This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Contact me when this article is cited  Related Content  • Related article  • Related letter  • Similar articles in JAMA  Topic Collections  • Statistics and Research Methods  • Drug Therapy  • Drug Therapy, Other  • Alert me on articles by topic  Social Bookmarking   What's this?

	Since this article does not have an abstract, we have provided the first 149 words of the full text and any section headings.

To the Editor: In their randomized trial, Dr Galløe and colleagues¹ compared the efficacy and safety of sirolimus-eluting and paclitaxel-eluting stents in a study design reflecting common clinical practice. In the trial design,² the authors defined the primary outcome measures as "MACE (cardiac death, MI, TVR, TLR, TVF) during 9 months." However, in the article's power calculation, the authors used estimated 5-year event rates for sample size calculation: "The SORT OUT II trial was therefore planned to enroll at least 1800 patients to detect a minimum relevant relative difference in rates of 25% (ie, rates of 20% vs 15%) with 5 years of follow-up."

Shorter follow-up length for primary outcome measure, compared with that used for sample size calculation, would be expected to reduce event rate and study power and could have led to the study finding of no statistically significant differences in clinical outcomes.

Financial Disclosures: None reported.

Hideaki Kaneda, MD, PhD
hdkaneda@gmail.com
Okinaka Memorial Institute for Medical Research
Tokyo, Japan

1. Galløe AM, Thuesen L, Kelbaek H; et al. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA. 2008;299(4):409-416. FREE FULL TEXT 2. Comparison of cypher select and taxus express coronary stents. http://www.clinicaltrials.gov/ct2/show/NCT00388934?term=00388934&rank=1. Accessed March 12, 2008.

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2008;299(17):2021-2022.

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

RELATED ARTICLE

Comparison of Paclitaxel- and Sirolimus-Eluting Stents in Everyday Clinical Practice: The SORT OUT II Randomized Trial
Anders M. Galløe, Leif Thuesen, Henning Kelbæk, Per Thayssen, Klaus Rasmussen, Peter R. Hansen, Niels Bligaard, Kari Saunamäki, Anders Junker, Jens Aarøe, Ulrik Abildgaard, Jan Ravkilde, Thomas Engstrøm, Jan S. Jensen, Henning R. Andersen, Hans E. Bøtker, Søren Galatius, Steen D. Kristensen, Jan K. Madsen, Lars R. Krusell, Steen Z. Abildstrøm, Ghita B. Stephansen, Jens F. Lassen, and for the SORT OUT II Investigators
JAMA. 2008;299(4):409-416.
ABSTRACT | FULL TEXT  

RELATED LETTER

Study Power in the SORT OUT II Trial—Reply
Anders Michael Galløe, Niels Bligaard, and Peter Riis Hansen
JAMA. 2008;299(17):2022.
EXTRACT | FULL TEXT