Abstract 12701: Safety and Tolerability of Angiotensin Receptor Neprilysin Inhibitor Initiation in High-Risk Acute Myocardial Infarction Relative to Drug Initiation Setting: A Subgroup Analysis of the PARADISE-MI Trial
De Pasquale, C; Claggett, B; Jering, K; McMurray, JJ; Mann, DL; Granger, C; Kober, L; Lewis, EF; Maggioni, APP; Rouleau, JL; Solomon, S ...
Published in: Circulation
The initiation of blood pressure lowering pharmacologic agents during an acute myocardial infarction (AMI) can be challenging. The PARADISE MI trial randomised AMI patients with LV dysfunction and/or pulmonary congestion to either sacubitril/valsartan or ramipril within 7 days of presentation. At the physician’s discretion, drug initiation occurred in the inpatient (IP), day of discharge (DD), or outpatient (OP) setting.
To explore the safety and tolerability of sacubitril/valsartan versus ramipril when initiated in AMI in the IP, DD or OP care setting.
Efficacy (cardiovascular death or incident heart failure), safety and tolerability were compared across initiation settings, and by randomization to either sacubitril/valsartan or ramipril.
Compared to IP, both DD and OP groups had fewer poor prognostic characteristics. Furthermore, serious adverse events were less frequent in the DD and OP compared to IP cohorts. The efficacy of sacubitril/valsartan on the primary outcome did not vary. Although overall adverse event rates were similar within initiation setting cohorts, systolic BP was lower with sacubitril/valsartan, regardless of initiation setting. The increased relative risk of hypotension with sacubitril/valsartan was similar across initiation settings.
In this analysis of the PARADISE-MI trial based on drug initiation setting, sacubitril/valsartan reduced BP compared to ramipril. However, the clinical setting of drug commencement did not impact adverse event or tolerability signals between sacubitril/valsartan and ramipril.