TY - JOUR
T1 - Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients
AU - CLASP IID Pivotal Trial Investigators
AU - Lim, D. Scott
AU - Smith, Robert L.
AU - Gillam, Linda D.
AU - Zahr, Firas
AU - Chadderdon, Scott
AU - Makkar, Raj
AU - von Bardeleben, Ralph Stephan
AU - Kipperman, Robert M.
AU - Rassi, Andrew N.
AU - Szerlip, Molly
AU - Goldman, Scott
AU - Inglessis-Azuaje, Ignacio
AU - Yadav, Pradeep
AU - Lurz, Philipp
AU - Davidson, Charles J.
AU - Mumtaz, Mubashir
AU - Gada, Hemal
AU - Kar, Saibal
AU - Kodali, Susheel K.
AU - Laham, Roger
AU - Hiesinger, William
AU - Fam, Neil P.
AU - Keßler, Mirjam
AU - O'Neill, William W.
AU - Whisenant, Brian
AU - Kliger, Chad
AU - Kapadia, Samir
AU - Rudolph, Volker
AU - Choo, Joseph
AU - Hermiller, James
AU - Morse, Michael A.
AU - Schofer, Niklas
AU - Gafoor, Sameer
AU - Latib, Azeem
AU - Koulogiannis, Konstantinos
AU - Marcoff, Leo
AU - Hausleiter, Jörg
N1 - Publisher Copyright:
© 2022 American College of Cardiology Foundation
PY - 2022/12/26
Y1 - 2022/12/26
N2 - 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 (Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial) randomized trial (NCT03706833) is the first to evaluate the safety and effectiveness of the PASCAL system compared with the MitraClip system in patients with significant symptomatic DMR. This report presents 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 echocardiography core laboratory and a clinical events committee. The primary safety endpoint was the composite major adverse event rate at 30 days. The primary effectiveness endpoint was the proportion of patients with mitral regurgitation (MR) ≤2+ at 6 months. Results: A prespecified interim analysis in 180 patients demonstrated noninferiority of the PASCAL system vs the MitraClip system for the primary safety and effectiveness endpoints of major adverse event rate (3.4% vs 4.8%) and 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]). Conclusions: The CLASP IID trial demonstrated safety and effectiveness of the PASCAL system and met noninferiority endpoints, expanding transcatheter treatment options for prohibitive surgical risk patients with significant symptomatic DMR.
AB - 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 (Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial) randomized trial (NCT03706833) is the first to evaluate the safety and effectiveness of the PASCAL system compared with the MitraClip system in patients with significant symptomatic DMR. This report presents 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 echocardiography core laboratory and a clinical events committee. The primary safety endpoint was the composite major adverse event rate at 30 days. The primary effectiveness endpoint was the proportion of patients with mitral regurgitation (MR) ≤2+ at 6 months. Results: A prespecified interim analysis in 180 patients demonstrated noninferiority of the PASCAL system vs the MitraClip system for the primary safety and effectiveness endpoints of major adverse event rate (3.4% vs 4.8%) and 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]). Conclusions: The CLASP IID trial demonstrated safety and effectiveness of the PASCAL system and met noninferiority endpoints, expanding transcatheter treatment options for prohibitive surgical risk patients with significant symptomatic DMR.
KW - CLASP IID
KW - M-TEER
KW - MitraClip system
KW - PASCAL system
KW - TMVr
KW - mitral valve transcatheter edge-to-edge repair
KW - transcatheter mitral valve repair
UR - http://www.scopus.com/inward/record.url?scp=85143665236&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85143665236&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2022.09.005
DO - 10.1016/j.jcin.2022.09.005
M3 - Article
C2 - 36121247
AN - SCOPUS:85143665236
SN - 1936-8798
VL - 15
SP - 2523
EP - 2536
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 24
ER -