The benefits of the Lotus valve system (Boston Scientific) held up in additional analyses of the first head-to-head comparison of two transcatheter aortic valves in patients with aortic stenosisat extreme or high surgical risk.[1]
The full REPRISE 3 data were published January 2 in JAMA, with lead author Dr Ted Feldman (NorthShore University Health System, Evanston, IL).
Feldman presented the initial results of the 912-patient study at EuroPCR 2017, as reported at the time by theheart.org | Medscape Cardiology. The results showed that the mechanically expanded Lotus valve was not inferior to the self-expanding first-generation CoreValve and second-generation Evolut R valves (Medtronic).
The primary safety end point — a composite of all-cause mortality, stroke, life-threatening/major bleeding, stage 2/3 acute kidney injury, and major vascular complications at 30 days — occurred in 20.3% of patients in the Lotus group and 17.2% of patients in the CoreValve group (noninferiority P = .003).
The 1-year composite primary effectiveness endpoint of all-cause death, disabling stroke, and moderate or greater paravalvular aortic leakage (PVL) occurred in 15.4% and 25.5% of patients, respectively (noninferiority P < .001).
Superiority testing of the primary effectiveness endpoint, however, gave the edge to the Lotus valve over the CoreValve in intention-to-treat (16.7% vs 29%) and as-treated (16.4% vs 28.6%; both P < .001) analyses — driven largely by less moderate or severe PVL.
The new report includes post hoc analyses comparing these key outcomes in the subset of patients implanted with the Evolut R valve, introduced midway in the study, with outcomes in the Lotus group, who received the first-generation valve throughout the study.
Overall, “the conclusions do not change,” Feldman said in an email.
The primary effectiveness endpoint occurred in 20.3% of 123 Evolut R patients vs 15.4% of 506 Lotus patients (difference, –4.9 percentage points; one-sided Farrington-Manning 97.5% confidence interval, infinity to 1.5%), suggesting that the Lotus was still noninferior to the CoreValve despite the significantly reduced sample size and correspondingly larger confidence interval.
Overall, PVL was less common with the Lotus than the Evolut R valve at discharge or 7 days, 30 days, 6 months, and 12 months; however, moderate or greater PVL at 1 year did not statistically differ between the two groups (0.9% vs 2.9%; P = .13).
The Lotus program took it on the chin last year after a worldwide recall of all Lotus heart valves due to premature release of a pin connecting the transcatheter valve to the delivery system.
Boston Scientific’s plans to relaunch the Lotus Edge valve in Europe by first quarter of 2018 and file for premarket approval in the United States this month have been delayed, however, after final testing revealed new issues with how the valve attaches to the delivery system.
An update on the status of the Lotus Edge is expected next month.
Boston Scientific funded the trial. Feldman reports receiving grants and personal fees from Boston Scientific, Abbott, Edwards, and WL Gore. Coauthor disclosures are listed in the paper.
Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.
Tidak ada komentar:
Posting Komentar