Moderate mitral regurgitation increased the risk of a first HF event or cardiovascular death compared to no mitral regurgitation in HFrEF patients (adjusted HR 1.11; 95% CI 1.01-1.23).
RCT (n=7,998)
Placebo-controlled
Randomized
Does moderate mitral regurgitation increase the risk of adverse outcomes in patients with HFrEF, and does it modify the efficacy of omecamtiv mecarbil?
Moderate mitral regurgitation is present in approximately 15% of HFrEF patients and independently predicts a higher risk of heart failure events or cardiovascular death, without modifying the treatment effect of omecamtiv mecarbil.
Hazard Ratio: 1.11 (95% CI 1.01–1.23)
Abstract Aims Given the emerging role of transcatheter valve repair in HFrEF patients with moderate/severe secondary mitral regurgitation (MR), we evaluated the prevalence and outcomes related to MR in the GALACTIC-HF trial. Methods and results The randomized GALACTIC-HF trial compared the efficacy and safety of omecamtiv mecarbil (OM) to placebo in 8,232 patients with HFrEF, with a primary composite outcome of a first HF event or cardiovascular death. Of 7998 patients (97.2%) with baseline data on MR, 5782 (72.3%) had no MR, 970 (12.1%) had mild MR, and 1221 (15.3%) had moderate MR (only 25 had severe MR). Patients with moderate MR had a higher risk of the primary outcome than those without MR (adjusted HR 1.11; 95% CI 1.01–1.23); risk was not higher in patients with mild MR. The association between moderate MR and the primary outcome was most prominent in patients with less severe HF (milder NYHA class, higher LVEF, and lower NT-proBNP) compared to more severe HF. In adjusted analyses, MR was not associated with mortality, and the results of all analyses remained consistent after including patients with severe MR. The beneficial treatment effect of OM versus placebo on clinical outcomes was not modified by MR. Over 80% of patients with moderate/severe MR fulfilled the broad inclusion criteria for COAPT and RESHAPE-HF2. Conclusions In GALACTIC-HF, almost 15% of HFrEF patients had moderate MR, which was associated with a higher risk of the primary outcome. Trial Registration GALACTIC-HF ClinicalTrials.gov Identifier: NCT02929329; EudraCT number, 2016-002299-28.
Chimura et al. (Fri,) conducted a rct in Heart failure with reduced ejection fraction (HFrEF) (n=7,998). Moderate mitral regurgitation vs. No mitral regurgitation was evaluated on First HF event or cardiovascular death (adjusted HR 1.11, 95% CI 1.01-1.23). Moderate mitral regurgitation increased the risk of a first HF event or cardiovascular death compared to no mitral regurgitation in HFrEF patients (adjusted HR 1.11; 95% CI 1.01-1.23).