Heart Failure
MD Conference Express ESC 2012
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