PCR STATEMENT on the 2-year clinical outcomes from the Evolut low risk trial
The Evolut Low Risk trial is a randomized noninferiority trial in which TAVI with a self-expanding supraannular bioprosthesis (CoreValve, Evolut R, or Evolut PRO; Medtronic) was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk (30-day surgical mortality risk mild paravalvular leak.
How will the results change the daily practice of physicians?
These data are highly likely to encourage the offer of TAVI with a self-expanding supraannular bioprosthesis as a non-inferior, less invasive alternative treatment option to surgery for patients with symptomatic, severe aortic stenosis and low surgical risk. Physicians (and patients) are likely to interpret the results favourably with regards to the numerical values of the primary outcome of death or disabling stroke at 2-years between the two groups.
Physicians should counsel patients specifically regarding the higher rate of pacemaker implantation with TAVI (21.1%), however, these historical data do not incorporate the contemporary cusp-overlay implantation technique for the self-expanding supraannular bioprosthesis that significantly reduces conduction disturbance (and the need for subsequent pacemaker).
Longer-term follow-up is needed to evaluate the differences demonstrated in the impact on patient outcomes. Of note, patients will be followed for 10 years and so such data will be forthcoming.
INFORMATION:
NOTES TO EDITORS
Key information
Complete 2-year follow-up from the Evolut low risk trial - John Forrest
Embargo will be lifted on Tuesday 18 May - 9:00 Paris time
Available on the Video on Demand Section - http://www.europcr.com
Livestream presentation on 18 May - 11:40 - Valvular Channel
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