ROADMAP results for HeartMate LVAD device for treatment of heart failure-Thoratec

Thoratec Corporation announced results from the ROADMAP Study (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients). For the primary endpoint, a composite of survival and functional improvement, ROADMAP demonstrated a statistically significant benefit of HeartMate II LVAD support relative to optimal medical management in ambulatory NYHA Class IIIB/IV (INTERMACS profile 4-7) heart failure patients. One-year study results were presented during the 35th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation (ISHLT 2015) in Nice, France. Survival in the HeartMate II group was 80% at one year, compared with 64% for medically managed patients on an as-treated basis. At one year of follow-up, 39% of patients within the HeartMate II group met the primary endpoint of survival on the original therapy along with a 75 meter increase in six minute walk test distance, compared with 21% of patients on optimal medical management, representing a statistically significant difference (p=0.017). These benefits came despite the fact that the LVAD cohort was more severely ill, with 65% of HeartMate II patients designated as INTERMACS profile 4 at baseline, compared with just 34% in the medical management group. Moreover, 17 patients in the optimal medical management group received delayed LVAD implants during the first year as a result of worsening heart failure, and results from these patients will be fully analyzed at two-year follow-up.