Herz
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The European Society of Cardiology (ESC) for the first time issued guidelines for percutaneous coronary interventions (PCI) in spring 2005. The strengths of recommendations stated in the ESC guidelines (as in those of the AHA/ACC [American Heart Association/American College of Cardiology]) are traditionally a combination of recommendation classes (I, IIa, and IIb) and a level of evidence (A, B, or C). This paper explains and discusses selected focal points of the ESC PCI guidelines based on three representative cases from daily practice. 1. ⋯ The traditional levels of evidence according to ESC, AHA and ACC criteria (levels A, B, or C) do no longer meet the actual requirements to assess the scientific evidence of randomized PCI trials and registry studies. For example, only two small randomized studies with few patients and insufficient statistical power utilizing a clinically insignificant surrogate endpoint would be enough to attain level of evidence A. Consequently, a new scoring system will be proposed, which considers criteria such as the importance of a primary clinical endpoint, the statistical power achieved, and the presence of an independent external data review and safety monitoring board.