Long term adherence in primary care versus a specialized heart failure clinic for outpatients with systolic heart failure

Abstract

Purpose: Most European countries have implemented Heart Failure (HF) clinic programs to educate the patients in self-care and optimize doses and adherence of neurohormonal blockade. The optimal duration of the HF clinic program is, however, unknown. This study was, therefore, designed to evaluate the effect of extended follow up in an outpatient HF clinic on long-term adherence to guideline based therapy. Methods: Multicenter (18 HF clinic's) randomized clinical trial. After education in self-care and optimization in guideline therapy in HF clinic systolic HF patients (N=921) were randomized to either extended follow up the HF clinic (N=461) or discharge to the primary care (N=460) and the patients were followed for a median of 2.5 years (range: 3 months-4.5 years). The effect of the HF clinic intervention on treatment adherence (time to 90 days break in treatment) estimated by drug dispensing from pharmacies with either an Angiotensin Converting Enzyme-Inhibitor/Angiotensin II Receptor Blocker (ACE-I/ARB), a Beta-Blocker (BB) or an Aldosterone Receptor Antagonist (ARA) was then evaluated in Cox Proportional Hazard Models. Subgroup analyses were performed to identify high-risk patients with particular benefit. Results: At randomization the two groups of patients were matched on baseline characteristics. Median Age was 69 years, 25% were females, LVEF was 30%, 90% were in NYHA class II-III and NT-proBNP was 801 pg/ml, 89% were treated with an ACE-I/ARB, 85% with a BB and 32% with an ARA. The HF clinic intervention did not reduce time to a 90 days break in treatment with either an ACE-I/ARB (Hazard ratio (HR): 0.82, 95%-Confidence Interval (CI): 0.34-1.97, P=0.650), a BB (HR: 1.09, 95%-CI: 0.53-2.66, P=0.820) or an ARA (HR: 1.30, 95% CI: 0.85-2.00, P=0.238). No interaction between adherence, the HF clinic intervention or any high-risk subgroup was observed (NT-proBNP > 1000 pg/ml, eGFR 0.05 for all). At follow up end adherence was 90% for ACE-I/ARB's, 88% for BB's and 75% for ARA's and did not differ between treatment arms (LogRank > 0.05 for all). Conclusions: Extended follow up in an outpatient HF clinic did not improve long-term adherence to guideline based therapy and adherence did not deteriorate when follow-up was shifted from the HF clinic to primary care. However, novel strategies to improve long term adherence for aldosterone receptor antagonists are needed.