Skip to main content

Advertisement

SpringerLink
Log in

Systematic review and meta-analysis of short-term outcomes with drug-coated balloons vs. stenting in acute myocardial infarction

  • Original Article
  • Published:
Cardiovascular Intervention and Therapeutics Aims and scope Submit manuscript

Abstract

The role of drug-coated balloons (DCBs) in patients with acute myocardial infarction (AMI) remains controversial. We performed a meta-analysis of all published studies comparing the outcomes of DCBs vs. stenting in AMI patients. Four studies with 497 patients (534 lesions) were included (three randomized controlled trials and one observational study). During a mean follow-up of 9 months (range 6–12 months), DCBs were associated with similar risk of major adverse cardiovascular events (5% vs. 4.4%; OR 1.24, 95% CI: [0.34, 4.51], p = 0.74, I2 = 35%), all-cause mortality (0.02% vs. 0.04%; OR 077, 95% CI: [0.15, 3.91], p = 0.75, I2 = 25%), cardiac death (0.01% vs. 0.02%; OR 0.64, 95% CI: [0.16, 2.64], p = 0.54), myocardial infarction (0% vs. 1.4%; OR 0.18, 95% CI: [0.01, 3.56], p = 0.26), and target lesion revascularization (3.7% vs. 2%; OR 1.74, 95% CI: [0.42, 7.13], p = 0.44, I2 = 17%) compared with stenting. During a mean follow-up of 7 months (range 6–9 months), DCBs had similar late lumen loss compared with stenting (mean difference 0.04 mm, 95% CI [– 0.21–0.28], p = 0.77, I2 = 92%). In patients with AMI, there was no statistical difference in the incidence of clinical and angiographic outcomes between AMI patients treated with DCB and DES. Larger studies with longer-term follow-up are needed to assess the clinical utility of DCBs in this setting.

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

Access this article

Log in via an institution

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

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio AL, Crea F, Goudevenos JA, Halvorsen S. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: the Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2017;39:119–77.

    Article  Google Scholar 

  2. Ogara PT, Kushner FG, Ascheim DD, Casey DE, Chung MK, De Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;61:e78–e140.

    Article  Google Scholar 

  3. Ong AT, McFadden EP, Regar E, de Jaegere PP, van Domburg RT, Serruys PW. Late angiographic stent thrombosis (LAST) events with drug-eluting stents. J Am Coll Cardiol. 2005;45:2088–92.

    Article  CAS  Google Scholar 

  4. Vlachojannis GJ, Smits PC, Hofma SH, Togni M, Vázquez N, Valdés M, Voudris V, Slagboom T, Goy J-J, den Heijer P. Biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: final 5-year report from the COMPARE II trial (abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent). JACC Cardiovasc Interv. 2017;10:1215–21.

    Article  Google Scholar 

  5. Madhavan MV, Kirtane AJ, Redfors B, Généreux P, Ben-Yehuda O, Palmerini T, Benedetto U, Biondi-Zoccai G, Smits PC, von Birgelen C, Mehran R, McAndrew T, Serruys PW, Leon MB, Pocock SJ, Stone GW. Stent-related adverse events >1 year after percutaneous coronary intervention. J Am Coll Cardiol. 2020;75:590–604.

    Article  CAS  Google Scholar 

  6. Hung M-J, Hsu K-H, Chang N-C, Tsimikas S, Hung M-Y. Prevalence of coronary artery spasm after stent placement and its association with inflammation. Int J Cardiol. 2015;179:252–5.

    Article  Google Scholar 

  7. Ann SH, Balbir Singh G, Lim KH, Koo BK, Shin ES. Anatomical and physiological changes after paclitaxel-coated balloon for atherosclerotic de novo coronary lesions: serial IVUS-VH and FFR study. PLoS ONE. 2016;11:e0147057.

    Article  Google Scholar 

  8. Kleber FX, Schulz A, Waliszewski M, Hauschild T, Bohm M, Dietz U, Cremers B, Scheller B, Clever YP. Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty. Clin Res Cardiol. 2015;104:217–25.

    Article  CAS  Google Scholar 

  9. Waksman R, Serra A, Loh JP, Malik F, Torguson R, Stahnke S, Rodriguez A. Drug-coated balloons for de novo coronary lesions: results from the Valentines II trial. EuroIntervention. 2013;9:613–9.

    Article  Google Scholar 

  10. Giacoppo D, Alfonso F, Xu B, Claessen BE, Adriaenssens T, Jensen C, Pérez-Vizcayno MJ, Kang D-Y, Degenhardt R, Pleva L. Paclitaxel-coated balloon angioplasty vs. drug-eluting stenting for the treatment of coronary in-stent restenosis: a comprehensive, collaborative, individual patient data meta-analysis of 10 randomized clinical trials (DAEDALUS study). Eur Heart J 2019.

  11. Megaly M, Rofael M, Saad M, Shishehbor M, Brilakis ES. Outcomes with drug-coated balloons for treating the side branch of coronary bifurcation lesions. J Invasive Cardiol. 2018;30:393–9.

    PubMed  Google Scholar 

  12. 12Megaly M, Ali A, Abraham B, Khalil C, Zordok M, Shaker M, Tawadros M, Hennawy BS, Elbadawi A, Omer M. Outcomes with drug-coated balloons in percutaneous coronary intervention in diabetic patients. Cardiovasc Revasc Med 2019.

  13. Megaly M, Rofael M, Saad M, Rezq A, Kohl LP, Kalra A, Shishehbor M, Soukas P, Abbott J, Brilakis ES. Outcomes with drug-coated balloons in small-vessel coronary artery disease. Catheter Cardiovasc Interv. 2019;93:E277–E286286.

    Article  Google Scholar 

  14. Megaly M, Saad M, Brilakis ES. Role of drug-coated balloons in small-vessel coronary artery disease. US Cardiol Rev. 2019;13:16–20.

    Article  Google Scholar 

  15. Ho HH, Tan J, Ooi YW, Loh KK, Aung TH, Yin NT, Sinaga DA, Jafary FH, Ong PJL. Preliminary experience with drug-coated balloon angioplasty in primary percutaneous coronary intervention. World J Cardiol. 2015;7:311.

    Article  Google Scholar 

  16. Vos NS, Dirksen MT, Vink MA, van Nooijen FC, Amoroso G, Herrman J, Kiemeneij F, Patterson MS, Slagboom T, van der Schaaf RJ. 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;10:584–90.

    Article  Google Scholar 

  17. Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB. Meta-analysis of observational studies in epidemiology: a proposal for reporting. JAMA. 2000;283:2008–122.

    Article  CAS  Google Scholar 

  18. Moher D, Liberati A, Tetzlaff J, Altman DG, Group P. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6:e1000097.

    Article  Google Scholar 

  19. 19Wells G. Wells GA, Shea B, O'Connell D, Peterson J, Welch V, Losos M, et al. The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses. 2011.

  20. Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, Savović J, Schulz KF, Weeks L, Sterne JA. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.

    Article  Google Scholar 

  21. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557.

    Article  Google Scholar 

  22. Egger M, Smith GD, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ. 1997;315:629–34.

    Article  CAS  Google Scholar 

  23. Gobić D, Tomulić V, Lulić D, Židan D, Brusich S, Jakljević T, Zaputović L. Drug-coated balloon versus drug-eluting stent in primary percutaneous coronary intervention: a feasibility study. Am J Med Sci. 2017;354:553–60.

    Article  Google Scholar 

  24. 24Vos NS, Fagel ND, Amoroso G, Herrman J-PR, Patterson MS, Piers LH, van der Schaaf RJ, Slagboom T, Vink MA. Paclitaxel-coated balloon angioplasty versus drug-eluting stent in acute myocardial infarction: the REVELATION Randomized Trial. JACC Cardiovasc Interv 2019.

  25. Scheller B, Ohlow M-A, Ewen S, Kische S, Rudolph TK, Clever YP, Wagner A, Richter S, El-Garhy M, Böhm M. Bare metal or drug-eluting stent versus drug-coated balloon in non-ST-elevation myocardial infarction: the randomised PEPCAD NSTEMI trial. EuroIntervention. 2020;15:1527.

    Article  Google Scholar 

  26. Nijhoff F, Agostoni P, Belkacemi A, Nathoe HM, Voskuil M, Samim M, Doevendans PA, Stella PR. 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. 2015;86:S34–S44.

    Article  Google Scholar 

  27. Serruys PW, De Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med. 1994;331:489–95.

    Article  CAS  Google Scholar 

  28. Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. N Engl J Med. 1994;331:496–501.

    Article  CAS  Google Scholar 

  29. Suryapranata H, Ottervanger J, Nibbering E, van’t Hof A, Hoorntje J, de Boer M, Al M, Zijlstra F. Long term outcome and cost-effectiveness of stenting versus balloon angioplasty for acute myocardial infarction. Heart 2001;85:667–71.

  30. Yamaji K, Kimura T, Morimoto T, Nakagawa Y, Inoue K, Kuramitsu S, Soga Y, Arita T, Shirai S, Ando K. Very long-term (15 to 23 years) outcomes of successful balloon angioplasty compared with bare metal coronary stenting. J Am Heart Assoc. 2012;1:e004085.

    Article  Google Scholar 

  31. Brodie BR, Pokharel Y, Garg A, Kissling G, Hansen C, Milks S, Cooper M, Mcalhany C, Stuckey TD. Very late hazard with stenting versus balloon angioplasty for ST-elevation myocardial infarction: a 16-year single-center experience. J Interv Cardiol. 2014;27:21–8.

    Article  Google Scholar 

  32. De Luca G, Suryapranata H, Stone GW, Antoniucci D, Biondi-Zoccai G, Kastrati A, Chiariello M, Marino P. Coronary stenting versus balloon angioplasty for acute myocardial infarction: a meta-regression analysis of randomized trials. Int J Cardiol. 2008;126:37–44.

    Article  Google Scholar 

  33. Leone AM, Rebuzzi AG, Burzotta F, De Maria GL, Gardi A, Basile E, Cialdella P, Damario D, Paraggio L, Porto I. Stent malapposition, strut coverage and atherothrombotic prolapse after percutaneous coronary interventions in ST-segment elevation myocardial infarction. J Cardiovasc Med. 2019;20:122–30.

    Article  Google Scholar 

  34. Gonzalo N, Barlis P, Serruys PW, Garcia-Garcia HM, Onuma Y, Ligthart J, Regar E. Incomplete stent apposition and delayed tissue coverage are more frequent in drug-eluting stents implanted during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction than in drug-eluting stents implanted for stable/unstable angina: insights from optical coherence tomography. JACC Cardiovasc Interv. 2009;2:445–52.

    Article  Google Scholar 

  35. Yamaji K, Natsuaki M, Morimoto T, Ono K, Furukawa Y, Nakagawa Y, Kadota K, Ando K, Shirai S, Watanabe H. Long-term outcomes after coronary stent implantation in patients presenting with versus without acute myocardial infarction (an Observation from Coronary Revascularization Demonstrating Outcome Study-Kyoto Registry Cohort-2). Am J Cardiol. 2015;116:15–23.

    Article  Google Scholar 

  36. Plass CA, Sabdyusheva-Litschauer I, Bernhart A, Samaha E, Petnehazy O, Szentirmai E, Petrasi Z, Lamin V, Pavo N, Nyolczas N, Jakab A, Murlasits Z, Bergler-Klein J, Maurer G, Gyongyosi M. Time course of endothelium-dependent and -independent coronary vasomotor response to coronary balloons and stents. Comparison of plain and drug-eluting balloons and stents. JACC Cardiovasc Interv 2012;5:741–51.

  37. Ali RM, Kader MASA, Ahmad WAW, Ong TK, Liew HB, Omar A-F, Zuhdi ASM, Nuruddin AA, Schnorr B, Scheller B. Treatment of coronary drug-eluting stent restenosis by a sirolimus-or paclitaxel-coated balloon. JACC Cardiovasc Interv. 2019;12:558–66.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Division of Cardiology, Banner University Medical Center-UA College of Medicine, Phoenix, AZ, USA

    Michael Megaly & Ashish Pershad

  2. Division of Internal Medicine, Hennepin Healthcare, Minneapolis, MN, USA

    Kevin G. Buda

  3. Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, 920 E 28th Street #300, Minneapolis, MN, 55407, USA

    Iosif Xenogiannis, Evangelia Vemmou, Ilias Nikolakopoulos, Santiago Garcia, M. Nicholas Burke & Emmanouil S. Brilakis

  4. Division of Cardiology, The Warren Alpert School of Medicine at Brown University Providence, Providence, RI, USA

    Marwan Saad, J. Dawn Abbott & Herbert D. Aronow

  5. Division of Cardiology, McGill University Health Centre, Montreal, QC, Canada

    Stéphane Rinfret

Authors
  1. Michael Megaly
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Kevin G. Buda
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Iosif Xenogiannis
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Evangelia Vemmou
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Ilias Nikolakopoulos
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Marwan Saad
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Stéphane Rinfret
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. J. Dawn Abbott
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Herbert D. Aronow
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Santiago Garcia
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Ashish Pershad
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. M. Nicholas Burke
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Emmanouil S. Brilakis
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Emmanouil S. Brilakis.

Ethics declarations

Conflict of interest

Emmanouil Brilakis: consulting/speaker honoraria from Abbott Vascular, American Heart Association (associate editor Circulation), Amgen, Biotronik, Boston Scientific, Cardiovascular Innovations Foundation (Board of Directors), ControlRad, CSI, Ebix, Elsevier, GE Healthcare, InfraRedx, Medtronic, Siemens, and Teleflex; research support from Regeneron and Siemens. Shareholder: MHI Ventures. M. Nicholas Burke: Shareholder, Egg Medical and MHI Ventures. Speaker, Opsens Medical. Santiago Garcia: Consultant for Surmodics, Osprey Medical, Medtronic, Edwards Lifesciences, and Abbott Vascular. Dr. Institutional grant support from Edwards Lifesciences, Abbott Vascular, and BSCI. Honoraria from the American College of Cardiology. Stephane Rinfret: Consultant, Boston Scientific, Abiomed, Abbott Vascular and Soundbite Medical. J Dawn Abbott: Research consultant for Pfizer and Recork. Herbert Aronow: Consultant, Silk Road Medical, Philips. All other authors have nothing to disclose.

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

Megaly, M., Buda, K.G., Xenogiannis, I. et al. Systematic review and meta-analysis of short-term outcomes with drug-coated balloons vs. stenting in acute myocardial infarction. Cardiovasc Interv and Ther 36, 481–489 (2021). https://doi.org/10.1007/s12928-020-00713-y

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12928-020-00713-y

Keywords

Search

Navigation