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Region Hovedstaden - en del af Københavns Universitetshospital
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Biolimus-eluting stents with biodegradable polymer versus bare-metal stents in acute myocardial infarction: two-year clinical results of the COMFORTABLE AMI trial

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Atrial Fibrillation and Percutaneous Coronary Intervention

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Impact of Diabetes Mellitus in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Bicuspid Aortic Valve Anatomy and Relationship With Devices: The BAVARD Multicenter Registry

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Infective Endocarditis Following Transcatheter Aortic Valve Replacement: Comparison of Balloon- Versus Self-Expandable Valves

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  • Lorenz Räber
  • Henning Kelbæk
  • Masanori Taniwaki
  • Miodrag Ostojic
  • Dik Heg
  • Andreas Baumbach
  • Clemens von Birgelen
  • Marco Roffi
  • David Tüller
  • Thomas Engstrøm
  • Aris Moschovitis
  • Giovanni Pedrazzini
  • Peter Wenaweser
  • Ran Kornowski
  • Klaus Weber
  • Thomas F Lüscher
  • Christian M Matter
  • Bernhard Meier
  • Peter Jüni
  • Stephan Windecker
  • COMFORTABLE AMI Trial Investigators
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BACKGROUND: This study sought to determine whether the 1-year differences in major adverse cardiac event between a stent eluting biolimus from a biodegradable polymer and bare-metal stents (BMSs) in the COMFORTABLE trial (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) were sustained during long-term follow-up.

METHODS AND RESULTS: A total of 1161 patients were randomly assigned to biolimus-eluting stent (BES) and BMS at 11 centers, and follow-up rates at 2 years were 96.3%. A subgroup of 103 patients underwent angiography at 13 months. At 2 years, differences in the primary end point of cardiac death, target-vessel myocardial infarction, and target lesion revascularization continued to diverge in favor of BES-treated patients (5.8%) compared with BMS-treated patients (11.9%; hazard ratio = 0.48; 95% confidence interval, 0.31-0.72; P < 0.001) with a significant risk reduction during the second year of follow-up (hazard ratio 1-2 years = 0.45; 95% confidence interval, 0.20-1.00; P = 0.049). Differences in the primary end point were driven by a reduction in target lesion revascularization (3.1% versus 8.2%; P < 0.001) and target-vessel reinfarction (1.3% versus 3.4%; P = 0.023). The composite of death, any reinfarction and revascularization (14.5% versus 19.3%; P = 0.03), and cardiac death or target-vessel myocardial infarction (4.2% versus 7.2%; P = 0.036) were less frequent among BES-treated patients compared with BMS-treated patients. The 13-month angiographic in-stent percent diameter stenosis amounted to 12.0 ± 7.2 in BES- and 39.6 ± 25.2 in BMS-treated lesions (P < 0.001).

CONCLUSIONS: Among patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention, BES continued to improve cardiovascular events compared with BMS beyond 1 year.

CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NTC00962416.

OriginalsprogEngelsk
TidsskriftCirculation. Cardiovascular interventions
Vol/bind7
Udgave nummer3
Sider (fra-til)355-64
Antal sider10
ISSN1941-7640
DOI
StatusUdgivet - jun. 2014

ID: 45030607