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Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients

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Abstract

Introduction

Drug-coated balloon (DCB) is an established treatment option for in-stent restenosis and small vessel, de novo, coronary artery disease (CAD). Although the use of this tool is increasing in everyday practice, data regarding performance in the treatment of de novo, large vessel CAD (LV-CAD) is still lacking. A systematic review and meta-analysis were conducted to evaluate the efficacy and safety of DCB versus drug-eluting stent (DES) in this setting.

Methods

A comprehensive literature search was performed including Medline, Embase, and Cochrane electronic databases up to January 24, 2024, for studies which compared the efficacy and safety of DCB versus DES in the treatment of de novo lesions in large vessels (≥ 2.5 mm), reporting at least one clinical outcome of interest (PROSPERO ID: CRD42023470417). The analyzed outcomes were cardiovascular death (CVD), myocardial infarction (MI), target lesion revascularization (TLR), all-cause death (ACD), and late lumen loss (LLL) at follow-up. The effect size was estimated using a random effects model as risk ratio (RR) and mean difference (MD) and relative 95% confidence interval (CI).

Results

A total of 13 studies (6 randomized controlled trials and 7 observational studies) involving 2888 patients (DCB n = 1334; DES n = 1533) with de novo LV-CAD were included in this meta-analysis following our inclusion criteria. No differences were observed between DCB and DES in terms of CVD (RR 0.49; 95% CI [0.23–1.03]; p = 0.06), MI (RR 0.48; 95% CI [0.16–1.45]; p = 0.89), TLR (RR 0.73; 95% CI [0.40–1.34]; p = 0.32), ACD (RR 0.78; 95% CI [0.57–1.07]; p = 0.12), and LLL (MD − 0.14; 95% CI [− 0.30 to 0.02]; p = 0.10) at follow-up. DES proved a higher mean acute gain versus DCB [1.94 (1.73, 2.14) vs 1.31 (1.02, 1.60); p = 0.0006].

Conclusion

Our meta-analysis showed that DCB PCI might provide a promising option for the management of selected, de novo LV-CAD compared to DES. However, more focused RCTs are needed to further prove the benefits of a “metal-free” strategy in this subset of CAD.

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Data availability

The data underlying this article are available in the article and its online supplementary material.

Abbreviations

ACD:

All-cause death

CAD:

Coronary artery disease

CI:

Confidence interval

CVD:

Cardiovascular death

DAPT:

Dual antiplatelet therapy

DCB:

Drug-coated balloon

DES:

Drug-eluting stent

ISR:

In-stent restenosis

LLL:

Late lumen loss

LV:

Large vessel

MACE:

Major adverse cardiovascular events

MD:

Mean difference

MI:

Myocardial infarction

MLD:

Minimal lumen diameter

PCB:

Paclitaxel-coated balloon

PCI:

Percutaneous coronary intervention

PRISMA:

Preferred Reporting Items for Systematic reviews and Meta-Analyses

QCA:

Quantitative coronary analysis

RR:

Risk ratio

RVD:

Reference vessel diameter

SCB:

Sirolimus-coated balloon

SVD:

Small vessel disease

TLF:

Target lesion failure

TLR:

Target lesion revascularization

ULM:

Unprotected left main

References

  1. Colombo A, Iakovou I (2004) Drug-eluting stents: the new gold standard for percutaneous coronary revascularisation. Eur Heart J 25:895–897. https://doi.org/10.1016/j.ehj.2004.04.004

    Article  PubMed  Google Scholar 

  2. Madhavan MV, Kirtane AJ, Redfors B et al (2020) Stent-related adverse events >1 year after percutaneous coronary intervention. J Am Coll Cardiol 75:590–604. https://doi.org/10.1016/j.jacc.2019.11.058

    Article  CAS  PubMed  Google Scholar 

  3. Gada H, Kirtane AJ, Newman W et al (2013) 5-year results of a randomized comparison of XIENCE V everolimus-eluting and TAXUS paclitaxel-eluting stents: final results from the SPIRIT III trial (clinical evaluation of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions). JACC Cardiovasc Interv 6:1263–1266. https://doi.org/10.1016/j.jcin.2013.07.009

    Article  PubMed  Google Scholar 

  4. Meunier L, Godin M, Souteyrand G et al (2023) Prospective, single-centre evaluation of the safety and efficacy of percutaneous coronary interventions following a decision tree proposing a no-stent strategy in stable patients with coronary artery disease (SCRAP study). Clin Res Cardiol 112:1164–1174. https://doi.org/10.1007/s00392-022-02054-7

    Article  CAS  PubMed  Google Scholar 

  5. Jeger RV, Eccleshall S, Wan Ahmad WA, et al (2020) Drug-coated balloons for coronary artery disease: third report of the international DCB consensus group. JACC: Cardiovascular Interventions 13:1391–1402. https://doi.org/10.1016/j.jcin.2020.02.043

  6. Latib A, Ruparelia N, Menozzi A et al (2015) 3-Year follow-up of the balloon elution and late loss optimization study (BELLO). JACC Cardiovasc Interv 8:1132–1134. https://doi.org/10.1016/j.jcin.2015.04.008

    Article  PubMed  Google Scholar 

  7. Jeger RV, Farah A, Ohlow M-A et al (2020) Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial. Lancet 396:1504–1510. https://doi.org/10.1016/S0140-6736(20)32173-5

    Article  CAS  PubMed  Google Scholar 

  8. Authors/Task Force members, Windecker S, Kolh P, et al (2014) 2014 ESC/EACTS guidelines on myocardial revascularization: the task force on myocardial revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J 35:2541–2619. https://doi.org/10.1093/eurheartj/ehu278

  9. Ielasi A, Buono A, Pellicano M et al (2021) A HYbrid APproach Evaluating a DRug-coated balloon in combination with a new-generation drug-eluting stent in the treatment of de novo diffuse coronary artery disease: the HYPER pilot study. Cardiovasc Revasc Med 28:14–19. https://doi.org/10.1016/j.carrev.2020.07.036

    Article  PubMed  Google Scholar 

  10. Rissanen TT, Uskela S, Eränen J et al (2019) 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. The Lancet 394:230–239. https://doi.org/10.1016/S0140-6736(19)31126-2

    Article  Google Scholar 

  11. Buono A, Pellicano M, Regazzoli D, et al (2023) Procedural and one-year outcomes following drug-eluting stent and drug-coated balloon combination for the treatment of de novo diffuse coronary artery disease: the HYPER study. Minerva Cardiol Angiol. https://doi.org/10.23736/S2724-5683.23.06352-4

  12. Mendis S, Thygesen K, Kuulasmaa K et al (2011) World Health Organization definition of myocardial infarction: 2008–09 revision. Int J Epidemiol 40:139–146. https://doi.org/10.1093/ije/dyq165

    Article  PubMed  Google Scholar 

  13. Garcia-Garcia HM, McFadden EP, Farb A et al (2018) Standardized end point definitions for coronary intervention trials: the Academic Research Consortium-2 consensus document. Eur Heart J 39:2192–2207. https://doi.org/10.1093/eurheartj/ehy223

    Article  PubMed  Google Scholar 

  14. Gobić D, Tomulić V, Lulić D et al (2017) Drug-coated balloon versus drug-eluting stent in primary percutaneous coronary intervention: a feasibility study. Am J Med Sci 354:553–560. https://doi.org/10.1016/j.amjms.2017.07.005

    Article  PubMed  Google Scholar 

  15. Gunawardena TD, Corballis N, Merinopoulos I, et al (2023) Drug-coated balloon vs. drug-eluting stents for de novo unprotected left main stem disease: the SPARTAN-LMS study. J Cardiovasc Dev Dis 10:84. https://doi.org/10.3390/jcdd10020084

  16. Her A-Y, Shin E-S, Lee JM et al (2018) Paclitaxel-coated balloon treatment for functionally nonsignificant residual coronary lesions after balloon angioplasty. Int J Cardiovasc Imaging 34:1339–1347. https://doi.org/10.1007/s10554-018-1351-z

    Article  PubMed  Google Scholar 

  17. Iwasaki Y, Koike J, Ko T et al (2021) Comparison of drug-eluting stents vs. drug-coated balloon after rotational atherectomy for severely calcified lesions of nonsmall vessels. Heart Vessels 36:189–199. https://doi.org/10.1007/s00380-020-01684-z

    Article  PubMed  Google Scholar 

  18. Nakamura H, Ishikawa T, Mizutani Y et al (2023) Clinical and angiographic outcomes of elective paclitaxel-coated balloon angioplasty in comparison with drug-eluting stents for de novo coronary lesions in large vessels. Int Heart J 64:145–153. https://doi.org/10.1536/ihj.22-498

    Article  CAS  PubMed  Google Scholar 

  19. Nijhoff F, Agostoni P, Belkacemi A et al (2015) Primary percutaneous coronary intervention by drug-eluting balloon angioplasty: the nonrandomized fourth arm of the DEB-AMI (drug-eluting balloon in ST-segment elevation myocardial infarction) trial. Catheter Cardiovasc Interv 86:S34–S44. https://doi.org/10.1002/ccd.26060

    Article  PubMed  Google Scholar 

  20. Nishiyama N, Komatsu T, Kuroyanagi T et al (2016) Clinical value of drug-coated balloon angioplasty for de novo lesions in patients with coronary artery disease. Int J Cardiol 222:113–118. https://doi.org/10.1016/j.ijcard.2016.07.156

    Article  PubMed  Google Scholar 

  21. Scheller B, Ohlow M-A, Ewen S, et al Bare metal or drug-eluting stent versus drug-coated balloon in non-ST-elevation myocardial infarction: the randomised PEPCAD NSTEMI trial. In: EuroIntervention. https://eurointervention.pcronline.com/article/randomized-comparison-of-bare-metal-or-drug-eluting-stent-versus-drug-coated-balloon-in-non-st-elevation-myocardial-infarction-pepcad-nstemi. Accessed 21 Sep 2023

  22. Vos NS, Fagel ND, Amoroso G, et al (2019) Paclitaxel-coated balloon angioplasty versus drug-eluting stent in acute myocardial infarction: the REVELATION randomized trial. JACC: Cardiovasc Interv 12:1691–1699. https://doi.org/10.1016/j.jcin.2019.04.016

  23. Hao X, Huang D, Wang Z et al (2021) Study on the safety and effectiveness of drug-coated balloons in patients with acute myocardial infarction. J Cardiothorac Surg 16:178. https://doi.org/10.1186/s13019-021-01525-8

    Article  PubMed  Google Scholar 

  24. Yu X, Wang X, Ji F et al (2022) A non-inferiority, randomized clinical trial comparing paclitaxel-coated balloon versus new-generation drug-eluting stents on angiographic outcomes for coronary de novo lesions. Cardiovasc Drugs Ther 36:655–664. https://doi.org/10.1007/s10557-021-07172-4

    Article  CAS  PubMed  Google Scholar 

  25. Gitto M, Sticchi A, Chiarito M, et al Drug-coated balloon angioplasty for de novo lesions on the left anterior descending artery. Circulation: Cardiovasc Interv 0:e013232. https://doi.org/10.1161/CIRCINTERVENTIONS.123.013232

  26. Merinopoulos I, Gunawardena T, Corballis N et al (2023) Paclitaxel drug-coated balloon-only angioplasty for de novo coronary artery disease in elective clinical practice. Clin Res Cardiol 112:1186–1193. https://doi.org/10.1007/s00392-022-02106-y

    Article  PubMed  Google Scholar 

  27. Kleber FX, Rittger H, Bonaventura K et al (2013) Drug-coated balloons for treatment of coronary artery disease: updated recommendations from a consensus group. Clin Res Cardiol 102:785–797. https://doi.org/10.1007/s00392-013-0609-7

    Article  CAS  PubMed  Google Scholar 

  28. Pósa A, Nyolczas N, Hemetsberger R et al (2010) Optimization of drug-eluting balloon use for safety and efficacy: evaluation of the 2nd generation paclitaxel-eluting DIOR-balloon in porcine coronary arteries. Catheter Cardiovasc Interv 76:395–403. https://doi.org/10.1002/ccd.22468

    Article  PubMed  Google Scholar 

  29. Cortese B, Silva Orrego P, Agostoni P et al (2015) Effect of drug-coated balloons in native coronary artery disease left with a dissection. JACC Cardiovasc Interv 8:2003–2009. https://doi.org/10.1016/j.jcin.2015.08.029

    Article  PubMed  Google Scholar 

  30. Leone PP, Mangieri A, Regazzoli D et al (2023) Drug-coated balloon angioplasty guided by postpercutaneous coronary intervention pressure gradient: the REDUCE-STENT retrospective registry. JACC Cardiovasc Interv 16:363–365. https://doi.org/10.1016/j.jcin.2022.09.054

    Article  PubMed  Google Scholar 

  31. Cortese B, Caiazzo G, Di Palma G, De Rosa S (2021) Comparison between sirolimus- and paclitaxel-coated balloon for revascularization of coronary arteries: the SIRPAC (SIRolimus-PAClitaxel) study. Cardiovasc Revasc Med 28:1–6. https://doi.org/10.1016/j.carrev.2021.04.013

    Article  PubMed  Google Scholar 

  32. Cortese B, Testa L, Heang TM et al (2023) Sirolimus-coated balloon in an all-comer population of coronary artery disease patients: the EASTBOURNE prospective registry. JACC Cardiovasc Interv 16:1794–1803. https://doi.org/10.1016/j.jcin.2023.05.005

    Article  PubMed  Google Scholar 

  33. Cortese B, D’Ascenzo F, Fetiveau R et al (2018) Treatment of coronary artery disease with a new-generation drug-coated balloon: final results of the Italian Elutax SV rEgistry-DCB-RISE. J Cardiovasc Med (Hagerstown) 19:247–252. https://doi.org/10.2459/JCM.0000000000000632

    Article  CAS  PubMed  Google Scholar 

  34. Ninomiya K, Serruys PW, Colombo A, et al A prospective randomized trial comparing sirolimus-coated balloon with paclitaxel-coated balloon in de novo small vessels. JACC: Cardiovascular Interventions 0: https://doi.org/10.1016/j.jcin.2023.09.026

  35. Cortese B, Di Palma G, Guimaraes MG, et al (2020) Drug-coated balloon versus drug-eluting stent for small coronary vessel disease: PICCOLETO II randomized clinical trial. JACC: Cardiovascular Interventions 13:2840–2849. https://doi.org/10.1016/j.jcin.2020.08.035

  36. Yerasi C, Case BC, Forrestal BJ et al (2020) Drug-coated balloon for de novo coronary artery disease: JACC state-of-the-art review. J Am Coll Cardiol 75:1061–1073. https://doi.org/10.1016/j.jacc.2019.12.046

    Article  CAS  PubMed  Google Scholar 

  37. Spaulding C, Krackhardt F, Bogaerts K et al (2023) Comparing a strategy of sirolimus-eluting balloon treatment to drug-eluting stent implantation in de novo coronary lesions in all-comers: design and rationale of the SELUTION denovo trial. Am Heart J 258:77–84. https://doi.org/10.1016/j.ahj.2023.01.007

    Article  CAS  PubMed  Google Scholar 

  38. Greco A, Sciahbasi A, Abizaid A et al (2022) Sirolimus-coated balloon versus everolimus-eluting stent in de novo coronary artery disease: rationale and design of the TRANSFORM II randomized clinical trial. Catheter Cardiovasc Interv 100:544–552. https://doi.org/10.1002/ccd.30358

    Article  PubMed  Google Scholar 

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Author notes

  1. Rodolfo Caminiti and Giampiero Vizzari contributed equally to this manuscript as a first author.

Authors and Affiliations

  1. Unità Operativa Di Cardiologia Ospedaliera, IRCCS Ospedale Galeazzi Sant’Ambrogio, Via Belgioioso 173, 20157, Milan, Italy

    Rodolfo Caminiti, Alfonso Ielasi, Carolina Montonati, Dario Pellegrini, Mariano Pellicano & Maurizio Tespili

  2. Cardiology Unit, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy

    Rodolfo Caminiti, Giampiero Vizzari, Giampaolo Vetta, Antonio Parlavecchio & Antonio Micari

  3. Heart Rhythm Management Centre, Postgraduate Program in Cardiac Electrophysiology and Pacing, Universitair Ziekenhuis Brussel-Vrije Universiteit Brussel, European Reference Networks Guard-Heart, Brussels, Belgium

    Giampaolo Vetta & Domenico Giovanni Della Rocca

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Caminiti, R., Vizzari, G., Ielasi, A. et al. Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients. Clin Res Cardiol (2024). https://doi.org/10.1007/s00392-024-02481-8

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