PARTNER (Cohort B) Trial

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Mandana Chitsazan, M.D. [2]

Objective

To assess the outcomes with transcatheter aortic valve implantation (TAVI) compared with standard therapy among patients with severe symptomatic aortic stenosis who were poor surgical candidates for surgical aortic valve replacement

Methods

The Placement of Aortic Transcatheter Valves (PARTNER) trial Cohort B was a prospective, multicenter, randomized, active-treatment-controlled clinical trial comparing TAVI with standard therapy in high-risk patients with severe aortic stenosis who were not suitable candidates for surgery.

High-risk patient: defined by a Society of Thoracic Surgeons (STS) risk score of 10% or higher or by the presence of coexisting conditions that would be associated with a predicted risk of death by 30 days after surgery of 15% or higher.

Patient not suitable for surgery: defined as having coexisting conditions that would be associated with a predicted probability of 50% or more of either death by 30 days after surgery or a serious irreversible condition.

Patients were randomly assigned to two groups:

• Standard therapy (including balloon aortic valvuloplasty)
• Transfemoral transcatheter aortic valve implantation

Study device: The Edwards SAPIEN heart-valve system (Edwards Lifesciences) consisting of a trileaflet bovine pericardial valve and a balloon-expandable, stainless-steel support frame

The primary endpoint: the rate of death from any cause over the duration of the trial

Results

A total of 358 patients were enrolled at 21 centers. At 1 year, the rate of death from any cause was 30.7% in TAVI group, as compared with 50.7% in standard therapy group(hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P<0.001). The rate of the composite endpoint of death from any cause or repeat hospitalization was 42.5% with TAVI as compared with 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35 to 0.59; P<0.001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among TAVI patients (25.2% vs. 58.0%, P<0.001). At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs. 1.1%, P=0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001).

Conclusion

In patients with severe aortic stenosis who were poor surgical candidates, TAVI (compared with standard therapy) significantly decreased the rates of all-cause mortality, rehospitalizations, and cardiac symptoms at the expense of higher incidence of major strokes and major vascular complications.