TCT 2022: Pascal non-inferior to MitraClip in head-to-head trial in degenerative MR patients
The first randomised trial to compare two transcatheter edge-to-edge repair (TEER) devices —CLASP IID—has concluded that degenerative mitral regurgitation (MR) patients see similar clinical outcomes with the Pascal (Edwards Lifesciences) as with Mitraclip (Abbott).
Findings of the trial were presented during a late-breaking clinical science session at the 2022 Transcatheter Cardiovascular Therapeutics meeting (TCT, 16–19 September, Boston, USA) by Scott Lim (University of Virginia, Charlottesville, USA) and Konstantinos Koulogiannis (Atlantic Health System Morristown Medical Center, Morristown, USA) and published simultaneously in JACC: Cardiovascular Interventions.
The trial included 43 sites in the USA, Canada, and Europe, randomising 180 patients at prohibitive surgical with 3+ or 4+ degenerative MR risk 2:1 to receive either the Pascal (n=117) or MitraClip (n=63) device. The trial’s primary safety endpoint was a composite major adverse event (MAE) rate at 30 days, and the primary effectiveness endpoint was the proportion of patients with MR ≤2+ at six months.
