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Valve Disease2011New England Journal of Medicine

PARTNER 1

Placement of Aortic Transcatheter Valves 1

Sample Size
1,057
Study Design
Two parallel, multicenter, randomized controlled trials (Cohort A: TAVR vs SAVR; Cohort B: TAVR vs standard medical therapy)
Year Published
2011
Category
Valve Disease

Clinical Question

Is TAVR a viable treatment for patients with severe aortic stenosis who are at high surgical risk or considered inoperable?

Population

Patients with severe symptomatic aortic stenosis. Cohort A: high surgical risk (STS score ≥10%). Cohort B: deemed inoperable by two cardiac surgeons.

Intervention

Transfemoral or transapical TAVR with the Edwards SAPIEN valve

Control

Cohort A: surgical aortic valve replacement. Cohort B: standard medical therapy including balloon aortic valvuloplasty.

Primary Endpoint

All-cause mortality at 1 year (Cohort B) and at 2 years (Cohort A)

Key Findings

1

Cohort B (inoperable): TAVR reduced 1-year mortality from 50.7% (medical therapy) to 30.7% (absolute reduction 20%; p<0.001).

2

Cohort A (high-risk): TAVR was noninferior to SAVR, with 1-year mortality of 24.2% vs 26.8% (p=0.001 for noninferiority).

3

TAVR was associated with higher rates of major vascular complications (11.0% vs 3.2%) and paravalvular aortic regurgitation.

4

SAVR had higher rates of major bleeding (19.5% vs 9.3%) and new-onset atrial fibrillation.

5

5-year follow-up showed equivalent mortality between TAVR and SAVR in Cohort A (67.8% vs 62.4%; p=0.76).

Impact on Clinical Practice

PARTNER 1 was a watershed moment in cardiovascular medicine. For the first time, a nonsurgical alternative to open-heart valve replacement demonstrated clear clinical benefit. Cohort B established that TAVR could save the lives of patients who had no other option, with a dramatic 20% absolute reduction in mortality compared to medical therapy alone. Cohort A proved that TAVR was a safe and effective alternative to surgery in high-risk patients, establishing the principle that transcatheter approaches could match surgical outcomes. This launched the era of transcatheter valve therapy and set the stage for subsequent trials to expand TAVR to lower-risk populations. The trial led to FDA approval of the Edwards SAPIEN valve in 2011 for inoperable patients and in 2012 for high-risk patients, creating an entirely new treatment paradigm for aortic stenosis worldwide.

Guideline Impact

PARTNER 1 directly led to ACC/AHA Class I recommendations for TAVR in inoperable patients and Class IIa recommendations for TAVR in high-risk patients. It established the Heart Team approach to decision-making as the standard of care for aortic stenosis management.

Limitations

First-generation SAPIEN valve had higher paravalvular leak rates than contemporary devices, limiting generalizability to current practice.

The trial included transapical access in the surgical arm, which has since fallen out of favor due to higher complication rates.

Long-term valve durability beyond 5 years remained uncertain with transcatheter valves.

Reviewed by Rahul R. Handa, MD
Cardiovascular & Thoracic Surgeon

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