. 2023 Aug 28;13(9):1819. doi: 10.3390/life13091819

Table 2.

Main results of randomized controlled trials on cerebral protection devices in transcatheter aortic valve replacement.

RCT	Year	Sample Size	Prosthetic Valve	Endpoints	Results
DEFLECT III [56]	2015	TriGuard (n = 46) Controls (n = 39)	Balloon-expandable Self-expandable	– Safety endpoint: all-cause mortality, all stroke, life-threatening bleeding, acute kidney injury, and major vascular complications; – Efficacy endpoints: cerebral ischemic lesions on DW-MRI; neurocognitive deterioration.	– Strokes: CPD = 2, control = 2; – Safety endpoint: CPD 21.7% vs. control 30.8% (p = 0.34); – Efficacy endpoint: higher freedom from the ischemic lesion with CPD (46% ITT); lower new neurocognitive deterioration (CPD 3.1% vs. control 15.4%, p = 0.16).
EMBOL-X [57]	2015	Embol-x (n = 14) Controls (n = 16)	Balloon-expandable	– Efficacy endpoints: number of lesions on DW-MRI; lesion size.	– No strokes reported; – New lesion on DW-MRI: CPD 57% vs. control 69% (p = 0.70). – Smaller lesions with CPD (p = 0.27).
MISTRAL-C [58]	2016	Sentinel (n = 32) Controls (n = 33)	Balloon-expandable Self-expandable	– Primary endpoint: new cerebral lesions on DW-MRI; – Secondary endpoint: neurocognitive deterioration.	– Strokes: CPD = 1, control = 6; – New brain lesion: CPD 73% vs. control 87% (p = 0.31). – >10 new brain lesions: CPD 0% vs. control 20% (p = 0.03). – Smaller total lesion volume with CPD (p = 0.057); – Neurocognitive deterioration: CPD 4% vs. control 27% (p = 0.017).
CLEAN-TAVI [23]	2016	Claret Montage Dual Filter System (n = 50) Controls (n = 50)	Self-expandable	– Primary endpoint: new cerebral lesions on DW-MRI; – Secondary endpoints: difference in the volume of new lesions on DW-MRI; neurocognitive deterioration.	– Strokes: CPD = 5, control = 5; – N. of new lesions lower in the CPD group (p < 0.001); – The volume of new lesions is lower in the CPD group (p = 0.001). – Neurocognitive deterioration: no differences;
SENTINEL [43]	2017	Sentinel (n = 123) Controls (n = 119)	Balloon-expandable Self-expandable	– Safety endpoint: all-cause mortality, all stroke, acute kidney injury; – Efficacy endpoints: difference in the volume of new lesions on DW-MRI; neurocognitive deterioration.	– Stokes: CPD 5.6% vs. control 9.1% (p = 0.25); – Safety endpoint: CPD 7.3% vs. control 9.9% (p = 0.41); – Volume of new lesions: CPD 102.8 mm³ vs. control 178 mm³ (p = 0.33); – Neurocognitive deterioration: no differences.
REFLECT II [42]	2021	TriGuard 3 (n = 121) Controls (n = 58)	Balloon-expandable Self-expandable	– Safety endpoint: all-cause mortality, all stroke, life-threatening bleeding, acute kidney injury, major vascular complications, coronary artery obstruction, and valve-related dysfunction; Efficacy endpoints: all-cause mortality or stroke; neurocognitive deterioration; freedom from new lesions on DW-MRI; the difference in the volume of new lesions on DW-MRI.	– Strokes: CPD 8.3% vs. control 5.3% (p = 0.57); – Safety endpoint: CPD 15.9% vs. control 7% (p = 0.11); – Efficacy endpoint: neurocognitive deterioration CPD 14.1% vs. control 7.6% (p = 0.18); new ischemic lesions CPD 85% vs. control 84.9% (p = 1); similar volume of new lesions (p = 0.405).
PROTECTED TAVR [51]	2022	Sentinel (n = 1501) Controls (n = 1499)	Balloon-expandable Self-expandable	– Primary endpoint: clinical stroke; – Secondary endpoints: disabling stroke, death, transient ischemic attack, delirium, major or minor vascular complications at the CPD access site, and acute kidney injury.	– Primary endpoint: CPD 2.3% vs. control 2.9% (p = 0.30); – Secondary endpoints: disabling stroke CPD 0.5% vs. control 1.3% (p < 0.05); death CPD 0.5% vs. control 0.3%; transient ischemic attack CPD 0.1% vs. control 0.1%.