Drug-eluting balloon as an alternative to coronary stent in the treatment of de novo atherosclerotic lesions of native coronary arteries — the future we have already been in? Review
https://doi.org/10.15829/1728-8800-2025-4362
EDN: PBQGLV
Abstract
In the last decade, the disadvantages of coronary artery (CA) drugeluting stenting have become increasingly obvious. Metallization of the artery, loss of vasoreactivity and chronic inflammation at the implantation site lead to restenosis and an increased risk of repeated revascularization. In this regard, the "leaving nothing behind" concept is attracting increasing interest, which came to coronary revascularization from lower limb arterial disease strategies. The treatment methods within this concept in CA include the use of biodegradable scaffolds and drug-eluting balloons (DEB). Despite the fact that both Russian and foreign guidelines for DEB establish the role of in-stent restenosis treatment, large studies demonstrate the efficacy and safety of DEB in the treatment of de novo coronary lesions. The review systematizes the latest data on the DEB potential in the treatment of de novo native coronary lesions.
About the Authors
D. K. Vasiliev
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation
Russian Federation
Moscow
N. A. Arablinsky
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation
Russian Federation
Moscow
References
1. Shakhnovich RM, Ruda MYa. The evolution of myocardial infarction treatment over the past decades. The significance of E.I. Chazov works. Therapeutic Archive. 2019;91(6):25-33. (In Russ.) doi:10.26442/00403660.2019.06.000291.
2. Fletcher AP, Alkjaersig N, Smyrniotis FE, et al. The treatment of patients suffering from early myocardial infarction with massive and prolonged streptokinase therapy. Trans Assoc Am Physicians. 1958;71:287-96.
3. Chazov EI, Andreenko GV. The first experience of thrombosis therapy with domestic fibrinolysin. Kardiologiia. 1962;(4):59-63. (In Russ.)
4. Sigwart U, Puel J, Mirkovitch V, et al. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987;316(12):701-6. doi:10.1056/NEJM198703193161201.
5. Barbarash OL, Karpov YuA, Panov AV, et al. 2024 Clinical practice guidelines for Stable coronary artery disease. Russian Journal of Cardiology. 2024;29(9):6110. (In Russ.) doi:10.15829/1560-4071-2024-6110.
6. Wang Y, Zhan J, Bian W, et al. Local hemodynamic analysis after coronary stent implantation based on Euler-Lagrange method. J Biol Phys. 2021;47(2):143-70. doi:10.1007/s10867-021-09571-y.
7. Chi G, AlKhalfan F, Lee JJ, et al. Factors associated with early, late, and very late stent thrombosis among patients with acute coronary syndrome undergoing coronary stent placement: analysis from the ATLAS ACS 2-TIMI 51 trial. Front Cardiovasc Med. 2024;10:1269011. doi:10.3389/fcvm.2023.1269011.
8. Alfonso F, Coughlan JJ, Giacoppo D, et al. Management of instent restenosis. EuroIntervention. 2022;18(2):e103-23. doi:10.4244/EIJ-D-21-01034.
9. Madhavan MV, Kirtane AJ, Redfors B, et al. Stent-Related Adverse Events >1 Year After Percutaneous Coronary Intervention. J Am Coll Cardiol. 2020;75(6):590-604. doi:10.1016/j.jacc.2019.11.058.
10. Picard F, Pighi M, Marquis-Gravel G, et al. The Ongoing Saga of the Evolution of Percutaneous Coronary Intervention: From Balloon Angioplasty to Recent Innovations to Future Prospects. Can J Cardiol. 2022;38(10 Suppl1):S30-41. doi:10.1016/j.cjca.2022.06.019.
11. Jeger RV, Eccleshall S, Wan Ahmad WA, et al. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC: Cardiovasc Interv. 2020; 13(12):1391-402. doi:10.1016/j.jcin.2020.02.043.
12. Muramatsu T, Kozuma K, Tanabe K, et al. Task Force of the Japanese Association of Cardiovascular Intervention, Therapeutics (CVIT). Clinical expert consensus document on drugcoated balloon for coronary artery disease from the Japanese Association of Cardiovascular Intervention and Therapeutics. Cardiovasc Interv Ther. 2023;38(2):166-76. doi:10.1007/s12928-023-00921-2.
13. Latib A, Colombo A, Castriota 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):2473-80. doi:10.1016/j.jacc.2012.09.020.
14. Cortese B, Di Palma G, Guimaraes MG, 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):2840-9. doi:10.1016/j.jcin.2020.08.035.
15. Jeger RV, Farah A, Ohlow MA, et al. BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018;392(10150):849-56. doi:10.1016/S0140-6736(18)31719-7.
16. Tang Y, Qiao S, Su X, et al. RESTORE SVD China Investigators. DrugCoated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease: The RESTORE SVD China Randomized Trial. JACC Cardiovasc Interv. 2018;11(23):2381-92. doi:10.1016/j.jcin.2018.09.009.
17. Ninomiya K, Serruys PW, Colombo A, et al. A Prospective Randomized Trial Comparing Sirolimus-Coated Balloon With PaclitaxelCoated Balloon in De novo Small Vessels. JACC Cardiovasc Interv. 2023;16(23):2884-96. doi:10.1016/j.jcin.2023.09.026.
18. Gobić D, Tomulić V, Lulić D, et al. Drug-Coated Balloon Versus Drug-Eluting Stent in Primary Percutaneous Coronary Intervention: A Feasibility Study. Am J Med Sci. 2017;354(6):553- 60. doi:10.1016/j.amjms.2017.07.005.
19. Vos NS, Fagel ND, Amoroso G et al. Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial. JACC Cardiovasc Interv. 2019;12(17):1691-9. doi:10.1016/j.jcin.2019.04.016.
20. Rissanen TT, Uskela S, Eränen J, et al. DEBUT trial investigators. 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. 2019;394(10194):230-9. doi:10.1016/S0140-6736(19)31126-2.
21. Yu X, Wang X, Ji F, et al. A Non-inferiority, Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus NewGeneration Drug-Eluting Stents on Angiographic Outcomes for Coronary De novo Lesions. Cardiovasc Drugs Ther. 2022; 36(4):655-64. doi:10.1007/s10557-021-07172-4.
22. Gao C, He X, Ouyang F, et al.; REC-CAGEFREE I Investigators. Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial. Lancet. 2024;404(10457):1040- 50. doi:10.1016/S0140-6736(24)01594-0.
23. Gunawardena TD, Corballis N, Merinopoulos I, et al. Drug-Coated Balloon vs. Drug-Eluting Stents for De novo Unprotected Left Main Stem Disease: The SPARTAN-LMS Study. J Cardiovasc Dev Dis. 2023;10(2):84. doi:10.3390/jcdd10020084.
24. Collet C, Mizukami T, Grundeken MJ. Contemporary techniques in percutaneous coronary intervention for bifurcation lesions. Expert Rev Cardiovasc Ther. 2018;16(10):725-34. doi:10.1080/14779072.2018.1523717.
25. Safonova OO, Maksimkin DA, Chepurnoy AG, et al. Drugeluting balloon catheters in the treatment of left main coronary artery bifurcation lesions. Russian Journal of Cardiology and Cardiovascular Surgery. 2022;15(6):554-9. (In Russ.) doi:10.17116/kardio202215061554.
26. Kleber FX, Rittger H, Ludwig J, 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):613-21. doi:10.1007/s00392-015-0957-6.
27. Jing QM, Zhao X, Han YL, et al. A drug-eluting Balloon for the trEatment of coronarY bifurcatiON lesions in the side branch: a prospective multicenter ranDomized (BEYOND) clinical trial in China. Chin Med J (Engl). 2020;133(8):899-908. doi:10.1097/CM9.0000000000000743.
28. Eraliev T, Khelimskii D, Badoian A, et al. Long-term outcomes of drug-eluting balloons for treatment of side branches in patients with true coronary bifurcation lesions. Patologiya krovoobrashcheniya i kardiokhirurgiya. 2022;26(4):7-18. (In Russ.) doi:10.21688/1681-3472-2022-4-7-18.
29. Gao X, Tian N, Kan J, et al. Drug-Coated Balloon Angioplasty of the Side Branch During Provisional Stenting: The Multicenter Randomized DCB-BIF Trial. J Am Coll Cardiol. 2025;85(1):1-15. doi:10.1016/j.jacc.2024.08.067.
Supplementary files
Review
For citations:
Vasiliev D.K., Arablinsky N.A. Drug-eluting balloon as an alternative to coronary stent in the treatment of de novo atherosclerotic lesions of native coronary arteries — the future we have already been in? Review. Cardiovascular Therapy and Prevention. 2025;24(5):4362. (In Russ.) https://doi.org/10.15829/1728-8800-2025-4362. EDN: PBQGLV
Views:
34
Email this article 
