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5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial

Mack, Michael J et al.

The lancet. Volume 385:Issue 9986 (2015); pp 2477-2484 -- Elsevier

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  • Title:
    5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial
  • Author: Mack, Michael J;
    Leon, Martin B;
    Smith, Craig R;
    Miller, D Craig;
    Moses, Jeffrey W;
    Tuzcu, E Murat;
    Webb, John G;
    Douglas, Pamela S;
    Anderson, William N;
    Blackstone, Eugene H;
    Kodali, Susheel K;
    Makkar, Raj R;
    Fontana, Gregory P;
    Kapadia, Samir;
    Bavaria, Joseph;
    Hahn, Rebecca T;
    Thourani, Vinod H;
    Babaliaros, Vasilis;
    Pichard, Augusto;
    Herrmann, Howard C;
    Brown, David L;
    Williams, Mathew;
    Davidson, Michael J;
    Svensson, Lars G;
    Akin, Jodi
  • Found In: The lancet. Volume 385:Issue 9986 (2015); pp 2477-2484
  • Journal Title: The lancet
  • Subjects: Medicine; Medicine--Periodicals; Periodicals; Electronic journals; Dewey: 610.5
  • Rights: legaldeposit
  • Publication Details: Elsevier
  • Abstract: Summary: Background:

    The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that mortality at 1 year, 2 years, and 3 years is much the same with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for high-risk patients with aortic stenosis. We report here the 5-year outcomes.

    Methods:

    We did this randomised controlled trial at 25 hospitals, in Canada (two), Germany (one), and the USA (23). We used a computer-generated randomisation sequence to randomly assign high-risk patients with severe aortic stenosis to either SAVR or TAVR with a balloon-expandable bovine pericardial tissue valve by either a transfemoral or transapical approach. Patients and their treating physicians were not masked to treatment allocation. The primary outcome of the trial was all-cause mortality in the intention-to-treat population at 1 year, we present here predefined outcomes at 5 years. The study is registered withClinicalTrials.gov, numberNCT00530894.

    Findings:

    We screened 3105 patients, of whom 699 were enrolled (348 assigned to TAVR, 351 assigned to SAVR). Overall mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 11·7%. At 5 years, risk of death was 67·8% in the TAVR group compared with 62·4% in the SAVR group (hazard ratio 1·04, 95% CI 0·86–1·24; p=0·76). We recorded no structural valve deterioration requiring surgical valve replacement in either group. Moderate or severe aortic regurgitation occurred in 40 (14%) of 280 patients in the TAVR group and two (1%) of 228 in the SAVR group (p<0·0001), and was associated with increased 5-year risk of mortality in the TAVR group (72·4% for moderate or severe aortic regurgitation vs 56·6% for those with mild aortic regurgitation or less; p=0·003).

    Interpretation:

    Our findings show that TAVR as an alternative to surgery for patients with high surgical risk results in similar clinical outcomes.

    Funding:

    Edwards Lifesciences.


  • Identifier: System Number: LDEAvdc_100063526168.0x000001; Journal ISSN: 0140-6736; 10.1016/S0140-6736(15)60308-7
  • Publication Date: 2015
  • Physical Description: Electronic
  • Shelfmark(s): ELD Digital store

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