Impact of age, sex, therapeutic intent, race and severity of advanced heart failure on short-term principal outcomes in the MOMENTUM 3 trial
Daniel J Goldstein, Mandeep R Mehra, Yoshifumi Naka, Christopher Salerno, Nir Uriel, David Dean, Akinobu Itoh, Francis D Pagani, Eric R Skipper, Geetha Bhat, Nirav Raval, Brian A Bruckner, Jerry D Estep, Rebecca Cogswell, Carmelo Milano, Lahn Fendelander, John B O'Connell, Joseph Cleveland, MOMENTUM 3 Investigators, Daniel J Goldstein, Mandeep R Mehra, Yoshifumi Naka, Christopher Salerno, Nir Uriel, David Dean, Akinobu Itoh, Francis D Pagani, Eric R Skipper, Geetha Bhat, Nirav Raval, Brian A Bruckner, Jerry D Estep, Rebecca Cogswell, Carmelo Milano, Lahn Fendelander, John B O'Connell, Joseph Cleveland, MOMENTUM 3 Investigators
Abstract
Background: Primary outcomes analysis of the Multicenter Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3 (MOMENTUM 3) trial short-term cohort demonstrated a higher survival rate free of debilitating stroke and reoperation to replace/remove the device (primary end-point) in patients receiving the HeartMate 3 (HM3) compared with the HeartMate (HMII). In this study we sought to evaluate the individual and interactive effects of pre-specified patient subgroups (age, sex, race, therapeutic intent [bridge to transplant/bridge to candidacy/destination therapy] and severity of illness) on primary end-point outcomes in MOMENTUM 3 patients implanted with HM3 and HMII devices.
Methods: Cox proportional hazard models were used to analyze patients enrolled in the "as-treated cohort" (n = 289) of the MOMENTUM 3 trial to: (1) determine interaction of various subgroups on primary end-point outcomes; and (2) identify independent variables associated with primary end-point success.
Results: Baseline characteristics were well balanced among HM3 (n = 151) and HMII (n = 138) cohorts. No significant interaction between the sub-groups on primary end-point outcomes was observed. Cox multivariable modeling identified age (≤65 years vs >65 years, hazard ratio 0.42 [95% confidence interval 0.22 to 0.78], p = 0.006]) and pump type (HM3 vs HMII, hazard ratio 0.53 [95% confidence interval 0.30 to 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.
Conclusions: This analysis of MOMENTUM 3 suggests that younger age (≤65 years) at implant and pump choice are associated with a greater likelihood of primary end-point success. These findings further suggest that characterization of therapeutic intent into discrete bridge-to-transplant and destination therapy categories offers no clear clinical advantage, and should ideally be abandoned.
Trial registration: ClinicalTrials.gov NCT02224755.
Keywords: HeartMate 3; HeartMate II; MOMENTUM 3; mechanical circulatory support; ventricular assist devices.
Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed