MedWire News: Results of the PARTNER trial show that transcatheter aortic valve replacement (TAVR) is not inferior to conventional aortic valve replacement surgery (AVR) for 1-year mortality rates in patients with aortic stenosis who are at high risk for dying during surgery.

Major strokes and vascular complications events were more frequent with TAVR, whereas major bleeding and new-onset atrial fibrillation was more common with AVR.

The trial included 699 high-risk patients from 26 sites. Patients were randomly assigned to undergo TAVR - through transfemoral access (244 patients) or a transapical approach (104) - or AVR (351); 42 patients were not treated with the approaches to which they were originally assigned.

In an intent-to-treat analysis, 1-year all-cause mortality with TAVR was not inferior to that seen with AVR, at 24.2% versus 26.8%, respectively (p=0.001 for non-inferiority).

Similarly, among the 492 patients eligible for transfemoral access, TAVR was judged to be non-inferior for all-cause deaths at 1 year.

"TAVR is already the standard of care for inoperable patients with severe aortic stenosis. These results indicate that TVR is a very acceptable alternative to AVR in selected high-risk operable patients," said principal investigator Craig Smith (Columbia University Medical Center, New York, USA).

The PARTNER (Placement of AoRTic traNscathetER valves) trial was the first randomized study comparing TAVR with conventional valve replacement surgery in patients with severe, symptomatic aortic stenosis and high surgical risk. High risk was defined as a predicted risk of operative mortality of ≥15% (as determined by the site surgeon and cardiologist), and a minimum guideline threshold Society of Thoracic Surgeons (STS) risk score of ≥10%.

TAVR patients received a 23- or 26-mm Edwards Sapien bioprosthethic device under multi-modality imaging. The device consists of a tri-leaflet bovine pericardial valve and a balloon-expandable, stainless-steel support frame.

Analysis of 30-day mortality trial data revealed that TAVR was associated with significantly lower all-cause mortality than AVR among patients with transfemoral access (3.7% versus 8.2%, respectively; p=0.05). At 1 year, however, there were no significant differences in all-cause deaths among all patients in intent-to-treat or as-treated analyses, or in the subgroups of patients treated via transfemoral or transapical access.

Major strokes at 1 year occurred in 5.1% of patients in the TAVR group, compared with 3.5% in the AVR group (p=0.07), and major vascular complications occurred in 11.0% versus 3.2%, respectively (p<0.001).

Major bleeding was seen in 9.3% of those treated with TAVR versus 19.5% of those treated with surgery (p<0.0001), and new-onset atrial fibrillation was seen in 8.6% versus 16.0%, respectively (p<0.001).

There were no significant 1-year differences in New York Heart Association Functional Class or 6-minute walk test.

MedWire (www.medwire-news.md) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2011

Meeting website