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Randomized Controlled Trial
. 2019 May 2;380(18):1706-1715.
doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.

Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients

Jeffrey J Popma  1 , G Michael Deeb  1 , Steven J Yakubov  1 , Mubashir Mumtaz  1 , Hemal Gada  1 , Daniel O'Hair  1 , Tanvir Bajwa  1 , John C Heiser  1 , William Merhi  1 , Neal S Kleiman  1 , Judah Askew  1 , Paul Sorajja  1 , Joshua Rovin  1 , Stanley J Chetcuti  1 , David H Adams  1 , Paul S Teirstein  1 , George L Zorn 3rd  1 , John K Forrest  1 , Didier Tchétché  1 , Jon Resar  1 , Antony Walton  1 , Nicolo Piazza  1 , Basel Ramlawi  1 , Newell Robinson  1 , George Petrossian  1 , Thomas G Gleason  1 , Jae K Oh  1 , Michael J Boulware  1 , Hongyan Qiao  1 , Andrew S Mugglin  1 , Michael J Reardon  1 ; Evolut Low Risk Trial Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients

Jeffrey J Popma et al. N Engl J Med. .

Abstract

Background: Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients.

Methods: We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk. When 850 patients had reached 12-month follow-up, we analyzed data regarding the primary end point, a composite of death or disabling stroke at 24 months, using Bayesian methods.

Results: Of the 1468 patients who underwent randomization, an attempted TAVR or surgical procedure was performed in 1403. The patients' mean age was 74 years. The 24-month estimated incidence of the primary end point was 5.3% in the TAVR group and 6.7% in the surgery group (difference, -1.4 percentage points; 95% Bayesian credible interval for difference, -4.9 to 2.1; posterior probability of noninferiority >0.999). At 30 days, patients who had undergone TAVR, as compared with surgery, had a lower incidence of disabling stroke (0.5% vs. 1.7%), bleeding complications (2.4% vs. 7.5%), acute kidney injury (0.9% vs. 2.8%), and atrial fibrillation (7.7% vs. 35.4%) and a higher incidence of moderate or severe aortic regurgitation (3.5% vs. 0.5%) and pacemaker implantation (17.4% vs. 6.1%). At 12 months, patients in the TAVR group had lower aortic-valve gradients than those in the surgery group (8.6 mm Hg vs. 11.2 mm Hg) and larger effective orifice areas (2.3 cm2 vs. 2.0 cm2).

Conclusions: In patients with severe aortic stenosis who were at low surgical risk, TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery with respect to the composite end point of death or disabling stroke at 24 months. (Funded by Medtronic; ClinicalTrials.gov number, NCT02701283.).

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