[Skip to Content]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address Please contact the publisher to request reinstatement.
[Skip to Content Landing]
Citations 0
May 7, 2008

Study Power in the SORT OUT II Trial

JAMA. 2008;299(17):2021-2022. doi:10.1001/jama.299.17.2021-c

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.”

First Page Preview View Large
First page PDF preview
First page PDF preview