Sacubitril/valsartan reduced mitral regurgitation to a greater extent than valsartan alone in patients with HF and chronic functional mitral regurgitation, according to findings published in Circulation.
The researchers conducted the PRIME double-blind trial of 118 patients (mean age, 63 years; 61% men) with HF with reduced ejection fraction and chronic functional mitral regurgitation secondary to left ventricular dysfunction who were taking standard medical therapy for HF. Patients were assigned valsartan alone or sacubitril/valsartan (Entresto, Novartis) and were assessed via echocardiography.
The primary outcome was change in effective regurgitant orifice area of functional mitral regurgitation at 12 months.
Changes in regurgitant volume, LV end-systolic volume, LV end-diastolic volume and incomplete mitral leaflet closure area served as secondary endpoints.
Compared with the valsartan group, the sacubitril/valsartan group had a greater decrease in effective regurgitant orifice area (–0.058 cm2 vs. –0.018 cm2; P = .032), Duk-Hyun Kang, MD, PhD, from the division of cardiology at Asan Medical Center in Seoul, South Korea, and colleagues wrote.
The sacubitril/valsartan group also had a greater decrease in regurgitant volume vs. the valsartan group (mean difference, –7.3 mL; 95% CI, –12.6 to –1.9), according to the researchers.
Decrease in LV end-diastolic volume index was greater in the sacubitril/valsartan group (mean difference, –7 mL/m2; 95% CI, –13.8 to –0.2), Kang and colleagues wrote, noting that there were no significant differences in other LV metrics, in incomplete mitral leaflet closure area and in changes in BP.
At least one serious adverse event occurred in 12% of patients in the sacubitril/valsartan group and 16% of patients in the valsartan group (P = .54), according to the researchers.
“Angiotensin receptor-neprilysin inhibitor may be considered for optimal medical therapy
of stable patients with heart failure and functional mitral regurgitation,” Kang and colleagues wrote. – by Erik Swain
Disclosures: The study was funded in part by Novartis, which supplied sacubitril/valsartan. The authors report no relevant financial disclosures.