CLASP IID: PASCAL System vs. MitraClip in Patients With Severe DMR

In the first randomized controlled study to evaluate transcatheter edge-to-edge repair (TEER) outcomes, the PASCAL system demonstrated non-inferiority in safety and effectiveness when compared with the MitraClip system. The results from the CLASP IID trial, which were presented Sept. 17 as part of TCT 2022 in Boston and simultaneously published in JACC: Cardiovascular Interventions, shows promised in terms of expanding transcatheter treatment options for patients with severe symptomatic degenerative mitral regurgitation (DMR).

Researchers randomized patients with 3+ or 4+ DMR at prohibitive surgical risk to PASCAL or MitraClip. The primary safety endpoint was a composite of major adverse event (MAE) at 30 days, while the primary effectiveness endpoint was the proportion of patients with mitral regurgitation (MR) ≤2+ at six months.

Results of a prespecified interim analysis in 180 patients demonstrated noninferiority for both the primary safety endpoint and the primary effectiveness endpoint (MAE: 3.4% vs. 4.8%, MR ≤2+: 96.5% vs. 96.8%, respectively). Researchers noted that functional and quality-of-life outcomes significantly improved in both groups (p<0.05).

"The excellent safety and effectiveness outcomes in both treatment groups are indicative of the tremendous improvements in contemporary [Mitral valve]-TEER technology as well as operator skill and experience and will expand treatment options for patients," said D. Scott Lim, MD, et al. Lim and colleagues added that "continued patient follow-up to five years will confirm long-term outcomes with the PASCAL system in comparison to the MitraClip system."

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and VHD, Interventions and Structural Heart Disease, Mitral Regurgitation

Keywords: Transcatheter Cardiovascular Therapeutics, TCT22, Mitral Valve Insufficiency, Mitral Valve, Heart Valve Prosthesis Implantation

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