Skip to main content
SpringerLink
Log in

Short and long-term benefits of sirolimus-eluting stent in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials

  • Published:
Journal of Thrombosis and Thrombolysis Aims and scope Submit manuscript

Abstract

Background Recent concerns have emerged on the potential higher risk of stent thrombosis after DES implantation, that might be even more pronounced among STEMI patients. The aim of the current study was to perform a meta-analysis to evaluate the benefits and safety of Sirolimus-Eluting Stent (SES) as compared to BMS in patients undergoing primary angioplasty for STEMI. Methods The literature was scanned by formal searches of electronic databases (MEDLINE and CENTRAL). We examined all completed randomized trials of DES for STEMI. The following keywords were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, stenting, DES, sirolimus-eluting stent (SES), Cypher. Information on study design, type of stent, inclusion and exclusion criteria, primary endpoint, number of patients, angiographic and clinical outcome, were extracted by two investigators. Disagreements were resolved by consensus. Results A total of 9 trials were included in the meta-analysis, involving 2,769 patients (1389 or 50.2% randomized to DES and 1,380 or 49.8% randomized to BMS). At 12 months follow-up, SES was associated with a significant reduction in TVR (4.9% vs. 13.6%, p < 0.0001), with a trend in benefits in mortality (2.9% vs. 4.2%, p = 0.08) and reinfarction (3.0% vs. 4.3%, p = 0.06), without any significant difference in stent thrombosis (1.9% vs. 2.5%, p = 0.36). Safety and efficacy of DES were confirmed at 2–3 years follow-up (data available from 4 trials including 569 patients). Conclusions This meta-analysis shows that among selected STEMI patients undergoing primary angioplasty, SES as compared to BMS is safe and associated with a significant reduction in TVR at 1 and 2–3 years follow-up.

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
Fig. 3
Fig. 4
Fig. 5
Fig. 6

Similar content being viewed by others

References

  1. Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O’Shaughnessy C et al (2003) SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 349:1315–1323. doi:10.1056/NEJMoa035071

    Article  PubMed  CAS  Google Scholar 

  2. Stone GW, Ellis SG, Cox DA, Hermiller J, O’Shaughnessy C, Mann JT et al (2004) TAXUS-IV Investigators; TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 350:221–231. doi:10.1056/NEJMoa032441

    Article  PubMed  CAS  Google Scholar 

  3. Ardissino D, Cavallini C, Bramucci E, Indolfi C, Marzocchi A, Manari A et al (2004) SES-SMART Investigators. Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries: a randomized trial. JAMA 292:2727–2734. doi:10.1001/jama.292.22.2727

    Article  PubMed  CAS  Google Scholar 

  4. Colombo A, Moses JW, Morice MC, Ludwig J, Holmes DR Jr, Spanos V et al (2004) Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions. Circulation 109:1244–1249. doi:10.1161/01.CIR.0000118474.71662.E3

    Article  PubMed  Google Scholar 

  5. Roiron C, Sanchez P, Bouzamondo A, Lechat P, Montalescot G (2006) Drug eluting stents: an updated meta-analysis of randomised controlled trials. Heart 92:641–649. doi:10.1136/hrt.2005.061622

    Article  PubMed  CAS  Google Scholar 

  6. McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T et al (2004) Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet 364:1519–1521. doi:10.1016/S0140-6736(04)17275-9

    Article  PubMed  CAS  Google Scholar 

  7. Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G et al (2005) Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 293:2126–2130. doi:10.1001/jama.293.17.2126

    Article  PubMed  CAS  Google Scholar 

  8. Lagerqvist B, James SK, Stenestrand U, Lindbäck J, Nilsson T, Wallentin L, SCAAR Study Group (2007) Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med 356:1009–1019. doi:10.1056/NEJMoa067722

    Article  PubMed  CAS  Google Scholar 

  9. Spertus JA, Kettelkamp R, Vance C, Decker C, Jones PG, Rumsfeld JS et al (2006) Prevalence, predictors, and outcomes of premature discontinuation of thienopyridine therapy after drug-eluting stent placement: results from the PREMIER registry. Circulation 113:2803–2809. doi:10.1161/CIRCULATIONAHA.106.618066

    Article  PubMed  CAS  Google Scholar 

  10. Kernis SJ, Cohen D, Rein K (2005) Clinical outcome associated with use of drug-eluting stents compared with bare metal stent for primary percutaneous intervention. Am J Cardiol 96(suppl 7A):47H

    Google Scholar 

  11. Daemen J, Tanimoto S, Garcia-Garcia HM, Kukreja N, van de Sande M, Sianos G et al (2007) Comparison of three-year clinical outcome of sirolimus- and paclitaxel-eluting stents versus bare metal stents in patients with ST-segment elevation myocardial infarction (from the RESEARCH and T-SEARCH Registries). Am J Cardiol 99:1027–1032. doi:10.1016/j.amjcard.2006.11.070

    Article  PubMed  CAS  Google Scholar 

  12. Kastrati A, Dibra A, Spaulding C, Laarman GJ, Menichelli M, Valgimigli M, Di Lorenzo E, Kaiser C, Tierala I, Mehilli J, Seyfarth M, Varenne O, Dirksen MT, Percoco G, Varricchio A, Pittl U, Syvänne M, Suttorp MJ, Violini R, Schömig A (2007) Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. Eur Heart J 28:2706–2713. doi:10.1093/eurheartj/ehm402

    Article  PubMed  Google Scholar 

  13. De Luca G, Stone GW, Suryapranata H, Laarman GJ, Menichelli M, Kaiser C, Valgimigli M, Di Lorenzo E, Dirksen MT, Spaulding C, Pittl U, Violini R, Percoco G, Marino P (2008) Efficacy and safety of drug-eluting stents in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials. Int J Cardiol, Apr 2 [Epub ahead of print]

  14. Schömig A, Dibra A, Windecker S, Mehilli J, Suárez de Lezo J, Kaiser C, Park SJ, Goy JJ, Lee JH, Di Lorenzo E, Wu J, Jüni P, Pfisterer ME, Meier B, Kastrati A (2007) A meta-analysis of 16 randomized trials of sirolimus-eluting stents versus paclitaxel-eluting stents in patients with coronary artery disease. J Am Coll Cardiol 50:1373–1380. doi:10.1016/j.jacc.2007.06.047

    Article  PubMed  Google Scholar 

  15. Egger M, Smith GD (1998) Bias in location and selection of studies. BMJ 31:61–66

    Google Scholar 

  16. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF (1999) Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses. Lancet 354:1896–1900. doi:10.1016/S0140-6736(99)04149-5

    Article  PubMed  CAS  Google Scholar 

  17. Valgimigli M, Bolognese L, Anselmi M, Campo G, Rodriguez AE, de Cesare N et al (2005) Tirofiban and sirolimus-eluting stent vs abciximab and bare-metal stent for acute myocardial infarction: a randomized trial. JAMA 293:2109–2117. doi:10.1001/jama.293.17.2109

    Article  PubMed  Google Scholar 

  18. Laarman GJ, Suttorp MJ, Dirksen MT, van Heerebeek L, Kiemeneij F, Slagboom T et al (2006) Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. N Engl J Med 355:1105–1113. doi:10.1056/NEJMoa062598

    Article  PubMed  CAS  Google Scholar 

  19. Spaulding C, Henry P, Teiger E, Beatt K, Bramucci E, Carrié D et al (2006) TYPHOON investigators. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. N Engl J Med 355:1093–1104. doi:10.1056/NEJMoa062006

    Article  PubMed  CAS  Google Scholar 

  20. Di Lorenzo E, Varricchio A, Lanzillo T (2005) Paclitaxel and Sirolimus stent implantation in patients with acute myocardial infarction. Circulation 112(Abstract Suppl):II-478

    Google Scholar 

  21. Menichelli M, Parma A, Pucci E, Fiorilli R, De Felice F, Nazzaro M et al (2007) Randomized trial of sirolimus-eluting stent versus bare-metal stent in acute myocardial infarction (SESAMI). J Am Coll Cardiol 49:1924–1930. doi:10.1016/j.jacc.2007.01.081

    Article  PubMed  CAS  Google Scholar 

  22. Pittl U, Kaiser C, Brunner-La Rocca HP (2006) BASKET Investigators. Safety and efficacy of drug eluting stents versus bare metal stents in primary angioplasty of patients with acute ST-elevation myocardial infarction—a prospective randomized study. Eur Heart J 27(Abstract Suppl):650

    Google Scholar 

  23. Sardella G, Paroli M, Mancone M (2006) Impact of paclitaxel-eluting stent implantation in patients with STEMI on anti-inflammatory IL-10-producing T regulatory 1 (Tr1) cells. Eur Heart J 27(Abstract Suppl):831

    Google Scholar 

  24. Pasceri V, Granatelli A, Pristipino C (2003) A randomized trial of a rapamycin-eluting stent in acute myocardial infarction: preliminary results. Am J Cardiol 92(Suppl 6A):1L

    Google Scholar 

  25. Tierala I (2005) The Helsinki area acute myocardial infarction treatment re-evaluation—Should the patient get a drug-eluting or a normal stent (HAAMU-STENT) study. http://www.tctmd.com/csportal/appmanager/tctmd/main?_nfpb=true&_pageLabel=TCTMDContent&hdCon=1453095

  26. van der Hoeven BL, Liem SS, Jukema JW, Suraphakdee N, Putter H, Dijkstra J, Atsma DE, Bootsma M, Zeppenfeld K, Oemrawsingh PV, van der Wall EE, Schalij MJ (2008) Sirolimus-eluting stents versus bare-metal stents in patients with ST-segment elevation myocardial infarction: 9-month angiographic and intravascular ultrasound results and 12-month clinical outcome results from the MISSION! Intervention study. J Am Coll Cardiol 51:618–626. doi:10.1016/j.jacc.2007.09.056

    Article  PubMed  Google Scholar 

  27. Díaz de la Llera LS, Ballesteros S, Nevado J, Fernández M, Villa M, Sánchez A, Retegui G, García D, Martínez A (2007) Sirolimus-eluting stents compared with standard stents in the treatment of patients with primary angioplasty. Am Heart J 154:164.e1–164.e6

    Article  Google Scholar 

  28. Chechi T, Vittori G, Biondi Zoccai GG, Vecchio S, Falchetti E, Spaziani G, Baldereschi G, Giglioli C, Valente S, Margheri M (2007) Single-center randomized evaluation of paclitaxel-eluting versus conventional stent in acute myocardial infarction (SELECTION). J Interv Cardiol 20:282–291. doi:10.1111/j.1540-8183.2007.00270.x

    Article  PubMed  Google Scholar 

  29. Kelbæk H, Thuesen L, Helqvist S et al (2008) Drug-eluting versus bare metal stents in patients with st-segment-elevation myocardial infarction: eight-month follow-up in the Drug Elution and Distal Protection in Acute Myocardial Infarction (DEDICATION) trial. Circulation 118:1155–1162

    Article  PubMed  Google Scholar 

  30. Karjalainen PP, Ylitalo A, Niemelä M et al (2008) Titanium-nitride-oxide coated stents versus paclitaxel-eluting stents in acute myocardial infarction: a 12-months follow-up report from the TITAX AMI trial. EuroIntervention 4:234–241

    PubMed  Google Scholar 

  31. Valgimigli M, Campo G, Percoco G, Bolognese L, Vassanelli C, Colangelo S, de Cesare N, Rodriguez AE, Ferrario M, Moreno R, Piva T, Sheiban I, Pasquetto G, Prati F, Nazzaro MS, Parrinello G, Ferrari R, for the Multicentre Evaluation of Single High-Dose Bolus Tirofiban vs Abciximab With Sirolimus-Eluting Stent or Bare Metal Stent in Acute Myocardial Infarction Study (MULTISTRATEGY) Investigators (2008) Comparison of angioplasty with infusion of tirofiban or abciximab and with implantation of sirolimus-eluting or uncoated stents for acute myocardial infarction: the MULTISTRATEGY randomized trial. JAMA, Mar 30 [Epub ahead of print]

  32. Stone GWA (2008) Prospective, randomized comparison of paclitaxel-eluting TAXUS stents vs. bare metal stents during primary angioplasty in acute myocardial infarction- One year results of HORIZONS AMI. http://www.clinicaltrialresults.org/. Accessed 18 Oct 2008

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

    Article  PubMed  Google Scholar 

  34. Suryapranata H, De Luca G, van‘t Hof AW, Ottervanger JP, Hoorntje JC, Dambrink JH et al (2005) Is routine stenting for acute myocardial infarction superior to balloon angioplasty? A randomized comparison in a large unselected cohort of patients. Heart 91:641–645. doi:10.1136/hrt.2004.056705

    Article  PubMed  CAS  Google Scholar 

  35. De Luca G, Ernst N, van’t Hof AW, Ottervanger JP, Hoorntje JC, Gosselink AT et al (2006) Predictors and clinical implications of early reinfarction after primary angioplasty for ST-segment elevation myocardial infarction. Am Heart J 151:1256–1259. doi:10.1016/j.ahj.2005.06.047

    Article  PubMed  Google Scholar 

  36. Ruygrok PN, Melkert R, Morel MA et al (1999) Does angiography six months after coronary intervention influence management and outcome? Benestent II Investigators. J Am Coll Cardiol 34:1507–1511. doi:10.1016/S0735-1097(99)00380-0

    Article  PubMed  CAS  Google Scholar 

  37. Pinto DS, Stone GW, Ellis SG, Cox DA, Hermiller J, O’Shaughnessy C et al (2006) TAXUS-IV investigators. Impact of routine angiographic follow-up on the clinical benefits of paclitaxel-eluting stents: results from the TAXUS-IV trial. J Am Coll Cardiol 48:32–36. doi:10.1016/j.jacc.2006.02.060

    Article  PubMed  Google Scholar 

  38. Bainey KR, Norris CM, Graham MM, Ghali WA, Knudtson ML, Welsh RC, For the APPROACH investigators (2008) Clinical in-stent restenosis with bare metal stents: is it truly a benign phenomenon? Int J Cardiol 128:378–382

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Division of Cardiology, Ospedale “Maggiore della Carità”, Eastern Piedmont University, C.so Mazzini, 18, 24100, Novara, Italy

    Giuseppe De Luca

  2. Centro di Biotecnologie per la Ricerca Medica Applicata (BRMA), Eastern Piedmont University, Novara, Italy

    Giuseppe De Luca

  3. Institute of Cardiology, University of Ferrara, Ferrara, Italy

    Marco Valgimigli & Gianfranco Percoco

  4. Assistance Publique-Hopitaux de Paris Cochin Hospital, Paris 5 Medical School Rene Descartes University and INSERM Unite 780 Avenir, Paris, France

    Christian Spaulding

  5. Division of Cardiology, San Camillo Hospital, Rome, Italy

    Maurizio Menichelli & Roberto Violini

  6. Division of Cardiology, University Hospital Basel, Basel, Switzerland

    Hans Peter Brunner-La Rocca & Undine Pittl

  7. Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands

    Bas L. van der Hoeven

  8. Division of Cardiology, S.G. Moscati, Avellino, Italy

    Emilio Di Lorenzo

  9. Hemodynamics and Interventional Cardiology Unit, University Hospital Virgen del Rocio, Seville, Spain

    Luis-S. Diaz de la Llera

  10. Interventional Cardiology Unit, San Filippo Neri Hospital, Rome, Italy

    Vincenzo Pasceri

  11. The Cardiovascular Research Foundation, Columbia University Medical Center, New York City, USA

    Gregg W. Stone

Authors
  1. Giuseppe De Luca
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Marco Valgimigli
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Christian Spaulding
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Maurizio Menichelli
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Hans Peter Brunner-La Rocca
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Bas L. van der Hoeven
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Emilio Di Lorenzo
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Luis-S. Diaz de la Llera
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Vincenzo Pasceri
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Undine Pittl
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Gianfranco Percoco
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Roberto Violini
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Gregg W. Stone
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Giuseppe De Luca.

Rights and permissions

Reprints and permissions

About this article

Cite this article

De Luca, G., Valgimigli, M., Spaulding, C. et al. Short and long-term benefits of sirolimus-eluting stent in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials. J Thromb Thrombolysis 28, 200–210 (2009). https://doi.org/10.1007/s11239-009-0305-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11239-009-0305-7

Keywords

Search

Navigation