Consensus on definitions of clinical endpoints: percutaneous coronary and valvular intervention trials

Summary

Controlled clinical trials are a cornerstone in the search for medical therapeutic advances. The process by which clinical trials in cardiovascular medicine are designed, conducted, analysed, presented, and published has evolved dramatically over the last decades.

To evaluate the effects of a particular treatment strategy on mortality and major morbidity within a disease entity, large, global studies with relatively long-term clinical endpoints are conducted. One of the substantial challenges in the conduct of clinical trials relates to the definition, collection and accurate assessment of endpoint data in a consistent and timely manner.

Globalisation in percutaneous cardiovascular intervention research calls for standardisation and uniform definition of clinical endpoints and the harmonisation of clinical event adjudication. Consensus on uniform definitions is required to enable meaningful, albeit informal and indirect, comparisons between clinical trials and to aggregate outcome data within trial programmes and beyond. This process must be based on considerations ranging from historical legacy to key pathophysiologic mechanisms and relevance to clinical interpretability.

The purpose of this chapter is to introduce the interested reader to the process of consensus clinical endpoint definitions generation, to provide an appraisal of the most used endpoints and refer to the context of their rationale. We...