Journal of Thrombosis and Thrombolysis

, Volume 38, Issue 3, pp 355–363 | Cite as

Sirolimus-eluting versus paclitaxel-eluting stent in primary angioplasty: a pooled patient-level meta-analysis of randomized trials

  • Giuseppe De Luca
  • Jeffrey Wirianta
  • Jae-Hwan Lee
  • Christoph Kaiser
  • Emilio Di Lorenzo
  • Harry Suryapranata
Article

Abstract

Large interests have been focused on the role of drug-eluting stents in the setting of ST-segment elevation myocardial infarction (STEMI) and concerns have emerged regarding an higher risk of stent thrombosis. Aim of the current study was to perform a meta-analysis using individual patient data to evaluate the long-term safety and effectiveness of sirolimus-eluting stent (SES) as compared to paclitaxel-eluting stent (PES) in patients undergoing primary percutaneous coronary intervention (PCI) for STEMI. The literature was scanned by formal searches of electronic databases (MEDLINE and CENTRAL). We examined all completed randomized trials of SES versus PES for STEMI. No language restriction was applied. Primary study endpoint was the occurrence of major adverse cardiac events (MACE). Secondary endpoints were the occurrence of death, reinfarction, stent thrombosis, target-vessel revascularization (TVR). Individual patient data were obtained from 4 out of 5 trials identified, including a total of 1,000 patients, 504 (50.4 %) randomized to SES and 496 (49.6 %) randomized to PES. At long-term follow-up (1,021 [372–1,351] days), no difference was observed between SES and PES in terms of TVR (10 vs 11.6 %, HR [95 % CI 0.73 [0.45–1.16], p = 0.18, p het = 0.92]) (primary endpoint) or death (9.4 vs 10.4 %, HR [95 % CI 0.95 [0.58–1.54], p = 0.82, p het = 0.89]), reinfarction (8.2 vs 10.4 %, HR [95 % CI 0.91 [0.53–1.57], p = 0.73, p het = 0.83]), stent thrombosis (7.4 vs 4.6 %, HR [95 % CI 1.04 [0.55–2.05], p = 0.92, p het = 0.65]), and MACE (10 vs 13.6 %, HR [95 % CI 0.86 [0.63–1.18], p = 0.36, p het = 0.84]) (secondary endpoints). The present pooled patient-level meta-analysis demonstrates that, among STEMI patients undergoing primary PCI, SES and PES are associated with a similar outcome at long-term follow-up, in terms of death, reinfarction, stent thrombosis, TVR and MACE.

Keywords

Primary angioplasty STEMI Drug eluting stent Meta-analysis Randomized trials Sirolimus Paclitaxel 

Notes

Acknowledgments

Prof. De Luca had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. This study has no financial support.

References

  1. 1.
    De Luca G, Cassetti E, Marino P (2009) Percutaneous coronary intervention-related time delay, patient’s risk profile, and survival benefits of primary angioplasty vs lytic therapy in ST-segment elevation myocardial infarction. Am J Emerg Med 27:712–719PubMedCrossRefGoogle Scholar
  2. 2.
    De Luca G, Biondi-Zoccai G, Marino P (2008) Transferring patients with ST-segment elevation myocardial infarction for mechanical reperfusion: a meta-regression analysis of randomized trials. Ann Emerg Med 52:665–676PubMedCrossRefGoogle Scholar
  3. 3.
    De Luca G, Navarese EP, Cassetti E, Verdoia M, Suryapranata H (2011) Metaanalysis of randomized trials of glycoprotein IIb/IIIa inhibitors in high-risk acute coronary syndromes patients undergoing invasive strategy. Am J Cardiol 107:198–203PubMedCrossRefGoogle Scholar
  4. 4.
    De Luca G, Suryapranata H, Stone GW, Antoniucci D, Tcheng JE, Neumann FJ et al (2005) Abciximab as adjunctive therapy to reperfusion in acute ST-segment elevation myocardial infarction: a meta-analysis of randomized trials. JAMA 293:1759–1765PubMedCrossRefGoogle Scholar
  5. 5.
    De Luca G, Bellandi F, Huber K (2011) Noc M, Petronio AS, Arntz HR, Maioli M, Gabriel HM, Zorman S, DE Carlo M, Rakowski T, Gyongyosi M, Dudek D. Early glycoprotein IIb–IIIa inhibitors in primary angioplasty–abciximab long-term results (EGYPT-ALT) cooperation: individual patient’s data meta-analysis. J Thromb Haemost 9:2361–2370CrossRefGoogle Scholar
  6. 6.
    Stone GW, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, On behalf of the HORIZONS-AMI trial investigators et al (2011) Heparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction (HORIZONS-AMI): final 3-year results from a multicentre, randomised controlled trial. Lancet 377:2193–2204PubMedCrossRefGoogle Scholar
  7. 7.
    De Luca G, Cassetti E, Verdoia M, Marino P (2009) Bivalirudin as compared to unfractionated heparin among patients undergoing coronary angioplasty: a meta-analysis of randomised trials. Thromb Haemost 102:428–436PubMedGoogle Scholar
  8. 8.
    Stone GW, Grines CL, Cox DA, Garcia E, Tcheng JE, Griffin JJ et al (2002) Controlled abciximab and device investigation to lower late angioplasty complications (CADILLAC) investigators. Comparison of angioplasty with stenting, with or without abciximab, in acute myocardial infarction. N Engl J Med 346:957–966PubMedCrossRefGoogle Scholar
  9. 9.
    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 91:641–645PubMedCentralPubMedCrossRefGoogle Scholar
  10. 10.
    De Luca G, Suryapranata H, Stone GW, Antoniucci D, Biondi-Zoccai G, Kastrati A et al (2008) Coronary stenting versus balloon angioplasty for acute myocardial infarction: a meta-regression analysis of randomized trials. Int J Cardiol 126:37–44PubMedCrossRefGoogle Scholar
  11. 11.
    Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O’Shaughnessy C, SIRIUS Investigators et al (2003) Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 349:1315–1323PubMedCrossRefGoogle Scholar
  12. 12.
    De Luca G, Valgimigli M, Spaulding C, Menichelli M, Brunner-La Rocca HP, van der Hoeven BL, Di Lorenzo E, Diaz de la Llera LS, Pasceri V, Pittl U, Percoco G, Violini R, Stone GW (2009) Short and long-term benefits of sirolimus-eluting stent in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials. J Thromb Thrombolysis 28:200–210Google Scholar
  13. 13.
    De Luca G, Stone GW, Suryapranata H, Laarman GJ, Menichelli M, Kaiser C et al (2009) Efficacy and safety of drug-eluting stents in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials. Int J Cardiol 133:213–222PubMedCrossRefGoogle Scholar
  14. 14.
    Schomig A, Dibra A, Windecker S et al (2007) A meta-analysis of 16 randomized trials of sirolimus-eluting stents versus paclitax eleluting stents in patients with coronary artery disease. J Am Coll Cardiol 50:1373–1380PubMedCrossRefGoogle Scholar
  15. 15.
    Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW, Academic Research Consortium (2007) Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 115:2344–2351PubMedCrossRefGoogle Scholar
  16. 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 354:1896–1900PubMedCrossRefGoogle Scholar
  17. 17.
    Lee JH, Kim HS, Lee SW et al (2008) Prospective randomized comparison of sirolimus-versus paclitaxel-eluting stents for the treatment of acute ST elevation myocardial infarction: pROSIT trial. Catheter Cardiovasc Interv 72:25–32PubMedGoogle Scholar
  18. 18.
    Kim HS, Lee JH, Lee SW, Kim YH, Park JH, Choi SW, Jeong JO, Seong IW, Rhee KS, Ko JK, Jo SH (2011) Choi YJ.Long-term safety and efficacy of sirolimus- vs. paclitaxel-eluting stent implantation for acute ST-elevation myocardial infarction: 3-year follow-up of the PROSIT trial. Int J Cardiol 147:253–257PubMedCrossRefGoogle Scholar
  19. 19.
    Juwana YB, Suryapranata H, Ottervanger JP et al (2009) Comparison of rapamycin- and paclitaxel-eluting stents in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction. Am J Cardiol 104:205–209PubMedCrossRefGoogle Scholar
  20. 20.
    Di Lorenzo E, De Luca G, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G (2009) The PASEO (PaclitAxel or Sirolimus-Eluting stent versus bare metal stent in primary angioplasty) randomized trial. JACC Cardiovasc Interv 2:515–523PubMedCrossRefGoogle Scholar
  21. 21.
    Di Lorenzo E, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F et al (2009) Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial. Am Heart J 158:e43–e50PubMedCrossRefGoogle Scholar
  22. 22.
    Pittl U, Kaiser C, Brunner-La Rocca HP, BASKET Investigators (2006) 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):650Google Scholar
  23. 23.
    Lee CW, Park DW, Lee SH, Kim YH, Hong MK, Kim JJ, Park SW, Yun SC, Seong IW, Lee JH, Lee NH, Cho YH, Cheong SS, Lim DS, Yang JY, Lee SG, Kim KS, Yoon J, Jeong MH, Seung KB, Hong TJ, Park SJ, ZEST-AMI Investigators (2009) Comparison of the efficacy and safety of zotarolimus-, sirolimus-, and paclitaxel-eluting stents in patients with ST-elevation myocardial infarction. Am J Cardiol. 104:1370–1376PubMedCrossRefGoogle Scholar
  24. 24.
    De Luca G, Dirksen MT, Spaulding C, Kelbaek H, Schalij M, Thuesen L, van der Hoeven B, Vink MA, Kaiser C, Musto C, Chechi T, Spaziani G, de Díaz la Llera LS, Pasceri V, Di Lorenzo E, Violini R, Cortese G, Suryapranata H, Stone GW (2012) Drug-Eluting Stent in Primary Angioplasty (DESERT) Cooperation. Drug-eluting vs bare-metal stents in primary angioplasty: a pooled patient-level meta-analysis of randomized trials. Arch Intern Med 172:611–621PubMedCrossRefGoogle Scholar
  25. 25.
    Palmerini T, Biondi-Zoccai G, Della Riva D, Stettler C, Sangiorgi D, D’Ascenzo F, Kimura T, Briguori C, Sabatè M, Kim HS, De Waha A, Kedhi E, Smits PC, Kaiser C, Sardella G, Marullo A, Kirtane AJ, Leon MB, Stone GW (2012) Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet 379:1393–1402PubMedCrossRefGoogle Scholar
  26. 26.
    Hofma SH, Brouwer J, Velders MA, van’t Hof AW, Smits PC, Queré M, de Vries CJ, van Boven AJ (2012) Second-generation everolimus-eluting stents versus first-generation sirolimus-eluting stents in acute myocardial infarction. 1-year results of the randomized XAMI (XienceV Stent vs. Cypher Stent in Primary PCI for Acute Myocardial Infarction) trial. J Am Coll Cardiol 60:381–387PubMedCrossRefGoogle Scholar
  27. 27.
    Sabate M, Cequier A, Iñiguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Gómez-Hospital JA, Baz JA, Martin-Yuste V, van Geuns RJ, Alfonso F, Bordes P, Tebaldi M, Masotti M, Silvestro A, Backx B, Brugaletta S, van Es GA, Serruys PW (2012) Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial. Lancet 380:1482–1490PubMedCrossRefGoogle Scholar
  28. 28.
    Navarese EP, Kubica J, Castriota F, Gibson CM, De Luca G, Buffon A, Bolognese L, Margheri M, Andreotti F, Di Mario C, De Servi S (2011) Safety and efficacy of biodegradable vs durable polymer drug-eluting stents: evidence from a meta-analysis of randomised trials. EuroIntervention 7:985–994PubMedCrossRefGoogle Scholar
  29. 29.
    Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C et al (2009) Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 361:1045–1057PubMedCrossRefGoogle Scholar
  30. 30.
    Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, TRITON-TIMI 38 Investigators et al (2007) Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 357:2001–2015PubMedCrossRefGoogle Scholar
  31. 31.
    Verdoia M, Schaffer A, Barbieri L, Cassetti E, Piccolo R, Galasso G, Marino P, Sinigaglia F, De Luca G (2013) Benefits from new ADP-antagonists as compared to clopidogrel in patients with stable angina or acute coronary syndrome undergoing invasive management: a meta-analysis of randomized trials. J Cardiovasc Pharmacol. doi: 10.1097/FJC.0000000000000052 Google Scholar

Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  • Giuseppe De Luca
    • 1
    • 2
  • Jeffrey Wirianta
    • 3
  • Jae-Hwan Lee
    • 4
  • Christoph Kaiser
    • 5
  • Emilio Di Lorenzo
    • 6
  • Harry Suryapranata
    • 7
  1. 1.Division of Cardiology, Ospedale “Maggiore Della Carità”Eastern Piedmont UniversityNovaraItaly
  2. 2.Centro di Biotecnologie per la Ricerca Medica Applicata (BRMA)Eastern Piedmont UniversityNovaraItaly
  3. 3.Cardiovascular Center CinereJakartaIndonesia
  4. 4.Cardiovascular Center in Chungnam National University HospitalChungnam National UniversityDaejeonKorea
  5. 5.Department of CardiologyUniversity Hospital BaselBaselSwitzerland
  6. 6.Division of CardiologyS.G. MoscatiAvellinoItaly
  7. 7.Department of CardiologyUMC St RadboudNijmegenThe Netherlands

Personalised recommendations