Cardiology Letters 2025, 34(1):18-28
Current role of drug-coated balloons in interventional cardiology
- I. Kardiologická klinika LF UPJŠ a VÚSCH, a. s., Košice, Slovenská republika
The number of coronary artery disease cases has been steadily increasing in recent years, thereby raising the importance of percutaneous coronary intervention as a key therapeutic procedure. Continuous advancements in medical technology are also impacting interventional cardiology. Although drug-coated balloons (DCB) are becoming increasingly popular and are used in a variety of situations, with a growing body of data supporting their efficacy and safety, guidelines have largely overlooked them, with few exceptions. The aim of this article is to provide an overview of the latest knowledge in this field, focusing on the application of DCB in revascularization procedures.
Keywords: coronary stenosis; drug-coated balloons; drug-eluting stents
Published: January 1, 2025 Show citation
References
- Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, et al. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022;145:e4-e17.
Go to original source... - Venkitachalam L, Kip KE, Selzer F, Wilensky RL, Slater J, Mulukutla SR, et al. Twenty-year evolution of percutaneous coronary intervention and its impact on clinical outcomes: a report from the National Heart, Lung, and Blood Institute-sponsored, multicenter 1985-1986 PTCA and 1997-2006 Dynamic Registries. Circ Cardiovasc Interv. 2009;2:6-13.
Go to original source... - Stefanini GG, Byrne RA, Windecker S, Kastrati A. State of the art: coronary artery stents - past, present and future. EuroIntervention. 2017;13:706-716.
Go to original source... - Byrne RA, Joner M, Alfonso F, Kastrati A. Drug-coated balloon therapy in coronary and peripheral artery disease. Nat Rev Cardiol. 2014;11:13-23.
Go to original source... - Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, et al. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020;13:1391-1402.
Go to original source... - Byrne RA, Joner M, Kastrati A. Stent thrombosis and restenosis: what have we learned and where are we going? The Andreas Grüntzig Lecture ESC 2014. Eur Heart J. 2015;36:3320-3331.
Go to original source... - Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, et al. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006;355:2113-2124.
Go to original source... - Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, et al. Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. Clin Res Cardiol. 2008;97:773-781.
Go to original source... - Byrne RA, Neumann FJ, Mehilli J, Pinieck S, Wolff B, Tiroch K, et al. Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial. Lancet. 2013;381:461-467.
Go to original source... - Rittger H, Waliszewski M, Brachmann J, Hohenforst-Schmidt W, Ohlow M, Brugger A, et al. Long-Term Outcomes After Treatment With a Paclitaxel-Coated Balloon Versus Balloon Angioplasty: Insights From the PEPCAD-DES Study (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent Please Paclitaxel-Coated Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter). JACC Cardiovasc Interv. 2015;8:1695-1700.
Go to original source... - Xu B, Gao R, Wang J, Yang Y, Chen S, Liu B, et al. A prospective, multicenter, randomized trial of paclitaxel-coated balloon versus paclitaxel-eluting stent for the treatment of drug-eluting stent in-stent restenosis: results from the PEPCAD China ISR trial. JACC Cardiovasc Interv. 2014;7:204-211.
Go to original source... - Chin K. In-stent restenosis: the gold standard has changed. EuroIntervention. 2011;7(Suppl K):K43-K46.
Go to original source... - Siontis GC, Stefanini GG, Mavridis D, Siontis KC, Alfonso F, PérezVizcayno M, et al. Percutaneous coronary interventional strategies for treatment of in-stent restenosis: a network meta-analysis. Lancet. 2015;386:655-664.
Go to original source... - Giacoppo D, Alfonso F, Xu B, Claessen BEMP, Adriaenssens T, Jensen C, et al. Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stent Implantation in Patients With Coronary Stent Restenosis. J Am Coll Cardiol. 2020;75:2664-2678.
Go to original source... - Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, et al. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024;45:3415-3537.
Go to original source... - Alfonso F, Coughlan JJ, Giacoppo D, Kastrati A, Byrne RA. Management of in-stent restenosis. EuroIntervention. 2022;18:e103-e123.
Go to original source... - Scheller B, Rissanen TT, Farah A, Ohlow MA, Mangner N, Wöhrle J, et al. Drug-Coated Balloon for Small Coronary Artery Disease in Patients With and Without High-Bleeding Risk in the BASKET-SMALL 2 Trial. Circ Cardiovasc Interv. 2022;15:e011569.
Go to original source... - Lazar FL, Onea HL, Olinic DM, Cortese B. A 2024 scientific update on the clinical performance of drug-coated balloons. AsiaIntervention. 2024;10:15-25.
Go to original source... - Wybraniec MT, Bańka P, Bochenek T, Roleder T, Mizia-Stec K. Small vessel coronary artery disease: How small can we go with myocardial revascularization? Cardiol J. 2021;28:767-778.
Go to original source... - Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, et al. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol. 2010;99:165-174.
Go to original source... - Jeger RV, Farah A, Ohlow MA, Shroff A, Wong Y, Ho MY, et al. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018;392:849-856.
Go to original source... - Latib A, Colombo A, Castriota F, De Marco F, Meliga E, De Carlo M, et al. A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study. J Am Coll Cardiol. 2012;60:2473-2480.
Go to original source... - Tian J, Tang YD, Qiao S, Su X, Chen Y, Jin Z, et al. Two-year follow-up of a randomized multicenter study comparing a drug-coated balloon with a drug-eluting stent in native small coronary vessels: The RESTORE Small Vessel Disease China trial. Catheter Cardiovasc Interv. 2020;95(Suppl. 1):587597.
Go to original source... - Cortese B, Di Palma G, Guimaraes MG, Stefanini GG, Siontis KC, Agostoni P, et al. Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial. JACC Cardiovasc Interv. 2020;13:2840-2849.
Go to original source... - Cortese B. The PICCOLETO study and beyond. EuroIntervention. 2011;7(Suppl K):K53-K56.
Go to original source... - Yu X, Ji F, Xu F, Liu Z, Zhong W, Lu J, et al. Treatment of large de novo coronary lesions with paclitaxel-coated balloon only: results from a Chinese institute. Clin Res Cardiol. 2019;108:234-243.
Go to original source... - Shin ES, Ann SH, Balbir Singh G, Lim KH, Kleber FX, Koo BK. Fractional flow reserve-guided paclitaxel-coated balloon treatment for de novo coronary lesions. Catheter Cardiovasc Interv. 2016;88:193-200.
Go to original source... - Lu W, Zhu Y, Han Z, Sun Y, Zhang S, Zhao Q, et al. Short-term outcomes from drug-coated balloon for coronary de novo lesions in large vessels. J Cardiol. 2019;73:151-155.
Go to original source... - Uskela S, Kärkkäinen JM, Eränen J, Rissanen T, Knuuti J, Heikkilä M, et al. Percutaneous coronary intervention with drug-coated balloon-only strategy in stable coronary artery disease and in acute coronary syndromes: An all-comers registry study. Catheter Cardiovasc Interv. 2019;93:893-900.
Go to original source... - Cortese B, Silva Orrego P, Agostoni P, Siontis KC, Stefanini GG, Di Palma G, et al. Effect of Drug-Coated Balloons in Native Coronary Artery Disease Left With a Dissection. JACC Cardiovasc Interv. 2015;8:2003-2009.
Go to original source... - Kumsars I, Holm NR, Niemelä M, Adlam D, Hildick-Smith D, Rasouli M, et al. Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch: the Nordic-Baltic Bifurcation Study IV. Open Heart. 2020;7:e000947.
Go to original source... - Mathey DG, Wendig I, Boxberger M, Bonaventura K, Kleber FX, Scheller B. Treatment of bifurcation lesions with a drug-eluting balloon: the PEPCAD V (Paclitaxel Eluting PTCA Balloon in Coronary Artery Disease) trial. EuroIntervention. 2011;7(Suppl K):K61-K65.
Go to original source... - Kleber FX, Rittger H, Ludwig J, Wolny M, Dietz U, Scheller B. Drug-eluting balloons as stand alone procedure for coronary bifurcational lesions: results of the randomized multicenter PEPCAD-BIF trial. Clin Res Cardiol. 2016;105:613-621.
Go to original source... - Zheng Y, Li J, Wang L, et al. Effect of Drug-Coated Balloon in Side Branch Protection for de novo Coronary Bifurcation Lesions: A Systematic Review and Meta-Analysis. Front Cardiovasc Med. 2021;8:758560.
Go to original source... - Ybarra LF, Rinfret S, Brilakis ES, Karmpaliotis D, Azzalini L, Grantham JA, et al. Definitions and Clinical Trial Design Principles for Coronary Artery Chronic Total Occlusion Therapies: CTO-ARC Consensus Recommendations. Circulation. 2021;143:479-500.
Go to original source... - Werner GS, Martin-Yuste V, Hildick-Smith D, Agostoni P, Collet JP, Siontis GC, et al. A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions. Eur Heart J. 2018;39:2484-2493.
Go to original source... - Schumacher SP, Stuijfzand WJ, de Winter RW, Hooijman J, Berent P, Van Gaal WJ, et al. Ischemic Burden Reduction and Long-Term Clinical Outcomes After Chronic Total Occlusion Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2021;14:1407-1418.
Go to original source... - Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019;40:87-165.
Go to original source... - Yang SS, Tang L, Ge GG, Liu Y, Guo J, Xu J, et al. Efficacy of drugeluting stent for chronic total coronary occlusions at different follow-up duration: a systematic review and meta-analysis. Eur Rev Med Pharmacol Sci. 2015;19:1101-1116.
- Köln PJ, Scheller B, Liew HB, Wüstner J, Demir I, Hoebel M, et al. Treatment of chronic total occlusions in native coronary arteries by drug-coated balloons without stenting - A feasibility and safety study. Catheter Cardiovasc Interv. 2017;90:936-943.
- Jun EJ, Shin ES, Teoh EV, Fajardo M, Kim HS, Egan A, et al. Acute and long-term outcomes of drug-coated balloon treatment of coronary bifurcation lesions. Circ Cardiovasc Interv. 2016;9:e004079.
- Costopoulos C, Latib A, Naganuma T, Kim YH, Waalewijn R, Farah A, et al. One-year outcomes of paclitaxel-coated balloon versus drug-eluting stent for in-stent restenosis: results from the PEPCAD-BIF study. J Am Coll Cardiol. 2018;71:29-39.
- Byrne RA, Rossello X, Coughlan JJ, Wittenberg R, Kienlen S, Tilsed P, et al. Coronary revascularization in stable coronary artery disease: a randomized controlled trial. Lancet. 2021;397:11611172.
- Vos NS, Dirksen MT, Vink MA, van Nooijen FC, Amoroso G, Herrman JPR, et al. Safety and feasibility of a Paclitaxel-eluting balloon angioplasty in Primary Percutaneous coronary intervention in Amsterdam (PAPPA): one-year clinical outcome of a pilot study. EuroIntervention. 2014;10:584-590.
Go to original source... - Belkacemi A, Agostoni P, Nathoe HM, Windecker S, Mattheeuw S, Hermans F, et al. Comparative effectiveness of paclitaxeleluting stents in patients with coronary artery disease: A meta-analysis. JACC Cardiovasc Interv. 2017;10:1019-1030.
- Scheller B, Ohlow MA, Ewen S, Buechner G, Weidinger F, Di Napoli F, et al. Drug-coated balloon angioplasty for coronary artery disease: current status and future perspectives. EuroIntervention. 2018;14:40-49.
- Merinopoulos I, Gunawardena T, Corballis N, Bhalraam U, Gilbert T, Maart C, et al. Paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease in elective clinical practice. Clin Res Cardiol. 2023;112:1186-1193.
Go to original source... - Vos NS, Fagel ND, Amoroso G, Langhans L, Veenstra C, Moll F, et al. Bifurcation lesions: treatment strategy using drug-coated balloons. Heart. 2018;104:1314-1319.
- Tao L. Stepwise dual antiplatelet therapy de-escalation in patients after drug-coated balloon angioplasty (REC-CAGEFREE II trial). Prezentované na EuroPCR 2024. 15. máj 2024. Paríž, Francúzsko.
- Ouriel K, Adelman MA, Rosenfield K, McManus D, Stoica M, Soni H, et al. Revascularization of chronic total occlusion in patients with severe coronary artery disease. J Vasc Interv Radiol. 2021;32:957-963.

