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Complete 2-Year Data From Evolut Low-Risk Trial Reassuring for TAVI

May 19, 2021 Among patients at low risk for surgery, TAVI with the Evolut prosthetic valve (Medtronic) is noninferior to surgery with regard to the endpoint of death or disabling stroke at 2 years, according to additional data from the Evolut Low-Risk Trial. The findings strengthen the original results, presented at American College of Cardiology (ACC) 2019 meeting and simultaneously published in the New England Journal of Medicine, which showed noninferiority of TAVI compared with surgery for death and disabling stroke at 24 months in a Bayesian analysis once 850 of the 1,414 enrolled patients had reached 12-month follow-up. In the complete analysis, presented by John Forrest, MD (Yale School of Medicine, New Haven, CT), yesterday at EuroPCR 2021, all patients had completed 2-year follow-up, representing 97.3% and 92.3% of the patients originally randomized to TAVI and surgery, respectively. Longer-term follow-up will evaluate patient endpoints out to 10 years, said Forrest.

Tragedy as Catalyst: How COVID-19 May Transform Clinical Research for Good

December 14, 2020 In a world indelibly changed by COVID-19 more than 72 million confirmed cases and 1.6 million deaths, and counting people and institutions have proven adaptable and resilient: look no further than the development of vaccines and the rollout now underway. That achievement would not have been possible without improvements and acceleration in the clinical research enterprise, something also seen within cardiology research, which had to respond quickly once it became clear that COVID-19 was affecting not just the lungs, but also the heart and other organs. This story is part of Envision Change, an end-of-2020 series imagining a different future for cardiology, medicine, research, and health. SEE ALSO: Funding the Future, Remaking Medicine, Heroes to Human.

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