title: Drug-eluting vs bare-metal stents in primary angioplasty: a pooled patient-level meta-analysis of randomized trials.
abstract: BACKGROUND
  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). Our objective was to perform a meta-analysis using individual patient data to evaluate the long-term safety and effectiveness of DES compared with bare-metal stents (BMS) in patients undergoing primary percutaneous coronary intervention for STEMI.
  
  
  METHODS
  Formal searches of electronic databases (MEDLINE and CENTRAL) and scientific session presentations from January 2000 to June 2011.
  
  
  METHODS
  We examined all completed randomized trials of DES for STEMI.
  
  
  METHODS
  Individual patient data.
  
  
  RESULTS
  Individual patient data were obtained from 11 of 13 trials identified, including a total of 6298 patients (3980 [63.2%] randomized to DES [99% sirolimus-eluting or paclitaxel-eluting stents] and 2318 [36.8%] randomized to BMS). At long-term follow-up (mean [SD], 1201 [440] days), DES implantation significantly reduced the occurrence of target-vessel revascularization (12.7% vs 20.1%; hazard ratio [95% CI], 0.57 [0.50-0.66]; P < .001, P value for heterogeneity, .20), without any significant difference in terms of mortality, reinfarction, and stent thrombosis. However, DES implantation was associated with an increased risk of very late stent thrombosis and reinfarction.
  
  
  CONCLUSIONS
  The present pooled patient-level meta-analysis demonstrates that among patients with STEMI undergoing primary percutaneous coronary intervention, sirolimus-eluting and paclitaxel-eluting stents compared with BMS are associated with a significant reduction in target-vessel revascularization 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 these DES.
authors.affiliation: Division of Cardiology, Ospedale "Maggiore della Carità," Eastern Piedmont University, Novara, Italy. giuseppe.deluca@maggioreosp.novara.it
authors.forename: Giuseppe
authors.initials: G
authors.lastname: De Luca
authors.forename: Maurits T
authors.initials: MT
authors.lastname: Dirksen
authors.forename: Christian
authors.initials: C
authors.lastname: Spaulding
authors.forename: Henning
authors.initials: H
authors.lastname: Kelbaek
authors.forename: Martin
authors.initials: M
authors.lastname: Schalij
authors.forename: Leif
authors.initials: L
authors.lastname: Thuesen
authors.forename: Bas
authors.initials: B
authors.lastname: van der Hoeven
authors.forename: Marteen A
authors.initials: MA
authors.lastname: Vink
authors.forename: Christoph
authors.initials: C
authors.lastname: Kaiser
authors.forename: Carmine
authors.initials: C
authors.lastname: Musto
authors.forename: Tania
authors.initials: T
authors.lastname: Chechi
authors.forename: Gaia
authors.initials: G
authors.lastname: Spaziani
authors.forename: Luis Salvador
authors.initials: LS
authors.lastname: Díaz de la Llera
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Pasceri
authors.forename: Emilio
authors.initials: E
authors.lastname: Di Lorenzo
authors.forename: Roberto
authors.initials: R
authors.lastname: Violini
authors.forename: Giuliana
authors.initials: G
authors.lastname: Cortese
authors.forename: Harry
authors.initials: H
authors.lastname: Suryapranata
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D006329:Heart Conduction System / Q000503:physiopathology*; D006801:Humans; D015994:Incidence; D009203:Myocardial Infarction / Q000453:epidemiology* / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D009204:Myocardial Revascularization / Q000706:statistics & numerical data*; D016017:Odds Ratio; D017239:Paclitaxel / Q000009:adverse effects; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D012307:Risk Factors; D020123:Sirolimus / Q000009:adverse effects; D015607:Stents / Q000009:adverse effects*; D013927:Thrombosis / Q000139:chemically induced / Q000453:epidemiology* / Q000209:etiology; D013997:Time Factors
chemical_list: D017239:Paclitaxel; D020123:Sirolimus