Comparison and Analysis between the NAV6 Embolic Protection Filter and SpiderFX EPD Filter in Superficial Femoral Artery Lesions
Table 4
Major adverse events.
% (n/N)
Emboshield NAV6 (N = 161)
SpiderFX EPD (N = 346)
value
Freedom from MAE
92.0% (149/161)
91.6% (317/346)
0.721
Death
0.6% (1/161)
0.3% (1/346)
0.582
MI (modified ARC)
1.2% (2/161)
2.9% (10/346)
0.252
TVR
0.0% (0/161)
0.6% (2/346)
0.332
Thrombosis
0.6% (1/161)
1.2% (4/346)
0.556
Dissection (grade C or greater)
4.9% (8/161)
2.9% (10/346)
0.245
Distal embolization
0.6% (1/161)
0.9% (3/346)
0.767
Perforation at the level of the filter
0.0% (0/161)
0.0% (0/346)
N/A
Unplanned amputation
0.0% (0/161)
0.0% (0/346)
N/A
aBy the Newcombe score method. ARC, academic research consortium; MAE, major adverse event; MI, myocardial infarction; TVR, target vessel revascularization.