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TAVR 2-year outcomes similar with mechanical, self-expanding valves
At 2 years, patients undergoing transcatheter aortic valve replacement had similar rates of death or stroke regardless of whether they were treated with a mechanical or a self-expanding valve, according to new data from the REPRISE III trial.
As Cardiology Today’s Intervention previously reported, the mechanical valve (Lotus, Boston Scientific) was equivalent to the self-expanding valve (CoreValve, Medtronic) in 30-day safety and 1-year efficacy outcomes. Michael J. Reardon, MD, Allison Family Distinguished Chair of Cardiovascular Research in the department of cardiovascular surgery, professor of cardiovascular surgery at the Institute for Academic Medicine and full member of the Research Institute at Houston Methodist Hospital, and colleagues reported 2-year outcomes in JAMA Cardiology.
The researchers randomly assigned 912 patients (mean age, 83 years; 51% women) with severe symptomatic aortic stenosis at high or extreme risk for surgery to undergo TAVR with the mechanical valve or the self-expanding valve. The mechanical valve is not yet approved for commercial use in the United States.
The primary outcomes of the present analysis were all-cause mortality and all-cause mortality or disabling stroke.
At 2-years, 21.3% of patients in the mechanical group and 22.5% of patients in the self-expanding group died (HR = 0.94; 95% CI, 0.69-1.26), according to the researchers.
The 2-year rates of all-cause mortality or disabling stroke were 22.8% in the mechanical group and 27% in the self-expanding group (HR = 0.81; 95% CI, 0.61-1.07), Reardon and colleagues wrote.
Although overall stroke was similar between the groups (mechanical, 8.4%; self-expanding, 11.4%; HR = 0.75; 95% CI, 0.48-1.17), disabling stroke was higher in the self-expanding group (4.7% vs. 8.6%; HR = 0.53; 95% CI, 0.31-0.93), the researchers found.
“The mechanism for the higher stroke rate in the CoreValve arm is unknown, but could be due to the larger frame size and its interaction with the anatomy, or the play of chance,” Reardon and colleagues wrote.
Permanent pacemaker implantation was more common in the mechanical group (41.7% vs. 26.1%; HR = 1.87; 95% CI, 1.41-2.49), as was valve thrombosis (3% vs. 0%; P < .01).
The self-expanding group was more likely than the mechanical group to have a repeat procedure (0.6% vs. 2.9%; HR = 0.19; 95% CI, 0.05-0.7), valve migration (0% vs. 0.7%; P = .05) and embolization (0% vs. 2%; P < .01), according to the researchers.
Moderate or greater paravalvular leak occurred more often in the self-expanding group (0.3% vs. 3.8%; P < .01), Reardon and colleagues wrote.
More patients in the mechanical group improved in NYHA functional class, according to the researchers.
“The longer-term results from REPRISE III validate good outcomes with the Lotus valve, which compares favorably with a currently approved predicate device,” Reardon and colleagues wrote. – by Erik Swain
Disclosures: The study was funded by Boston Scientific. Reardon reports he received research grants from Boston Scientific and Medtronic. Please see the study for all other authors’ relevant financial disclosures.