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

March 16, 2019 | Jeffrey J. Popma, M.D., G. Michael Deeb, M.D., Steven J. Yakubov, M.D., Mubashir Mumtaz, M.D., Hernal 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 Tchetché, 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*
This study, conducted by the Evolut Low Risk Trial Investigators, aimed to evaluate the safety and effectiveness of transcatheter aortic-valve replacement (TAVR) with a self-expanding supraannular bioprosthesis in low-risk patients with severe aortic stenosis. The trial was a randomized, noninferiority study comparing TAVR to surgical aortic-valve replacement (SAVR) in 1468 patients. The primary endpoint was a composite of death or disabling stroke at 24 months, analyzed using Bayesian methods. Key findings include: - The 24-month incidence of the primary endpoint was 5.3% in the TAVR group and 6.7% in the SAVR group, with a noninferiority margin of 1.4 percentage points. - TAVR was associated with a lower incidence of disabling stroke, acute kidney injury, bleeding events, and atrial fibrillation compared to SAVR. - TAVR resulted in better functional improvement at 30 days, as indicated by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score. - Aortic-valve hemodynamics improved in both groups, with lower mean gradients and larger effective orifice areas in the TAVR group. - The study concluded that TAVR with a self-expanding supraannular bioprosthesis was noninferior to SAVR in terms of the risk of death or disabling stroke at 24 months in low-risk patients. The study highlights the potential benefits of TAVR as an alternative to SAVR in low-risk patients, offering a safer and more effective option for aortic valve replacement.This study, conducted by the Evolut Low Risk Trial Investigators, aimed to evaluate the safety and effectiveness of transcatheter aortic-valve replacement (TAVR) with a self-expanding supraannular bioprosthesis in low-risk patients with severe aortic stenosis. The trial was a randomized, noninferiority study comparing TAVR to surgical aortic-valve replacement (SAVR) in 1468 patients. The primary endpoint was a composite of death or disabling stroke at 24 months, analyzed using Bayesian methods. Key findings include: - The 24-month incidence of the primary endpoint was 5.3% in the TAVR group and 6.7% in the SAVR group, with a noninferiority margin of 1.4 percentage points. - TAVR was associated with a lower incidence of disabling stroke, acute kidney injury, bleeding events, and atrial fibrillation compared to SAVR. - TAVR resulted in better functional improvement at 30 days, as indicated by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score. - Aortic-valve hemodynamics improved in both groups, with lower mean gradients and larger effective orifice areas in the TAVR group. - The study concluded that TAVR with a self-expanding supraannular bioprosthesis was noninferior to SAVR in terms of the risk of death or disabling stroke at 24 months in low-risk patients. The study highlights the potential benefits of TAVR as an alternative to SAVR in low-risk patients, offering a safer and more effective option for aortic valve replacement.
Reach us at info@study.space
Understanding Transcatheter Aortic%E2%80%90Valve Replacement with a Self%E2%80%90Expanding Valve in Low%E2%80%90Risk Patients