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

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

May 2, 2019 | Jeffrey J. Popma, M.D., G. Michael Deeb, M.D., Steven J. Yakubov, M.D., Mubashir Murtaz, M.D., Hemal Gada, M.D., Daniel O'Hair, M.D., Tanvir Bajwa, M.D., John C. Heiser, M.D., William Merhi, D.O., Neal S. Kleiman, M.D., Judah Askew, M.D., Paul Sorajja, M.D., Joshua Rovin, M.D., Stanley J. Chetcuti, M.D., David H. Adams, M.D., Paul S. Teirstein, M.D., George L. Zorn III, M.D., John K. Forrest, M.D., Didier Tchétché, M.D., Jon Resar, M.D., Antony Walton, M.D., Nicolo Piazza, M.D., Ph.D., Basel Ramlawi, M.D., Newell Robinson, M.D., George Petrossian, M.D., Thomas G. Gleason, M.D., Jae K. Oh, M.D., Michael J. Boulware, Ph.D., Hongyan Qiao, Ph.D., Andrew S. Mugglin, Ph.D., and Michael J. Reardon, M.D., for the Evolut Low Risk Trial Investigators
A randomized noninferiority trial compared transcatheter aortic-valve replacement (TAVR) with a self-expanding supraannular bioprosthesis to surgical aortic-valve replacement in patients with severe aortic stenosis and low surgical risk. The primary endpoint was death or disabling stroke at 24 months. TAVR showed noninferiority to surgery, with a 5.3% incidence of the primary endpoint versus 6.7% in the surgery group. TAVR was associated with lower rates of disabling stroke, bleeding, acute kidney injury, and atrial fibrillation, but higher rates of moderate or severe aortic regurgitation and pacemaker implantation. At 12 months, TAVR had lower aortic-valve gradients and larger effective orifice areas compared to surgery. The study concluded that TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery in low-risk patients for the composite endpoint of death or disabling stroke at 24 months. The trial was funded by Medtronic and conducted in 86 centers worldwide. The study had limitations, including incomplete 24-month follow-up and potential bias in endpoint adjudication. Long-term follow-up is needed to assess the long-term outcomes of TAVR. The results support the use of TAVR in low-risk patients with severe aortic stenosis.A randomized noninferiority trial compared transcatheter aortic-valve replacement (TAVR) with a self-expanding supraannular bioprosthesis to surgical aortic-valve replacement in patients with severe aortic stenosis and low surgical risk. The primary endpoint was death or disabling stroke at 24 months. TAVR showed noninferiority to surgery, with a 5.3% incidence of the primary endpoint versus 6.7% in the surgery group. TAVR was associated with lower rates of disabling stroke, bleeding, acute kidney injury, and atrial fibrillation, but higher rates of moderate or severe aortic regurgitation and pacemaker implantation. At 12 months, TAVR had lower aortic-valve gradients and larger effective orifice areas compared to surgery. The study concluded that TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery in low-risk patients for the composite endpoint of death or disabling stroke at 24 months. The trial was funded by Medtronic and conducted in 86 centers worldwide. The study had limitations, including incomplete 24-month follow-up and potential bias in endpoint adjudication. Long-term follow-up is needed to assess the long-term outcomes of TAVR. The results support the use of TAVR in low-risk patients with severe aortic stenosis.
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[slides and audio] Transcatheter Aortic%E2%80%90Valve Replacement with a Self%E2%80%90Expanding Valve in Low%E2%80%90Risk Patients