Study finds Medtronic's CoreValve yields similar outcomes to Edwards' Sapien

Edwards Lifesciences' Sapien XT--Courtesy of Edwards

A randomized clinical trial comparing Medtronic's ($MDT) CoreValve to Edwards' ($EW) Sapien XT concluded that the clinical outcomes of the patients' receiving either TAVR device were similar. The study analyzed the results of 241 high-risk patients who received either device between March 2012 and December 2013 at 5 German centers.

The two devices are the market leaders in the burgeoning transaortic valve replacement market for elderly patients who are too frail for open heart surgery. They are the only TAVR lines available in the U.S. In a sign of their fierce rivalry, Edwards sought an injunction against the CoreValve in the country, alleging patent infringement. The companies agreed to a settlement which included a $750 million one-payment from Medtronic to Edwards.

The latest battle over superiority ends in a tie, although it should help Medtronic mitigate previous studies that have found the CoreValve to be associated with a higher rate of paravalvular leak.

"It is interesting to see that despite differences in device performance, including more leaks in the CoreValve group, this did not translate into higher mortality rates, even for cardiovascular death," Dr. Josep Rodés-Cabau of Canada's Laval University told the Cardiovascular Research Foundation's TCTMD. "We are learning that maybe in some patients the leaks are not so important, or perhaps that accurate evaluation of these leaks is not so easy."

Medtronic's CoreValve device
Medtronic's CoreValve--
Courtesy of Medtronic

One year after implantation, the 121 Sapien XT patient had an all-cause death rate of 17.4% (compared to 12.8% for CoreValve patients), cardiovascular death rate of 12.4% (compared to 9.4%), and stroke rate of 9.1% (compared to 3.4%). However, none of those differences met the criteria for statistical significance, meaning the differences had a significant probability of occurring due to random chance.

The rate of permanent pacemaker implantation was significantly higher among CoreValve patients (38% vs. 23.4%).

The 30-day results of the trial found that the Sapien XT had a higher rate of device success because it was associated with a lower rate of more-than-mild aortic regurgitation and less frequent need for more than one valve, according to TCTMD. But 30-day cardiovascular mortality was similar across both groups, at slightly higher than 4%.

It's important to note that both companies are currently selling upgraded, third-generation iterations of the devices used in the trial: the Sapien 3 and CoreValve Evolut R. Fundamental technical differences remain in place however. Most notably, Edwards' Sapien line uses a balloon-expandable replacement valve, while the CoreValve franchise uses a self-expanding valve.

May's EuroPCR conference was full of positive clinical data for both TAVRs, as well as their competitors, showing that the minimally invasive treatment paradigm is safely adding a treatment option for high-risk, elderly heart failure patients who would not have been eligible for any other intervention.

Both Edwards and Medtronic are hoping additional strong data will lead to use of their devices in intermediate-risk patients. Some go so far as to say that someday, all valve replacements will be conducted using a catheter-based procedure, as opposed to invasive open heart surgery.  

- here's the paper abstract
- here's some analysis from TCTMD