Impact of Initial RAAS Inhibitor on Hospitalization Risk in HFrEF Patients
Inhibition of the renin-angiotensin-aldosterone system (RAAS) is considered a key step in the treatment of heart failure with reduced ejection fraction (HFrEF). The preferred medication currently is the angiotensin II receptor and neprilysin inhibitor (ARNI) sacubitril/valsartan, which has shown to improve the prognosis of patients with HFrEF. A recently published study compared the initiation of ARNI or angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs) in patients with HFrEF who were not previously treated with a RAAS inhibitor in real-world practice.
Study Methodology and Population
The retrospective cohort study utilized data from the US Optum Electronic Health Records (EHR) database obtained from January 1, 2014, to December 31, 2019. It included patients older than 18 years with a diagnosis of heart failure and a left ventricular ejection fraction (EF LK) < 40%, who initiated therapy with sacubitril/valsartan or ACEi or ARBs from July 1, 2015, to March 31, 2019. Those who had used ARNI, ACEi, or ARBs in the year before the start of the observation were excluded. New ARNI users were matched with new ACEi/ARB users in a 1:2 ratio using the propensity score matching method based on preselected characteristics.
The primary outcome measured was the risk of hospitalization for heart failure. Other outcomes included the risk of any hospitalization, risk of hospitalization due to cardiovascular (CV) events, time to first hospitalization/emergency room visit due to heart failure, time to first any hospitalization, and a composite measure that included hospitalizations or emergency room visits for heart failure.
Findings
Criteria were met by 3,367 new users of sacubitril/valsartan and 50,872 new users of ACEi or ARBs. Comparison of the two cohorts revealed that patients initiated on ARNI were younger and more often male. This group also had more patients with tachycardia and synchronization therapy but a lower incidence of cerebrovascular events, renal failure, and dementia. The average EF LK was lower in this cohort, and patients were more frequently hospitalized for both heart failure and comorbidities. Propensity score matching was used for 91% of ARNI users and 12% of ACEi or ARB users, resulting in cohorts of 3,059 patients treated with ARNI and 6,118 with ACEi or ARBs.
The risk of hospitalization for heart failure was similar in both cohorts (31.45 cases per 100 patient-years [PY] vs. 32.35 cases per 100 PY; incidence rate ratio (IRR) 1.00; 95% confidence interval [CI] 0.91−1.11; p = 0.96). However, the risk of all hospitalizations was 13% lower in the cohort treated with sacubitril/valsartan (68.11 vs. 80.17 cases per 100 PY; IRR 0.87; 95% CI 0.81−0.93; p < 0.0001). Treatment with sacubitril/valsartan also resulted in a significantly lower incidence of the composite measure including hospitalizations for heart failure and emergency room visits (73.38 vs. 88.34 cases per 100 PY; IRR 0.87; 95% CI 0.81−0.94; p = 0.00023). The risk of hospitalizations for CV events was comparable in both cohorts, and similar results were observed for the time to occurrence of the studied events.
Discussion and Conclusion
The study demonstrated a significantly lower risk of all hospitalizations in HFrEF patients who initiated treatment with sacubitril/valsartan compared to those started on ACEi or ARBs. The same outcome was observed for the composite measure including hospitalizations for heart failure and emergency room visits. These findings partly align with results from previous studies. The similar rate of hospitalization for heart failure in both groups was somewhat surprising. A closer examination of the results indicates that HFrEF patients treated with ACEi or ARBs were more frequently attended to in emergency rooms than those treated with ARNI. None of the patients included in the study used RAAS inhibitors prior to the observation period.
Based on the findings of the above study, it can be stated that initiating treatment with sacubitril/valsartan in patients with heart failure and reduced ejection fraction who have not previously used RAAS system inhibitors significantly reduces the risk of hospitalization compared to initiating therapy with ACEi or ARBs.
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Source: Houchen E., Loefroth E., Schlienger R. Hospitalization rates in patients with heart failure and reduced ejection fraction initiating sacubitril/valsartan or angiotensin-converting enzyme inhibitors/angiotensin receptor blockers: a retrospective cohort study. Cardiol Ther 2022 Mar; 11 (1): 113−127, doi: 10.1007/s40119-021-00252-4.
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