dc.contributor.author | Lansky, AJ | |
dc.contributor.author | Makkar, R | |
dc.contributor.author | Nazif, T | |
dc.contributor.author | Messé, S | |
dc.contributor.author | Forrest, J | |
dc.contributor.author | Sharma, R | |
dc.contributor.author | Schofer, J | |
dc.contributor.author | Linke, A | |
dc.contributor.author | Brown, D | |
dc.contributor.author | Dhoble, A | |
dc.contributor.author | Horwitz, P | |
dc.contributor.author | Zang, M | |
dc.contributor.author | DeMarco, F | |
dc.contributor.author | Rajagopal, V | |
dc.contributor.author | Dwyer, MG | |
dc.contributor.author | Zivadinov, R | |
dc.contributor.author | Stella, P | |
dc.contributor.author | Rovin, J | |
dc.contributor.author | Parise, H | |
dc.contributor.author | Kodali, S | |
dc.contributor.author | Baumbach, A | |
dc.contributor.author | Moses, J | |
dc.contributor.author | REFLECT I Trial Investigators | |
dc.date.accessioned | 2021-07-13T07:58:32Z | |
dc.date.available | 2021-07-13T07:58:32Z | |
dc.date.issued | 2021-05-17 | |
dc.identifier.citation | 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 | en_US |
dc.identifier.uri | https://qmro.qmul.ac.uk/xmlui/handle/123456789/73018 | |
dc.description.abstract | AIMS : 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). METHODS AND RESULTS : 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. CONCLUSION : 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. | en_US |
dc.language | eng | |
dc.relation.ispartof | European Heart Journal | |
dc.rights | This is a pre-copyedited, author-produced version of an article accepted for publication in European Heart Journal following peer-review. The version of record: 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, 2021;, ehab213, https://doi.org/10.1093/eurheartj/ehab213 is available online at: https://doi.org/10.1093/eurheartj/ehab213 | |
dc.subject | Cerebral ischaemia | en_US |
dc.subject | Diffusion-weighted imaging | en_US |
dc.subject | Neuroprotection | en_US |
dc.subject | Stroke prevention | en_US |
dc.subject | Transcatheter aortic valve replacement | en_US |
dc.title | 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. | en_US |
dc.type | Article | en_US |
dc.identifier.doi | 10.1093/eurheartj/ehab213 | |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/34000004 | en_US |
pubs.notes | Not known | en_US |
pubs.publication-status | Published online | en_US |
rioxxterms.funder | Default funder | en_US |
rioxxterms.identifier.project | Default project | en_US |