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Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients. JACC. Cardiovascular interventions Lim, D. S., Smith, R. L., Gillam, L. D., Zahr, F., Chadderdon, S., Makkar, R., Stephan von Bardeleben, R., Kipperman, R. M., Rassi, A. N., Szerlip, M., Goldman, S., Inglessis-Azuaje, I., Yadav, P., Lurz, P., Davidson, C. J., Mumtaz, M., Gada, H., Kar, S., Kodali, S. K., Laham, R., Hiesinger, W., Fam, N. P., KeSSler, M., O'Neill, W. W., Whisenant, B., Kliger, C., Kapadia, S., Rudolph, V., Choo, J., Hermiller, J., Morse, M. A., Schofer, N., Gafoor, S., Latib, A., Koulogiannis, K., Marcoff, L., Hausleiter, J., CLASP IID Pivotal Trial Investigators 2022

Abstract

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.

View details for DOI 10.1016/j.jcin.2022.09.005

View details for PubMedID 36121247