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Assessing suitability for sacubitril-valsartan therapy in an Irish cohort: challenges and opportunities
Aidan Daly1, John J Coughlan2, Thomas Mross2
1University Hospital Kerry, Tralee, Co. Kerry, Ireland. jjaidandaly@gmail.com.
Insights
Few patients are eligible for sacubitril-valsartan therapy in real-world heart failure (HF) practice. This study found only 2.79% of discharged patients met PARADIGM-HF criteria, highlighting a gap in treatment applicability.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Research
Background:
- Sacubitril-valsartan demonstrated efficacy in the PARADIGM-HF trial for heart failure with reduced ejection fraction (HFrEF).
- The PARADIGM-HF trial utilized stringent exclusion criteria, raising questions about real-world applicability.
- This study assessed sacubitril-valsartan eligibility in a general hospital setting without specialized heart failure services.
Purpose of the Study:
- To determine the proportion of hospitalized heart failure patients eligible for sacubitril-valsartan based on PARADIGM-HF criteria.
- To evaluate the generalizability of PARADIGM-HF trial findings to routine clinical practice.
Main Methods:
- Retrospective analysis of patients discharged with congestive cardiac failure diagnosis.
- Hierarchical analysis of patient data using the hospital in-patient enquiry (HIPE) system.
- Eligibility assessment based on strict adherence to PARADIGM-HF inclusion criteria.
Main Results:
- The study cohort (143 patients) was older and more clinically unwell than the PARADIGM-HF population.
- Only 16.66% of patients had an ejection fraction ≤40%.
- A mere 2.79% (4/143) of patients met sacubitril-valsartan eligibility criteria at discharge, primarily due to higher ejection fractions and low ACEI/ARB use.
Conclusions:
- A significantly lower proportion of real-world heart failure patients are eligible for sacubitril-valsartan than anticipated.
- The majority of patients fell into the heart failure with preserved ejection fraction (HFpEF) category, for which sacubitril-valsartan is not indicated.
- Low adherence to guideline-directed medical therapy and lack of dedicated heart failure services may contribute to poor eligibility rates.
Introduction:
Sacubitril-valsartan has been shown by the PARADIGM-HF trial to decrease hospital admissions and improve mortality in patients with heart failure with reduced ejection fraction. The PARADIGM trial had stringent exclusion criteria. It is not known how applicable these trial criteria are to real-life practice. In this study, we sought to determine the percentage of patients eligible for sacubitril-valsartan therapy in a level 3 hospital without a dedicated heart failure service.
Methods:
All patients discharged from our service with a diagnosis of congestive cardiac using our hospital in-patient enquiry (HIPE) system underwent hierarchal analysis. In order to be deemed eligible for sacubitril-valsartan therapy, patients had to meet PARADIGM-HF inclusion criteria.
Results:
Our 143 patients represented a more clinically unwell, elderly cohort than the PARADIGM trial study population. Only 24 patients (16.66%) had an ejection fraction of 40% or less. Our results indicate that only 4/143 patients in a real-world setting (2.79%) were eligible for sacubitril-valsartan therapy at the point of discharge as per the PARADIGM-HF study criteria. This is primarily due to the higher than expected percentage of patients in our cohort with an ejection fraction of over 40% (n = 120) and the low percentage of patients on therapeutic doses of ACEI/ARB (n = 15).
Conclusions:
Our study showed that a smaller than expected proportion of our patients in real-world practice are suitable for sacubitril-valsartan therapy at discharge. Most patients were in the HFPEF cohort which does not currently have evidence for treatment with sacubitril-valsartan. Low rates of prescribing of basic heart failure medicatons and the absence of dedicated heart failure services in a non-tertiary centre may explain the poor compliance observed. Improving guideline adherence and increasing awareness of evidence-based medication use at primary and secondary care levels would be of benefit to Irish heart failure patients.
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