A Randomized Evaluation of the TriGUARD3 Cerebral Embolic Protection Device to Reduce the Impact of Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation - REFLECT II

Contribution To Literature:

The REFLECT II trial failed to show that cerebral embolic protection during TAVR was beneficial.

Description:

The goal of the trial was to compare cerebral embolic protection with the TriGUARD 3 device compared with usual care among patients undergoing transcatheter aortic valve replacement (TAVR).

Study Design

There were 2 phases to this study. In phase 1, patients who met enrollment criteria were randomized 2:1 to the TriGUARD HDH device versus usual care. In phase 2, patients who met enrollment criteria were randomized 2:1 to the TriGUARD 3 device versus usual care. There were 157 subjects in the TriGUARD 3 device group versus 119 subjects in the usual care group.

  • Total number of enrollees: 276
  • Duration of follow-up: 30 days
  • Mean patient age: 80 years
  • Percentage female: 45%
  • Percentage with diabetes mellitus: 39%

Inclusion criteria:

  • Severe aortic stenosis with planned TAVR procedure with a commercially available device

Exclusion criteria:

  • Prior AVR
  • Stroke/transient ischemic attack (TIA) <6 months
  • Contraindication to antiplatelet or anticoagulation therapy
  • Estimated glomerular filtration rate (eGFR) <30 ml/min
  • Severe peripheral vascular disease
  • Severe aortic calcification or atheroma
  • Contraindication to magnetic resonance imaging (MRI)

Other salient features/characteristics:

  • Prior stroke/TIA: 17%
  • Bicuspid aortic valve: 25%

Procedure success was 70%. During TAVR, 75% had complete cerebral coverage, 8% had partial coverage, and 17% had no coverage.

Principal Findings:

After enrollment of 179 of the 225 planned randomized patients, the sponsor suspended trial enrollment.

The primary safety endpoint at 30 days, 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: 15.9% of the cerebral embolic protection device group. The historical performance goal was 34.4% (p for noninferiority = 0.001). The actual frequency of the composite safety event in the control group was 7.0% (p = 0.11).

The primary efficacy score, all-cause mortality or any stroke at 30 days, National Institutes of Health Stroke Scale (NIHSS) worsening from baseline to 2-5 days, freedom from any cerebral ischemic lesions on diffusion-weighted (DW)-MRI at 2-5 days, and total volume of cerebral ischemic lesions on DW-MRI at 2-5 days: -8.58 in the cerebral embolic protection device group vs. 8.08 in the usual care group (p = 0.86).

Secondary endpoints:

  • All strokes at 30 days: 8.3% of the cerebral embolic protection device group vs. 5.3% of the usual care group (p = not significant)
  • All-cause mortality or any stroke at 30 days: 9.8% of the cerebral embolic protection device group vs. 6.7% of the usual care group (p = 0.48)
  • Life-threatening or disabling bleeding: 5.7% of the cerebral embolic protection device group vs. 0 of the usual care group (p = 0.12)
  • Major vascular complications: 7.0% of the cerebral embolic protection device group vs. 0 of the usual care group (p = 0.04)

Interpretation:

Among patients undergoing TAVR, cerebral embolic protection with the TriGUARD 3 device was not beneficial. This trial was inconclusive due to early termination of the study; however, based on the available data, cerebral embolic protection was associated with a numerically higher incidence of the composite safety endpoint compared with control. Cerebral embolic protection also failed to improve a composite efficacy endpoint. Although an area of intense research, routine cerebral embolic protection during TAVR has not been able to demonstrate a reduction in neurologic events.

References:

Presented by Dr. Jeffrey W. Moses at the Transcatheter Cardiovascular Therapeutics Virtual Meeting (TCT Connect), October 15, 2020.

Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Interventions and Vascular Medicine, Magnetic Resonance Imaging

Keywords: Acute Kidney Injury, Aortic Valve Stenosis, Cardiac Surgical Procedures, Cerebral Hemorrhage, Diffusion Magnetic Resonance Imaging, Embolic Protection Devices, Embolism, Geriatrics, Heart Valve Diseases, Hemorrhage, Intracranial Embolism, Ischemic Attack, Transient, Stroke, Transcatheter Aortic Valve Replacement, TCT20, Transcatheter Cardiovascular Therapeutics, Vascular Diseases


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