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CHOICE: Balloon-Expandable, Self-Expandable TAVR Yield Similar Outcomes at 1 Year
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One-year follow-up data from the CHOICE trial demonstrate similar outcomes after use of a balloon- or self-expanding valve in patients with aortic stenosis undergoing transcatheter aortic valve replacement, but a higher rate of device success with the balloon-expandable valve.
The study included 241 patients with symptomatic severe aortic stenosis who were randomly assigned to undergo TAVR with the Sapien XT (Edwards Lifesciences) balloon-expandable valve (n = 121) or the CoreValve (Medtronic) self-expanding valve (n = 120).
Results at 30 days were previously reported at the 2014 American College of Cardiology Scientific Sessions, The findings showed a higher rate of device success with Sapien XT compared with CoreValve (95.9% vs. 77.5%), along with increased likelihood of improvement in HF symptoms and a numerically higher rate of minor stroke.
Mohamed Abdel-Wahab
At 1-year follow-up, Mohamed Abdel-Wahab, MD, and colleagues observed similar rates of all-cause mortality (17.4% with Sapien XT vs. 12.8% with CoreValve; RR = 1.35; 95% CI, 0.73-2.5) and CV-related mortality (12.4% vs. 9.4%; RR = 1.32; 95% CI, 0.63-2.75) between the two groups. The stroke rate was numerically but not significantly higher with Sapien XT (9.1% vs. 3.4%; RR = 2.66; 95% CI, 0.87-8.12), while the rate of rehospitalization for HF was numerically higher with CoreValve (7.4% vs. 12.8%; RR = 0.58; 95% CI, 0.26-1.27).
The incidence of vascular and bleeding issues or endocarditis was infrequent between 30 days and 1 year of follow-up, with no significant differences between the groups. New pacemaker implantation was significantly more common with CoreValve at 1 year (38% of patients vs. 23.4%; P = .02).
Abdel-Wahab, head of the cardiac catheterization laboratory at Segeberger Kliniken, Bad Segeberg, Germany, and colleagues performed echocardiographic follow-up at 1 year in 89.6% of the surviving cohort. Among these patients, more-than-mild paravalvular regurgitation was more frequent with CoreValve compared with Sapien XT (12.1%of patients vs. 1.1%; P = .005). Prosthetic valve dysfunction was observed in 11.7% of the CoreValve group compared with 2.6% of the Sapien XT group (P = .009).
“Despite the higher device success rate and lower paravalvular regurgitation rate … with the balloon-expandable valve, no statistically significant differences in 1-year mortality rates were observed among the CHOICE patients treated with either balloon- or self-expandable valves, with limited statistical power,” the researchers concluded. “The numerically higher rate of thromboembolic events with the balloon-expandable valve underscores the necessity of adequately powered large comparative device trials in the TAVR field.” – by Adam Taliercio
Disclosure: Abdel-Wahab reports receiving an institutional research grant from Biotronik and St. Jude Medical, and serving as a proctor for Boston Scientific. See the full study for a list of all other authors’ relevant financial disclosures.
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