Table 2.
Summary of clinical trials of BDPS.
| Device | Stent design | Trial | Results | Refs |
|---|---|---|---|---|
| Igaki–Tamai | Material: PLLA; Coating: None; Drug: None | Follow up 50 patients with 84 Igaki–Tamai for >10 years | ST: 4%; 1 subacute and 1 very late thrombosis; Survival rates for all-cause death 87%, for cardiac death 98%, for MACEa) 50%; TLRb):16% (1 year), 22% (5 years), and 38% (10 years) | [39] |
| Absorb BVS 1.0 | Material: PLLA; Coating: PDLLAc); Drug: Everolimus | ABSORB Cohort A: Follow up 30 patients with single de novo lesions treated with 30 BVS for 5 years | ST: 0; LLLd): 0.44 ± 0.35 mm; MACE: 3.3% | [33] |
| Absorb BVS 1.1 | Material: PLLA; Coating: PDLLA; Drug: Everolimus | Absorb B1/B2: Follow up 101 patients for 2/3 years | ST:0; LLL: 0.27 ± 0.32 mm; MACE: 6.9% | [40,41] |
| Absorb BVS 1.1 | Material: PLLA; Coating: PDLLA; Drug: Everolimus | Absorb Extend: Follow up 512 patients for 1 year | ST: 0.8%; TLFe): 4.9%; MACE: 4.3% | [42] |
| Absorb BVS 1.1 | Material: PLLA; Coating: PDLLA; Drug: Everolimus | Absorb III: Follow up 1322 patients for 5 years | ST: 1.5%; TLF: 7.8% | [43] |
| Absorb BVS 1.1 | Material: PLLA; Coating: PDLLA; Drug: Everolimus | AIDA: Follow up 895 patients for 2 years | ST: 3.5%; TLF: 11.7% | [44] |
| DeSolve | Material: PLLA; Coating: PLLA; Drug: Novolimus | DESolve Nx: Follow up 126 patients in a multi-center trial for 2 years | ST: 0.8%; TLF: 5.7%; MACE: 5.7% | [45] |
| Fortitude | Material: PLLA; Coating: None; Drug: Sirolimus | FORTITUDE Study: Follow up 63 patients with single de novo coronary artery lesions for 9 months | ST: 0; TLF: 3.3%; MACE: 4.9%; Narrowing in the mean area: 9.1% | [46] |
| Xinsorb | Material: PLLA; Coating: PDLLA; Drug: Sirolimus | Follow up 30 patients with single de novo coronary artery lesions for 6 months | ST: 0; LLL: 0.18 ± 0.21 mm; MACE: 0 | [47] |
| Ideal BioStent | Material: Polylactide anhydride; Coating: Salicylate; Drug: Sirolimus |
WHISPER-trial: Follow up to 11 patients | High neointimal growth | [48] |
| ART18Z | Material: PDLLA; Coating: None; Drug: None | ARTDIVA-trial: Follow up 30 patients with single de novo lesions for 6 months | TLR: 10%; MACE: 0; Angiographic recoil: 4.3%; In-stent diameter stenosis: 12 ± 7% | [42] |
| REVA | Material: PTD-PCf); Coating: None; Drug: None | RESORB: Follow up 27 patients for 6 months | TLR: 66.7%; LLL: 1.81 mm; Leading to the scaffold redesign | [42] |
| ReZolve | Material: PTD-PC; Coating: None; Drug: Sirolimus | RESTORE-study: Follow up 50 patients for 1 year | Acute recoil: 3.8 ± 6.7%; LLL: 0.29 ± 0.33 mm at 12 months; MACE: 16.7% at 6 months | [42] |
| ReZolve2 | Material: PTD-PC; Coating: None; Drug: Sirolimus | RESTORE-II: Follow up 125 patients | Ongoing | [49] |
a)
MACE, major adverse cardiac event.
b)
TLR, target lesion revascularization.
c)
PDLLA, poly-D,L-lactic acid.
d)
LLL, late lumen loss.
e)
TLF, target lesion failure.
f)
PTD-PC, poly-tyrosine-derived polycarbonate.