TAVR is safe for intermediate-risk patients

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Takeaway

  • Transcatheter aortic valve replacement (TAVR) is safe in patients with severe aortic stenosis (AS) at intermediate surgical risk, with similar rates of mortality and disabling stroke at 2 y as surgical aortic valve replacement (SAVR).
  • TAVR patients had more major bleeding, major vascular complications, and permanent pacemaker (PPM) implantation and SAVR patients had more acute kidney injury (AKI) and atrial fibrillation (Afib).

Why this matters

  • Although TAVR has been studied extensively in high-risk patients, randomized studies of intermediate-risk patients were lacking.

Study design

  • Surgical Replacement and Transcatheter Aortic Valve Implantation noninferiority, multicenter, randomized trial.
  • 1657 patients with severe AS at intermediate surgical risk underwent TAVR (n=863) or SAVR (n=794).
  • Funding: Medtronic.

Key results

  • At 30 d, TAVR group had higher rates of major bleeding (12.2% vs 9.3%), major vascular complications (6% vs 1.1%), and PPM implantation (25.9% vs 6.6%), but SAVR group had higher rates of AKI (4.4% vs 1.7) and Afib (43.4% vs 12.9%).
  • At 1 y, more moderate or severe residual paravalvular regurgitation in TAVR (5.3% vs 0.6%).
  • At 2 y, rate of all-cause mortality or disabling stroke was 12.6% in TAVR and 14% in SAVR.

Limitations

  • High number of withdrawals from SAVR group.