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DEDICATE trial: the devil lies in the definition of "low risk"
1Department of Cardiac Surgery, Rabindranath Tagore International Institute of Cardiac Sciences, Narayana Health, 124, EM Bypass, Mukundapur, Kolkata, 700099 India.
Abstract:
Transcatheter aortic-valve replacement (TAVR) has evolved from a treatment strategy for high-risk patients to an option for low-risk individuals, prompting the need for rigorous comparisons with surgical aortic-valve replacement (SAVR). The German-Austrian Prospective Randomized Trial of Transcatheter Aortic Valve Implantation Versus Conventional Surgical Aortic Valve Replacement in Low and Intermediate Risk Patients (DEDICATE) trial compares low- and intermediate-risk patient undergoing SAVR and TAVR. This review outlines the trial design, key findings, strengths, and weaknesses of the study and also highlights the urgent need for standardized definitions of low-risk patients in future trials to ensure accurate comparisons and robust conclusions.
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