Applications and challenges of paclitaxel- coated balloons beyond coronary atherosclerotic heart disease

Table 1 Comparative efficacy and safety of paclitaxel-coated balloons vs uncoated balloon angioplasty in femoropopliteal and below-the-knee arteries

Clinical trials identifier/Ref.	Target vessel	Sample size (PCBs vs POBA)	Follow-up duration	Primary end point	Efficacy outcomes	Major adverse events rate (%)
Liistro et al[26], 2013	BTK vessel; with: Diabetes; critical limb ischemia (rutherford class ≥ 4), significant stenosis; occlusion > 40 mm)	65 vs 67	12 months	Binary in-segment restenosis (%); 27 vs 75; P < 0.001	Occlusion (%); 17.6 vs 55.4; complete index ulcer healing (%); 86 vs 67; P = 0.01	31 vs 51; P = 0.02; (mainly by a reduction in TLR and better ulcer healing)
Zeller et al[21], 2015	Stenosis; restenosis; occlusion of the infrapopliteal arteries (excluding in-stent restenosis and experiencing claudication or CLI)	36 vs 36	12 months	All-cause mortality, target vessel, amputation, thrombosis, revascularization (30 days) (%); 0% vs 8.3%; P = 0.239	Patency loss (6 months) (%); 17.1 vs 26.1; P = 0.298; major amputations of the target extremity (12 months) (%); 3.3 vs 5.6; P = 0.631	41.1 vs 39.1; P = 0.957
Rosenfield et al[25], 2015	With symptomatic femoropopliteal peripheral artery disease	316 vs 16	12 months	Primary patency of the target lesion (%); 65.2% vs 52.6%, P = 0.02	Primary safety end point	Restenosis without target lesion revascularization (%); 62% vs 62.5%; target lesion revascularization; 38% vs 37.5%
Kinstner et al[22], 2016	ISR of the SFA; P1 segment of the popliteal artery (accompanied by clinical symptoms)	35 vs 39	12 months	Primary patency (%); 40.7 vs 13.4; P = 0.02	Freedom from clinically driven TLR (%); 49.0 vs 22.1	Not mentioned
Iida et al[27], 2019	Superficial femoral; artery; proximal popliteal; artery	68 vs 32	24 months	Primary patency (%); 79.8 vs 46.9; P < 0.001	Free from CD-TLR (%); 90.8 vs 80.3; CD-TLR (%); 9.1 vs 20.7	15.4 vs 24.1; P = 0.384
Teichgräber et al[28], 2020	SFA; the proximal popliteal artery up to the P1 segment (with a lesion length ≤ 15 cm, accompanied by clinical symptoms)	85 vs 86	6 months	LLL after 6 months (mm); 0.14 vs 1.06; P < 0.001	TLR (%); 1.3 vs 17.1%; P < 0.001; restenosis (%); 13.2 vs 31.6; P = 0.011; primary patency (%); 94 vs 75; P < 0.001	Not mentioned
Krishnan et al[29], 2024	Rutherford clinical category 2 to 4 femoropopliteal PAD (accompanied by clinical symptoms)	200 vs 100	60 months	All-cause mortality (%); 20.6 vs 20.2; P = 0.934	Primary patency; TLR (%); 68.2 vs 67.2; P = 0.623	41.0 vs 44.6; P = 0.597

PCBs: Paclitaxel-coated balloons; POBA: Plain old balloon angioplasty; CD-TLR: Clinicallydriven target lesion revascularization; TLR: Target lesion revascularization; SFA: Superficial femoral artery; BTK: Below-the-knee; CLI: Critical limb ischemia; LLL: Late lumen loss; ISR: In-stentrestenosis; SFA: Superficial femoral artery; PAD: Peripheralartery disease.

Table 2 Comparative analysis of the efficacy of paclitaxel-coated balloons angioplasty and conventional balloon angioplasty in the hemodialysis pathway

Clinical trials identifier/Ref.	Study design	Types of pathological coronary vessels	Sample size (PCBs vs POBA)	Follow-up duration	Primary end point	Efficacy outcomes	Major adverse events rate (%)
Irani et al[12], 2018	Prospective Randomized Single-center Clinical Trial	AVF and AVG stenosis	63 vs 62	12 months	Primary patency restenosis rates a (6 months) (%); 34 vs 62.9; P = 0.01	Circuit primary patency (6 months) (%); 76 vs 56; P = 0.048; target lesion primary patency (6 months) (%); 51 vs 34; P = 0.04	Not mentioned
Liao et al[46], 2020	Single-center Prospective Randomized Controlled Trial	Venous anastomotic stenosis in dysfunctional AV grafts	22 vs 22	12 months	Target lesion primary patency (6 months) (%); 41 vs 9; P = 0.006	Circuit primary patency (6 months) (%); 36 vs 9; P = 0.013; target lesion primary patency (6 months) (%); 23 vs 9; P = 0.019	Have no statistical differences
Therasse et al[47], 2021	Prospective, Single-blinded, Randomized Multi-Center Clinical Trial	Dysfunctional arteriovenous fistulae	60 vs 60	12 months	LLL after 6 months (mm) (non-adjusted) (mm); 0.64 ± 1.20 vs 1.13 ± 1.51; P = 0.082	Restenosis rate (6 months) (%); 56.5 vs 81.1%; P = 0.008	53.3 vs 75.0; P = 0.013
Yin et al[48], 2021	Multicenter, Prospective, Randomized, Open-label, Blinded-endpoint, Controlled Trial	Consecutive adult patients with fistula dysfunction	78 vs 83	12 months	Target lesion primary patency (6 months) (%); 65 vs 37; P < 0.001	Target lesion (12 months) (%); 73 vs 58 P = 0.04; target shunt (12 months) (%) 73 vs 57; P = 0.04	41.1 vs 39.1; P = 0.957
Hsieh et al[45], 2023	Prospective, Single-Blinded, Randomised Controlled Study	Stent-graft stenosis in haemodialysis vascular access	20 vs 20	6 months	LLL after 6 months (mm); 1.82 ± 1.83 vs 3.63 ± 1.08; P = 0.001	Primary patency restenosis rates (6 months) (%); 80 vs 42; P = 0.005; circuit primary patency (6 months) (%); 35 vs 15; P = 0.086	Not mentioned
Zhao et al[49], 2024	Prospective, Multicenter, Randomized Controlled Study	Dysfunctional arteriovenous fistulae	122 vs 122	12 months	Primary patency (6 months) (%); 91 vs 67; P < 0.001	Primary patency restenosis rates (12 months) (%); 66 vs 46; P = 0.004	0 vs 2.5; P = 0.3

PCBs: Paclitaxel-coated balloons; POBA: Plain old balloon angioplasty; AV: Arteriovenous; AVF: Arteriovenous fistula; AVG: Arteriovenous graft; LLL: Late lumen loss.