Current evidence of drug-elution therapy for infrapopliteal arterial disease

Table 1 Assessment of amputation risk: wound (W), ischemia (I) and foot infection classification[6,7]

Component	Score	Description
W	0	No ulcer (ischemic rest pain)
	1	Small, shallow ulcer on distal leg or foot without gangrene
	2	Deeper ulcer with exposed bone, joint or tendon ± gangrenous changes limited to toes
	3	Extensive deep ulcer, full thickness heel ulcer ± calcaneal involvement ± extensive gangrene
I		ABI	Ankle pressure (mmHg)	Toe pressure or TcPO2
	0	≥ 0.80	> 100	≥ 60
	1	0.6-0.79	70-100	40-59
	2	0.4-0.59	50-70	30-39
	3	< 0.40	< 50	< 30
FI	0	No symptoms or signs of infection
	1	Local infection involving only skin and subcutaneous tissue
	2	Local infection involving deeper than skin/subcutaneous tissue
	3	Systemic inflammatory response syndrome

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.