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Copyright ©The Author(s) 2019.
World J Cardiol. Jan 26, 2019; 11(1): 13-23
Published online Jan 26, 2019. doi: 10.4330/wjc.v11.i1.13
Table 1 Assessment of amputation risk: wound (W), ischemia (I) and foot infection classification[6,7]
ComponentScoreDescription
W0No ulcer (ischemic rest pain)
1Small, shallow ulcer on distal leg or foot without gangrene
2Deeper ulcer with exposed bone, joint or tendon ± gangrenous changes limited to toes
3Extensive deep ulcer, full thickness heel ulcer ± calcaneal involvement ± extensive gangrene
IABIAnkle pressure (mmHg)Toe pressure or TcPO2
0≥ 0.80> 100≥ 60
10.6-0.7970-10040-59
20.4-0.5950-7030-39
3< 0.40< 50< 30
FI0No symptoms or signs of infection
1Local infection involving only skin and subcutaneous tissue
2Local infection involving deeper than skin/subcutaneous tissue
3Systemic inflammatory response syndrome
Table 2 Summary of randomized controlled trials investigating infrapopliteal drug-eluting technologies
TrialStudy designPatientsFollow-upCLILesion length (cm)Primary endpoints
DESFalkowski et al[25], 2009Single-centre BMS vs SES50 patients (25 vs 25)6 mo32%1.8 ± 2.4LLL: 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], 2012Multicentre PTA vs SES200 patients (101 vs 99)1 yr39%both 2.7 ± 2.11-yr in-segment binary restenosis by quantitative angiography: SES 22.4% vs PTA 41.9%, P = 0.019
Below Tepe et al[39], 2010Single-centre SES BMS vs PTA63 limbs (4-arm trial; PTA pooled)6 mo100%3.4 ± 0.36-mo restenosis: SES 9%, BMS 67% and PTA 75%
YUKON-BTX Rastan et al[26], 2012Multicentre BMS vs non-polymer SES161 patients (79 vs 82)3 yr46.60%3.1 ± 0.9Event-free survival: 65.8% SES vs 44.6% BMS; P = 0.02
DESTINY Bosiers et al[27], 2012Multicentre BMS vs Everolimus stent140 patients (66 vs 74)1 yr100%1.7 ± 1.0Angiographic primary patency: 85% DES vs 54% BMS; P = 0.0001
PADI van Overhagen et al[31], 2017Multicentre PTA vs PES137 patients (64 vs 73)5 yr100%2.2 ± 2.0Major 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
PCBDEBATE-BTK Liistro et al[45], 2013Single-centre PTA vs PCB132 patients (67 vs 65)1 yr100%13.0 ± 8.0
IN.PACT DEEP Zeller et al[46], 2014Multicentre PTA vs PCB358 patients (119 vs 239)1 yr99.70%11.1 ± 9.0TLR: 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], 2015Multicentre PTA vs PCB72 patients (36 vs 36)1 yr77.80%11.4 ± 8.76 mo patency loss: 17.1% PCB vs 26.1% PTA; P = 0.298
IDEAS Siablis et al[52], 2014Single-centre PCB vs DES50 patients (25 vs 25)6 mo100%DES 12.7 ± 4.6Angiographic binary restenosis: DES 28% vs 57.9% in PCB; P = 0.0457
PCB 14.8 ± 5.6