Table 3.
Studies evaluating the mid- to long-term performance of bioresorbable scaffolds in below-the-knee arterial disease.
| Trial (year) | Study design | Drug coating | Lesion length, mm | Limbs (n) | Lesions (n) | Primary patency, % | Limb salvage, % | ||||||
| 3 m | 6 m | 1 y | 3 y | 3 m | 6 m | 1 y | 3 y | ||||||
| Bosiers (2005) [61, 96] | Prospective case series | Magnesium alloy | 11 (2–20) | 20 | 20 | 89.5 | - | 73.3 | - | 100.0 | - | 94.7 | - |
| Bosiers (2009) [97] | Prospective case series | Magnesium alloy | 10.6 4.9 | 59 | 72 | - | 31.8 | - | - | 93.2 | 87.6 | - | - |
| Stabile (2016) [99] | Retrospective registry | Biolimus | 23.5 9.4 | 30 | - | 93.4 | - | - | 96.7 | - | |||
| Varcoe (2016) [63, 98] | Prospective case series | Everolimus | 19.2 (5–50) | 38 | 43 | - | 96.0 | 96.0 | 87.3 | - | 100.0 | 100.0 | 100.0 |
| Dia (2019) [100] | Retrospective case series | Everolimus | 30.9 (10–60) | 31 | - | - | - | 96.7 | - | - | - | 96.8 | - |
| Parikh (2019) [106] | Prospective case series | Sirolimus | 56 | 30 | - | - | - | 88.9 | - | - | - | - | - |
| Kum (2019) [101] | Retrospective case series | Everolimus | 22.7 17.2 | 41 | 53 | - | 95.0 | 86.0 | - | - | 93.0 | 85.0 | - |
| Huizing (2021) [102] | Pooled analysis | Everolimus | 21 (15–30) | 121 | 161 | 97.3 | 91.7 | 86.6 (2 y) | - | - | - | - | |
| Varcoe (2023) [103] | Prospective case series | Everolimus | 43.8 31.8 | 173 | 179 | - | - | 79.7 | - | - | 98.8 | 97.7 | - |
| Bosiers (2023) [104, 105] | Prospective case series | Sirolimus | 29.5 (5–100) | 60 | - | - | 90 | 88.3 | - | - | 97.0 | 95.0 | - |
| Brodmann (2023) [107] | Prospective case series | Sirolimus | 31.9 13.9 | 30 | 31 | - | 83.3 | - | - | - | 100 | - | - |
n, the number of people; m, month; y, year. Lesion length is represented in two ways: either as the mean value standard deviation (mean SD) or as the median value with the 25th percentile subtracted from the 75th percentile (mean (Q25–Q75)).