Table 3.
Clinical trials of Mg-based stents.
| Device | Stent design | Trial | Clinical outcomes | Refs |
|---|---|---|---|---|
| AMS | Coating: None; Drug: None | Preliminary study for AMS INSIGHT: 3-months follow up of 20 patients with CLI received AMS in infrapopliteal arteries | Stenosis rate: 10.5% at 1 month and 31.6% at 3 months; Limb Salvage Rate: 100% | [88] |
| AMS | Coating: None; Drug: None | Preliminary study for AMS INSIGHT: up to 12 months | Significant restenosis in 3 patients after 85, 107, and 181 days respectively; Limb Salvage Rate: 95% | [89] |
| AMS | Coating: None; Drug: None | AMS INSIGHT: Follow up 74 patients with CLI received AMS in infrapopliteal arteries and 75 patients with CLI after PTA for 6 months | Binary restenosis rate: 68.2% in AMS group and 42% in PTA group; LLL: 0.4 ± 0.8a) mm in AMS group and 0.7 ± 0.7 mm in PTA group; Limb Salvage Rate: 97% in AMS group and 96% in PTA group | [90] |
| AMS | Coating: None; Drug: None | PROGRESS AMS: Follow up 63 patients with lesions of 50–99% stenosis for 12 months | ST: 0; LLL: 1.08 ± 0.49 mm at 4 months; TLF: 23.8% at 4 months and 27% at 12 months; ISR: 47.5% at 4 months | [91] |
| AMS | Coating: None; Drug: None | Follow up 8 patients from PROGRESS AMS up to 28 months | ST: 0; LLL: 0.1 (−0.4 to 0.9)b) mm; In-stent diameter stenosis: 24.5% (11%–44%) | [39] |
| DREAMS (Biotronik) | Coating: PLGA; Drug: Paclitaxel | BIOSOLVE-I: Follow up 46 patients with lesions of 50–99% stenosis for 12 months | ST: 0; LLL: 0.65 ± 0.50 mm at 6 months and 0.52 ± 0.39 mm at 12 months; TLF: 4% at 6 months and 7% at 12 months; Lumen area stenosis: 43.38% at 6 months and 46.10% at 12 months; Neointimal hyperplasia area: 0.30 ± 0.41 mm2 at 6 months and 0.40 ± 0.32 mm2 at 12 months | [93] |
| DREAMS | Coating: PLGA; Drug: Paclitaxel | BIOSOLVE-1: 3-years follow up | ST: 0; LLL: 0.51 ± 0.46 mm at 12 months to 0.32 ± 0.32 mm at 28 ± 4 months(n = 7); TLF: no additional TLFs at 3-years follow up | [94] |
| DREAMS 2G (Biotronik) | Coating: PLLA; Drug: Sirolimus | BIOSOLVE-2: Follow up 123 patients with 50–99% stenosis for 6 months | ST: 0; LLL: 0.44 ± 0.36 mm; TLF: 3.3%; Neointimal hyperplasia area: 0.08 ± 0.09 mm2; Diameter stenosis in stent: 22.6 ± 12.9 mm | [95] |
| DREAMS 2G | Coating: PLLA; Drug: Sirolimus | BIOSOLVE-2: 12-months follow up | ST: 0; LLL: 0.37 ± 0.25 mm at 6 months to 0.39 ± 0.27 mm at 12 months (n = 42); TLF: no additional TLFs at 12-months follow up; Diameter stenosis in stent: 19.6 ± 8.4 mm at 6 months to 20.4 ± 8.6 mm at 12 months(n = 42) | [96] |
| DREAMS 2G | Coating: PLLA; Drug: Sirolimus | BIOSOLVE-2: In vivo serial invasive imaging of DREAMS 2G up to 12-months | OCT results: Mean lumen area: 6.34 ± 1.86 mm2 at 6 months (n = 65) and 6.46 ± 1.72 mm2 at 12 months (n = 25); Minimum lumen area: 4.53 ± 1.69 mm2 at 6 months (n = 65) and 4.81 ± 1.48 mm2 at 12 months (n = 25); IVUS results: 6.57 ± 1.40 mm2 at 6 months and 6.45 ± 1.28 mm2 at 12 months |
[97] |
| DREAMS 2G | Coating: PLLA; Drug: Sirolimus | BIOSOLVE-2: 3-years follow up | ST: 0; LLL: 0.39 ± 0.27 mm at 12 months to 0.54 ± 0.38 mm at 36 months; TLF: 6.8% at 36 months; Diameter stenosis: 3.8 ± 10.1% at 12 months and 4.1 ± 10.2% at 36 months (n = 25, angiographic) | [98] |
| Magmaris (Biotronik) | Coating: PLLA; Drug: Sirolimus | BIOSOLVE-3: Follow up 61 patients with lesions of 50–99% stenosis for 12 months | ST: 0; LLL: 0.39 ± 0.39 mm; TLF: 3.3% at 6 and 12 months | [99] |
| Magmaris | Coating: PLLA; Drug: Sirolimus | BIOSOLVE-3: 24-months follow up | ST: 0; TLF: 5.9% at 24 months | [100] |
| Magmaris | Coating: PLLA; Drug: Sirolimus | Preliminary study for MAGSTEMI: Follow up 20 patients with STEMI for 59–326 days | TLF: 5% at 102 days | [103] |
| Magmaris | Coating: PLLA; Drug: Sirolimus | MAGSTEMI: Follow up 74 patients treated with Magmaris and 76 patients treated with Orsiro for 12 months | In stent acute gain: 2.30 ± 0.48 mm (Magmaris) and 2.49 ± 0.48 mm (Orsiro); LLL: 0.61 ± 0.55 mm (Magmaris) and 0.06 ± 0.21 mm (Orsiro); In stent diameter stenosis rate: 30.3 ± 19.7% (Magmaris) and 7.7 ± 7.2% (Orsiro) |
[104] |
| Magmaris | Coating: PLLA; Drug: Sirolimus | BIOSOLVE-4: First cohort of 1075 patients with 1121 lesions | ST: 0.5% at 6 months and 12 months; TLF: 2.7% at 6 months and 4.3% at 12 months | [105] |
| Magmaris | Coating: PLLA; Drug: Sirolimus | BIOSOLVE-4: Second cohort of 2054 with simple lesions | Still in progress | [106] |
a)
Values are mean ± SD.
b)
Values are median (range).