Impact of Beta Blockers on TAVI (BETA-TAVI)

The BETA-TAVI trial is a prospective, investigator-initiated, multicenter, randomized, open-label, non-inferiority trial designed to evaluate the safety of continuing versus temporarily interrupting chronic beta-blocker therapy in patients undergoing transcatheter aortic valve implantation (TAVI) for severe symptomatic aortic stenosis. A total of 348 patients receiving chronic oral beta-blocker therapy will be randomized in a 1:1 ratio to either continuation of their prescribed beta-blocker from at least 72 hours before TAVI through 7 days after the procedure or temporary interruption of beta-blocker therapy during the same period. Treatment modifications will be permitted when clinically indicated. The primary objective is to determine whether beta-blocker continuation is non-inferior to interruption regarding the incidence of new permanent pacemaker implantation within 7 days after TAVI, using an absolute non-inferiority margin of 6.5 percentage points. Secondary outcomes include atrioventricular conduction disturbances, atrial and ventricular arrhythmias, hemodynamic deterioration, subsequent permanent pacemaker implantation, and all-cause and cardiovascular mortality. Clinical follow-up will be performed at discharge, 7 days, 30 days, and 12 months after TAVI.

Study population Eligibility Adults scheduled to undergo TAVI for severe symptomatic aortic stenosis are eligible when they are receiving chronic oral beta-blocker therapy and satisfy all inclusion criteria without meeting any exclusion criterion. Inclusion criteria Age 18 years or older. Severe symptomatic aortic stenosis, defined by one or more of the following: mean transvalvular gradient \>=40 mmHg, peak aortic-jet velocity \>=4.0 m/s, aortic-valve area \