Skip to main content
Log in

Effect of Paclitaxel-Coated Balloon Angioplasty on Side Branch Lesion and Cardiovascular Outcomes in Patients with De Novo True Coronary Bifurcation Lesions Undergoing Percutaneous Coronary Intervention

  • Original Article
  • Published:
Cardiovascular Drugs and Therapy Aims and scope Submit manuscript

Abstract

Purpose

To compare the effects of paclitaxal-coated balloon (PCB) versus conventional balloon (CB) on side branch (SB) lesion and cardiovascular outcomes in patients with de novo true bifurcation lesions.

Methods

In total, 219 patients with de novo true bifurcation lesions were enrolled and divided into PCB group (102 cases) and CB group (117 cases) according to angioplasty strategy in SB. Drug-eluting stent (DES) was implanted in main vessel (MV) for each subject. All subjects underwent a 12-month follow-up for late lumen loss (LLL), restenosis, and major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI). MACEs included cardiac death, nonfatal myocardial infarction, and unstable angina requiring admission.

Results

There were no differences in diameter, minimum lumen diameter (MLD), and stenosis for bifurcation lesions between the two groups before and immediately after PCI (P > 0.05). After 12-month follow-up, no differences occurred in MV-MLD and MV-LLL between the two groups (P > 0.05); SB-MLD in PCB group was higher than that in CB group (1.97 ± 0.36 mm vs. 1.80 ± 0.43 mm, P = 0.007); SB-LLL in PCB group was lower than that in CB group (0.11 ± 0.18 mm vs. 0.19 ± 0.25 mm, P = 0.024). Multivariate COX analyses indicated that PCB group had lower MACE risk than CB group (HR = 0.480, 95%CI 0.244–0.941, P = 0.033).

Conclusion

PCB could decrease SB-LLL and MACE risk in patients with de novo true coronary bifurcation lesion 12 months after single-DES intervention.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2

Similar content being viewed by others

Data Availability

The data used to support the findings of this study are available from the corresponding author upon request.

References

  1. Lassen JF, Holm NR, Banning A, et al. Percutaneous coronary intervention for coronary bifurcation disease: 11th consensus document from the European Bifurcation Club. EuroIntervention. 2016;12:38–46.

    Article  Google Scholar 

  2. Généreux P, Kumsars I, Lesiak M, et al. A randomized trial of a dedicated bifurcation stent versus provisional stenting in the treatment of coronary bifurcation lesions. J Am Coll Cardiol. 2015;65:533–43.

    Article  Google Scholar 

  3. Al Suwaidi J, Berger PB, Rihal CS, et al. Immediate and long-term outcome of intracoronary stent implantation for true bifurcation lesions. J Am Coll Cardiol. 2000;35:929–36.

    Article  CAS  Google Scholar 

  4. Kumsars I, Holm NR, Niemelä 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:e947.

    Article  Google Scholar 

  5. Zamani P, Kinlay S. Long-term risk of clinical events from stenting side branches of coronary bifurcation lesions with drug-eluting and bare-metal stents: an observational meta-analysis. Catheter Cardiovasc Interv. 2011;77:202–12.

    Article  Google Scholar 

  6. Yerasi C, Case BC, Forrestal BJ, et al. Drug-coated balloon for de novo coronary artery disease. J Am Coll Cardiol. 2020;75:1061–73.

    Article  CAS  Google Scholar 

  7. Rissanen TT, Uskela S, Eränen J, 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. 2019;394:230–9.

    Article  Google Scholar 

  8. 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.

    Article  CAS  Google Scholar 

  9. Ang H, Lin J, Huang YY, et al. Drug-coated balloons: technologies and clinical applications. Curr Pharm Des. 2018;24:381–96.

    Article  CAS  Google Scholar 

  10. Vos Nicola S, Fagel Nick D, Amoroso Giovanni, Herrman Jean-Paul R, Patterson Mark S, Piers Lieuwe H, van der Schaaf René J, Slagboom Ton, Vink Maarten A. Paclitaxel-coated balloon angioplasty versus drug-eluting stent in acute myocardial infarction. JACC Cardiovasc Interv. 2019;12:1691–9.

    Article  Google Scholar 

  11. Elwany M, Palma GD, Cortese B. Treatment of coronary bifurcation lesions: current knowledge and future perspectives. Future Cardiol. 2018;14:165–79.

    Article  CAS  Google Scholar 

  12. Leesar MA, Hakeem A, Azarnoush K, Thuesen L. Coronary bifurcation lesions: present status and future perspectives. Int J Cardiol. 2015;187:48–57.

    Article  Google Scholar 

  13. Perl L, Witberg G, Greenberg G, Vaknin-Assa H, Kornowski R, Assali A. Prognostic significance of the Medina classification in bifurcation lesion percutaneous coronary intervention with second-generation drug-eluting stents. Heart Vessels. 2020;35:331–9.

    Article  Google Scholar 

  14. Collet C, Capodanno D, Onuma Y, et al. Left main coronary artery disease: pathophysiology, diagnosis, and treatment. Nat Rev Cardiol. 2018;15:321–31.

    Article  Google Scholar 

  15. Asano T, Serruys PW, Collet C, et al. Angiographic late lumen loss revisited: impact on long-term target lesion revascularization. Eur Heart J. 2018;39:3381–9.

    Article  Google Scholar 

  16. Thygesen K, Alpert JS, Jaffe AS, et al. Fourth universal definition of myocardial infarction (2018)[J]. Circulation. 2018;138:e618–51.

    Article  Google Scholar 

  17. Suzuki N, Asano T, Nakazawa G, et al. Clinical expert consensus document on quantitative coronary angiography from the Japanese Association of Cardiovascular Intervention and Therapeutics. Cardiovasc Interv Ther. 2020;35:105–16.

    Article  CAS  Google Scholar 

  18. Zheng W, Li Y, Tian J, et al. Effects of ticagrelor versus clopidogrel in patients with coronary bifurcation lesions undergoing percutaneous coronary intervention. BioMed Res Int. 2019;2019:1–12.

    Google Scholar 

  19. Zhang J, Ye F, Xu K, et al. Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial. Eur Heart J. 2020;41:2523–36.

    Article  Google Scholar 

  20. Naganuma T, Chieffo A, Meliga E, et al. Long-term clinical outcomes after percutaneous coronary intervention for ostial/mid-shaft lesions versus distal bifurcation lesions in unprotected left main coronary artery: the DELTA Registry (drug-eluting stent for left main coronary artery disease): a multicenter registry evaluating percutaneous coronary intervention versus coronary artery bypass grafting for left main treatment. JACC Cardiovasc Interv. 2013;6:1242–9.

    Article  Google Scholar 

  21. Ford TJ, McCartney P, Corcoran D, et al. Single- versus 2-stent strategies for coronary bifurcation lesions: a systematic review and meta-analysis of randomized trials with long-term follow-up. J Am Heart Assoc. 2018;7(11):e008730.

    Article  Google Scholar 

  22. Chen S, Zhang J, Han Y, et al. Double kissing crush versus provisional stenting for left main distal bifurcation lesions: DKCRUSH-V randomized trial. J Am Coll Cardiol. 2017;70:2605–17.

    Article  Google Scholar 

  23. Burzotta F, Trani C, Todaro D, et al. Prospective randomized comparison of sirolimus- or everolimus-eluting stent to treat bifurcated lesions by provisional approach. JACC Cardiovasc Interv. 2011;4:327–35.

    Article  Google Scholar 

  24. Chen S, Santoso T, Zhang J, et al. Clinical outcome of double kissing crush versus provisional stenting of coronary artery bifurcation lesions. Circ Cardiovasc Interv. 2017;10(2):e004497.

    Article  Google Scholar 

  25. Tang Y, Qiao S, Su X, et al. Drug-coated balloon versus drug-eluting stent for small-vessel disease. JACC Cardiovasc Interv. 2018;11:2381–92.

    Article  Google Scholar 

  26. Lee W, Hsueh S, Chen C, et al. The comparison of clinical outcomes after drug-eluting balloon and drug-eluting stent use for left main bifurcation in-stent restenosis. Int Heart J. 2018;59:935–40.

    Article  Google Scholar 

  27. Harada Y, Colleran R, Pinieck S, et al. Angiographic and clinical outcomes of patients treated with drug-coated balloon angioplasty for in-stent restenosis after coronary bifurcation stenting with a two-stent technique. EuroIntervention. 2017;12:2132–9.

    Article  Google Scholar 

  28. Berland J, Lefevre T, Brenot P, et al. DANUBIO-a new drug-eluting balloon for the treatment of side branches in bifurcation lesions: six-month angiographic follow-up results of the DEBSIDE trial. EuroIntervention. 2015;11:868–76.

    Article  Google Scholar 

  29. Mathey DG, Wendig I, Boxberger M, Bonaventura K, Kleber FX. 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:K61–5.

    Article  Google Scholar 

  30. Belkacemi A, Agostoni P, Voskuil M, Stella P. Coronary bifurcation lesions treated with the drug-eluting balloon: a preliminary insight from the DEBIUT study. EuroIntervention. 2011;7 Suppl K:K66–9.

    Article  Google Scholar 

  31. Lopez MJ, Nogales AJ, Doncel VL, et al. A prospective randomised study of the paclitaxel-coated balloon catheter in bifurcated coronary lesions (BABILON trial): 24-month clinical and angiographic results. EuroIntervention. 2014;10:50–7.

    Article  Google Scholar 

  32. Goto K, Mintz GS, Litherland C, et al. Lumen measurements from quantitative coronary angiography and IVUS: A PROSPECT substudy. JACC Cardiovasc Imaging. 2016;9:1011–3.

    Article  Google Scholar 

  33. Lee J, Seo K, Yang H, et al. Comparison of three-dimensional quantitative coronary angiography and intravascular ultrasound for detecting functionally significant coronary lesions. Cardiovasc Diagn Ther. 2020;10:1256–63.

    Article  Google Scholar 

  34. Tomaniak M, Masdjedi K, Zandvoort LJ, et al. Correlation between 3D-QCA based FFR and quantitative lumen assessment by IVUS for left main coronary artery stenoses. Catheter Cardiovasc Interv. 2021;97:E495–501.

    Article  Google Scholar 

  35. Vergallo R, Porto I, De Maria GL, et al. Dual quantitative coronary angiography accurately quantifies intracoronary thrombotic burden in patients with acute coronary syndrome: comparison with optical coherence tomography imaging. Int J Cardiol. 2019;292:25–31.

    Article  Google Scholar 

  36. Gil RJ, Bil J, Legutko J, et al. Comparative assessment of three drug eluting stents with different platforms but with the same biodegradable polymer and the drug based on quantitative coronary angiography and optical coherence tomography at 12-month follow-up. Int J Cardiovasc Imaging. 2018;34:353–65.

    Article  Google Scholar 

  37. Rittger H, Waliszewski M, Brachmann J, 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;8:1695–700.

    Article  Google Scholar 

  38. Candy N, Ng E, Velu R. Paclitaxel-coated balloon reduces target lesion revascularization compared with standard balloon angioplasty. J Vasc Surg. 2017;65:558–70.

    Article  Google Scholar 

Download references

Funding

This study was funded by the Natural Science Foundation of Chongqing (grant no. cstc2017jcyjAX0042).

Author information

Authors and Affiliations

Authors

Contributions

Qi Mao contributed to the study conception and design. Youmei Li and Huanyun Liu analyzed the patient data regarding coronary angiograph. Data collection was performed by Denglu Zhou and Jianhua Zhao. The first draft of this manuscript was written by Youmei Li and Qi Mao. All authors commented previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Qi Mao.

Ethics declarations

Ethics Approval

All procedures performed in this study involving human participants were in accordance with the ethical standards of the institution (ethics committee of Xinqiao Hospital, Chongqing). Informed consent was obtained from all individual participants of this study.

Conflict of Interest

The authors declare no competing interests.

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Li, Y., Mao, Q., Liu, H. et al. Effect of Paclitaxel-Coated Balloon Angioplasty on Side Branch Lesion and Cardiovascular Outcomes in Patients with De Novo True Coronary Bifurcation Lesions Undergoing Percutaneous Coronary Intervention. Cardiovasc Drugs Ther 36, 859–866 (2022). https://doi.org/10.1007/s10557-021-07225-8

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10557-021-07225-8

Keywords

Navigation