Although there are a considerable number of caveats from the study comparing the CoreValve (Medtronic) and SapienXT (Edwards Life Sciences), the self-expanding CoreValve came out ahead after 5 years in the investigator-initiated CHOICE study sponsored by Heart Center, Leipzig, Germany.
The investigator-initiated CHOICE study was a randomized controlled multicenter study comparing the acute hemodynamic performance of the Edwards Sapien XT and the Medtronic CoreValve transcatheter heart valves in high risk patients with severe symptomatic aortic stenosis. It was sponsored and organized by an organization in Germany, The Heart Center officially titled Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH.
As reported in TCTMD by Michael O’Riordan, the CHOICE study was an investigator-initiated trial in 241 high-risk patients with severe aortic stenosis. The study commenced by 2012 and completed at the end of 2018. By 2014 the earliest results appeared to favor the balloon-expandable Sapien XT (Edwards) based on the observation of better sealing and less paravalvular leak compared with CoreValve. It should be noted that the early hemodynamic differences observed by investigators precluded any meaningful clinical endpoints as noted in the TCTMD article by Mr. Riordan.
By 5 years, the rate of all-cause mortality among patients treated with Sapien XT and CoreValve was 53.4% and 47.6%, respectively (P = 0.38). Roughly one in six patients had a stroke and approximately one-quarter of study participants were re-hospitalized for heart failure, but there were no significant differences in rates between the balloon-expandable and self-expanding valve study arms. The need for a new permanent pacemaker was significantly higher with the self-expanding CoreValve (40.4% vs 25.4%; P = 0.01).
Forward flow hemodynamics favored CoreValve throughout the study, with the mean pressure gradient significantly higher and mean effective orifice area significantly smaller with the balloon-expandable Sapien XT device. Differences in paravalvular aortic regurgitation—which was significantly lower with Sapien XT at 30 days and 12 months—were not evident at 5 years.
At five years, the two heart valve products appeared to perform just as well but there were some long-term differences. The study investigators found that rates of mortality, stroke, and repeat hospitalization for heart failure were comparable for both Sapien XT and CoreValve valves.
However after five year, the investigators recorded Structural valve deterioration (SVD) documented in six patients treated with Sapien XT, including four patients with moderate SVD and two with severe SVD; there was no such trend observed in any patient with the CoreValve.
A post hoc analysis included an assessment of bioprosthetic valve dysfunction (includes SVD, non-SVD, valve thrombosis, and endocarditis), which was not significantly different between the two valves.
Of the seven cases of valve thrombosis observed by the investigators (6 with Sapien XT and 1 with CoreValve-all seven patients did not take oral anticoagulation.
Mohamed Abdel-Wahab, MD (Heart Center Leipzig) told TCTMD that “we were actually surprised to see the opposite at 5 years. Obviously, leaks were an issue with the old CoreValve—we know this, and this is why the device has improved and the reason we have other devices that are repositionable—but there are obviously other downsides, at least hypothetical, for the balloon—expandable device that offset the better sealing.”
Dr. Abdel-Wahab noted to TCTMD that the balloon-expandable device (Sapien XT) might contribute to the higher risk of SVD but the “subtle” differences in valve thrombosis and SVD would require further confirmation given the small numbers.
TCTMD reported that during the EuroPCR 2019, Alain Cribier, MD (Hôpital Charles Nicolle, Rouen, France), noted during the CHOICE study presentation said the findings are reassuring given the lack of substantive differences between the two valves. “Of course, we’re talking about the first-generation devices,” he said. He cautioned against making too much of the findings, particularly since 50% of the patients had died at 5 years.
Mohamed Abdel-Wahab, MD Heart Center Leipzig
Source: Clinical trials