Table 2.
Summary of randomized controlled trials investigating infrapopliteal drug-eluting technologies
| Trial | Study design | Patients | Follow-up | CLI | Lesion length (cm) | Primary endpoints | |
| DES | Falkowski et al[25], 2009 | Single-centre BMS vs SES | 50 patients (25 vs 25) | 6 mo | 32% | 1.8 ± 2.4 | LLL: SES 0.46 ± 0.72 vs BMS 1.70 ± 0.94 mm; P < 0.001 |
| 6-mo restenosis: SES 16% vs BMS 76%; P < 0.001 | |||||||
| 6-mo TLR: SES 12% vs BMS 14.56%; P < 0.05 | |||||||
| ACHILLES Scheinert et al[28], 2012 | Multicentre PTA vs SES | 200 patients (101 vs 99) | 1 yr | 39% | both 2.7 ± 2.1 | 1-yr in-segment binary restenosis by quantitative angiography: SES 22.4% vs PTA 41.9%, P = 0.019 | |
| Below Tepe et al[39], 2010 | Single-centre SES BMS vs PTA | 63 limbs (4-arm trial; PTA pooled) | 6 mo | 100% | 3.4 ± 0.3 | 6-mo restenosis: SES 9%, BMS 67% and PTA 75% | |
| YUKON-BTX Rastan et al[26], 2012 | Multicentre BMS vs non-polymer SES | 161 patients (79 vs 82) | 3 yr | 46.60% | 3.1 ± 0.9 | Event-free survival: 65.8% SES vs 44.6% BMS; P = 0.02 | |
| DESTINY Bosiers et al[27], 2012 | Multicentre BMS vs Everolimus stent | 140 patients (66 vs 74) | 1 yr | 100% | 1.7 ± 1.0 | Angiographic primary patency: 85% DES vs 54% BMS; P = 0.0001 | |
| PADI van Overhagen et al[31], 2017 | Multicentre PTA vs PES | 137 patients (64 vs 73) | 5 yr | 100% | 2.2 ± 2.0 | Major amputation: DES 19.3% vs 34.0% PTA; P = 0.091 | |
| Amputation-free survival: DES 26.2% vs PTA 15.3%, P = 0.041 | |||||||
| Event-free survival: 31.8% DES vs 20.4% PTA, P = 0.043 | |||||||
| PCB | DEBATE-BTK Liistro et al[45], 2013 | Single-centre PTA vs PCB | 132 patients (67 vs 65) | 1 yr | 100% | 13.0 ± 8.0 | |
| IN.PACT DEEP Zeller et al[46], 2014 | Multicentre PTA vs PCB | 358 patients (119 vs 239) | 1 yr | 99.70% | 11.1 ± 9.0 | TLR: 9.2% PCB vs 13.1% PTA; P = 0.291 | |
| LLL: 0.61 ± 0.78 mm DCB vs 0.62 ± 0.78 mm PTA; P = 0.950 | |||||||
| BIOLUX P-II Zeller et al[47], 2015 | Multicentre PTA vs PCB | 72 patients (36 vs 36) | 1 yr | 77.80% | 11.4 ± 8.7 | 6 mo patency loss: 17.1% PCB vs 26.1% PTA; P = 0.298 | |
| IDEAS Siablis et al[52], 2014 | Single-centre PCB vs DES | 50 patients (25 vs 25) | 6 mo | 100% | DES 12.7 ± 4.6 | Angiographic binary restenosis: DES 28% vs 57.9% in PCB; P = 0.0457 | |
| PCB 14.8 ± 5.6 |
PTA: Percutaneous transluminal angioplasty; CLI: Critical limb ischemia; BMS: Bare metal stent; PCB: Paclitaxel-coated balloon; DES: Drug-eluting stent; PES: Paclitaxel-eluting stent; SES: Sirolimus-eluting stent; TLR: Target lesion revascularization; CLI: Critical leg ischemia; LLL: Late lumen loss.