Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement: REFLECT II |
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| Authors: | Tamim M. Nazif Jeffrey Moses Rahul Sharma Abhijeet Dhoble Joshua Rovin David Brown Philip Horwitz Rajendra Makkar Robert Stoler John Forrest Steven Messé Sarah Dickerman Joseph Brennan Robert Zivadinov Michael G. Dwyer Alexandra J. Lansky |
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| Affiliation: | 1. Columbia University Medical Center, New York, New York, USA;2. University of Texas Health Science Center, Houston, Texas, USA;3. Division of Cardiology, Stanford University, Stanford, California, USA;4. Morton Plant Hospital, Clearwater, Florida, USA;5. Heart Hospital Baylor, Plano, Texas, USA;6. University of Iowa, Iowa City, Iowa, USA;7. Cedars-Sinai Medical Center, Los Angeles, California, USA;8. Baylor Heart and Vascular Hospital, Dallas, Texas, USA;9. Division of Cardiology, Yale School of Medicine, New Haven, Connecticut, USA;10. Department of Neurology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA;11. Buffalo Neuroimaging Analysis Center, Department of Neurology, State University of New York at Buffalo, Buffalo, New York, USA;12. Barts Heart Centre, London and Queen Mary University of London, London, United Kingdom |
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| Abstract: | ObjectivesThe REFLECT II (Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Implantation) trial was designed to investigate the safety and efficacy of the TriGUARD 3 (TG3) cerebral embolic protection in patients undergoing transcatheter aortic valve replacement.BackgroundCerebral embolization occurs frequently following transcatheter aortic valve replacement and procedure-related ischemic stroke occurs in 2% to 6% of patients at 30 days. Whether cerebral protection with TriGuard 3 is safe and effective in reducing procedure-related cerebral injury is not known.MethodsThis prospective, multicenter, single-blind, 2:1 randomized (TG3 vs. no TG3) study was designed to enroll up to 345 patients. The primary 30-day safety endpoint (Valve Academic Research Consortium-2 defined) was compared with a performance goal (PG). The primary hierarchical composite efficacy endpoint (including death or stroke at 30 days, National Institutes of Health Stroke Scale score worsening in hospital, and cerebral ischemic lesions on diffusion-weighted magnetic resonance imaging at 2 to 5 days) was compared using the Finkelstein-Schoenfeld method.ResultsREFLECT II enrolled 220 of the planned 345 patients (63.8%), including 41 roll-in and 179 randomized patients (121 TG3 and 58 control subjects) at 18 US sites. The sponsor closed the study early after the U.S. Food and Drug Administration recommended enrollment suspension for unblinded safety data review. The trial met its primary safety endpoint compared with the PG (15.9% vs. 34.4% (p < 0.0001). The primary hierarchal efficacy endpoint at 30 days was not met (mean scores [higher is better]: ?8.58 TG3 vs. 8.08 control; p = 0.857). A post hoc diffusion-weighted magnetic resonance imaging analysis of per-patient total lesion volume above incremental thresholds showed numeric reductions in total lesion volume >500 mm3 (?9.7%) and >1,000 mm3 (?44.5%) in the TG3 group, which were more pronounced among patients with full TG3 coverage: ?51.1% (>500 mm3) and ?82.9% (>1,000 mm3).ConclusionsThe REFLECT II trial demonstrated that the TG3 was safe compared with a historical PG but did not meet its pre-specified primary superiority efficacy endpoint. |
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