Interpreting Neurologic Outcomes in a Changing Trial Design Landscape: An Analysis of HeartWare Left Ventricular Assist Device Using a Hybrid Intention to Treat Population

Abstract

Randomized controlled trials can provide optimal clinical evidence to assess the benefits of new devices, and it is these data that often shape device usage in real-world practice. However, individual clinical trial results sometimes appear discordant for the same device, and alternative devices are sometimes not employed in similar patient populations. To make sound evidence-based decisions, clinicians routinely rely on cross-trial comparisons from different trials of similar but not identical patient populations to assess competing technology when head-to-head randomized comparisons are unavailable.

Figure 1.

Generation of the hybrid long-term HVAD population.

Figure 2.

A: Incidence of total neurologic events in the HYBRID HVAD group compared with the MOMENTUM 3 HeartMate 3 (HM3) group.^, There were 413/524 of HVAD patients and 130/151 HM3 patients on support at the time of the 6-month analysis, and 224/524 of HVAD patients and 117/189 HM3 patients on support at the time of the 2-year analysis. B: Comparison of freedom from disabling stroke rates in MOMENTUM 3 and ENDURANCE Supplemental. The freedom from disabling strokes (strokes with a modified Rankin Score (mRS) > 3) in the HM3 and HM2 cohorts of the MOMENTUM Trial compared with the freedom from disabling strokes in the ENDURANCE Supplemental Trial. (HM3 and HM2 curves reprinted with permission from Mehra, et al. Copyright ©2018 Massachusetts Medical Society.)