Primary outcomes analysis of the MOMENTUM 3 trial short term cohort demonstrated a higher survival rate free of debilitating stroke and reoperation to replace/remove the device (primary endpoint) in patients receiving the HeartMate 3 (HM3) compared to the HeartMate (HMII). We sought to evaluate the individual and interactive effects of pre-specified patient subgroups (age, sex, race, therapeutic intent (BTT/BTC/DT) and severity of illness) on primary endpoint outcomes in MOMENTUM 3 patients implanted with HM3 and HMII.
Cox proportional hazard models were used to analyze patients enrolled into the “as treated cohort” (n=289) of the MOMENTUM 3 trial to: (1) determine interaction of various subgroups on primary endpoint outcomes; and (2) identify independent variables associated with primary endpoint success.
Baseline characteristics were well balanced among HM3 (n=151) and HMII (n=138) cohorts. No significant interaction between the sub-groups on primary endpoint outcomes was observed. Cox multivariable modeling identified age (≤ 65 years vs. >65 years, HR: 0.42 [95% CI: 0.22-0.78, p=0.006]) and pump type (HM3 vs. HMII, HR: 0.53 [95% CI: 0.30-0.96], p=0.034) to be independent predictors of primary outcomes success. After adjusting for age, no significant impact of sex, race, therapeutic intent, and INTERMACS profiles on primary outcomes were observed.
This analysis of MOMENTUM 3 suggests that younger age (≤ 65 years) at implant and pump choice are associated with a greater likelihood of primary endpoint success. These further suggest that characterization of therapeutic intent into discrete BTT and DT categories offers no clear clinical advantage, and should ideally be abandoned.