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

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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

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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

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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

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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.[1]

## References

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1. ↑ Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG; et al. (2010). "Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery". N Engl J Med. 363 (17): 1597–607. doi:10.1056/NEJMoa1008232. PMID 20961243.CS1 maint: Explicit use of et al. (link) CS1 maint: Multiple names: authors list (link)  Review in: Evid Based Med. 2011 Jun;16(3):74-5