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A Mixed Bag for TriGuard 3’s Performance in REFLECT II

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Study findings point out the device met the primary safety endpoint compared to historical controls but did not demonstrate superiority for the primary hierarchical efficacy endpoint.

Results from a trial evaluating Venus Medtech’s TriGuard 3 (TG3) cerebral embolic deflection filter in patients undergoing transcatheter aortic valve replacement were a mixed bag.

On one hand, the REFLECT II findings showed the device met the primary safety endpoint compared to historical controls but on the other, the technology did not demonstrate superiority for the primary hierarchical efficacy endpoint.

The REFLECT II findings were presented at Transcatheter Cardiovascular Therapies (TCT) Connect, the 32nd annual scientific symposium of the Cardiovascular Research Foundation (CRF).

Embolic protection devices are used to reduce the number of complications due to debris being released into the bloodstream and causing blockages in smaller vessels. 

REFLECT II intended to randomize 295 patients 2:1 to TAVR with TG3 vs. control. The primary safety endpoint was a composite of all-cause mortality, stroke, life-threatening or disabling bleeding, stage 2/3 acute kidney injury, coronary artery obstruction requiring intervention, major vascular complication, and valve-related dysfunction requiring intervention (VARC 2 defined) at 30 days.

The endpoint was compared with a Performance Goal of 34.4%. The primary efficacy endpoint was a hierarchical composite of all-cause mortality or stroke at 30 days, NIHSS worsening, absence of diffusion-weighted magnetic resonance imaging (DWI) lesions post-procedure, and total volume of cerebral lesions (TLV) by DWI.

Cumulative scores derived by the Finkelstein-Schoenfeld method were summed for each patient and compared between groups. The REFLECT II analysis population included 283 patients [41 roll-in, 121 randomized to TG3 and 121 controls (58 randomized in phase II and 63 pooled from REFLECT phase I)]. TG3 was delivered and positioned in the aortic arch prior to TAVR in 100% of cases and retrieved intact in all cases. After enrollment of 179 of the 225 planned randomized patients, the sponsor suspended trial enrollment with the concurrence of the FDA and DMC.

TG3 met the primary safety endpoint (22.5% vs 34.4% PG, pnon-inferiority=0.0001). However, superiority for the primary efficacy endpoint was not met, with similar win-ratios and win% (TG3 0.84 (45.7%) vs 1.19 (54.3%), p=0.857) between groups. Median TLV was not different with TG3 protection (215.39 mm3 vs 188.09 mm3 , p=0.405).

“Compared to controls, the primary 30-day safety endpoint was higher with TriGuard 3 due primarily to TAVR related vascular and bleeding complications,” said Jeffrey W. Moses, MD. Dr. Moses is a Professor of Cardiology at Columbia University Vagelos College of Physicians and Surgeons, Director of Interventional Cardiovascular Therapeutics, NewYork-Presbyterian/Columbia University Irving Medical Center and Director of Advanced Cardiac Interventions, St. Francis Hospital and Heart Center. “While the study did not demonstrate the superiority of TriGuard 3 compared to pooled controls for the primary hierarchical efficacy endpoint, a post hoc DW-MRI analysis suggests that TG3 may reduce larger ischemic lesions. Improved device stability to achieve reliable, complete cerebral coverage may improve outcomes.”

TG3 was originally developed by Keystone Heart. However, the company was acquired by Venus in 2018.

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