Document Detail


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.
MedLine Citation:
PMID:  22910755     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
CONTEXT: The efficacy and safety of drug-eluting stents compared with bare-metal stents remains controversial in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).
OBJECTIVE: To compare stents eluting biolimus from a biodegradable polymer with bare-metal stents in primary PCI.
DESIGN, SETTING, AND PATIENTS: A prospective, randomized, single-blinded, controlled trial of 1161 patients presenting with STEMI at 11 sites in Europe and Israel between September 19, 2009, and January 25, 2011. Clinical follow-up was performed at 1 and 12 months.
INTERVENTION: Patients were randomized 1:1 to receive the biolimus-eluting stent (n = 575) or the bare-metal stent (n = 582).
MAIN OUTCOME MEASURES: Primary end point was the rate of major adverse cardiac events, a composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization at 1 year.
RESULTS: Major adverse cardiac events at 1 year occurred in 24 patients (4.3%) receiving biolimus-eluting stents with biodegradable polymer and 49 patients (8.7%) receiving bare-metal stents (hazard ratio [HR], 0.49; 95% CI, 0.30-0.80; P = .004). The difference was driven by a lower risk of target vessel-related reinfarction (3 [0.5%] vs 15 [2.7%]; HR, 0.20; 95% CI, 0.06-0.69; P = .01) and ischemia-driven target-lesion revascularization (9 [1.6%] vs 32 [5.7%]; HR, 0.28; 95% CI, 0.13-0.59; P < .001) in patients receiving biolimus-eluting stents compared with those receiving bare-metal stents. Rates of cardiac death were not significantly different (16 [2.9%] vs 20 [3.5%], P = .53). Definite stent thrombosis occurred in 5 patients (0.9%) treated with biolimus-eluting stents and 12 patients (2.1%; HR, 0.42; 95% CI, 0.15-1.19; P = .10) treated with bare-metal stents.
CONCLUSION: Compared with a bare-metal stent, the use of biolimus-eluting stents with a biodegradable polymer resulted in a lower rate of the composite of major adverse cardiac events at 1 year among patients with STEMI undergoing primary PCI.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00962416.
Authors:
Lorenz Räber; Henning Kelbæk; Miodrag Ostojic; Miodrag Ostoijc; Andreas Baumbach; Dik Heg; David Tüller; Clemens von Birgelen; Marco Roffi; Aris Moschovitis; Ahmed A Khattab; Peter Wenaweser; Robert Bonvini; Giovanni Pedrazzini; Ran Kornowski; Klaus Weber; Sven Trelle; Thomas F Lüscher; Masanori Taniwaki; Christian M Matter; Bernhard Meier; Peter Jüni; Stephan Windecker;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  JAMA     Volume:  308     ISSN:  1538-3598     ISO Abbreviation:  JAMA     Publication Date:  2012 Aug 
Date Detail:
Created Date:  2012-08-22     Completed Date:  2012-08-27     Revised Date:  2014-09-17    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  United States    
Other Details:
Languages:  eng     Pagination:  777-87     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00962416
Export Citation:
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MeSH Terms
Descriptor/Qualifier:
Absorbable Implants*
Aged
Drug-Eluting Stents*
Female
Humans
Male
Metals
Middle Aged
Myocardial Infarction / mortality*,  therapy*
Myocardial Ischemia
Myocardial Reperfusion / methods*
Myocardial Revascularization
Polymers
Prospective Studies
Recurrence
Risk
Single-Blind Method
Sirolimus / administration & dosage,  analogs & derivatives*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Biolimus A9; 0/Metals; 0/Polymers; W36ZG6FT64/Sirolimus
Investigator
Investigator/Affiliation:
Lorenz Räber / ; Peter Jüni / ; Stephan Windecker / ; Jonathan Sterne / ; Michel Bertrand / ; Philip Urban / ; Pascal Vranckx / ; Gerrit Hellige / ; Igal Moarof / ; Brigitte Wanner / ; Anna Plym / ; Lucia Kacina / ; Sandro Baumgartner / ; Timon Spörri / ; Jürgen Nagler-Ihlein / ; Thorsten Ihlmann / ; Thomas Engstrøm / ; Lene Holmvang / ; Erik Jørgensen / ; Maria D Radu / ; Kari Saunamäki / ; Branko Beleslin / ; Dejan Orlic / ; Jelena Kostic / ; Vladan Vukcevic / ; Sujatha Kesavan / ; Julian Strange / ; Tom W Johnson / ; Franz Eberli / ; David Kurz / ; Rainer Zbinden / ; K Gert van Houwelingen / ; Martin G Stoel / ; J Hans W Louwerenberg / ; Tiziano Mocetti / ; Maria Grazia Rossi / ; David Carballo / ; Francois Mach / ; Pierre-Frédéric Keller / ; Roberto Corti / ; Roland Klingenberg / ; Ulf Landmesser / ; Abid Assali / ; Hana Vaknin-Assa / ; Michael Pieper / ; Hector M Garcia Garcia / ; Bindu Kalesan /
Comments/Corrections
Comment In:
Dtsch Med Wochenschr. 2012 Oct;137(42):2136   [PMID:  23227521 ]
JAMA. 2012 Aug 22;308(8):814-5   [PMID:  22910760 ]
Erratum In:
JAMA. 2012 Oct 17;308(15):1526
Note: Ostoijc, Miodrag [corrected to Ostojic, Miodrag]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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