Journal article
A randomized evaluation of the TriGuard™ HDH cerebral embolic protection device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation: the REFLECT I trial
European heart journal, Vol.42(27), pp.2670-2679
07/15/2021
DOI: 10.1093/eurheartj/ehab213
PMID: 34000004
Abstract
The REFLECT I trial investigated the safety and effectiveness of the TriGuard™ HDH (TG) cerebral embolic deflection device in patients undergoing transcatheter aortic valve replacement (TAVR).
This prospective, multicentre, single-blind, 2:1 randomized (TG vs. no TG) study aimed to enrol up to 375 patients, including up to 90 roll-in patients. The primary combined safety endpoint (VARC-2 defined early safety) at 30 days was compared with a performance goal. The primary efficacy endpoint was a hierarchical composite of (i) all-cause mortality or any stroke at 30 days, (ii) National Institutes of Health Stroke Scale (NIHSS) worsening at 2-5 days or Montreal Cognitive Assessment worsening at 30 days, and (iii) total volume of cerebral ischaemic lesions detected by diffusion-weighted magnetic resonance imaging at 2-5 days. Cumulative scores were compared between treatment groups using the Finkelstein-Schoenfeld method. A total of 258 of the planned, 375 patients (68.8%) were enrolled (54 roll-in and 204 randomized). The primary safety outcome was met compared with the performance goal (21.8% vs. 35%, P < 0.0001). The primary hierarchical efficacy endpoint was not met (mean efficacy score, higher is better: -5.3 ± 99.8 TG vs. 11.8 ± 96.4 control, P = 0.31). Covert central nervous system injury was numerically lower with TG both in-hospital (46.1% vs. 60.3%, P = 0.0698) and at 5 days (61.7 vs. 76.2%, P = 0.054) compared with controls.
REFLECT I demonstrated that TG cerebral protection during TAVR was safe in comparison with historical TAVR data but did not meet the predefined effectiveness endpoint compared with unprotected TAVR controls.
Details
- Title: Subtitle
- A randomized evaluation of the TriGuard™ HDH cerebral embolic protection device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation: the REFLECT I trial
- Creators
- Alexandra J Lansky - Queen Mary University of LondonRajendra Makkar - Cedars-Sinai Medical CenterTamim Nazif - Columbia UniversitySteven Messé - Hospital of the University of PennsylvaniaJohn Forrest - Yale UniversityRahul Sharma - Stanford UniversityJoachim Schofer - Universität HamburgAxel Linke - University Hospital Dresden Heart Center, Dresden,DE.David Brown - Heart Hospital Baylor PlanoAbhijeet Dhoble - [University of Texas Health Science Center, Houston, TX, USA]Phillip Horwitz - University of IowaMing Zang - Swedish Medical CenterFrederico DeMarco - San Donato, Milan, ItalyVivek Rajagopal - Piedmont Atlanta HospitalMichael G Dwyer - University at Buffalo, State University of New YorkRobert Zivadinov - University at Buffalo, State University of New YorkPieter Stella - University Medical Center UtrechtJoshua Rovin - BayCare Health SystemHelen Parise - Yale UniversitySusheel Kodali - Columbia UniversityAndreas Baumbach - Queen Mary University of LondonJeffrey Moses - Columbia University
- Resource Type
- Journal article
- Publication Details
- European heart journal, Vol.42(27), pp.2670-2679
- DOI
- 10.1093/eurheartj/ehab213
- PMID
- 34000004
- ISSN
- 0195-668X
- eISSN
- 1522-9645
- Grant note
- name: Keystone Heart, Ltd Tampa
- Language
- English
- Date published
- 07/15/2021
- Academic Unit
- Cardiovascular Medicine; Internal Medicine
- Record Identifier
- 9984359875102771
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