Details of Pascal’s Experiments vs MitraClip CLASP IID
The CLASP IID trial was a prospective, multicenter, international, randomized controlled trial to evaluate the safety and efficacy of a transcatheter Pascal valve repair system compared to the MitraClip system in patients with significant DMR symptoms.
Enrollment of patients with 3+ or 4+ DMR at high surgical risk was considered. Those considered candidates for TEER with both regimens were randomly selected to undergo treatment with either the Pascal Repair System or the MitraClip System in a 2:1 ratio.
The primary safety endpoint was the compound major adverse event (MAE) rate at 30 days including cardiovascular death, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding and non-elective mitral re-intervention (either percutaneous or surgically). Echocardiograms were collected at baseline, during procedure, discharge and all follow-up visits for 30 days, six months and annually over five years.
The analysis was completed on 180 patients in an adaptive Bayesian design. Patients were randomized at 43 sites in the United States, Canada and Europe between November 2018 and December 2021 (117 Pascal and 63 MitraClip).
At 30 days, the rate of major adverse events was 3.4% for the Pascal regimen versus 4.8% for the MitraClip regimen (difference -1.3%, 95% CI 5.1%).
The primary efficacy endpoint was the proportion of patients with an MR of ≤2+ at six months (96.5% for Pascal versus 96.8% for MitraClip, difference -0.3%, 95% CI -6.2%). In addition, patients in both treatment groups had significant improvements in functional outcomes and quality of life (P < 0.05).
What is degenerative coronary reflux disease?
Severe DMR is associated with poor prognosis, including higher mortality, increased hospitalizations for heart failure, and poor functional outcomes and quality of life. Medical treatment plays a limited role, and in current guidelines, surgical mitral valve repair with proven efficacy and a well-established safety profile is recommended for asymptomatic and/or impaired left ventricular systolic function.
It is thought that patients may be under treatment because of the high risks of surgery, under referral and aversion to surgery. In addition, tip-to-tip repair via catheterization with MitraClip may not be appropriate or ideal for all anatomy, so patients need to undergo an imaging examination to assess cardiac anatomy.
Disclosures: The study was funded by Edwards Lifesciences. Koulogiannis mentioned that he is a consultant and advisory board member for Edwards Lifesciences and a speaker at Abbott. Lim stated that he received research grants from Abbott and Edwards Live Sciences.