Why do you think your paper is highly cited?

Our paper discussed an important clinical topic that had created a major patient safety concern—stent thrombosis. It described a new standard for evaluating clinical research in this area.

 Does it describe a new discovery, methodology, or synthesis of knowledge?

It described a new standard methodology for the design and reporting of results evaluating the clinical trials of coronary stents.

 Would you summarize the significance of your paper in layman's terms?

A series of research studies had produced conflicting results regarding the safety and overall success of a new type of treatment for coronary artery disease. This treatment involved the placement of a stent or small metal tube to open a blocked artery. A new form of stent that was coated with medication had been thought to be more effective, since it prevented reblockage of the artery, but some studies had questioned if the stents had higher risk of clotting and causing major heart attacks. Our paper was significant because it provided a standardized method for trials to define these complications.

 How did you become involved in this research, and were there any problems along the way?

Our group has been involved in the design and analysis of coronary disease clinical trials for over 12 years. The major problem is that it is a rapidly evolving clinical area with a large number of competing clinical trials, making it essential to have standard methods for design and reporting.

 Where do you see your research leading in the future?

With the availability of standardized definitions, we will see future trials which allow for the pooling of results and address the impact of infrequent but serious clinical events.

 Do you foresee any social or political implications for your research?

The major implication is that our research highlights the issue of patient safety in clinical research and the importance of assessing safety outcomes by standardized definitions.

Donald E. Cutlip, M.D., F.A.C.C.
Director, Cardiac Catheterization Laboratory
Beth Israel Deaconess Medical Center
Associate Professor of Medicine
Harvard Medical School
Boston, MA, USA

Keywords: stent thrombosis, coronary artery disease, blocked artery, coronary disease clinical trials.