Transcatheter Versus Surgical Aortic Valve Replacement in Medicare Beneficiaries with Bicuspid Aortic Stenosis (TREAT-BICUSPID): Statistical Analysis Plan

This document provides the full statistical analysis plan (SAP) for the TRanscatheter VErsus Surgical Aortic Valve ReplacemenT in Medicare Beneficiaries with Bicuspid Aortic Stenosis (TREAT-BICUSPID) study. TREAT-BICUSPID is a retrospective, population-based cohort study of Medicare beneficiaries with bicuspid aortic stenosis (AS) undergoing aortic valve replacement (AVR) from 2012 to 2022. The study was designed to evaluate trends in relative use of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in this population over time, and compare 1-year outcomes of isolated TAVR and SAVR using an instrumental variable approach. The pre-specified SAP detailed in this document was posted on medRxiv prior to analysis of the primary outcomes.