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Paclitaxel-eluting versus bare metal stents in primary PCI: a pooled patient-level meta-analysis of randomized trials

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Abstract

Concerns have emerged regarding a higher risk of stent thrombosis after drug-eluting stent (DES) implantation, especially in the setting of ST-segment elevation myocardial infarction (STEMI). Therefore, we performed a meta-analysis based on individual patient data to evaluate long-term safety and effectiveness of paclitaxel-eluting stent (PES) as compared to bare metal stents (BMS) in patients undergoing primary percutaneous coronary intervention (PCI) for STEMI. We examined all completed randomized trials on PES for STEMI. Individual patient data were obtained from six trials. We performed survival analyses with the use of Cox-regression analysis stratified according to trial. Kaplan–Meier survival curves are presented with event rates reported as estimated probabilities. A subsequent landmark analysis was performed for patients who were event-free at 1-year follow-up in order to define outcome in terms of early (≤1 year) and late (>1 year) events. A total of six trials were finally included in the meta-analysis with 4435 patients, 2875 (64.8 %) assigned to PES and 1560 (35.2 %) to BMS. No significant differences in baseline characteristics were observed between the two groups. However, a significantly higher percentage of patients in the DES group were on dual antiplatelet therapy during 3-year follow-up, as compared to BMS. At long-term follow-up (1,095 [1,090–1,155] days), no significant difference between PES and BMS was observed in mortality (9.2 vs 11.9 %, respectively, HR [95 % CI] = 0.84 [0.67, 1.06], p = 0.15, pheterogeneity = 0.59), reinfarction (8.8 vs 7 %, respectively; HR [95 % CI] = 1.10 [0.84, 1.44], p = 0.51, pheterogeneity = 0.32), stent thrombosis (6.7 vs 4.0 % respectively, HR [95 % CI] = 1.13 [0.82, 1.55], p = 0.45, pheterogeneity = 0.99) and TVR (11.9 vs 20.0 %; HR [95 % CI] = 0.64 [0.54, 0.77], p < 0.0001, pheterogeneity = 0.25). Landmark analysis showed that PES was associated with a significantly higher rate of very late reinfarction (>1 year) (5.6 vs 3.9 %, HR [95 % CI] = 1.61 [1.05–2.47], p = 0.03, pheterogeneity = 0.51], very late ST (2.9 vs 1.1 %, HR [95 % CI] = 1.88 [1.00–3.54], p = 0.05, pheterogeneity = 0.94]. The present pooled patient-level meta-analysis demonstrates that among STEMI patients undergoing primary PCI, PES compared to BMS is associated with a significant reduction in TVR at long-term follow-up. Although there were no differences in cumulative mortality, reinfarction or stent thrombosis, the incidence of very late reinfarction and stent thrombosis was increased with PES.

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References

  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 27:712–719

    Article  PubMed  Google Scholar 

  2. De Luca G, Suryapranata H, Marino P (2008) Reperfusion strategies in acute ST-elevation myocardial infarction: an overview of current status. Prog Cardiovasc Dis 50:352–382

    Article  PubMed  Google Scholar 

  3. De Luca G, Bellandi F, Huber K, Noc M, Petronio AS, Arntz HR, Maioli M, Gabriel HM, Zorman S, DE Carlo M, Rakowski T, Gyongyosi M, Dudek D (2011) Early glycoprotein IIb–IIIa inhibitors in primary angioplasty-abciximab long-term results (EGYPT-ALT) cooperation: individual patient’s data meta-analysis. J Thromb Haemost 9:2361–2370

    Article  Google Scholar 

  4. De Luca G, Smit JJ, Ernst N, Suryapranata H, Ottervanger JP, Hoorntje JC, Dambrink JH, Gosslink AT, de Boer MJ, van’t Hof AW (2005) Impact of adjunctive tirofiban administration on myocardial perfusion and mortality in patients undergoing primary angioplasty for ST-segment elevation myocardial infarction. Thromb Haemost 93:820–823

    PubMed  Google Scholar 

  5. 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 377:2193–2204

    Article  CAS  PubMed  Google Scholar 

  6. Navarese EP, De Luca G, Castriota F, Kozinski M, Gurbel PA, Gibson CM, Andreotti F, Buffon A, Siller-Matula JM, Sukiennik A, De Servi S, Kubica J (2011) Low-molecular-weight heparins vs. unfractionated heparin in the setting of percutaneous coronary intervention for ST-elevation myocardial infarction: a meta-analysis. J Thromb Haemost 9:1902–1915

    Article  CAS  PubMed  Google Scholar 

  7. Escolar E, Mintz GS, Popma J, Michalek A, Kim SW, Mandinov L, Koglin J, Stone G, Ellis SG, Grube E, Dawkins KD, Weissman NJ (2007) Meta-analysis of angiographic versus intravascular ultrasound parameters of drug-eluting stent efficacy (from TAXUS IV, V, and VI). Am J Cardiol 100:621–626

    Article  CAS  PubMed  Google Scholar 

  8. Stone GW, Ellis SG, Colombo A, Grube E, Popma JJ, Uchida T, Bleuit JS, Dawkins KD, Russell ME (2011) Long-term safety and efficacy of paclitaxel-eluting stents final 5-year analysis from the TAXUS Clinical Trial Program. JACC Cardiovasc Interv 4:530–542

    Article  PubMed  Google Scholar 

  9. 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

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  10. 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 133:213–222

    Article  PubMed  Google Scholar 

  11. De Luca G, Valgimigli M, Spaulding C, Menichelli M, Brunner-La Rocca HP, van der Hoeven BL et al (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 28:200–210

    Article  CAS  PubMed  Google Scholar 

  12. Dibra A, Tiroch K, Schulz S, Kelbaek H, Spaulding C, Laarman GJ et al (2010) A. Drug-eluting stents in acute myocardial infarction: updated meta-analysis of randomized trials. Clin Res Cardiol 99:345–357

    Article  CAS  PubMed  Google Scholar 

  13. 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

    Article  CAS  PubMed  Google Scholar 

  14. 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

    Article  CAS  PubMed  Google Scholar 

  15. 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

    Article  CAS  PubMed  Google Scholar 

  16. 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 

  17. 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

    Article  CAS  PubMed  Google Scholar 

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

    Article  Google Scholar 

  19. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, Clarke M, Devereaux PJ, Kleijnen J, Moher D (2009) The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Ann Intern Med 151:W65–W94

    Article  PubMed  Google Scholar 

  20. Vink MA, Dirksen MT, Suttorp MJ, Tijssen JG, van Etten J, Patterson MS et al (2011) 5-year follow-up after primary percutaneous coronary intervention with a paclitaxel-eluting stent versus a bare-metal stent in acute ST-segment elevation myocardial infarction: a follow-up study of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation) trial. JACC Cardiovasc Interv 4:24–29

    Article  PubMed  Google Scholar 

  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–e50

    Article  PubMed  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(Suppl):650 Abstract

    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(Suppl):831 Abstract

    Google Scholar 

  24. Tierala I 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. Accessed 10 Oct 2013

  25. Chechi T, Vittori G, Biondi Zoccai GG, Vecchio S, Falchetti E, Spaziani G et al (2007) Single-center randomized evaluation of paclitaxel-eluting versus conventional stent in acute myocardial infarction (SELECTION). J Interv Cardiol 20:282–291

    Article  PubMed  Google Scholar 

  26. Kaltoft A, Kelbaek H, Thuesen L, Lassen JF, Clemmensen P, Kløvgaard L et al (2010) Long-term outcome after drug-eluting versus bare-metal stent implantation in patients with ST-segment elevation myocardial infarction: 3-year follow-up of the randomized DEDICATION (Drug Elution and Distal Protection in Acute Myocardial Infarction) Trial. J Am Coll Cardiol 56:641–645

    Article  PubMed  Google Scholar 

  27. De Luca G, Ernst N, van’t Hof AW, Ottervanger JP, Hoorntje JC, Gosselink AT, Dambrink JH, de Boer MJ, Suryapranata H (2006) Predictors and clinical implications of early reinfarction after primary angioplasty for ST-segment elevation myocardial infarction. Am Heart J 151:1256–1259

    Article  PubMed  Google Scholar 

  28. De Luca G, Dirksen MT, Spaulding C, Kelbæk H, Schalij M, Thuesen L, van der Hoeven B, Vink MA, Kaiser C, Musto C, Chechi T, Spaziani G, Diaz de la Llera LS, Pasceri V, Di Lorenzo E, Violini R, Suryapranata H, Stone GW (2013) DESERT cooperation. Time course, predictors and clinical implications of stent thrombosis following primary angioplasty. Insights from the DESERT cooperation. Thromb Haemost 110:826–833

    Article  PubMed  Google Scholar 

  29. George BS, Voorhees WD 3rd, Roubin GS, Fearnot NE, Pinkerton CA, Raizner AE et al (1993) Multicenter investigation of coronary stenting to treat acute or threatened closure after percutaneous transluminal coronary angioplasty: clinical and angiographic outcomes. J Am Coll Cardiol 22:135–143

    Article  CAS  PubMed  Google Scholar 

  30. Schomig A, Neumann FJ, Kastrati A, Schuhlen H, Blasini R, Hadamitzky M et al (1996) A randomised comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents. N Engl J Med 334:1084–1089

    Article  CAS  PubMed  Google Scholar 

  31. De Luca G, Verdoia M, Suryapranata H (2012) Benefits from intracoronary as compared to intravenous abciximab administration for STEMI patients undergoing primary angioplasty: a meta-analysis of 8 randomized trials. Atherosclerosis 222:426–433

    Article  PubMed  Google Scholar 

  32. Verdoia M, Schaffer A, Barbieri L, Cassetti E, Piccolo R, Galasso G, Marino P, Sinigaglia F, De Luca G (2014) 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 63(4):339–350

    Article  CAS  PubMed  Google Scholar 

  33. De Luca G, Cassetti E, Verdoia M, Marino P (2009) Bivalirudin as compared to unfractionated heparin among patients undergoing coronary angioplasty: a meta-analyis of randomised trials. Thromb Haemost 102:428–436

    PubMed  Google Scholar 

  34. Capozzolo C, Piscione F, De Luca G, Cioppa A, Mazzarotto P, Leosco D, Golino P, Indolfi C, Chiariello M (2001) Direct coronary stenting: effect on coronary blood flow, immediate and late clinical results. Catheter Cardiovasc Interv 53:464–473

    Article  CAS  PubMed  Google Scholar 

  35. De Luca G, Marino P (2007) Adjunctive benefits from low-molecular-weight heparins as compared to unfractionated heparin among patients with ST-segment elevation myocardial infarction treated with thrombolysis. A meta-analysis of the randomized trials. Am Heart J 154(1085):e1–e6

    PubMed  Google Scholar 

  36. 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 

  37. Suryapranata H, De Luca G, Ottervanger JP, Hoorntje JC, Dambrink JH, Gosselink AT, Zijlstra F, de Boer MJ (2005) Is routine stenting for acute myocardial infarction superior to balloon angioplasty? A randomised comparison in a large cohort of unselected patients. Heart 91:641–645

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  38. De Luca G, Dirksen MT, Spaulding C, Kelbæk H, Schalij M, Thuesen L, van der Hoeven B, Vink MA, Kaiser C, Musto C, Chechi T, Spaziani G, Diaz de la Llera LS, Pasceri V, Di Lorenzo E, Violini R, Suryapranata H, Stone GW (2013) DESERT cooperation. Impact of age on long-term outcome after primary angioplasty with bare-metal or drug-eluting stent (from the DESERT cooperation). Am J Cardiol 112:181–186

    Article  PubMed  Google Scholar 

  39. De Luca G, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Carbone G, Pagliuca MR, Rosato G, Di Lorenzo E (2010) Impact of diabetes on long-term outcome in STEMI patients undergoing primary angioplasty with glycoprotein IIb-IIIa inhibitors and BMS or DES. J Thromb Thrombolysis 30:133–141

    Article  PubMed  Google Scholar 

  40. De Luca G, Gibson CM, Bellandi F, Noc M, Dudek D, Zeymer U, Arntz HR, Cutlip D, Maioli M, Zorman S, Mesquita Gabriel H, Emre A, Rakowski T, Gyongyosi M, Huber K, van’t Hof AW (2009) Diabetes mellitus is associated with distal embolization, impaired myocardial perfusion, and higher mortality in patients with ST-segment elevation myocardial infarction treated with primary angioplasty and glycoprotein IIb-IIIa inhibitors. Atherosclerosis 207:181–185

    Article  PubMed  Google Scholar 

  41. De Luca G, Dirksen MT, Spaulding C, Kelbæk H, Schalij M, Thuesen L, van der Hoeven B, Vink MA, Kaiser C, Musto C, Chechi T, Spaziani G, Diaz de la Llera LS, Pasceri V, Di Lorenzo E, Violini R, Suryapranata H, Stone GW (2013) DESERT cooperation. Impact of diabetes on long-term outcome after primary angioplasty: insights from the DESERT cooperation. Diabetes Care 36:1020–1025

    Article  PubMed Central  PubMed  Google Scholar 

  42. 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, Díaz de la Llera LS, Pasceri V, Di Lorenzo E, Violini R, Cortese G, Suryapranata H, Stone GW (2012) Drug-eluting versus bare metal stents in primary angioplasty: a pooled patient-level meta-analysis of randomized trials. Arch Intern Med 172:611–621

    Article  PubMed  Google Scholar 

  43. Stone GW, Ellis SG, Colombo A, Dawkins KD, Grube E, Cutlip DE et al (2007) Offsetting impact of thrombosis and restenosis on the occurrence of death and myocardial infarction after paclitaxel-eluting and bare metal stent implantation. Circulation 115:2842–2847

    Article  PubMed  Google Scholar 

  44. 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 380:1482–1490

    Article  CAS  PubMed  Google Scholar 

  45. Räber L, Kelbæk H, Ostojic M, Baumbach A, Heg D, Tüller D, von Birgelen C, Roffi M, Moschovitis A, Khattab AA, Wenaweser P, Bonvini R, Pedrazzini G, Kornowski R, Weber K, Trelle S, Lüscher TF, Taniwaki M, Matter CM, Meier B, Jüni P, Windecker S (2012) COMFORTABLE AMI Trial Investigators. Effect of biolimus-eluting stents with biodegradable polymer vs bare-metal stents on cardiovascular events among patients with acute myocardial infarction: the COMFORTABLE AMI randomized trial. JAMA 308:777–787

    Article  PubMed  Google Scholar 

  46. 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 7:985–994

    Article  PubMed  Google Scholar 

  47. Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S et al (2007) TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 357:2001–2015

    Article  CAS  PubMed  Google Scholar 

  48. 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 361:1045–1057

    Article  CAS  PubMed  Google Scholar 

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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.

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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. Department of Interventional Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands

    Maurits T. Dirksen & Marteen A. Vink

  4. The Heart Center, Rigshospitalet, Copenhagen, Denmark

    Henning Kelbæk

  5. Cardiac Department, Skejby Hospital, Skejby, Denmark

    Leif Thuesen

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

    Christoph Kaiser

  7. Ospedale Santa Maria Annunziata, Bagno a Ripoli, Florence, Italy

    Tania Chechi & Gaia Spaziani

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

    Emilio Di Lorenzo

  9. Department of Cardiology, UMC St Radboud, Nijmegen, The Netherlands

    Harry Suryapranata

  10. Columbia University Medical Center, New York, USA

    Gregg W. Stone

  11. Cardiovascular Research Foundation, New York, USA

    Gregg W. Stone

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  1. Giuseppe De Luca
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De Luca, G., Dirksen, M.T., Kelbæk, H. et al. Paclitaxel-eluting versus bare metal stents in primary PCI: a pooled patient-level meta-analysis of randomized trials. J Thromb Thrombolysis 39, 101–112 (2015). https://doi.org/10.1007/s11239-014-1091-4

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