Clinical application and expansion of paclitaxel-coated balloons in coronary atherosclerotic disease

Table 1 Clinical research on drug - coated balloon angioplasty for coronary small vessel disease

Trial	Intervention	Primary end point	Secondary end point	Follow-up time	TLR/TVR	MACE	LLL
RCT; RVD: < 3.0[9], 2024	DCB: 1133; DES: 1139	A DoCE (a composite of cardiovascular death, TV-MI, and CPI-TLR)	The rates of DoCE at 1 month and 12 months; rates of the individual components of the DoCE (i.e., cardiovascular death, TV-MI, CPI-TLR)	2 years	CPI-TLR: DCB vs DES; 3.1% vs 1.2%; P = 0.0021. CPI-TVR: DCB vs DES; 3.3% vs 1.6%, P = 0.0084	At 24 months, the DoCE occurred in 72 (6.4%) in the DCB group and 38 (3.4%) in the DES group	NR
RCT; RVD: 2-2.75[55], 2023	DCB: 118; DES: 114	The angiographic in-lesion LLL	Angiographic success and the absence of in-hospital cardiovascular complications, and MACEs, a composite of cardiac death, all MIs, TLR, and the individual components of MACEs at 1 year and 3 years	3 years	DCB vs DES; 8.8% vs 14.8%; P = 0.18	MACE: PCB vs PES; 10.8% vs 20.8%	The DCB vs the DES in terms of in-lesion LLL (0.04 ± 0.28 mm vs 0.17 ± 0.39 mm)
RCT; RVD ≤ 2.8[57], 2020	PCB: 90; POBA: 45	TVF	TLR and LLL	2 years	No significant difference in TVF	NR	The PCB vs the POBA in terms of in-lesion LLL (0.01 ± 0.31 mm vs 0.32 ± 0.34 mm)
RCT; RVD < 3[58], 2022	DCB: 546; DES: 212	MACEs	All-cause death, probable or definite stent thrombosis	3 years	1 year: No significant difference between DCB and DES; 3 years: Similar major adverse cardiac event rates	The consistently lower rates of MACE and its components in DCB	NR
RCT; RVD < 2.8[59], 2025	PCB: 90; PES: 92	Angiographic in-stent (or in-balloon) late lumen loss at follow-up angiography at 6 months	MACE	3 years	1100 days; TLR: PCB vs PES; 6.7% vs 13%, P = 0.14; TVR: PCB vs PES; 3.3% vs 6.5%, P = 0.32	1100 days; MACE: PCB vs PES; 14.4% vs 30.4%, P = 0.015	NR

RVD: Reference vessel diameter (mm); RCT: Randomized controlled trial; DES: Drug-eluting stents; DCB: Paclitaxel-coated balloon angioplasty; PCB: Paclitaxel-coated balloon; PES: Paclitaxel-eluting stents; POBA: Plain old balloon angioplasty; TV-MI: Target vessel myocardial infarction; MIs: Myocardial infarctions; CPI-TLR: Clinically and physiologically indicated target lesion revascularisation; DoCE: Device-oriented composite endpoint, including cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularisation; TVF: Target vessel failure; TLR: Target lesion revascularization; TVR: Target vessel revascularisation; LLL: Late lumen loss; MACEs: Major adverse cardiac events; NR: Not report.

Table 2  Clinical research on drug-coated balloon angioplasty for coronary large vessel disease

Trial	Intervention	Primary end point	Secondary end point	Follow-up time	TLR/TVR	MACE	LLL	DAPT
RCT; RVD: 3.08 ± 0.48[65], 2016	DCB: 27; DES: 33	TLR; LLL	NR	8-month	8-month, TLR: DCB vs DES 0% vs 6.1%, P = 0.193; TVR: NR	8-month, MACE: None of the patients in the LVD; group experienced MACE	8-month, LLL: DCB vs DES; 0.25 ± 0.25 mm vs 0.37 ± 0.40 mm, P = 0.185	NR
RCT; RVD: > 3.0[12], 2023	DCB: 544; DES: 693	All-cause mortality	Cardiovascular mortality, ACS, stroke or transient ischaemic attack, major bleeding and TLR	Median follow-up: DCB: 3.7 years DES: 3.6 years	DCB-only strategy has no increased all-cause mortality or any other major cardiovascular endpoints, including unplanned TLR, compared to DES	DCB-only angioplastyis safe compared to DES as part of routine clinical practice, in terms of all-cause mortality and MACE	NR	NR
RCT; RVD: 2.5-4.0[66], 2022	DCB: 108; DES: 108	TLR	MACE, cardiac death, TVMI, and vessel thrombosis	2 years	24-month, TLR: DCB vs DES 4.9% vs 16.33%, P = 0.008; TVR: NR	24-month, MACE: DCB vs DES 7.84% vs 19.39%, P = 0.01718	NR	NR
SCRS; RVD: ≥ 2.8[67], 2019	LVD: 200; SVD: 327	The efficacy and safety of DCB in the treatment of de novo lesions in large blood vessels	Indices related to the complexity of lesion preparation; LLL, TLR	Mean follow-up duration was 10.1 months	10.1-month, TLR/TVR: LVD vs SVD; 0% vs 0.30%	10.1-month, MACE: LVD vs SVD; 0% vs 1.40%	10.1-month, LLL: LVD vs SVD-0.17 ± 0.62 mm vs -0.17 ± 0.43 mm, P = 0.993	DCB-only therapy without stenting confers; the additional advantage of safety without the need for prolonged; DAPT
SCRS; RVD: > 2.75[68], 2024	DCB: 708; DES: 704	CD-TLR	All-cause mortality, major bleeding, MACE	24 months	CD-TLR: DCB vs DES: 5.5% vs 3.1%, P = 0.028	MACE: DCB vs DES: 7.6% vs 5.7%, P = 0.143	NR	NR
SCRS; RVD: > 2.75[69], 2023	PCB: 73; DES: 81	TLF	Angiographic restenosis	PCB: 1536 ± 538 days; DES: 1344 days ± 606 days	TLF: PCB vs DES; 6.8% vs 14.6%, P = 0.097	NR	NR	NR

Angiographic restenosis: Defined as a follow-up percent diameter stenosis > 50; LVD: Large vessel diameter; SVD: Small vessel diameter; DAPT: Double anti-platelet therapy; CD: Cardiac death; CD-TLR: Clinically driven target lesion revascularization; TLF: Target lesion failure; ACS: Acute coronary syndrome; SCRS: Single-center retrospective study; RVD: Reference vessel diameter (mm); RCT: Randomized controlled trial; DES: Drug-eluting stents; DCB: Paclitaxel-coated balloon angioplasty; PCB: Paclitaxel-coated balloon; PES: Paclitaxel-eluting stents; POBA: Plain old balloon angioplasty; TV-MI: Target vessel myocardial infarction; MIs: Myocardial infarctions; CPI-TLR: Clinically and physiologically indicated target lesion revascularisation; DoCE: Device-oriented composite endpoint, including cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularisation; TVF: Target vessel failure; TLR: Target lesion revascularization; TVR: Target vessel revascularisation; LLL: Late lumen loss; MACE: Major adverse cardiac events; NR: Not report.