Transcatheter aortic valve replacement (TAVI) with the new generation balloon expandable valve is at least as good as surgery in intermediate risk patients with severe symptomatic aortic stenosis. For those that can be accessedfemorally, TAVI seems even better than surgery.
In all, 2032 intermediate risk patients were randomized in 57 centers to TAVI with Sapien XT vs.open surgery. Access site (transfemoral or other) was chosen prior randomization.
The PARTNER 2 A cohort showed that death and disabling stroke risk at 2 years (primary end point) was no different between randomized patients with Sapien XTvs. open surgery (19.3% vs 21.1%, respectively).
More than three quarters of patients enrolledwere eligible for femoral access, and in this group in particular, TAVI was associated to a 21% reduction of relative risk in primary end point, just enough to make it significant (HR 0.79; IC 0.62 a 1.00; p=0.05).
Patients undergoing TAVI showedhigher rates of vascular complications and paravalvular leak, whereas those undergoing surgery showed higher rates of acute kidney failure, major bleeding and new-onset atrial fibrillation.