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Letters |

Study Power in the SORT OUT II Trial

Hideaki Kaneda, MD, PhD
JAMA. 2008;299(17):2021-2022. doi:10.1001/jama.299.17.2021-c.
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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.”


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May 7, 2008
Anders Michael Galløe, MD; Niels Bligaard, MD; Peter Riis Hansen, MD
JAMA. 2008;299(17):2021-2022. doi:10.1001/jama.299.17.2022-a.
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