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