CORRESPONDENCE: LETTER TO THE EDITOR
Concerns in the SESAMI Trial
Xiaohong Pan, PhD, MD*
* Department of Cardiology, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, Jjiefang Road 88, Hangzhou, Zhejiang 310009, China (Email: heartpanxh{at}hotmail.com).
In a clinical trial aiming to evaluate the safety and effectiveness of drug-eluting stents in comparison with bare-metal stents (BMS) in acute myocardial infarction (AMI), the description of the end points should be clear and identical. As an important composite clinical end point, major adverse cardiac events (MACE) was given 3 possible full names without any definition by Menichelli et al. (1) in the SESAMI (Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction) trial, which could cause confusion. In the Methods section, MACE was the abbreviation of "major adverse cardiovascular events." In Table 4 and the related results part, MACE referred to "major adverse coronary events." Furthermore, "major adverse cardiac events" appeared in the abstract and result part as another full name of MACE. According to the recommendation of the Academic Research Consortium (2), the term MACE can be device-oriented or patient-oriented. Without any definition and identical full name of MACE in the SESAMI trial, a formidable barrier was built to understanding the results and to comparison with other clinical trials.
My other concern is the inclusion criteria of the patients. In the Menichelli article (1), all the patients had AMI eligible for primary angioplasty, which seemed to be confirmed later in the catheterization and study procedure part. But in the slides presented by the author in EuroPCR 2006 (3), the rate of rescue coronary angioplasty accounted for 17.5% in the sirolimus-eluting stent (SES) group and 17.7% in the BMS group. The related information on rescue percutaneous coronary intervention in the study design and protocol should be described because it was a different treatment strategy for AMI patients.
By the way, the value of standard deviation of stent diameter in the SES group in Table 2 might be 0.34 instead of 0.034, according to the context.
 |
References
|
|---|
- Menichelli M, Parma A, Pucci E, et al. Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI) J Am Coll Cardiol 2007;49:1924-1930.[Abstract/Free Full Text]
- Cutlip DE, Windecker S, Mehran R, et al. for the Academic Research Consortium Clinical end points in coronary stent trials: a case for standardized definitions Circulation 2007;115:2344-2351.[Abstract/Free Full Text]
- Menichelli M. SESAMI TrialPresented at EuroPCR meeting, May 2006; Paris, Francehttp://www.tctmd.com 2007Accessed June 22, 2007.
Related Article
-
Reply
- Maurizio Menichelli
J. Am. Coll. Cardiol. 2008 51: 330.
[Full Text]
[PDF]
|
Top
References