May 4, 2015 — Thoratec Corp. 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 New York Heart Association (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.
"ROADMAP is an important study that improves understanding of the benefits and risks with LVAD therapy in ambulatory advanced heart failure patients not dependent on inotropic support. These patients are already included in the FDA [U.S. Food and Drug Administration]-approved indication for Destination Therapy, and many of these patients continue to get worse over time without an LVAD, so there is a penalty for watchful waiting and delayed decisions," said Jerry Estep, M.D., assistant professor of medicine and medical director of the Heart Transplant and LVAD Program at the Methodist DeBakey Heart and Vascular Center at Houston Methodist. Estep was presenter of the ROADMAP study data at ISHLT.
"This unique study provides evidence that the probability of survival with improved functional status is enhanced with LVAD support compared with optimal medical management, supporting the value of evaluating functionally limited ambulatory advanced heart failure patients for LVAD therapy," added Joseph G. Rogers, M.D., senior author and professor of medicine and senior vice chief for clinical affairs of the Division of Cardiology at Duke University.
Survival in the HeartMate II group was 80 percent at one year, compared with 64 percent for medically managed patients on an as-treated basis. At one year of follow-up, 39 percent of patients within the HeartMate II group met the primary endpoint of survival on the original therapy along with a 75 meter increase in 6-minute walk test distance, compared with 21 percent 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 percent of HeartMate II patients designated as INTERMACS profile 4 at baseline, compared with just 34 percent 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.
Overall functional improvement significantly favored HeartMate II support as measured by changes in 6-minute walk distance, health-related quality of life and NYHA classification. Within the LVAD group, 77 percent of patients at 12 months improved to NYHA Class I or II status compared with only 29 percent in NYHA Class II and no Class I patients in the optimal medical management group. Quality-of-life metrics favored HeartMate II despite the fact that adverse events in total were higher than with medical management. Adverse events were similar to rates observed in the Destination Therapy clinical trial, with bleeding the most frequent adverse event. Pump thrombus in this contemporary cohort was 1.1 percent at 90 days and 6.4 percent at one-year, with pump exchange for thrombus of 4.3 percent at one-year. Additionally, 30-day mortality within the LVAD group was only 1 percent, equivalent to optimal medical management.
ROADMAP is a prospective, multi-center, non-randomized, controlled, observational study designed to examine the effectiveness of HeartMate II support compared with optimal medical management for NYHA Class IIIB and IV patients categorized as INTERMACS profiles 4 through 7 and not dependent on intravenous inotropic support. The study enrolled 200 patients at 41 sites from October 2011 through July 2013, including 97 patients in the LVAD support group and 103 patients on optimal medical management. The one-year primary endpoint of survival with improvement in the 6-minute walk test of at least 75 meters compared with baseline has been met, while two-year follow-up of patients remains in progress.
For more information: www.thoratec.com