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European Heart Journal Advance Access originally published online on May 12, 2006
European Heart Journal 2006 27(12):1508-1509; doi:10.1093/eurheartj/ehl008
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© The European Society of Cardiology 2006. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Three-year duration of benefit from abciximab in patient receiving stents for acute myocardial infarction in the randomized double-blind ADMIRAL study

Jaime Dominguez

Department of Internal Medicine
Lincoln Hospital
New York
USA

Balavenkatesh Kanna

Department of Internal Medicine
Lincoln Hospital
New York
USA
Lincoln Hospital
Affiliated with Weill Medical College of Cornell University
Department of Internal Medicine
Suite 8-22,
234, East 149th Street
Bronx New York 10451
USA
Tel: +1 718 579 5000 ext. 5016
Fax: +1 718 579 4836
E-mail address: bvkanna{at}aol.com

We would like to raise the following issues in response to the article reporting results of the ADMIRAL study by Montalescot et al.1

Although the initial ADMIRAL trial2 demonstrated superiority of combined glycoprotein 2b3a receptor inhibitor and coronary stenting therapy, the outcomes of the 3-year follow-up data are subject to limitations. First, the effect of confounders such as status of coronary risk factors, life style modifications and treatment compliance in both study groups on outcomes at 3 years of unblinded follow-up is unclear.

Secondly, ascertainment of outcomes is subject to recall bias when self-reported data from a patient questionnaire is utilized for surveying endpoints.3 If recall bias exists, this can lead to misclassification of outcomes that may invalidate study findings.4

Further, the results of primary and secondary endpoints were either marginal or not statistically significant at an alpha level of 0.05 with wide confidence intervals that include the null hypothesis. Therefore, caution needs to be exercised when concluding that the ‘treatment elicits favourable clinical outcomes through the third year’, given the marginal differences between treatment groups, especially when the role of bias and confounding factors on outcomes are not fully clarified.5 Blinded, controlled long-term randomized interventional studies are further needed to clarify the interesting observations raised by this informative study.

References

  1. Montalescot G, Barragan P, Wittenberg O, et al. (2005) Three-year duration of benefit from abciximab in patient receiving stents for acute myocardial infarction in the randomized double-blind ADMIRAL study. Eur Heart J 26:2520–2523.[Abstract/Free Full Text]
  2. Montalescot G, Barragan P, Wittenberg O, et al. (2001) Platelet glycoprotein IIb/IIIa inhibition with coronary stenting for acute myocardial infarction. N Engl J Med 344:1895–1903.[Abstract/Free Full Text]
  3. Clarke PM, Fiebig DG, Gerdtham UG. Optimal recall length in survey design. http://www.economics.adelaide.edu.au/workshops/doc/optimalrecalllengthinsurveydesign.pdf.
  4. Moles DR and dos Santos Silva I. (2000) Causes, associations and evaluating evidence; can we trust what we read? Evid Based Dent 2:75–78.
  5. Mamdani M, Sykora K, Li P, Normand ST, et al. (2005) Reader's guide to critical appraisal of cohort studies: asessing potential for confounding. BMJ 330:960–962.[Free Full Text]

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This Article
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27/12/1508    most recent
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