The study compared treatment with optimal medical therapy to treatment with Thoratec’s HeartMate II left ventricular assist device as a destination therapy in ambulatory heart failure patients. After 12 months, the HeartMate II cohort showed significant improvement in survival and functional status, although that group’s risk of adverse events was higher than the control arm.
The survival rate for the HeartMate II group was 80% at 1 year, compared with 64% for medically managed patients on an as-treated basis. Thirty-nine percent of HeartMate II patients Roadmap’s primary endpoint of survival on the original therapy along with a 75 meter increase in 6-minute walk test distance, compared with 21% of patients in the control cohort. The results were presented April 17 at the International Society for Heart & Lung Transplantation in Nice, France.
"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," Thoratec said in a press release.
Leerink Partners analyst Danielle Antalffy said today that Roadmap could help open up LVAD therapy to an under-penetrated patient population, despite unexpectedly high stroke rates in a pair of studies backed by Thoratec rival HeartWare International (NSDQ:HTWR).
"Roadmap is certainly an encouraging 1st step in expanding the market into the less-sick patient population – positive for both THOR and HTWR," Antalffy wrote this morning in a note to investors, noting that 1 surgeon at the ISHLT meeting said that "perhaps the most important message from Roadmap is that we should not wait for patients to become inotrope-dependent before implanting them with an LVAD, which could open up the market ‘tremendously’ by driving at least a 50%+ increase in volumes."
"At the very least, we would expect Roadmap to motivate physicians and the industry to further explore LVAD adoption in the less-sick patient population," she wrote.
As for the implications for HeartWare, Antalffy said physicians at the ISHLT conference noted that the results do not reflect their own experience with the company’s HVAD device.
"It was almost shocking how the MEDACorp physicians with whom we spoke – even those who were more bearish on the data – expect no change in their HVAD [bridge-to-transplant] adoption because of the data. The overriding view was that the stroke data seen in Endurance 1 is not representative of their clinical practice," she wrote. "Regardless, all MEDACorp physicians we spoke with expect Endurance to secure FDA approval in [destination therapy] – which we believe will be a late-2016 event, following Endurance 2 follow-up – given that the FDA wants a 2nd device on the market."