Comparison and Analysis between the NAV6 Embolic Protection Filter and SpiderFX EPD Filter in Superficial Femoral Artery Lesions
Table 5
Subset analysis of event rates by calcified lesions in the Emboshield NAV6 group.
% (n/N)
Calcified NAV6 (N = 70)
Noncalcified NAV6 (N = 90)
Calcified SpiderFX (N = 131)
Noncalcified SpiderFX (N = 216)
Freedom from MAE
88.6% (62/70)
94.6% (87/91)
0.167
95.4% (125/131)
91.7% (198/216)
0.264
Death
0.0% (0/70)
1.1% (1/91)
0.379
0.0% (0/131)
0.5% (1/216)
0.434
MI (modified ARC)
0.0% (0/70)
2.2% (2/91)
0.379
1.5% (2/131)
3.7% (8/216)
0.237
TVR
0.0% (0/70)
0.0% (0/91)
N/A
0.0% (0/131)
0.9% (2/216)
0.268
Thrombosis
0.0% (0/70)
1.1% (1/91)
0.379
1.5% (2/131)
0.9% (2/216)
0.615
Dissection (grade C or greater)
11.4% (8/70)
0.0% (0/91)
0.001
0.7% (1/131)
1.4% (3/216)
0.033
Distal embolization
0.0% (0/70)
1.1% (1/91)
0.379
0.7% (1/131)
0.9% (2/216)
0.871
Perforation at the level of the filter
0.0% (0/70)
0.0% (0/91)
N/A
0.0% (0/131)
0.0% (0/216)
N/A
Unplanned amputation
0.0% (0/70)
0.0% (0/91)
N/A
0.0% (0/131)
0.0% (0/216)
N/A
aBy the Newcombe score method. ARC, academic research consortium; MAE, major adverse event; MI, myocardial infarction; TVR, target vessel revascularization.
