PARTNER (Cohort A) Trial

Aortic Stenosis Microchapters

Home

Patient Information

Overview

Historical Perspective

Classification

Pathophysiology

Causes

Differentiating Aortic Stenosis from other Diseases

Epidemiology and Demographics

Risk Factors

Natural History, Complications and Prognosis

Diagnosis

History and Symptoms

Physical Examination

Cardiac Stress Test

Electrocardiogram

Chest X Ray

MRI

Echocardiography

Cardiac Catheterization

Aortic Valve Area

Aortic Valve Area Calculation

Treatment

General Approach

Medical Therapy

Surgery

Percutaneous Aortic Balloon Valvotomy (PABV) or Aortic Valvuloplasty

Transcatheter Aortic Valve Replacement (TAVR)

TAVR vs SAVR
Critical Pathway
Patient Selection
Imaging
Evaluation
Valve Types
TAVR Procedure
Post TAVR management
AHA/ACC Guideline Recommendations

Follow Up

Prevention

Precautions and Prophylaxis

Cost-Effectiveness of Therapy

Future or Investigational Therapies

Case Studies

Case #1

PARTNER (Cohort A) Trial On the Web

Most recent articles

Most cited articles

Review articles

CME Programs

Powerpoint slides

Images

American Roentgen Ray Society Images of PARTNER (Cohort A) Trial

All Images
X-rays
Echo & Ultrasound
CT Images
MRI

Ongoing Trials at Clinical Trials.gov

US National Guidelines Clearinghouse

NICE Guidance

FDA on PARTNER (Cohort A) Trial

CDC on PARTNER (Cohort A) Trial

PARTNER (Cohort A) Trial in the news

Blogs on PARTNER (Cohort A) Trial

Directions to Hospitals Treating PARTNER (Cohort A) Trial

Risk calculators and risk factors for PARTNER (Cohort A) Trial

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

## Objective

[edit | edit source]

To compare the outcomes with transcatheter aortic valve implantation (TAVI) versus surgical valve replacement among high-risk patients with severe symptomatic aortic stenosis

## Methods

[edit | edit source]

The Placement of Aortic Transcatheter Valves (PARTNER) trial Cohort A was a prospective, multicenter, randomized, active-treatment-controlled clinical trial comparing transcatheter aortic-valve replacement with surgical aortic valve replacement in high-risk patients with severe aortic stenosis.

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.

Patients were randomly assigned to two groups:

* Surgical aortic valve replacement
* Transcatheter aortic valve implantation (either a transfemoral or a transapical approach)

Study device: The Edwards SAPIEN heart-valve system (Edwards Lifesciences)

The primary endpoint: the rate of death from any cause at 1 year

## Results

[edit | edit source]

A total of 699 patients were enrolled at 25 centers. At 30 days, the rates of death from any cause were 3.4% in the transcatheter group compared with 6.5% in the surgical group (P=0.07). At 1 year, the rates of death from any cause were 24.2% in the transcatheter group compared with 26.8% in the surgical group (P=0.44), a reduction of 2.6 percentage point in the transcatheter group (two-sided 95% confidence interval [CI], -9.3 to 4.1; upper limit of the one-sided 95% CI, 3.0 percentage points) was within the prespecified noninferiority margin of 7.5 percentage points (P=0.001 for noninferiority). Rates of all neurologic events (i.e., all strokes and transient ischemic attacks) were higher in the transcatheter group than in the surgical group at 30 days (5.5% vs. 2.4%, P=0.04) and at 1 year (8.3% vs. 4.3%, P=0.04). At 30 days, the rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group P=0.20) At 1 year, the rates of major strokes were 5.1% in the transcatheter group and 2.4% in the surgical group (P=0.07). At 30 days, the transcatheter group had a significantly higher rate of major vascular complications than did the surgical group (11.0% vs. 3.2%, P<0.001) but had lower rates of major bleeding events (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%), P=0.006). At 30 days, more patients in the transcatheter group had an improvement in cardiac symptoms, but at 1 year there was no significant difference between the two groups.

## Conclusion

[edit | edit source]

In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic valve replacement were associated with similar rates of survival at 1 year and resulted in similar improvements in cardiac symptoms (noninferiority of the transcatheter group, as compared with the surgical group).[1]

## References

[edit | edit source]

1. ↑ Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG; et al. (2011). "Transcatheter versus surgical aortic-valve replacement in high-risk patients". N Engl J Med. 364 (23): 2187–98. doi:10.1056/NEJMoa1103510. PMID 21639811.CS1 maint: Explicit use of et al. (link) CS1 maint: Multiple names: authors list (link)