Abstract
Background
Several concerns have emerged on the higher risk of in-stent thrombosis after drug-eluting stent (DES) implantation, especially in the setting of STEMI patients. Few data have even been reported in high-risk patients, such as those with anterior MI. Therefore this represents the aim of the current study.
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 key words were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, stenting, DES, sirolimus-eluting stent (SES), Cypher, paclitaxel-eluting stent (PES), Taxus. No language restrictions were enforced.
Results
Individual patient’s data were obtained from 11 out of 13 trials, including a total of 2,782 patients with anterior MI [1,739 or 62.5 % randomized to DES and 1,043 or 37.5 % randomized to bare-metal stent (BMS)]. At long-term follow-up, no significant benefit was observed with DES as compared to BMS in terms of mortality [9.8 vs 10.9 %, HR (95 % CI) = 0.81 (0.61, 1.07), p = 0.13, p heterogeneity = 0.18], reinfarction [8.8 vs 6.4 %, respectively; HR (95 % CI) = 1.14 (0.80, 1.61), p = 0.47, p heterogeneity = 0.82], and stent thrombosis [5.6 vs 5 %, OR (95 % CI) = 0.88 (0.59, 1.30), p = 0.51, p heterogeneity = 0.65], whereas DES was associated with a significant reduction in terms of target-vessel revascularization (TVR) [13.7 vs 23.4 %; OR (95 % CI) = 0.56 (0.46, 0.69), p < 0.0001, p het = 0.81] that was observed at both early (within 1 year) [7 vs 14.7 %, HR (95 % CI) = 0.56 (0.46, 0.69), p < 0.0001, p het = 0.81] and late (>1 year) follow-up [7.2 vs 9 %, HR (95 % CI) = 0.67 (0.47, 0.96), p = 0.03, p het = 0.96].
Conclusions
This study showed that among patients with anterior STEMI undergoing primary angioplasty, SES and PES, as compared to BMS, are associated with a significant reduction in TVR at long-term follow-up. No concerns were found with the use of first-generation DES in terms of mortality.
References
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
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
Vandecasteele EH, De Buyzere M, Gevaert S, de Meester A, Convens C, Dubois P, Boland J, Sinnaeve P, De Raedt H, Vranckx P, Coussement P, Evrard P, Beauloye C, Renard M, Claeys MJ (2013) Reperfusion therapy and mortality in octogenarian STEMI patients: results from the Belgian STEMI registry. Clin Res Cardiol 102(11):837–845
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
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
Stone GW, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Dangas G, Wong SC, Fahy M, Parise H, Mehran R, On behalf of the HORIZONS-AMI Trial Investigators (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 [Epub ahead of print]
Stone GW, Grines CL, Cox DA, Garcia E, Tcheng JE, Griffin JJ, Guagliumi G, Stuckey T, Turco M, Carroll JD, Rutherford BD, Lansky AJ, Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) Investigators (2002) Comparison of angioplasty with stenting, with or without abciximab, in acute myocardial infarction. N Engl J Med 346:957–966
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
De Luca G, Suryapranata H, van’t Hof AW, Ottervanger JP, Hoorntje JC, Dambrink JH, Gosselink AT, de Boer MJ (2009) Routine stenting vs. balloon angioplasty in ST-segment elevation myocardial infarction due to proximal left anterior descending coronary artery occlusion. J Cardiovasc Med 10:22–26
Stone GW, Ellis SG, Cox DA, Hermiller J, O’Shaughnessy C, Mann JT, TAXUS-IV Investigators et al (2004) A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 350:221–231
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 (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
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 28:200–210
Piccolo R, Cassese S, Galasso G, Niglio T, De Rosa R, De Biase C, Piscione F (2012) Long-term clinical outcomes following sirolimus-eluting stent implantation inpatients with acute myocardial infarction. A meta-analysis of randomized trials. Clin Res Cardiol 101:885–893
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, Drug-Eluting Stent in Primary Angioplasty (DESERT) Cooperation (2012) Drug-eluting vs bare-metal stents in primary angioplasty: a pooled patient-level meta-analysis of randomized trials. Arch Intern Med 172:611–21
Egger M, Smith GD (1998) Bias in location and selection of studies. BMJ 31:61–66
Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group (2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med 151:264–9, W64
Tebaldi M, Arcozzi C, Campo G, Percoco G, Ferrari R, Valgimigli M, STRATEGY Investigators (2009) The 5-year clinical outcomes after a randomized comparison of sirolimus-eluting versus bare-metal stent implantation in patients with ST-segment elevation myocardial infarction. J Am Coll Cardiol 54:1900–1901
Vink MA, Dirksen MT, Suttorp MJ, Tijssen JG, van Etten J, Patterson MS, Slagboom T, Kiemeneij F, Laarman GJ (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
Spaulding C, Teiger E, Commeau P, Varenne O, Bramucci E, Slama M, Beatt K, Tirouvanziam A, Polonski L, Stella PR, Clugston R, Fajadet J, de Boisgelin X, Bode C, Carrié D, Erglis A, Merkely B, Hosten S, Cebrian A, Wang P, Stoll HP, Henry P (2011) Four-year follow-up of TYPHOON (trial to assess the use of the CYPHer sirolimus-eluting coronary stent in acute myocardial infarction treated with BallOON angioplasty). JACC Cardiovasc Interv 4:14–23
Di Lorenzo E, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G, De Luca G (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
Violini R, Musto C, De Felice F, Nazzaro MS, Cifarelli A, Petitti T, Fiorilli R (2010) Maintenance of long-term clinical benefit with sirolimus-eluting stents in patients with ST-segment elevation myocardial infarction 3-year results of the SESAMI (sirolimus-eluting stent versus bare-metal stent in acute myocardial infarction) trial. J Am Coll Cardiol 55:810–814
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):650
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
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
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
Atary JZ, van der Hoeven BL, Liem SS, Jukema JW, van der Bom JG, Atsma DE, Bootsma M, Zeppenfeld K, van der Wall EE, Schalij MJ (2010) Three-year outcome of sirolimus-eluting versus bare-metal stents for the treatment of ST-segment elevation myocardial infarction (from the MISSION! Intervention Study). Am J Cardiol 106:4–12
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
Kaltoft A, Kelbaek H, Thuesen L, Lassen JF, Clemmensen P, Kløvgaard L, Engstrøm T, Bøtker HE, Saunamäki K, Krusell LR, Jørgensen E, Tilsted HH, Christiansen EH, Ravkilde J, Køber L, Kofoed KF, Terkelsen CJ, Helqvist S (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
Karjalainen. TITAX AMI Trial. http://www.tctmd.com/csportal/appmanager/tctmd/tct2007?_nfpb=true&_pageLabel=TCT2007Content&hdCon=1518259
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, 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 299:1788–1799
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.e1–6
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
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
The Epistent investigators (1998) Randomised placebo-controlled and balloon-angioplasty-controlled trial to assess safety of coronary stenting with use of platelet glycoprotein-IIb/IIIa blockade. Lancet 352:87–92
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
Suryapranata H, van’t Hof AW, Hoorntje JC, de Boer MJ, Zijlstra F (1998) Randomised comparison of coronary stenting with balloon angioplasty in selected patients with acute myocardial infarction. Circulation 97: 2502–2505
Antoniucci D, Santoro GM, Bolognese L, Valenti R, Trapani M, Fazzini PF (1998) A clinical trial comparing primary stenting of the infarct-related artery with optimal primary angioplasty for acute myocardial infarction: results from the Florence randomised elective stenting in acute coronary occlusion (FRESCO) trial. J Am Coll Cardiol 31:1234–1239
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
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
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
Steg PG, Fox KA, Eagle KA, Furman M, Van de Werf F, Montalescot G, Goodman SG, Avezum A, Huang W, Gore JM, Global Registry of Acute Coronary Events (GRACE) Investigators (2009) Mortality following placement of drug-eluting and bare-metal stents for ST-segment elevation acute myocardial infarction in the Global Registry of Acute Coronary Events. Eur Heart J 30:321–329
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 151:1256–9
Wöhrle J, Brodie B, Witzenbichler B, Dudek D, Kornowski R, Metzger C, Grines C, McAndrew TC, Parise H, Sergie Z, Mehran R, Stone GW (2013) Impact of bivalirudin and paclitaxel-eluting stents on outcomes in patients undergoing primary percutaneous coronary intervention of the left anterior descending artery. Am J Cardiol 112:753–760
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 380:1482–1489
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, COMFORTABLE AMI Trial Investigators (2012) 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(8):777–787
Gomez-Lara J, Brugaletta S, Gomez-Hospital JA, Ferreiro JL, Roura G, Romaguera R, Martin-Yuste V, Masotti M, Iñiguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Serruys P, Sabate M, Cequier A (2013) Everolimus-eluting stent versus bare metal stent in proximal left anterior descending ST-elevation myocardial infarction: insights from the EXAMINATION trial. Am Heart J 166:119–126
de Waha A, Cassese S, Park DW, Burzotta F, Byrne RA, Tada T, King LA, Park SJ, Schömig A, Kastrati A (2012) Everolimus-eluting versus sirolimus-eluting stents: an updated meta-analysis of randomized trials. Clin Res Cardiol 101:461–7
De Luca G, Suryapranata H, de Boer MJ, Ottervanger JP, Hoorntje JC, Gosselink AT, Dambrink JH, Ernst N, van’t Hof AW, Ongoing Tirofiban In Myocardial Infarction Evaluation (On-TIME) study group (2007) Combination of electrocardiographic and angiographic markers of reperfusion in the prediction of infarct size in patients with ST-segment elevation myocardial infarction undergoing successful primary angioplasty. Int J Cardiol 117:232–7
De Luca G, Maas AC, Suryapranata H, Ottervanger JP, Hoorntje JC, Gosselink AT, Dambrink JH, de Boer MJ, van’t Hof AW (2005) Prognostic significance of residual cumulative ST-segment deviation after mechanical reperfusion in patients with ST-segment elevation myocardial infarction. Am Heart J 150:1248–1254
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 [Epub ahead of print]
Theidel U, Asseburg C, Giannitsis E, Katus H (2013) Cost-effectiveness of ticagrelor versus clopidogrel for the prevention of atherothrombotic events in adult patients with acute coronary syndrome in Germany. Clin Res Cardiol 102(6):447–458
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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. All authors declare that they participated in the study and that they have seen and approved the final version.
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De Luca, G., Dirksen, M.T., Spaulding, C. et al. Drug-eluting stents in patients with anterior STEMI undergoing primary angioplasty: a substudy of the DESERT cooperation. Clin Res Cardiol 103, 685–699 (2014). https://doi.org/10.1007/s00392-014-0702-6
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DOI: https://doi.org/10.1007/s00392-014-0702-6