Drug-Coated Balloon Angioplasty and Debulking for the Treatment of Femoropopliteal In-Stent Restenosis: A Systematic Review and Meta-Analysis

Table 1

Characteristics of included trials.

(a)

		Hypertension	DM	CAD	Dyslipidemia	Age,		Male gender	Lesion length, mm	Rutherford class	ISR Tosaka classification	ABI
Ott, I. 2017 ISAR-PEBIS	DCB	33 (92%)	12 (33%)	17 (47%)	35 (97%)		36	67%		Class 2: 1; class 3: 34; class 4: 0; class 5: 1	Class 1: 10; class 2: 13; class 3: 13
	PTA	30 (88%)	12 (35%)	16 (47%)	33 (97%)		34	70%		Class 2: 0; class 3: 33; class 4: 0; class 5: 1	Class 1: 17; class 2: 7; class 3: 10
Kinstner, C. M. 2016 PACUBA	DCB	26 (79%)	17 (52%)	12 (36%)			35	57%		Class 2: 3; class 3: 32	Class 1: 8; class 2: 16; class 3: 11
	PTA	27 (79%)	13 (38%)	14 (41%)			39	59%		Class 2: 8; class 3: 30	Class 1: 2; class 2: 26; class 3: 11
Krankenberg, H. 2015 FAIR	DCB	52 (83.9%)	28 (45.2%)	26 (41.9%)			62	53.2%		Class 2: 27; class 3: 32; class 4: 1; class 5: 2	Class 1: 16; class 2: 32; class 3: 14
	PTA	53 (93.0%)	17 (29.8)	22 (38.6%)			57	70.2%		Class 2: 27; class 3: 24; class 4: 6; class 5: 0	Class 1: 16; class 2: 30; class 3: 11
Dippel, E. J. 2015 EXCITE	LD+PTA	95.8	47.0	64.3			169	62.7%
	PTA	95.8	47.0	68.8			81	61.7%
Liistro, F. 2014 DEBATE-	DCB	39 (88.6%)	44 (100%)	9 (20.5%)			44	72.7%		Class ≥4: 33	Class 1: 7; class 2: 15; class 3: 22
	PTA	38 (90.5%)	42 (100%)	12 (28.6%)			42	54.8%		Class ≥4: 28	Class 1: 6; class 2: 8; class 3: 28

(b)

	Design	Year	Inclusion criteria	Exclusion criteria	Outcome	Follow-up month
Ott, I. 2017	Dual-center, prospective, randomized, active-controlled	2010.4-2013.12	SFA ISR symptomatic ISR >70% or occlusion of SFA at the stented site	Acute ischemia and/or acute thrombosis of the SFA, untreated ipsilateral iliac or popliteal artery stenosis >70%, severe renal insufficiency, life expectancy <1 year, and any contraindication to study medications	Percentage diameter stenosis (DS); binary restenosis rate; TLR; target vessel thrombosis, ipsilateral amputation, or bypass surgery of the affected limb; and all-cause mortality at 24 months	6 and 24
Kinstner, C. M. 2016	Dual- center, prospective, single-blind, randomized	2010.11-2012.12	SFA and popliteal artery ISR; age>50 years; symptomatic ISR >50%	Inability to give written informed consent; known allergy, hypersensitivity, or intolerance to radiologic contrast media, aspirin, clopidogrel or ticlopidine, and paclitaxel; and creatinine >2.5 mg/dl	Primary patency, technical success, TLR; ABI; sustained clinical improvement by ≥1 Rutherford category	6 and 12
Krankenberg, H. 2015	Multicenter, prospective, block-randomized, nonblinded	2010.1-2012.11	SFA ISR of up to 20 cm in length.	Untreated ipsilateral iliac artery stenosis, ongoing dialysis treatment, and treatment with oral anticoagulants other than antiplatelet agents	Binary restenosis rate; primary angiographic success; freedom from TLR; ABI; sustained clinical improvement by ≥1 Rutherford category; major adverse vascular events	6 and 12
Dippel, E. J. 2015	Multicenter, prospective, randomized, controlled	2011.6-2012.2	Femoropopliteal ISR, symptomatic ISR >50%,		Freedom from TLR; TLR; ABI; Rutherford score; all-cause death; amputation	6 and 12
Liistro, F. 2014	Single-site prospective, controlled	2010.1-2011.12	Diabetic patients with ISR of the superficial femoral and proximal popliteal arteries		Binary restenosis rate; TLR, major adverse events	6 and 12

DCB: drug-coated balloon angioplasty; PTA: percutaneous transluminal angioplasty; LD: laser debulking; DM: diabetes mellitus; CAD: coronary artery disease; ISR: in-stent restenosis; ABI: indicates ankle brachial index; SFA: superficial femoral artery.