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CHOICE: Outcomes similar between two TAVR systems at 5 years
At 5 years, there were no differences in mortality, stroke or rehospitalization between balloon-expandable and self-expanding valves in patients who underwent transcatheter aortic valve replacement, according to new data from the CHOICE trial presented at EuroPCR.
As Cardiology Today previously reported, CHOICE was the first head-to-head randomized controlled trial comparing the balloon-expandable valve (Sapien XT, Edwards Lifesciences) and the self-expanding valve (CoreValve, Medtronic); both valves were earlier generations than what is available today. At 30 days, the balloon-expandable valve was associated with a higher rate of device success and a lower rate of more-than-mild aortic regurgitation compared with the self-expanding valve.
Mohamed Abdel-Wahab, MD, consultant cardiologist and head of the department of structural heart disease at Heart Center Leipzig, Germany, presented 5-year results.
In the initial cohort, 121 patients were assigned the balloon-expandable valve and 120 patients were assigned the self-expanding valve. At 5 years, in the balloon-expandable group, 63 patients had died, 56 were alive and accounted for, one was lost to follow-up and one withdrew, whereas in the self-expanding group, 54 patients had died, 61 were alive an accounted for, two were lost to follow-up and three withdrew.
At 5 years, the rates of all-cause mortality were 53.4% in the balloon-expandable group and 47.6% in the self-expanding group (log-rank P = .38), Abdel-Wahab said during a presentation.
CV mortality also did not significantly differ between the groups (balloon-expandable, 31.6%; self-expanding, 21.5%; log-rank P = .12).
There were also no significant differences at 5 years in the following outcomes: stroke (P = .73) repeat hospitalization for HF (P = .75), MI (P = .08), major bleeding (P = .26) and major vascular complications (P = .89), according to the researchers.
The self-expanding group more often required a new pacemaker (25.4% vs. 40.4%; P = .01), Abdel-Wahab said.
Paravalvular aortic regurgitation was on average more severe in the self-expanding group up to 1 year, but the difference had disappeared by 5 years (P = .57), according to the researchers.
Overall rates of bioprosthetic valve dysfunction were similar in both groups at 5 years, but the balloon-expandable group had higher rates of structural valve deterioration and valve thrombosis and a trend toward a lower rate of moderate to severe paravalvular leak compared with the self-expanding group, the researchers found.
“The CHOICE trial shows comparative mortality, stroke and rehospitalization rates at 5 years after transfemoral TAVR with the early-generation balloon-expandable and self-expanding valves,” Abdel-Wahab said during the presentation. “The initial differences in paravalvular leaks were not evident at 5 years. Forward flow hemodynamics were superior with the self-expanding device at all time points, particularly at 5 years. Subtle differences in clinical valve thrombosis and structural valve deterioration favoring the self-expanding valve need further confirmation.” – by Erik Swain
Reference:
Abdel-Wahab M, et al. Trials and registries – Long-term clinical outcomes after TAVI. Presented at: EuroPCR; May 21-24, 2019; Paris.
Disclosure: Abdel-Wahab reports he received consultant fees or honoraria from Boston Scientific, Edwards Lifesciences and Medtronic.