What proportion of patients with chronic heart failure are eligible for sacubitril–valsartan?

Pellicori, Pierpaolo; Urbinati, Alessia; Shah, Parin; Macnamara, Alexandra; Kazmi, Syed; Dierckx, Riet; Zhang, Jufen; Cleland, John G.F.; Clark, Andrew L.

doi:10.1002/ejhf.788

Cited by 68 publications

(84 citation statements)

References 25 publications

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“…Similar results were shown in a previous study, where 7% of the total heart failure population in a single‐centre setting fulfilled the PARADIGM‐HF criteria 20. This highlights the need for studies in heart failure with ejection fraction > 40%.…”

Section: Discussionsupporting

confidence: 89%

Eligibility of sacubitril–valsartan in a real‐world heart failure population: a community‐based single‐centre study

2018

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AimsThis study aims to investigate the eligibility of the Prospective Comparison of Angiotensin Receptor–Neprilysin Inhibitor (ARNI) with ACE inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM‐HF) study to a real‐world heart failure population.Methods and resultsMedical records of all heart failure patients living within the catchment area of Umeå University Hospital were reviewed. This district consists of around 150 000 people. Out of 2029 patients with a diagnosis of heart failure, 1924 (95%) had at least one echocardiography performed, and 401 patients had an ejection fraction of ≤35% at their latest examination. The major PARADIGM‐HF criteria were applied, and 95 patients fulfilled all enrolment criteria and thus were eligible for sacubitril–valsartan. This corresponds to 5% of the overall heart failure population and 24% of the population with ejection fraction ≤ 35%. The eligible patients were significantly older (73.2 ± 10.3 vs. 63.8 ± 11.5 years), had higher blood pressure (128 ± 17 vs. 122 ± 15 mmHg), had higher heart rate (77 ± 17 vs. 72 ± 12 b.p.m.), and had more atrial fibrillation (51.6% vs. 36.2%) than did the PARADIGM‐HF population.ConclusionsOnly 24% of our real‐world heart failure and reduced ejection fraction population was eligible for sacubitril–valsartan, and the real‐world heart failure and reduced ejection fraction patients were significantly older than the PARADIGM‐HF population. The lack of data on a majority of the patients that we see in clinical practice is a real problem, and we are limited to extrapolation of results on a slightly different population. This is difficult to address, but perhaps registry‐based randomized clinical trials will help to solve this issue.

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Section: Discussionsupporting

confidence: 89%

Eligibility of sacubitril–valsartan in a real‐world heart failure population: a community‐based single‐centre study

2018

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“…Therefore, NYHA functional class presents difficulty for use as a criterion on which to base eligibility for treatment with sacubitril/valsartan. Therefore, we had conducted a sensitivity analysis in which we considered those with missing EF and NYHA class data and missing NYHA class data only eligible for sacubitril/valsartan, and in this scenario, our eligibility rate rose to 37–46%, a similar rate as that reported earlier …”

Section: Discussionsupporting

confidence: 54%

“…We found that nearly one in three patients with HFrEF at the VAGLAHS was eligible for treatment with sacubitril/valsartan. It has been estimated that if the criteria from the PARADIGM‐HF trial are strictly followed, then sacubitril/valsartan should be prescribed to < 25% of patients with HFrEF . Researchers found that 12% of patients in a community HF clinic in the United Kingdom were eligible for sacubitril/valsartan treatment using the PARADIGM‐HF trial criteria .…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Patients with Heart Failure to Determine Eligibility for Treatment with Sacubitril/Valsartan: Insights from a Veterans Administration Healthcare System

et al. 2019

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Study Objective Despite evidence that supports the use of sacubitril/valsartan – the first angiotensin II receptor blocker–neprilysin inhibitor – for mortality reduction in patients with heart failure (HF), it remains underprescribed. The objective of this study was to evaluate eligibility for initiation of sacubitril/valsartan treatment in patients with HF within the largest Veterans Administration healthcare system in the United States. Design Cross‐sectional study. Setting Veterans Affairs Greater Los Angeles Healthcare System (VAGLAHS). Patients A total of 2985 patients with a HF diagnosis who were alive as of November 1, 2017. Measurements and Main Results Eligibility for sacubitril/valsartan initiation was based on inclusion and exclusion criteria from the Prospective Comparison of Angiotensin Receptor–Neprilysin Inhibitor with Angiotensin‐Converting–Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM‐HF) trial and the VA Criteria for Use. The proportion of eligible patients was estimated, and characteristics of eligible patients were compared with those in the PARADIGM‐HF trial. Of the 2985 patients with HF who were alive as of November 1, 2017, 965 (32.3%) had HF with reduced ejection fraction (HFrEF). Of these patients with HFrEF, 263 (27.3%) fulfilled eligibility criteria and were considered candidates for sacubitril/valsartan initiation. Of the 702 patients who did not fulfil eligibility criteria, the most common reasons were New York Heart Association functional class I (35.3%) and B‐type natriuretic peptide level of 100 pg/ml or lower (22.2%). Compared with patients in the PARADIGM‐HF trial, VAGLAHS patients were older (70.4 vs 63.8 yrs) and more likely to be male (98.5% vs 79.0%), and a higher proportion had New York Heart Association functional class III symptoms (35.4% vs 23.1%). Of the 965 patients with HFrEF, 34 (3.5%) had an active sacubitril/valsartan prescription as of November 1, 2017, of whom 27 (79.4%) did not meet criteria. Conclusion Whereas 27% of patients with HFrEF were eligible to initiate sacubitril/valsartan, only 3.5% of these patients were prescribed the medication. Although sacubitril/valsartan reduced morbidity and mortality in clinical trials, it remains underused within this VA healthcare system. This analysis provides important insights into the VA and other healthcare systems regarding the opportunity for optimizing guideline‐directed HF therapy.

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“…This agent is now licenced for use in certain well‐defined circumstances . However, as is always the case with novel therapeutic strategies, there is a need to look closely at how this agent performs in the routine community HF‐rEF population, who are likely to be older, more frail, and have increased burden of comorbidities . This ‘community testing' of a new compound may be of particular importance with sacubitril‐valsartan, given its widespread biological effects on various neuroendocrine and signalling systems, potentially affecting these to different degrees in community patients compared with clinical trial patients.…”

Section: Introductionmentioning

confidence: 99%

Sacubitril‐Valsartan in a routine community population: attention to volume status critical to achieving target dose

et al. 2020

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Aims In the PARADIGM‐heart failure trial, sacubitril‐valsartan demonstrated a reduction in heart failure admissions and reduced all‐cause mortality in patients with heart failure with reduced ejection fraction. Although real world data have shown similar benefits regarding efficacy and safety, there has been difficulty in achieving the target dose (TD). The factors preventing the achievement of TD remains unclear. This study assesses the tolerability, ability to achieve, and factors linked to attaining TD in a routine clinical population. Methods and results This is a retrospective single‐centre review of patients switched from angiotensin‐converting enzyme inhibitors/angiotensin receptor blockers to sacubitril‐valsartan between May 2016 and August 2018. Baseline and follow‐up clinical characteristics and biomarker profiles were collected. Univariate and multivariate analyses were used to analyse predictors of achieving TD. Clinical response to sacubitril‐valsartan was defined as a reduction in N terminal pro BNP of ≥30%, or an increase in left ventricular ejection fraction of ≥5% compared with baseline values. To date, a total of 322 patients (75% male patients) have been switched to sacubitril‐valsartan. Those still in the titration phase were excluded (n = 25). Sacubitril‐valsartan was not tolerated in 40 patients (12.4%). Those intolerant were older (73.4 years [68.3, 80.6] vs. 69.1 years [61.2, 76]; P = 0.003) and had worse renal function with estimated glomerular filtration rate (53.5 mL/min/1.72 m2 [36.8, 60.2] vs 60 mL/min/1.72 m2 [47, 77]; P ≤ 0.001). Of the remaining 257 patients, TD (97/103 mg BD) was achieved in 194 patients (75.5%), while 37 patients (11.4%) were maintained on 49/51 mg BD and 26 patients (8.1%) remained on 24/26 mg BD. Symptomatic hypotension (74.6%) was the main impediment to attaining TD, followed by renal deterioration (12.7%), and to a lesser extent hyperkalaemia and gastrointestinal symptoms (4.8% each). Diuretic dose decrease was achieved in 37.2% of patients, and this was the strongest independent predictor of achieving TD (odds ratio = 2.1; 95% confidence interval [1.16, 3.8]; P = 0.014). Responder status by N terminal pro BNP criterion was observed in 99 of 214 patients (46.3%) while 70 of 142 (49.3%) attained the left ventricular ejection fraction response status. Achieving this response was independently linked to achieving TD. Conclusions Sacubitril‐valsartan was well tolerated. Achievement of TD was possible in the majority of the cohort and was linked to response metrics. Reduction in diuretic was required in a large percentage of the population and was the strongest predictor of attaining TD. Therefore, careful clinical attention to volume status assessment is essential to maximising the benefits of sacubitril‐valsartan.

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What proportion of patients with chronic heart failure are eligible for sacubitril–valsartan?

Abstract: Of patients with HFrEF referred to a clinic such as ours, only 21% fulfilled the PARADIGM-HF randomization criteria, on which the ESC Guidelines are based; this proportion rises to 60% if background medication is ignored.

Cited by 68 publications

References 25 publications

Eligibility of sacubitril–valsartan in a real‐world heart failure population: a community‐based single‐centre study

Eligibility of sacubitril–valsartan in a real‐world heart failure population: a community‐based single‐centre study

Evaluation of Patients with Heart Failure to Determine Eligibility for Treatment with Sacubitril/Valsartan: Insights from a Veterans Administration Healthcare System

Sacubitril‐Valsartan in a routine community population: attention to volume status critical to achieving target dose

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