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Drug-Coated Balloons for Coronary Interventions: A Focused Review Cover

Drug-Coated Balloons for Coronary Interventions: A Focused Review

Methodist DeBakey Cardiovascular Journal
Volume 21 (2025): Issue 4
By: ,   and    
Open Access
|Oct 2025
Figures & tables

Figures & Tables

Figure 1

Drug-coated balloon mechanism of action. Reproduced with permission from Boston Scientific.

Figure 2

Main characteristics and differences between paclitaxel and sirolimus drug-coated balloons. DCB: drug-coated balloon; PCB: paclitaxel-coated balloon; SCB: sirolimus-coated balloon; ISR: in-stent restenosis; MLD: mean lumen diameter

Table 1

Summary of the main randomized clinical trials of the use of DCB in coronary ISR. BMS: bare metal stent; DCB: drug-coated balloon; DES: drug-coated stent; EES: everolimus-eluting stent; LLL: late lumen loss; MACE: major adverse clinical events; MLD: mean lumen diameter; ISR: in-stent restenosis; OCT: optical coherence tomography; PCB: paclitaxel-coated balloon; PES: paclitaxel-eluting stent; POBA: plain old balloon angioplasty; SCB: sirolimus-coated balloon; SES: sirolimus-eluting stent; TLF: target lesion failure; TVR: target vessel revascularization *P-value was not calculated for PES-PCB head-to-head comparison in late lumen loss.

STUDY NAMEYEARARMSnMAIN FINDINGSMAIN CONCLUSION
BMS ISR
PACOCATH ISR I & II242012POBA vs PCB108Angiography (6 months):

  • – LLL: 0.8 ± 0.79 vs 0.11 ± 0.44 (P = .001)

  • – Restenosis: 43% vs 5 % (P = .002)

MACE (5 years): 59% vs 28 % (P = .002)		Treatment of ISR with PCB is safe and consistently reduces repeat revascularization during long-term follow-up.
AGENT IDE252025POBA vs PCB600TLF (2 years): 34 % vs 27% (P = .04)Consistent results were observed at 2-year follow-up, with a significantly reduced instance of TLF.
PEPCAD II262015PES vs PCB131Angiography (6 months):

  • – LLL: 0.38 ± 0.61 vs 0.17 ± 0.42 (P = .032)

  • – Restenosis: 20.3% vs 7 % (P = .006)

Lesion-related MACE (3 years): 18.5% vs 9.1 % (P = .13)		PCB consistently reduced LLL and restenosis compared to PES, indicating stability of the lesions treated.
RIBS V272016EES vs PCB189Angiography (6 months):

  • – LLL: 0.04 ± 0.5 vs 0.14 ± 0.5 (P = .14)

  • – Restenosis: 4.7% vs 9.5 % (P = .22)

MACE (3 years): 10% vs 12 % (P = .64)		EES was associated with superior angiographic effectiveness and reduces the need for target lesion revascularization compared to PCB.
SEDUCE282014EES vs PCB50Angiography (9 months):

  • – LLL: 0.08 ± 0.4 vs 0.16 ± 0.49 (P = .557)

  • – Restenosis: 4.6% vs 9.1 % (P = .550)

Percentage uncovered struts (OCT-9 months): 3.1% vs 1.4% (P = .025)		PCB was associated with better healing characteristics but appeared to be slightly less effective compared to EES.
TIS292016EES vs PCB136Angiography (12 months):

  • – LLL: 0.44 ± 0.73 vs 0.09 ± 044 (P = .0004)

  • – Restenosis: 19.12% vs 8.7% (P = .078)

MACE (1 year): 19.12% vs 10.29 % (P = .213)		Treatment of BMS ISR using PEB was associated with non-inferior angiographic results compared with the implantation of second-generation EES.
DES ISR
PEPCAD-DES302012POBA vs PCB110Angiography (6 months):

  • – LLL: 1.03 ± 0.77 vs 0.43 ± 0.61 (P < .001)

  • – Restenosis: 58.1% vs 17.2% (P = .001)

MACE (3 year): 52.6% vs 20.8 % (P = .001)		Angioplasty with PCB is superior to POBA in DES-ISR.
PEPCAD CHINA ISR312014PES vs PCB220Angiography (9 months):

  • – In-segment LLL: 0.55 ± 0.61 vs 0.46 ± 0.51 (P = .0005)*

  • – In-segment restenosis: 23.8% vs 18.6% (P = .39)

TVR (1 year): 17.5% vs 15.5 % (P = .69)		Angioplasty with DCB was noninferior to DES implantation in terms of angiographic effectiveness.
ISAR DESIRE 3322013PES vs PCB268aAngiography (6-8 months):

  • – LLL: 0.34 ± 0.61 vs 0.37 ± 0.59 (P: N/A)*

  • – Restenosis: 23.9% vs 26.5% (P = .61)

MACE (1 year): 19.3% vs 23.5 % (P = .5)		Angioplasty with DCB was associated with noninferior effectiveness compared with DES implantation.
RIBS IV332015EES vs PCB309Angiography (6-9 months):

  • – LLL: 0.18 ± 0.6 vs 0.3 ± 0.6 (P = .06)

  • – Restenosis: 11% vs 19% (P = .06)

MACE (9 months): 10% vs 18 % (P = .042)		In DES-ISR, EES provided superior long-term clinical and angiographic results compared with DEB.
RESTORE342018EES vs PCB172Angiography (9 months):

  • – In-segment LLL: 0.19 ± 0.41 vs 0.15 ± 0.49 (P = .54)

  • – In-segment restenosis: 5.6% vs 19.5% (P = .65)

MACE (1 year): 4.7% vs 7% (P = .51)		In DES-ISR, both DCB and DES strategies were safe and effective up to 1-year post-procedure, with DES showing superior angiographic results.
Mixed ISR
BIOLUX352018SES vs PCB229Angiography (6 months):

  • – In-stent LLL: 0.2 ± 0.7 vs 0.03 ± 0.4 (P = .4)

  • – In-segment restenosis: N/A

MACE (TLF) (8 months): 18.6% vs 17.9% (P > .99)		In DES or BMS ISR, Angiographic results at 6 months and clinical outcomes up to 18 months post procedure are comparable between DCB and repeat DES groups.
DARE362018EES vs PCB278Angiography (6 months):

  • – In-segment MLD: 1.74 ± 0.61 vs 1.71 ± 0.51 (P < .65)

  • – In-segment restenosis: 20.9% vs 18.1% (P = .6)

MACE (1 year): 9.2% vs 10.5% (P = .66)		In DES or BMS ISR, treatment with DCB is non-inferior to DES in terms of angiographic and clinical end points.
Figure 3

Coronary angiogram images demonstrating treatment of in-stent restenosis (ISR) using a drug-coated balloon (DCB). (A) Pre-treatment image showing 90% ISR in the affected artery. (B) Deployment of a 2.5 × 15 mm AGENT drug-coated balloon, inflated to 6 atm for 60 seconds. (C) Post-treatment image showing complete resolution of ISR with 0% stenosis after DCB intervention.

Figure 4

Drug-coated balloon coronary angioplasty indications.

Figure 5

Central illustration: Drug-coated balloon indication and treatment strategy in coronary artery disease. Adopted from the international DCB consensus group. DCB: drug-coated balloon; DES: drug-eluting stent; FFR: fractional flow reserve; ISR: in-stent restenosis; IVL: Intravascular lithotripsy; IVUS: intravascular ultrasound; NC: non-compliant; OCT: optical coherence tomography; OA: orbital atherectomy; PCI: percutaneous coronary intervention; RA: rotational atherectomy; SC: semi compliant

Table 2

Summary of the main clinical trials of the use of DCB in de novo small vessel coronary artery disease. PCB: paclitaxel-coated balloon; DES: drug coated stent; MACE: major adverse clinical events; DCB: drug coated balloon; LLL: late lumen loss; TLR: target lesion revascularization; BMS: bare metal stent

STUDY NAMEYEARARMSnMAIN FINDINGSMAIN CONCLUSION
PICCOLETO582010PCB vs DES57Angiography (6 months):

  • – % diameter stenosis 43.6% vs 24.3% (P = .029)

  • – Restenosis: 32% vs 10.3 % (P = .043)

MACE (9 months): 35.7% vs 13.8 % (P = .054)		DCB angioplasty exhibited inferior antirestenotic efficacy compared to DES implantation.
BELLO592012PCB vs DES182Angiography (6 months)

  • – LLL: 0.08 ± 0.38 vs 0.29 ± 0.44 mm (P = .001)

  • – Restenosis: 10% vs 14.6% (P = .35)

TLR (2 years): 4.4 % vs 7.6% (P = .37)
MACE (6 months): 10% vs 16.3% (P = .021)		PCB shows lower angiographic late loss with comparable rates of restenosis and revascularization to DES.
BASKET-SMALL 2652018PCB vs DES758Follow-up (12 months):
Lesion-related MACE (12 months): 7.3% vs 7.5 % (P = .918)		PCB demonstrated non-inferiority to DES for MACE up to 12 months and similar event rates among both groups.
RESTORE SVD612018PCB vs DES230Angiography (9 months):

  • – LLL: 29.6 ± 02.0% vs 24.1 ± 2.0% (P for non-inferiority < .001)

TLR (1 year): 4.4% vs 2.6 % (P = .72)		PCB shows comparable clinical effectiveness and safety to DES implantation at 1 year.
PICCOLETO II642020PCB vs DES232Angiography (6 months):

  • – LLL: 0.04 vs 0.17 mm (P for noninferiority = .001)

MACE (12 months): 5.6% vs 7.5% (P = .55)		PCB showed noninferior angiographic effectiveness at 6 months and similar event rates at 1 year.
PEPCAD662013PCB vs BMS120Angiography (6 months)

  • – LLL: 0.32 ± 0.56 mm vs 0.28 ± 0.53 (P = .1)

TLR (1 year) 4.9% vs 28.1% (P < .001)
MACE (12 & 36 months) 6.1% vs 37.5% (P < .001)		PCB demonstrated similar angiographic outcomes to BMS at 6 months with positive clinical outcomes of MACE and TLR at 1 and 3 years.
Figure 6

Coronary angiogram images illustrating treatment of de novo small vessel disease using a drug-coated balloon (DCB). (A) Pre-treatment image showing 90% stenosis proximal segment of the 1st diagonal branch. (B) Deployment of a 2.5 × 15 mm AGENT drug-coated balloon, inflated to 8 atm for 60 seconds. (C) Post-treatment image showing a significant reduction in stenosis to 20% following DCB intervention.

Figure 7

Coronary angiogram images demonstrating treatment of a de novo small vessel disease involving the ostial first diagonal branch with 90% stenosis using a drug-coated balloon (DCB). (A) Pre-treatment image showing 90% stenosis at the ostium of the first diagonal branch. (B) Deployment of a 2.5 × 12 mm AGENT DCB, inflated to 4 atm for 60 seconds. (C) Post-treatment image showing a reduction in stenosis to 30% and improved vessel patency following DCB intervention.

Table 3

Summary of the main clinical trials of the use of DCB in coronary bifurcation lesions. BMS: bare metal stent; MB: main branch; DCB: drug coated balloon; SB: side branch; POBA: plain old balloon angioplasty; DES: drug coated stent; LLL: late lumen loss; MACE: major adverse clinical events; PCB: paclitaxel-coated balloon; TLR: target lesion revascularization

STUDY NAMEYEARARMSnMAIN FINDINGSMAIN CONCLUSION
DEBIUT762012(A) BMS MB/DCB SB
(B) BMS MB/POBA SB
(C) DES MB/POBA SB		117Angiography (6 & 12 months):
LLL proximal MB, distal MB, distal SB (P = .001)
LLL (A): 0.58 ± 0.65, 0.41 ± 0.60, and 0.19 ± 0.66 mm
LLL (B): 0.60 ± 0.65, 0.49 ± 0.85, and 0.21 ± 0.57 mm
LLL (C): 0.13 ± 0.45, 0.19 ± 0.64, and 0.11 ± 0.43 mm
MACE (12 months)- A/B/C: 24.2%, 28.6%, 15% (P = .45)		Pretreatment of both MB and SB with PCB did not demonstrate any angiographic or clinical advantages over conventional BMS when using a provisional T-stenting approach. Additionally, DES showed better angiographic outcomes compared to both PCB and BMS.
PEPCAD-V702011BMS to MB & PCB to SB28Angiography (9 months):
LLL: MB 0.38 ± 0.46, SB 0.21 ± 0.48		Percutaneous treatment of bifurcation lesions with PCB to the SB was 100% successful and showed similar angiographic results to DES at 9 months.
PEPCAD-BIF712016PCB vs POBA of SB64Angiography (9 months):
LLL: 0.13 mm 0.51 mm (P = .013)		PCB is a superior strategy to POBA of side branch vessels in bifurcation lesions.
BIOLUX-1722015DES to MB & PCB to SB35Angiography (9 months):
LLL of SB: 0.10 ± 0.43		DES to the main branch and PCB to the side branch is a safe and effective strategy to treat bifurcation lesions.
BABILON752014(PCB) BMS MB & PCB SB vs (DES) DES MB & POBA SB*108Angiography (9 months):
LLL (MB): PCB 0.31 ± 0.48 mm DES 0.16 ± 0.38 mm (P = .15)
LLL (SB): PCB -0.04 ± 0.76 mm DES -0.03 ± 0.51 mm (P = .983)
MACE (2 years): PCB 17.3% vs DES 7.1% (P = .045)		PCB bifurcation pretreatment with BMS in the MB resulted in higher LLL and more MACE events than everolimus DES, while both strategies had similar outcomes in the SB.
EASTBOURNE-BIF742024DES MB & PCB to SB vs de novo non-bifurcation lesions194Angiography (12 months):
TLR: 4.2% vs 2% (P = .28)
MACE 8.8% vs 5.2% (P = .081)		The use of this DCB, either alone or in combination with drug-eluting stents, could offer a safe and effective alternative to stents for treating bifurcations.

[i] *NOTE: MB pre-dilation with PCB in the BMS MB group

DOI: https://doi.org/10.14797/mdcvj.1607 | Journal eISSN: 1947-6108
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Language: English
Page range: 37 - 53
Submitted on: Apr 4, 2025
Accepted on: Jun 11, 2025
Published on: Oct 1, 2025
Published by: Houston Methodist DeBakey Heart & Vascular Center
In partnership with: Paradigm Publishing Services
Keywords:
drug-coated balloon,
coronary artery disease,
in-stent restenosis,
interventional cardiology,
percutaneous coronary intervention

© 2025 Akash H. Patel, Mark W. Abdelnour, Antonio H. Frangieh, published by Houston Methodist DeBakey Heart & Vascular Center
This work is licensed under the Creative Commons Attribution-NonCommercial 4.0 License.

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