PARTNER 2A

Placement of Aortic Transcatheter Valves 2, Cohort A

Patient / Population Intervention / Exposure Comparison Outcome

In 2,032 intermediate-risk patients with severe aortic stenosis, transcatheter aortic-valve replacement was non-inferior for 2-year death or disabling stroke compared with surgical aortic-valve replacement.

2,032

Design

Multicentre RCT, non-inferiority

Endpoint

Death from any cause or disabling stroke at 2 years

Relevance

ResultTAVR (SAPIEN XT) 19.3% vs surgery 21.1% (HR 0.89, 95% CI 0.73-1.09); non-inferiority met (P=0.001), with a trend favouring TAVR in the transfemoral cohort.

Leon MB, et al. N Engl J Med. 2016;374(17):1609-20. 10.1056/NEJMoa1514616

Discussion & critique

Used the now-superseded SAPIEN XT (more paravalvular leak and vascular complications) and included transthoracic access in some patients. Pivotal in extending TAVR from high-risk to intermediate-risk aortic stenosis.