Coronary Drug-Coated Balloons: Should We Choose a Stentless Approach?

DCB: Stentless Approach?

Authors

DOI:

https://doi.org/10.5281/zenodo.8031627

Keywords:

Coronary artery disease, DCBs, drug-coated balloons, indication, perspective

Abstract

Although drug-eluting stents are still the standard interventional treatment for coronary artery disease, drug-coated balloons (DCBs) represent a novel alternative therapeutic approach in specific anatomic situations. DCBs work by rapidly and uniformly transferring antiproliferative medications into the vessel wall during single balloon inflation using a lipophilic matrix, all without the need for long-term implants. Despite the fact that their usage is well-established for in-stent restenosis of both bare-metal and drug-eluting stents, current randomized trial data show a strong effectiveness and safety profile in de novo small-vessel disease and high bleeding risk. There are also newer signs that are emerging, such as bifurcation lesions, large-vessel disease, diabetes mellitus, and acute coronary syndromes. These expanding indications for DCBs may potentially reduce the reliance on coronary stents or shift towards a stentless perspective.

References

Jeger R V., 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(12):1391-1402. doi:10.1016/J.JCIN.2020.02.043

Laksono S, Setianto B, Surya SP. Drug-eluting balloon: is it useful? Egypt Hear J. 2020;72(1). doi:10.1186/S43044-020-00116-7

Speck U, Stolzenburg N, Peters D, Scheller B. How does a drug-coated balloon work? Overview of coating techniques and their impact. J Cardiovasc Surg (Torino). 2016;57:3-11.

Gao L, Chen YD. Application of drug-coated balloon in coronary artery intervention: challenges and opportunities. J Geriatr Cardiol. 2016;13(11):906. doi:10.11909/J.ISSN.1671-5411.2016.11.005

Kleber FX, Mathey DG, Rittger H, Scheller B. How to use the drug-eluting balloon: recommendations by the German consensus group. EuroIntervention J Eur Collab with Work Gr Interv Cardiol Eur Soc Cardiol. 2011;7 Suppl K:K125-8. doi:10.4244/EIJV7SKA21

Cortese B, Berti S, Biondi-Zoccai G, Colombo A. Limbruno U, Bedogni F, et al. Drug-coated balloon treatment of coronary artery disease: A position paper of the Italian Society of Interventional Cardiology. Catheter Cardiovasc Interv. 2014;83(3):427-435. doi:10.1002/CCD.25149

Biondi-Zoccai G, Moretti C, Abbate A, Sheiban I. Percutaneous coronary intervention for small vessel coronary artery disease. Cardiovasc Revascularization Med. 2010;11(3):189-198. doi:10.1016/J.CARREV.2009.04.007

Unverdorben M, Kleber FX, Heuer H, Fıgulla HR, Vallbracht C, Leschke M, et al. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter in the PEPCAD I study: are lesions clinically stable from 12 to 36 months? EuroIntervention J Eur Collab with Work Gr Interv Cardiol Eur Soc Cardiol. 2013;9(5):620-628. doi:10.4244/EIJV9I5A99

Latib A, Colombo A, Castriota F, Micari A, Cremonesi A, De Felice F. 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(24):2473-2480. doi:10.1016/J.JACC.2012.09.020

Naganuma T, Latib A, Sgueglia GA, Menozzi A, Castriota F, Micari A, et al. A 2-year follow-up of a randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels the BELLO study. Int J Cardiol. 2015;184(1):17-21. doi:10.1016/j.ijcard.2015.01.080

Herrador JA, Fernandez JC, Guzman M, Aragon V. Drug-eluting vs. conventional balloon for side branch dilation in coronary bifurcations treated by provisional T stenting. J Interv Cardiol. 2013;26(5):454-462. doi:10.1111/JOIC.12061

Kleber FX, Rittger H, Ludwig J, Schulz A, Mathey D, BoxBerger M, et al. Drug eluting balloons as stand alone procedure for coronary bifurcational lesions: results of the randomized multicenter PEPCAD-BIF trial. Clin Res Cardiol. 2016;105(7):613-621. doi:10.1007/S00392-015-0957-6/METRICS

Rosenberg M, Waliszewski M, Chin K, Ahmad WAW, Caramanno G, Milazzo D,et al. Prospective, large-scale multicenter trial for the use of drug-coated balloons in coronary lesions: The DCB-only All-Comers Registry. Catheter Cardiovasc Interv. 2019;93(2):181-188. doi:10.1002/CCD.27724

Rissanen TT, Uskela S, Eränen J, Mantyla P, Annika O, RomppanenH, et al. Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial. Lancet (London, England). 2019;394(10194):230-239. doi:10.1016/S0140-6736(19)31126-2

Venetsanos D, Lawesson SS, Panayi G, Tödt T, Berglud U, Swahn E, Alfredsson J, et al. Long-term efficacy of drug coated balloons compared with new generation drug-eluting stents for the treatment of de novo coronary artery lesions. Catheter Cardiovasc Interv. 2018;92(5):E317-E326. doi:10.1002/CCD.27548

Denardo SJ, Carpinone PL, Vock DM, Techeng J, Phillips H, Willenberg B, et al. Detailed analysis of polymer response to delivery balloon expansion of drug-eluting stents versus bare metal stents. EuroIntervention J Eur Collab with Work Gr Interv Cardiol Eur Soc Cardiol. 2013;9(3):389-397. doi:10.4244/EIJV9I3A62

Kukula K, Klopotowski M, Kunicki PK, Jamiolkowski J, Debski A, Bekta P, et al. Platelet aggregation and risk of stent thrombosis or bleeding in interventionally treated diabetic patients with acute coronary syndrome. BMC Cardiovasc Disord. 2016;16(1):1-8. doi:10.1186/S12872-016-0433-X/FIGURES/2

Wöhrle J, Zadura M, Möbius-Winkler S, Leschke M, Opitz C, Ahmed W, et al. SeQuent Please World Wide Registry: Clinical Results of SeQuent Please Paclitaxel-Coated Balloon Angioplasty in a Large-Scale, Prospective Registry Study. J Am Coll Cardiol. 2012;60(18):1733-1738. doi:10.1016/J.JACC.2012.07.040

Ali RM, Degenhardt R, Zambahari R, Tresukosol D, Ahmad WAW, Kamar HBH, et al. Paclitaxel-eluting balloon angioplasty and cobalt-chromium stents versus conventional angioplasty and paclitaxel-eluting stents in the treatment of native coronary artery stenoses in patients with diabetes mellitus. EuroIntervention. 2011;7 Suppl K(SUPPL. K):K83-92. doi:10.4244/EIJV7SKA15

Mieres J, Fernandez-Pereira C, Risau G, Solorzano L, Pauletto R, Rodriguez-Granillo AM, et al. One-year outcome of patients with diabetes mellitus after percutaneous coronary intervention with three different revascularization strategies: Results from the DiabEtic Argentina Registry (DEAR). Cardiovasc Revascularization Med. 2012;13(5):265-271. doi:10.1016/J.CARREV.2012.06.001

Li SX, Chaudry HI, Lee J, Curran T, Kumar V, Wong K, et al. Patterns of in-hospital mortality and bleeding complications following PCI for very elderly patients: insights from the Dartmouth Dynamic Registry. J Geriatr Cardiol. 2018;15(2):131. doi:10.11909/J.ISSN.1671-5411.2018.02.006

Palmerini T, Della Riva D, Benedetto U, Reggiani LB, Feres F, Abizaid A, et al. Three, six, or twelve months of dual antiplatelet therapy after DES implantation in patients with or without acute coronary syndromes: an individual patient data pairwise and network meta-analysis of six randomized trials and 11 473 patients. Eur Heart J. 2017;38(14):1034-1043. doi:10.1093/EURHEARTJ/EHW627

Uskela S, Kärkkäinen JM, Eränen J, Siljandar A, Mathyla P, Mustonen J, 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(5):893-900. doi:10.1002/CCD.27950

Vos NS, Dirksen MT, Vink MA, Nooijen F, AmorosoG, Herman JP, 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(5):584-590. doi:10.4244/EIJV10I5A101

Ho HH, Tan J, Ooi YW, Loh KK, Aung TH, Yin NT, et al. Preliminary experience with drug-coated balloon angioplasty in primary percutaneous coronary intervention. World J Cardiol. 2015;7(6):311. doi:10.4330/WJC.V7.I6.311

Scheller B, Ohlow MA, Ewen S, Kische S, Rudolph T, Clever Y, et al. Bare metal or drug-eluting stent versus drug-coated balloon in non-ST-elevation myocardial infarction: the randomised PEPCAD NSTEMI trial. EuroIntervention. 2020;15(17):1527-1533. doi:10.4244/EIJ-D-19-00723

Carrick D, Oldroyd KG, McEntegart M, Haig C, Petrie M, Eteiba H, et al. A Randomized Trial of Deferred Stenting Versus Immediate Stenting to Prevent No- or Slow-Reflow in Acute ST-Segment Elevation Myocardial Infarction (DEFER-STEMI). J Am Coll Cardiol. 2014;63(20):2088. doi:10.1016/J.JACC.2014.02.530

Vos NS, Fagel ND, Amoroso G, Herrman JP, Patterson M, Piers L,et al. Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial. JACC Cardiovasc Interv. 2019;12(17):1691-1699. doi:10.1016/J.JCIN.2019.04.016

Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning A, Benedetto U, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019;40(2):87-165. doi:10.1093/EURHEARTJ/EHY394

Cortese B, Di Palma G, Guimaraes MG, Piraino D Orrefa P, Buccheri D, et al. Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial. JACC Cardiovasc Interv. 2020;13(24):2840-2849. doi:10.1016/J.JCIN.2020.08.035

Jeger R V., Farah A, Ohlow MA, Mangner N, Winkler S, Leibundgut G, et al. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018;392(10150):849-856. doi:10.1016/S0140-6736(18)31719-7

Tang Y, Qiao S, Tian J, Chen Y, Jin Z, Chen H, et al. Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease: The RESTORE SVD China Randomized Trial. JACC Cardiovasc Interv. 2018;11(23):2381-2392. doi:10.1016/J.JCIN.2018.09.009

Byrne RA, Joner M, Alfonso F, Kastrati A. Drug-coated balloon therapy in coronary and peripheral artery disease. Nat Rev Cardiol. 2014;11(1):13-23. doi:10.1038/NRCARDIO.2013.165

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Published

2023-06-13

How to Cite

Purwowiyoto, S. L. (2023). Coronary Drug-Coated Balloons: Should We Choose a Stentless Approach? DCB: Stentless Approach?. Advances in Cardiac Research, 1(1). https://doi.org/10.5281/zenodo.8031627

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