Leaving Nothing Behind: Expanding the Clinical Frontiers of Drug-Coated Balloon Angioplasty in Coronary Artery Disease
Abstract
:1. Introduction and Rationale
- Complex Lesion Subsets. Bifurcation side branches, long diffuse segments, and heavily calcified disease often pose increased technical and clinical risks for stenting. DCBs may simplify the procedure and reduce future reintervention complexity [1].
2. Methods
3. Procedural Considerations for Optimal Drug-Coated Balloon Angioplasty
4. Clinical Applications of Drug-Coated Balloons: Lesion-Specific Evidence
4.1. Small-Vessel Disease
4.2. In-Stent Restenosis
4.3. Bifurcation Lesions
4.4. Diffuse Coronary Artery Disease
4.5. Chronic Total Occlusions (CTOs)
Lesion Type | Study | Design | No. of Patients | Primary Endpoint | Follow-Up | Main Findings |
---|---|---|---|---|---|---|
Small-vessel disease | Basket Small-2 [15,18] | RCT | 758 | MACEs (CV death, MI, TVR) | 12 months | DCB non-inferior to DES (7.5% vs. 7.3%, p = 0.918) |
Piccoleto Ii [8] | RCT | 232 | LLL, MACEs | 12 months | Superior to DES (0.04 vs. 0.17 mm, p = 0.03) | |
Restore Svd China [19] | RCT | 230 | Diameter stenosis, TLF | 24 months | DCB and DES comparable | |
In-stent restenosis | Ribs Iv [22] | RCT | 309 | In-segment LLL, TLR, MACEs | 36 months | Superior to POBA, comparable to DES |
Isar-Desire 3 [21] | RCT | 402 | Diameter stenosis (%), TLR, MI | 36 months | Comparable to DES, superior to POBA | |
Bifurcation lesions | Pepcad-Bif [32] | RCT | 64 | Angiographic LLL, TLR | 9 months | DCB superior vs. POBA (0.13 vs. 0.51 mm, p = 0.013) |
Debside [33] | Observational | 52 | TLR | 12 months | Effective side-branch treatment, TLR 7.7% | |
Hyper [34] | Observational | 210 | MACEs (CV death, MI), TLR | 12 months | Hybrid strategy effective, low TLR (5.5%) | |
Diffuse coronary lesions | Spartan [39] | Observational | 1517 | All-cause mortality | NR | Similar mortality to DES |
Leone et al. [40] | Observational | 93 | MACEs (CV death, MI), TLR | 12 months | High procedural success, low TLR (5.8%) | |
Costopoulos et al. [38] | Observational | 212 | MACEs (CV death, MI), TLR | 12 months | Outcomes comparable to DES, less stenting | |
Xu et al. [41] | Observational | 109 | MACEs, TLR | 12 months | Hybrid approach effective, low TLR | |
Chronic total occlusions | Koln et al. [43] | Observational | 34 | MACEs (CV death, MI), TLR | 9 months | Safe, low MACE rate (11.8%), feasible |
Wang et al. [44] | RCT | 591 | Angiographic LLL, MACEs | 3 years | Less LLL in DCB, comparable restenosis and MACEs |
5. Special Populations and Clinical Settings
5.1. High Bleeding Risk (HBR)
5.2. Acute Coronary Syndromes (ACSs)
5.3. Diabetes Mellitus
Clinical Setting | Study | Design | No. of Patients | Primary Endpoint | Follow-Up | Main Findings |
---|---|---|---|---|---|---|
High bleeding risk | Debut [11] | RCT | 208 | MACEs (CV death, MI, TLR) | 12 months | DCB superior to BMS (1% vs. 14%, p < 0.001) |
Panelux [12] | Observational | 432 | TLF, CV death, MI, TLR | 12 months | Low TLF (5.6%), safe short DAPT duration (median 33 days) | |
Ultimate Iii [48] | RCT | 448 | In-segment LLL | 7 month | IVUS-guided DCB superior to angiography-guided | |
Uskela et al. [47] | Observational | 301 | MACEs, BARC 2–5 bleeding | 12 months | Low TLR (1.4–2.8%), acceptable bleeding rate (5.9%) | |
Rasanen et al. [10] | Observational | 114 | TLR, bleeding | 12 months | Low TLR (0–3%), acceptable bleeding with SAPT (10.5%) | |
Diabetes mellitus | BASKET-SMALL 2 (DM Substudy) [56] | RCT (subanalysis) | 263 | MACEs (CV death, MI, TLR) | 12 months | DCB comparable vs. DES (10.1% vs. 13.7%, p = 0.52) |
PICCOLETO II (DM Substudy) [57] | RCT (subanalysis) | 232 | MACEs, TLR | 36 month | Low TLR rates similar to DES, sustained benefit | |
RESTORE SVD China (DM Substudy) [19] | RCT (subanalysis) | 230 | In-segment LLL, TLR | 9 months | Comparable outcomes for DCB vs. DES (12% vs. 11.1%) | |
EASTBOURNE (DM Substudy) [58] | Observational | 424 | MACEs, TLR | 12 months | Low TLR (3.6%), favorable MACE (6.5%) | |
EASTBOURNE-BIF (DM Substudy) [60] | Observational | 210 | MACEs, TLR | 12 months | Effective in bifurcation lesions, low TLR (4.5%) | |
Acute Coronary Syndrome (NSTEMI) | Pepcad Nstemi [51] | RCT | 210 | LLL | 9 months | DCB non-inferior to DES |
Besic et al. [52] | Observational | 120 | Restenosis rate, TLR | 12 months | Lower TLR (4.5% DCB + BMS vs. 7.9% BMS alone, p = 0.29) | |
Acute Coronary syndrome (STEMI) | Deb-Ami [50] | RCT | 150 | LLL | 6 months | DES superior angiographically, similar clinical outcomes |
Pappa [53] | Observational | 100 | MACEs (CV death, MI) | 6 months | Feasible DCB-only STEMI, low MACE rate (5%) | |
Merinopoulos et al. [54] | Observational | 1139 | TLR, MACEs | 12 months | Comparable TLR and MACEs for DCB vs. DES (7.0% vs. 6.8%) |
6. Future Perspectives and Conclusions
Funding
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
ACS | Acute Coronary Syndromes |
BMS | Bare-Metal Stent |
CAD | Coronary Artery Disease |
CTO | Chronic Total Occlusion |
DAPT | Dual Antiplatelet Therapy |
DCB | Drug-Coated Balloon |
DEB | Drug-Eluting Balloon |
DES | Drug-Eluting Stent |
DM | Diabetes Mellitus |
HBR | High Bleeding Risk |
ISR | In-Stent Restenosis |
IVUS | Intravascular Ultrasound |
LLL | Late Lumen Loss |
MACE | Major Adverse Cardiovascular Event |
NSTEMI | Non-ST Elevated Myocardial Infarction |
NCB | Non-compliant Balloon |
OCT | Optical Coherence Tomography |
PCB | Paclitaxel-Coated Balloon |
PCI | Percutaneous Coronary Intervention |
RCT | Randomized Controlled Trial |
SAPT | Single Antiplatelet Therapy |
SCB | Sirolimus-Coated Balloon |
STEMI | ST-Elevated Myocardial Infarction |
SVD | Small-Vessel Disease |
TLF | Target Lesion Failure |
TLR | Target Lesion Revascularization |
TVR | Target Vessel Revascularization |
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Marchetta, M.; Sasso, S.; Paragliola, V.; Maffi, V.; Chiricolo, G.; Massaro, G.; Russo, G.; Benedetto, D.; Muscoli, S.; Colonna, G.; et al. Leaving Nothing Behind: Expanding the Clinical Frontiers of Drug-Coated Balloon Angioplasty in Coronary Artery Disease. J. Cardiovasc. Dev. Dis. 2025, 12, 176. https://doi.org/10.3390/jcdd12050176
Marchetta M, Sasso S, Paragliola V, Maffi V, Chiricolo G, Massaro G, Russo G, Benedetto D, Muscoli S, Colonna G, et al. Leaving Nothing Behind: Expanding the Clinical Frontiers of Drug-Coated Balloon Angioplasty in Coronary Artery Disease. Journal of Cardiovascular Development and Disease. 2025; 12(5):176. https://doi.org/10.3390/jcdd12050176
Chicago/Turabian StyleMarchetta, Marcello, Stefano Sasso, Vincenzo Paragliola, Valerio Maffi, Gaetano Chiricolo, Gianluca Massaro, Giulio Russo, Daniela Benedetto, Saverio Muscoli, Giuseppe Colonna, and et al. 2025. "Leaving Nothing Behind: Expanding the Clinical Frontiers of Drug-Coated Balloon Angioplasty in Coronary Artery Disease" Journal of Cardiovascular Development and Disease 12, no. 5: 176. https://doi.org/10.3390/jcdd12050176
APA StyleMarchetta, M., Sasso, S., Paragliola, V., Maffi, V., Chiricolo, G., Massaro, G., Russo, G., Benedetto, D., Muscoli, S., Colonna, G., Mirizzi, A. M., Cortese, B., Sangiorgi, G. M., & Andò, G. (2025). Leaving Nothing Behind: Expanding the Clinical Frontiers of Drug-Coated Balloon Angioplasty in Coronary Artery Disease. Journal of Cardiovascular Development and Disease, 12(5), 176. https://doi.org/10.3390/jcdd12050176