Donald E. Cutlip talks with
ScienceWatch.com and answers a few questions about
this month's New Hot Paper in the field of Clinical
Article Title: Clinical end points in coronary
stent trials - A case for standardized
DE;;Windecker, S;Mehran, R;Boam, A;Cohen, DJ;van Es,
GA;Steg, PG;Morel, MA;Mauri, L;Vranckx, P;McFadden,
E;Lansky, A;Hamon, M;Krucoff, MW;Serruys, PW;Acad Res
Year: MAY 1 2007
* Harvard Univ, Sch Med, Harvard Clin Res Inst, 930
Commonwealth Ave, Boston, MA 02215 USA.
* Harvard Univ, Sch Med, Harvard Clin Res Inst, Boston, MA
(addresses have been truncated)
Why do you think your paper is highly
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?
highlights the issue of
patient safety in clinical
research and the importance
of assessing safety outcomes
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
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
Where do you see your research leading in the
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