Edwards Lifesciences (NYSE:EW) and Medtronic (NYSE:MDT) both won some love from Wall Street today as new reports coming out of this year’s American College of Cardiology conference suggested that the procedure may be safer than previously reported.
A pair of Medtronic and Edwards registries tracking outcomes among TAVI patients, both of which were released today at the ACC meeting in Chicago, found lower stroke rates than previously reported in the pivotal Partner trials.
MDT shares were trading 3% higher to $49.85 and EW shares were up 3% to $73.53 as of about 10:30 a.m. today.
"We were extremely pleased with the low stroke rates," Dr. Axel Linke, who presented results from the Advance study of Medtronic’s CoreValve TAVI system, said during the conference. "So far we don’t have an explanation."
The Advance study included more than 1,000 patients across 44 centers in 12 countries, finding a 12.8% mortality rate and 8.4% cardiovascular mortality rate at 6 months, with higher mortality among patients rated more at risk, TheHeart.org reported. At 30 days all-cause mortality and cardiovascular mortality rates were 4.5% and 3.4%.*
The trial concluded with a major stroke rate of 2.9% at 30 days, a significant slide from the 3.8% rate in the Partner trial’s cohort A and the 5% rate in the Partner trial’s cohort B.
Although Linke couldn’t point to any clear cause, he suggested that the trial may have benefited from physicians and centers which had previous experience with the procedure. He also suggested that the improvement may be related to the CoreValve system’s "more passive process" of deployment when compared to the Sapien system assessed in the Partner trials.
In Edwards’ 4-year follow up of its Sapien TAVI patients the major stroke rate amounted to 2.3% at 30 days, lagging far behind more likely causes of noncardiac death, which were mostly attributable to pulmonary or renal complications, the news site reported.
Among nearly 400 patients, about half had died at 4 years. Dr. Josep Rodés-Cabau, who presented the Sapien trial results at the conference today, noted that non-cardiac deaths made up ⅔ of the deaths.
While the results were significant in pinpointing possible predictive factors for late mortality in TAVI patients, specifically chronic obstructive pulmonary disease, chronic kidney disease, chronic atrial fibrillation and frailty, Rodés-Cabau stressed that the findings represent a stepping stone to more solid patient selection recommendations.
"What we’ve seen is that a significant number of these patients die within the first months or years of the procedure, and we have identified four important comorbidities that are very prevalent," he said. "In our daily experience we have been refusing many more patients now than we were in the past."
Sapien landed FDA clearance in November 2011 for treatments of patients too sick to undergo open-heart surgery. Medtronic’s CoreValve TAVI system is expected to hit the U.S. market in 2014.
Correction: This article originally stated that the 12.8% mortality rate and 8.4% cardiovascular mortality rate in the Advance study applied to the 30-day follow-up, but they applied to the 6-month results from the study.
