Key result
PASCAL proves noninferior to MitraClip for major events and MR reduction in prohibitive surgical risk.
Why the study?
Severe symptomatic DMR carries a poor prognosis if untreated, and new transcatheter options warrant head-to-head evaluation against established therapies.
Does the PASCAL system provide non-inferior safety and effectiveness compared to the MitraClip system in patients with significant symptomatic 3+ or 4+ degenerative mitral regurgitation at prohibitive surgical risk?
RCT (n=180)
2:1
Does the PASCAL system provide non-inferior safety and effectiveness compared to the MitraClip system in patients with significant symptomatic 3+ or 4+ degenerative mitral regurgitation at prohibitive surgical risk?
Answers are grounded in this paper and cite their sources.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The CLASP IID trial is the first randomized, controlled trial to directly compare the two TEER therapies and further establishes the safety and effectiveness of mitral valve TEER for degenerative mitral regurgitation patients with prohibitive surgical risk. It met its primary safety and effectiveness endpoints, with the Pascal system demonstrating low composite major adverse events and a significant, sustained MR reduction.”
“The two devices have different design features that I think may be beneficial in different anatomies. As an example, since the Pascal device is hollow nitinol and can flex, even though it is about twice the size of the MitraClip, the data we have suggests it can go into smaller mitral valve annuli at the same frequency of use; it's a bigger amount of device in there, but the gradients are the same, essentially because the Pascal device doesn't obstruct the inflow as much due to its flexibility. Whereas the mechanical closure of MitraClip is definitely much stronger, so if you are going after a valve that has calcium in the leaflet tips or very thick leaflets that need to be held together, the MitraClip may be more helpful for that.”
“The CLASP IID randomized trial further establishes the Pascal system as a safe and effective therapy, expanding the armamentarium of transcatheter mitral valve treatment options for patients with DMR. Several distinct design characteristics of the Pascal system, including the flexible nitinol design and elongation capability, contribute to the positive outcomes of this study.”
The PASCAL system is safe and non-inferior to the MitraClip system for transcatheter edge-to-edge repair in patients with severe degenerative mitral regurgitation at prohibitive surgical risk.
BACKGROUND Severe symptomatic degenerative mitral regurgitation (DMR) has a poor prognosis in the absence of treatment, and new transcatheter options are emerging. OBJECTIVES The CLASP IID randomized trial (NCT03706833) is the first to evaluate the safety and effectiveness of the PASCAL system compared to the MitraClip system in patients with significant symptomatic DMR. In this report, we present the primary safety and effectiveness endpoints for the trial. METHODS Patients with 3+ or 4+ DMR at prohibitive surgical risk were assessed by a central screening committee and randomized 2:1 (PASCAL:MitraClip). Study oversight also included an echocardiographic core laboratory and a clinical events committee. The primary safety endpoint was a composite major adverse event (MAE) rate at 30 days. The primary effectiveness endpoint was the proportion of patients with MR ≤2+ at 6 months. RESULTS A pre-specified interim analysis in 180 patients demonstrated non-inferiority of the PASCAL system vs. MitraClip system for the primary safety and effectiveness endpoints, MAE: 3.4% vs. 4.8%, MR ≤2+: 96.5% vs. 96.8%, respectively. Functional and quality-of-life outcomes significantly improved in both groups (p<0.05). The proportion of patients with MR ≤1+ was durable in the PASCAL group from discharge to 6 months [PASCAL: 87.2% and 83.7% (p=0.317 vs. discharge); MitraClip: 88.5% and 71.2% (p=0.003 vs. discharge), respectively]. CONCLUSIONS The CLASP IID trial demonstrated safety and effectiveness of the PASCAL system and met non-inferiority endpoints, expanding transcatheter treatment options for prohibitive surgical risk patients with significant symptomatic DMR.
Journal, society, and media accounts. Useful signal, not independent expert judgment.
No takes yet. Share an insight, caveat, or question.
Lim et al. (2022) conducted an RCT in Severe symptomatic degenerative mitral regurgitation (DMR) (n=180). PASCAL system vs. MitraClip system was evaluated on Proportion of patients with MR ≤2+ at 6 months. The PASCAL system was noninferior to the MitraClip system for 30-day major adverse events (3.4% vs 4.8%) and 6-month MR ≤2+ (96.5% vs 96.8%) in patients with prohibitive surgical risk.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: