Transcatheter aortic valve implantation (TAVI) offers an effective, less invasive therapeutic alternative to surgical aortic valve replacement in patients with symptomatic, severe aortic stenosis. Although TAVI is demonstrated to be superior to medical therapy or surgery in patients who are at prohibitive or high risk for aortic valve surgery, less is known about TAVI in patients who are at low risk for complications or death from surgery. At EuroPCR 2021, Dr J Forrest will present the complete 2-year follow-up 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<3%). The primary end point was a composite of death or disabling stroke at 24 months.
The as-treated cohort consisted of 1414 patients. Attempted TAVI or surgery was performed in 730 and 684 patients, respectively. Completed 2-year follow-up was available for 97.3% in the TAVI group and 92.3% in the surgery group. At 12 months, the primary outcome occurred in 2.5% in the TAVI vs. 4.3% in the surgical group (p=0.057). At 24 months, the primary outcome occurred in 4.3% in the TAVI vs. 6.3% in the surgical group (p=0.084). In a landmark analysis from 12 to 24 months, the primary outcome occurred in 1.9% in the TAVI vs. 2.1% in the surgical group (p=0.742); thereby indicating no late adverse catch-up phenomenon in the less-invasive TAVI therapy group.
Also additionally reported, at 2-years, TAVI with a self-expanding supraannular bioprosthesis was superior to surgery in regards to valve hemodynamics and prosthesis-patient mismatch. Conversely, surgery was superior to TAVI in regards to the incidence of pacemaker implantation and > 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.
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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
About EuroPCR 2021
The World-Leading Course in interventional cardiovascular medicine and the official annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) will take place from 18 to 20 May 2021 online, http://www.europcr.com and in different hubs (depending on the sanitary situation).
The detailed Course Programme is available on: https://www.pcronline.com/Courses/EuroPCR.
About PCR
The mission of PCR is to serve the needs of each individual patient by helping the cardiovascular community to share knowledge, experience and practice. PCR offers a large range of many other educational meetings and resources for the continuing education of the interventional cardiovascular community. These include major annual Courses across the globe, e-Learning with high-profile PCR Webinars, Courses specifically dedicated to valvular heart disease, tailor-made PCR Seminars on specific topics, online resources and medical publications such as EuroIntervention, the official journal of the EAPCI.
Gateways to all PCR activities are available on http://www.pcronline.com.
For further information, please contact Ce?lia Vila?: cvila@europa-group.com.
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