Table 2.

Events adjudicated by the Clinical Events Committee through 24 months^a

	Eluvia (n = 56)	Zilver PTX (n = 28)	Difference [95% CI]	pb
All deaths	5.6% (3/54)	11.1% (3/27)	− 5.6% [− 18.9%, 7.8%]	0.39
Target lesion revascularizationc	5.6% (3/54)	18.5% (5/27)	− 13.0% [− 28.8%, 2.9%]	0.11
Target limb amputation	0.0% (0/54)	3.7% (1/27)	− 3.7% [− 10.8%, 3.4%]	0.33
Stent thrombosis	1.9% (1/54)	0.0% (0/27)	1.9% [− 1.7%, 5.4%]	1.00

^aThe CEC-adjudicated denominator is based on 1) subjects with CEC-adjudicated events (i.e., any death, target lesion/vessel revascularization, target limb amputation, stent thrombosis) through 24 months and 2) subjects with no events but their follow-up time reach on (or beyond) the earliest visit window

^bP values from 2-sided Fisher’s exact test

^cAll target lesion revascularizations met the criteria for “clinically driven;” i.e., a reintervention within 5 mm proximal or distal to the original treatment segment for angiographic diameter stenosis  ≥ 50% in the presence of recurrent symptoms (i.e., increase in Rutherford class by 1 or more) or ABI decrease of at least 0.15 or 20% in the treated segment