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© The European Society of Cardiology 2005. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Patient selection bias in primary percutaneous coronary intervention trials: a critical issue

Angela Migliorini and David Antoniucci*

Division of Cardiology, Careggi Hospital, Viale Morgagni, I-50134 Florence, Italy

* Corresponding author. Tel: +39 055 4277966; fax: +39 055 4277625. E-mail address: david.antoniucci{at}virgilio.it

The ‘frequentist’ approach in randomized study designs and the inclusion of a large number of patients (high statistical inference) have frequently produced inconclusive, or conflicting, or negative results despite the high potential for a strong impact on outcome of the study drug, or device, or strategy. In many studies, the adoption of rigid criteria for randomization resulted in the exclusion of many patients at high risk of adverse events and prevented the correct assessment of the efficacy of the study treatment. This review will focus on two issues that are still matter of debate due to the incapacity of concluded randomized trials to provide an unequivocal answer: the routine use of an emergency revascularization strategy in cardiogenic shock complicating acute myocardial infarction (AMI) and the routine use of abciximab in the setting of primary percutaneous coronary intervention (PCI) for AMI.

Key Words: Primary PCI • Cardiogenic shock • Abciximab


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