SAcubitril/valsartan versus ramipril in patients with ST-segment Elevation Myocardial Infarction and cardiogenic SHOCK (SAVE-SHOCK): a pilot randomized controlled trial.

Abstract

Objectives: To evaluate the safety and efficacy of sacubitril/valsartan versus ramipril in patients with STEMI and cardiogenic shock.

Methods: Patients who received primary percutaneous coronary intervention (PPCI) for STEMI complicated with cardiogenic shock were randomized 1:1 to sacubitril/valsartan versus ramipril after clinical stabilization. The primary outcome was major adverse cardiac events (MACE) at 30 days and 6 months. Secondary in-hospital clinical outcomes included recurrent shock, new or re-initiation of vasoactive medications, and acute kidney injury (AKI). All-cause death, cardiac death, hospitalization due to heart failure (HF), myocardial infarction (MI), and stroke were examined at 30 days and 6 months. Study ID 016-01-2018.

Results: 100 patients with STEMI and cardiogenic shock were included (mean age 54.7±10.3 years, 87% men). Initiation of sacubitril/valsartan and ramipril occurred at 38.18±18.44 versus 39.0±21.03 hours after stabilization, respectively. The primary outcome was similar between both groups at 30 days and 6 months. No difference in in-hospital or 30-day clinical outcomes was observed. However, at 6 months, patients in the sacubitril/valsartan arm suffered less hospitalization with HF (18% vs 38%, P=0.044) compared with patients in the ramipril arm. Other clinical outcomes at 6 months were similar between both groups.

Conclusions: Sacubitril/valsartan in patients with STEMI and cardiogenic shock may be associated with improved clinical outcome at 6 months compared with ramipril. Larger randomized controlled trials with longer follow-up are recommended.