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Valve Disease2016New England Journal of Medicine

PARTNER 2

Placement of Aortic Transcatheter Valves 2

Sample Size
2,032
Study Design
Multicenter, randomized, noninferiority trial
Year Published
2016
Category
Valve Disease

Clinical Question

Is TAVR noninferior to surgery for patients with severe aortic stenosis who are at intermediate surgical risk?

Population

Patients with severe symptomatic aortic stenosis and an STS-PROM score of 4-8%, indicating intermediate surgical risk, at 57 centers.

Intervention

TAVR with the SAPIEN XT or SAPIEN 3 balloon-expandable valve

Control

Surgical aortic valve replacement (SAVR)

Primary Endpoint

Composite of death from any cause or disabling stroke at 2 years

Key Findings

1

The primary endpoint occurred in 19.3% of TAVR patients vs 21.1% of surgery patients at 2 years (p=0.25 for superiority; met noninferiority).

2

In the transfemoral-access cohort, TAVR was associated with lower rates of death or disabling stroke compared with surgery (16.8% vs 20.4%).

3

TAVR resulted in significantly lower rates of acute kidney injury (1.3% vs 3.1%), severe bleeding (10.4% vs 43.4%), and new-onset atrial fibrillation (9.1% vs 26.4%).

4

SAVR was associated with lower rates of major vascular complications (5.5% vs 7.9%) and paravalvular aortic regurgitation.

5

Hospital length of stay was significantly shorter with TAVR (6 vs 9 days).

Impact on Clinical Practice

PARTNER 2 bridged the gap between the high-risk population of PARTNER 1 and the eventual low-risk expansion of PARTNER 3. By demonstrating noninferiority of TAVR in intermediate-risk patients, it extended the reach of transcatheter therapy to a much larger patient population. The finding that transfemoral TAVR was particularly favorable compared with surgery was important, as it underscored the value of the least invasive access route. The dramatic reductions in bleeding, acute kidney injury, and atrial fibrillation reinforced the physiologic advantages of avoiding sternotomy, cardiopulmonary bypass, and aortic cross-clamping. This trial led to FDA expansion of TAVR indications to intermediate-risk patients in 2016, roughly doubling the eligible patient population and establishing TAVR as a mainstream treatment option for aortic stenosis.

Guideline Impact

The 2017 ACC/AHA Focused Update on Valvular Heart Disease incorporated PARTNER 2 to recommend TAVR as a reasonable alternative to surgery in intermediate-risk patients (Class IIa). The ESC/EACTS guidelines similarly updated to support TAVR consideration for intermediate-risk patients aged 70 or older.

Limitations

The SAPIEN XT valve used in much of the trial has been superseded by the SAPIEN 3, which has lower paravalvular regurgitation rates.

Two-year follow-up may be insufficient to assess valve durability in a relatively younger intermediate-risk population.

The superiority endpoint was not met in the overall cohort, and the transfemoral subgroup benefit was a prespecified secondary analysis.

Reviewed by Farhan Ayubi, DO
Vascular & Endovascular Surgeon

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