Introduction
Materials and Methods
Study Population
Assessments and Definitions
Statistical Analysis
Results
Patients
Eluvia (N = 56) | Zilver PTX (N = 28) | p | |
---|---|---|---|
Age (y) | 73.7 ± 7.7 | 74.3 ± 7.3 | 0.71 |
Male | 76.8% (43/56) | 75.0% (21/28) | 0.86 |
Smoking history | |||
Current | 16.1% (9/56) | 25.0% (7/28) | 0.33 |
Previous | 62.5% (35/56) | 60.7% (17/28) | 0.87 |
Medically treated diabetes mellitus | 53.6% (30/56) | 53.6% (15/28) | 1.00 |
ABI | 0.7 ± 0.2 | 0.7 ± 0.2 | 1.00 |
Arterial Segments | |||
Ostial | 1.8% (1/56) | 0.0% (0/28) | 1.00a |
Proximal superficial femoral artery | 17.9% (10/56) | 14.3% (4/28) | 0.77a |
Mid-superficial femoral artery | 71.4% (40/56) | 71.4% (20/28) | 1.00 |
Distal superficial femoral artery or proximal popliteal artery | 50.0% (28/56) | 60.7% (17/28) | 0.35 |
Lesion length (mm) | 91.8 ± 38.0 | 87.4 ± 41.7 | 0.63 |
Reference vessel diameter (mm) | 5.1 ± 0.8 | 5.0 ± 0.7 | 0.49 |
Calcification | |||
None/mild | 39.3% (22/56) | 17.9% (5/28) | 0.05 |
Moderate | 32.1% (18/56) | 50.0% (14/28) | 0.11 |
Severe | 28.6% (16/56) | 32.1% (9/28) | 0.74 |
% Diameter stenosis | 79.9 ± 14.0 | 74.9 ± 14.3 | 0.12 |
50%-99% | 80.4% (45/56) | 82.1% (23/28) | 0.84 |
100% (Occlusion) | 19.6% (11/56) | 17.9% (5/28) | 0.84 |
Safety and Efficacy
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 |
Antiplatelet Medication Use
Clinical Outcomes
Baseline | 1 Month | 6 Months | 12 Months | 24 Months | |
---|---|---|---|---|---|
Eluvia | |||||
Walking impairment | 58.48 ± 32.78 (56) | 92.41 ± 17.79 (56) | 90.63 ± 15.49 (56) | 84.55 ± 21.78 (55) | 77.55 ± 26.64 (49) |
Change from baseline | – | 33.93 ± 34.19 (56) | 32.14 ±34.28 (56) | 25.91 ± 39.95 (55) | 21.43 ± 38.19 (49) |
Pa | – | < .0001 | < .0001 | < .0001 | 0.0003 |
Distance | 58.10 ± 32.16 (56) | 92.14 ± 18.54 (56) | 87.96 ± 24.12 (56) | 84.84 ± 28.98 (55) | 80.54 ± 33.33 (49) |
Change from baseline | – | 34.04 ± 30.12 (56) | 29.86 ± 29.46 (56) | 27.51 ± 32.10 (55) | 23.16 ± 34.65 (49) |
Pa | – | < .0001 | < .0001 | < .0001 | < .0001 |
Speed | 39.62 ± 21.01 (56) | 52.23 ± 25.54 (56) | 50.87 ± 24.27 (56) | 51.42 ± 26.18 (55) | 51.71 ± 31.13 (49) |
Change from baseline | – | 12.62 ± 22.34 (56) | 11.26 ± 23.85 (56) | 11.56 ± 25.35 (55) | 12.91 ± 26.44 (49) |
Pa | – | < .0001 | 0.0008 | 0.0013 | 0.0013 |
Stair climbing | 56.85 ± 32.73 (56) | 74.26 ± 29.17 (56) | 73.44 ± 30.09 (56) | 67.12 ± 33.30 (55) | 72.96 ± 34.23 (49) |
Change from baseline | – | 17.41 ± 29.09 (56) | 16.59 ± 31.73 (56) | 9.54 ± 30.55 (55) | 14.88 ± 33.07 (49) |
Pa | – | < .0001 | 0.0003 | 0.0243 | 0.0028 |
Zilver PTX | |||||
Walking impairment | 58.04 ± 25.51 (28) | 84.82 ± 23.90 (28) | 73.21 ± 32.58 (28) | 71.30 ± 33.76 (27) | 75.00 ± 29.88 (22) |
Change from baseline | – | 26.79 ± 28.81 (28) | 15.18 ± 34.25 (28) | 12.96 ± 35.61 (27) | 17.05 ± 30.26 (22) |
Pa | – | < .0001 | 0.0266 | 0.0697 | 0.0152 |
Distance | 57.68 ± 33.84 (28) | 80.18 ± 24.71 (28) | 71.40 ± 33.91 (28) | 64.33 ± 37.01 (27) | 67.97 ± 39.93 (22) |
Change from baseline | – | 22.50 ± 29.02 (28) | 13.72 ± 27.84 (28) | 4.67 ± 31.61 (27) | 5.69 ± 29.78 (22) |
Pa | – | 0.0003 | 0.0147 | 0.4501 | 0.3803 |
Speed | 37.38 ± 21.36 (28) | 48.10 ± 24.36 (28) | 44.53 ± 27.46 (28) | 43.20 ± 31.52 (27) | 46.39 ± 30.19 (22) |
Change from baseline | – | 10.71 ± 19.57 (28) | 7.14 ± 21.90 (28) | 5.23 ± 26.34 (27) | 5.88 ± 27.36 (22) |
Pa | – | 0.0074 | 0.0958 | 0.3114 | 0.3249 |
Stair climbing | 44.20 ± 33.15 (28) | 56.10 ± 35.49 (28) | 55.66 ± 37.03 (28) | 57.10 ± 40.94 (27) | 63.26 ± 40.14 (22) |
Change from baseline | – | 11.90 ± 30.00 (28) | 11.46 ± 39.29 (28) | 13.58 ± 37.22 (27) | 18.56 ± 35.21 (22) |
Pa | – | 0.0452 | 0.1345 | 0.0692 | 0.0220 |
Eluvia | Zilver PTX | Difference [95% CI] | p | |
---|---|---|---|---|
1 Month | ||||
Mobility | 48.2% (27/56) | 35.7% (10/28) | 12.5% [− 9.6%, 34.6%] | 0.28 |
Self-care | 1.8% (1/56) | 3.6% (1/28) | − 1.8% [− 9.5%, 5.9%] | 1.00a |
Usual activities | 19.6% (11/56) | 35.7% (10/28) | − 16.1% [− 36.6%, 4.5%] | 0.11 |
Pain/discomfort | 44.6% (25/56) | 39.3% (11/28) | 5.4% [− 16.9%, 27.6%] | 0.64 |
Anxiety/depression | 10.7% (6/56) | 17.9% (5/28) | − 7.1% [− 23.5%, 9.2%] | 0.49a |
6 Months | ||||
Mobility | 48.2% (27/56) | 21.4% (6/28) | 26.8% [6.7%, 46.8%] | 0.02 |
Self-care | 1.8% (1/56) | 0.0% (0/28) | 1.8% [− 1.7%, 5.3%] | 1.00a |
Usual activities | 19.6% (11/56) | 32.1% (9/28) | − 12.5% [− 32.7%, 7.7%] | 0.20 |
Pain/discomfort | 41.1% (23/56) | 28.6% (8/28) | 12.5% [− 8.6%, 33.6%] | 0.26 |
Anxiety/depression | 8.9% (5/56) | 21.4% (6/28) | − 12.5% [− 29.4%, 4.4%] | 0.17a |
12 Months | ||||
Mobility | 40.0% (22/55) | 22.2% (6/27) | 17.8% [− 2.6%, 38.1%] | 0.11 |
Self-care | 1.8% (1/55) | 0.0% (0/27) | 1.8% [− 1.7%, 5.3%] | 1.00a |
Usual activities | 20.0% (11/55) | 33.3% (9/27) | − 13.3% [− 34.0%, 7.4%] | 0.19 |
Pain/discomfort | 47.3% (26/55) | 25.9% (7/27) | 21.3% [0.2%, 42.5%] | 0.06 |
Anxiety/depression | 10.9% (6/55) | 11.1% (3/27) | − 0.2% [− 14.6%, 14.2%] | 1.00a |
24 Months | ||||
Mobility | 40.8% (20/49) | 27.3% (6/22) | 13.5% [− 9.6%, 36.7%] | 0.27 |
Self-care | 4.1% (2/49) | 4.5% (1/22) | − 0.5% [− 10.8%, 9.9%] | 1.00a |
Usual activities | 14.3% (7/49) | 31.8% (7/22) | − 17.5% [−39.3%, 4.3%] | 0.11a |
Pain/discomfort | 38.8% (19/49) | 40.9% (9/22) | − 2.1% [− 26.8%, 22.5%] | 0.86 |
Anxiety/depression | 12.2% (6/49) | 18.2% (4/22) | − 5.9% [− 24.5%, 12.6%] | 0.49a |