PLEASANTON, Calif., April 17, 2015 /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, today 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 today 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 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 Dr. Jerry Estep, 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 and 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 Dr. Joseph G. Rogers, 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% 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.
Overall functional improvement significantly favored HeartMate II support as measured by changes in six minute walk distance, health related quality of life, and NYHA classification. Within the LVAD group, 77% of patients at twelve months improved to NYHA Class I or II status compared with only 29% 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% at 90 days and 6.4% at one-year, with pump exchange for thrombus of 4.3% at one-year. Additionally, 30 day mortality within the LVAD group was only 1%, 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 six minute walk test of at least 75 meters compared with baseline has been met, while two-year follow-up of patients remains in progress.
Thoratec is a world leader in therapies to address advanced-stage heart failure. The company's products include the HeartMate II® LVAS (Left Ventricular Assist Systems) and Thoratec® VAD (Ventricular Assist Device) with more than 20,000 devices implanted in patients suffering from heart failure. Thoratec also manufactures the CentriMag® and PediMag®/PediVAS® product lines. Thoratec is headquartered in Pleasanton, California. For more information, visit the company's website at http://www.thoratec.com.
Thoratec, the Thoratec logo, HeartMate and HeartMate II are registered trademarks of Thoratec Corporation. CentriMag and PediMag are registered trademarks of Thoratec LLC, and PediVAS is a registered trademark of Thoratec Switzerland GmbH.
The preceding paragraphs contain forward-looking statements within the meaning of Sections 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements can be identified by the words, "believes," "views," "expects," "plans," "projects," "should," "hopes," "could," "will," "estimates," "potential," and other similar words. Actual results, events or performance could differ materially from these forward-looking statements based on a variety of factors, many of which are beyond Thoratec's control. Therefore, readers are cautioned not to put undue reliance on these statements. Investors are cautioned that all such statements involve risks and uncertainties, including risks related to regulatory approvals, the growth of existing markets for our products, customer and physician acceptance of Thoratec products, the effects of international and FDA regulatory requirements, our ability to address quality issues adequately and on a timely basis without a resulting recall of products or interruption of manufacturing or shipment of products, the effects of healthcare reimbursement and coverage policies, and the effects of competition. Forward-looking statements contained in this press release should be considered in light of these factors and those factors discussed from time to time in Thoratec's public reports filed with the Securities and Exchange Commission, such as those discussed under the heading, "Risk Factors," in Thoratec's most recent annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and other SEC filings. These forward-looking statements speak only as of the date hereof. Thoratec undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
SOURCE Thoratec Corporation