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To the Editor: We have 2 concerns about the methodology of the trial reported by Dr Steinhubl and colleagues.¹

First, the authors used symptoms of angina pectoris as objective evidence of ischemia. In reality, symptoms of angina pectoris are subjective and may not correlate well with the presence of cardiac ischemia. Previous studies have used more objective criteria such as electrocardiographic changes or elevated biochemical markers of cardiac ischemia.²

Second, the study had 2 main objectives: to evaluate the benefit of long-term treatment with clopidogrel after PCI and to determine the benefit of initiating clopidogrel with a preprocedure loading dose, both in addition to aspirin therapy. It is not clear, however, how the authors adjusted their statistical tests for multiple comparisons arising from these hypotheses.

Javier Borja, MD; Iñaki Pérez, BS; Guillermo De la Cruz, MD
Clinical Research and Development Unit
J. Uriach & Cía
Palau-solita i Plegamans
Barcelona, Spain

1. Steinhubl SR, Berger PB, Mann JT 3rd, Fry ET, DeLago A, Wilmer C, Topol EJ. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JAMA. 2002;288:2411-2420. FREE FULL TEXT 2. Invasive compared with non-invasive treatment in unstable coronary-artery disease: FRISC II prospective randomised multicentre study. Fragmin and Fast Revascularisation during InStability in Coronary artery disease (FRISC II) Investigators. Lancet. 1999;354:708-715. FULL TEXT | WEB OF SCIENCE | PUBMED

Letters Section Editor: Stephen J. Lurie, MD, PhD, Senior Editor.

JAMA. 2003;289:1926.

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