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  • PARTNER B Original

    • PARTNER B

    "Transcatheter Aortic-Valve Implantation for Inoperable Severe Aortic Stenosis".The New England Journal of Medicine. 2010. 363:1597-1607.DOI:10.1056/NEJMoa1008232. ClinicalTrials.gov number, NCT00530894.PubMed•Full text•PDF

    Contents


    1Clinical Question
    2Bottom Line
    3Major Points
    4Guidelines
    5Design
    6Population
    6.1Inclusion Criteria
    6.2Exclusion Criteria
    6.3Baseline Characteristics
    7Interventions
    8Outcomes
    8.1Primary Outcome
    8.2Secondary Outcomes
    9Criticisms
    10Funding
    11Further Reading

    Clinical Question


    Does transcatheter aortic-valve implantation (TAVI) improve survival in patients with severe aortic stenosis who are not suitable candidates for surgery?

    Bottom Line


    In patients with severe aortic stenosis who are not suitable candidates for surgery, TAVI compared with standard therapy significantly reduced rates of death from any cause, repeat hospitalization, and cardiac symptoms, despite a higher incidence of major strokes and vascular events.

    Major Points


    For patients with severe aortic stenosis who are not candidates for surgical aortic valve replacement, TAVI is a potential life-saving option. The PARTNER trial compared TAVI with standard therapy and found that TAVI significantly reduced one-year mortality (30.7% vs. 50.7%) and rates of hospitalization without an increased risk of early mortality when compared to standard therapy.

    Guidelines


    As of the latest update from the American College of Cardiology/American Heart Association, TAVI is a class I recommendation for patients with severe aortic valve stenosis who are not surgical candidates, providing a heart team agrees on the treatment and life expectancy is greater than 12 months.

    Design


    - Multicenter, randomized, controlled trial
    - N=358 patients with severe aortic stenosis and inoperable condition
    - TAVI (n=179) vs. standard therapy (n=179)
    - Setting: 21 centers (17 in the USA)
    - Enrollment: 2007-2009
    - Mean follow-up: 1.6 years (minimum follow-up 1 year, maximum 2.8 years)
    - Analysis: Intention-to-treat
    - Primary Outcomes: Death from any cause

    Population


    - Inclusion Criteria: Patients with severe aortic stenosis and symptoms, in whom surgeons deemed surgery as high-risk or contraindicated
    - Exclusion Criteria: Bicuspid or noncalcified aortic valve, MI within prior 7 days, need for bypass grafting, LVEF <20%, aortic annulus diameter <18mm or >25mm, significant aortic regurgitation, among others
    - Baseline Characteristics: Similar between groups, high-risk population with an STS score of 11.6±6.0%

    Interventions


    - TAVI via transfemoral route with the Edwards SAPIEN heart-valve system
    - Standard therapy included balloon aortic valvuloplasty as per usual care

    Outcomes


    - Primary Outcome: One-year mortality was significantly lower in the TAVI group compared to standard therapy (30.7% vs. 50.7%, HR 0.55, 95% CI 0.40-0.74, P<0.001)
    - Secondary Outcomes: At one year, TAVI reduced the composite endpoint of death from any cause or repeat hospitalization (42.5% vs. 71.6%, HR 0.46, P<0.001), despite a higher incidence of major strokes (7.8% vs. 3.9%, not statistically significant) and major vascular complications in the TAVI group

    Criticisms


    - High surgical risk patients may not represent broader aortic stenosis population
    - Increased stroke rate in TAVI group raises concern

    Funding


    The PARTNER trial was funded by Edwards Lifesciences.

    Further Reading


    The full text of the article and supplementary material can be found at NEJM.org.