Comparison and Analysis between the NAV6 Embolic Protection Filter and SpiderFX EPD Filter in Superficial Femoral Artery Lesions
Table 6
Subset analysis of event rates by chronic total occlusions in the Emboshield NAV6 group.
% (n/N)
CTO NAV6 (N = 46)
Non-CTO NAV6 (N = 115)
value
CTO SpiderFX (N = 95)
Non-CTO SpiderFX (N = 251)
value
Freedom from MAE
84.8% (39/46)
94.8% (109/115)
0.074
88.4% (84/95)
92.4% (232/251)
0.334
Death
0.0% (0/46)
0.9% (1/115)
0.526
0.0% (0/95)
0.4% (1/251)
0.538
MI (modified ARC)
2.2% (1/46)
0.9% (1/115)
0.113
5.3% (5/95)
2.0% (5/251)
0.105
TVR
0.0% (0/46)
0.0% (0/115)
0.0% (0/95)
0.8% (2/251)
0.383
Thrombosis
0.0% (0/46)
0.9% (1/115)
0.526
0.0% (0/95)
1.6% (4/251)
0.216
Dissection (grade C or greater)
10.9% (5/46)
2.6% (3/115)
0.030
5.3% (5/95)
2.0% (5/251)
0.105
Distal embolization
2.2% (1/46)
0.0% (0/115)
0.113
1.1% (1/95)
0.8% (2/251)
0.819
Perforation at the level of the filter
0.0% (0/46)
0.0% (0/115)
N/A
0.0% (0/95)
0.0% (0/251)
N/A
Unplanned amputation
0.0% (0/46)
0.0% (0/115)
N/A
0.0% (0/95)
0.0% (0/251)
N/A
aBy the Newcombe score method. ARC, Academic Research Consortium; CTO, chronic total occlusion; MAE, major adverse event; MI, myocardial infarction; TVR, target vessel revascularization.
