CORRESPONDENCE: LETTER TO THE EDITOR
Reply
Maurizio Menichelli, MD*
* San Camillo Hospital of Rome, via della Grande Muraglia 46, Rome 00144, Italy (Email: menichelli747{at}yahoo.com).
We appreciate the effort made by Dr. Pan in emphasizing the need for consistent end points in the medical literature. He refers to the "formidable barrier" reported by Dr. Cutlip (1) in understanding results across clinical trials. We agree that consistency across well-considered end point definitions is critical.
In our trial (2), we used a device-oriented composite definition of major adverse cardiac events (MACE). However, as Dr. Cutlip reported, "composite acronyms such as MACE have been used so frequently with so many variations in definition that the ARC recommends that the term be avoided altogether."
In designing the SESAMI (Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction) trial, we tried to establish consistency among end point definitions. Indeed, this trial was among the first to adopt and utilize the new Academic Research Consortium definition of stent thrombosis—well before Dr. Cutlip’s article was published.
As far as inclusion criteria are concerned, all of the patients presented with ST-elevation myocardial infarction and were eligible for primary angioplasty. We adopted the same strategy for all the patients once they were in our catheterization laboratory; however, a small portion of them had previously received thrombolytic therapy, as reported in Table 1 of our original study (2).
Dr. Pan surmises correctly that decimal point was misplaced in the standard deviation value for the sirolimus-eluting stent diameter in Table 2 of our study (2). The correct value is 0.034.
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References
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- 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, 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]
Related Article
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Concerns in the SESAMI Trial
- Xiaohong Pan
J. Am. Coll. Cardiol. 2008 51: 329-330.
[Full Text]
[PDF]
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