One-Year Outcomes From the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation

Firas Zahr; Robert L Smith; Linda D Gillam; Scott Chadderdon; Raj Makkar; Ralph Stephan von Bardeleben; Tobias Friedrich Ruf; Robert M Kipperman; Andrew N Rassi; Molly Szerlip; Scott Goldman; Ignacio Inglessis-Azuaje; Pradeep Yadav; Philipp Lurz; Charles J Davidson; Mubashir Mumtaz; Hemal Gada; Saibal Kar; Susheel K Kodali; Roger Laham; William Hiesinger; Neil P Fam; Mirjam Keßler; William W O'Neill; Brian Whisenant; Chad Kliger; Samir Kapadia; Volker Rudolph; Joseph Choo; James Hermiller; Michael A Morse; Niklas Schofer; Sameer Gafoor; Azeem Latib; Paul Mahoney; Tsuyoshi Kaneko; Pinak B Shah; John A Riddick; Kamran I Muhammad; Peter Boekstegers; Matthew J Price; Fabien Praz; Konstantinos Koulogiannis; Leo Marcoff; Jörg Hausleiter; D Scott Lim; CLASP IID Pivotal Trial Investigators

doi:10.1016/j.jcin.2023.10.002

One-Year Outcomes From the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation

JACC Cardiovasc Interv. 2023 Oct 26:S1936-8798(23)01358-4. doi: 10.1016/j.jcin.2023.10.002. Online ahead of print.

Authors

Firas Zahr¹, Robert L Smith², Linda D Gillam³, Scott Chadderdon⁴, Raj Makkar⁵, Ralph Stephan von Bardeleben⁶, Tobias Friedrich Ruf⁶, Robert M Kipperman³, Andrew N Rassi⁷, Molly Szerlip², Scott Goldman⁸, Ignacio Inglessis-Azuaje⁹, Pradeep Yadav¹⁰, Philipp Lurz¹¹, Charles J Davidson¹², Mubashir Mumtaz¹³, Hemal Gada¹³, Saibal Kar¹⁴, Susheel K Kodali¹⁵, Roger Laham¹⁶, William Hiesinger¹⁷, Neil P Fam¹⁸, Mirjam Keßler¹⁹, William W O'Neill²⁰, Brian Whisenant²¹, Chad Kliger²², Samir Kapadia²³, Volker Rudolph²⁴, Joseph Choo²⁵, James Hermiller²⁶, Michael A Morse²⁷, Niklas Schofer²⁸, Sameer Gafoor²⁹, Azeem Latib³⁰, Paul Mahoney³¹, Tsuyoshi Kaneko³², Pinak B Shah³², John A Riddick³³, Kamran I Muhammad³⁴, Peter Boekstegers³⁵, Matthew J Price³⁶, Fabien Praz³⁷, Konstantinos Koulogiannis³, Leo Marcoff³, Jörg Hausleiter³⁸, D Scott Lim³⁹; CLASP IID Pivotal Trial Investigators

Affiliations

¹ Oregon Health and Science University, Portland, Oregon, USA. Electronic address: zahr@ohsu.edu.
² Baylor Scott and White the Heart Hospital Plano, Plano, Texas, USA.
³ Atlantic Health System Morristown Medical Center, Morristown, New Jersey, USA.
⁴ Oregon Health and Science University, Portland, Oregon, USA.
⁵ Cedars-Sinai Medical Center, Los Angeles, California, USA.
⁶ University Medical Centre Mainz, Mainz, Germany.
⁷ Kaiser Permanente San Francisco Medical Center, San Francisco, California, USA.
⁸ Lankenau Medical Center, Wynnewood, Pennsylvania, USA.
⁹ Massachusetts General Hospital, Boston, Massachusetts, USA.
¹⁰ Piedmont Heart Institute, Atlanta, Georgia, USA.
¹¹ University of Leipzig, Leipzig, Germany.
¹² Northwestern University, Chicago, Illinois, USA.
¹³ UPMC Pinnacle, Harrisburg, Pennsylvania, USA.
¹⁴ Los Robles Regional Medical Center, Thousand Oaks, California, USA.
¹⁵ Columbia University Medical Center, New York, New York, USA.
¹⁶ Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
¹⁷ Stanford University Medical Center, Palo Alto, California, USA.
¹⁸ St. Michael's Hospital, Toronto, Ontario, Canada.
¹⁹ University of Ulm, Ulm, Germany.
²⁰ Henry Ford Hospital, Detroit, Michigan, USA.
²¹ Intermountain Medical Center, Salt Lake City, Utah, USA.
²² Northwell-Lenox Hill, New York, New York, USA.
²³ Cleveland Clinic Foundation, Cleveland, Ohio, USA.
²⁴ Ruhr-Universität Bochum, Bochum, Bad Oeynhausen, Germany.
²⁵ The Christ Hospital, Cincinnati, Ohio, USA.
²⁶ St. Vincent Heart Center of Indiana, Indianapolis, Indiana, USA.
²⁷ Ascension Saint Thomas Hospital, Nashville, Tennessee, USA.
²⁸ University Heart and Vascular Center Hamburg, Hamburg, Germany.
²⁹ Swedish Medical Center, Seattle, Washington, USA.
³⁰ Montefiore Medical Center, Bronx, New York, USA.
³¹ Sentara Norfolk General Hospital, Norfolk, Virginia, USA.
³² Brigham and Women's Hospital, Boston, Massachusetts, USA.
³³ Tristar Centennial Medical Center, Nashville, Tennessee, USA.
³⁴ Oklahoma Heart Institute, Tulsa, Oklahoma, USA.
³⁵ Helios Clinic, Siegburg, Germany.
³⁶ Scripps Clinic, La Jolla, California, USA.
³⁷ University Hospital Bern, Bern, Switzerland.
³⁸ Klinikum der Universität München, Munich, Germany.
³⁹ University of Virginia Health System Hospital, Charlottesville, Virginia, USA.

PMID: 37962288
DOI: 10.1016/j.jcin.2023.10.002

Abstract

Background: The CLASP IID (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical) trial is the first randomized controlled trial comparing the PASCAL system and the MitraClip system in prohibitive risk patients with significant symptomatic degenerative mitral regurgitation (DMR).

Objectives: The study sought to report primary and secondary endpoints and 1-year outcomes for the full cohort of the CLASP IID trial.

Methods: Prohibitive-risk patients with 3+/4+ DMR were randomized 2:1 (PASCAL:MitraClip). One-year assessments included secondary effectiveness endpoints (mitral regurgitation [MR] ≤2+ and MR ≤1+), and clinical, echocardiographic, functional, and quality-of-life outcomes. Primary safety (30-day composite major adverse events [MAE]) and effectiveness (6-month MR ≤2+) endpoints were assessed for the full cohort.

Results: Three hundred patients were randomized (PASCAL: n = 204; MitraClip: n = 96). At 1 year, differences in survival, freedom from heart failure hospitalization, and MAE were nonsignificant (P > 0.05 for all). Noninferiority of the PASCAL system compared with the MitraClip system persisted for the primary endpoints in the full cohort (For PASCAL vs MitraClip, the 30-day MAE rates were 4.6% vs 5.4% with a rate difference of -0.8% and 95% upper confidence bound of 4.6%. The 6-month MR≤2+ rates were 97.9% vs 95.7% with a rate difference of 2.2% and 95% lower confidence bound (LCB) of -2.5%, for, respectively). Noninferiority was met for the secondary effectiveness endpoints at 1 year (MR≤2+ rates for PASCAL vs MitraClip were 95.8% vs 93.8% with a rate difference of 2.1% and 95% LCB of -4.1%. The MR≤1+ rates were 77.1% vs 71.3% with a rate difference of 5.8% and 95% LCB of -5.3%, respectively). Significant improvements in functional classification and quality of life were sustained in both groups (P <0.05 for all vs baseline).

Conclusions: The CLASP IID trial full cohort met primary and secondary noninferiority endpoints, and at 1 year, the PASCAL system demonstrated high survival, significant MR reduction, and sustained improvements in functional and quality-of-life outcomes. Results affirm the PASCAL system as a beneficial therapy for prohibitive-surgical-risk patients with significant symptomatic DMR.

Keywords: CLASP IID; DMR; M-TEER; MitraClip system; PASCAL system; degenerative mitral regurgitation; mitral valve transcatheter edge-to-edge repair.