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In Reply: Dr Scharnetzky and colleagues raise questions about site-level bias, suggesting differential enrollment between European and North American centers. However, patient selection criteria and sampling (every n^th patient) were strictly prespecified and identical at each participating center. Neither site nor investigator had control over patient selection or sampling.

The use of blood-sparing therapy differed among the 69 centers in 16 countries. Post-hoc analyses of long-term all-cause mortality rates for patients treated with aprotinin for the European centers showed a 5-year covariate-adjusted HR of 1.48 (95% confidence interval [CI], 1.10-2.00); for the North American centers, the adjusted HR was 1.39 (95% CI, 0.96-2.00). However, these post-hoc subset analyses must be interpreted with caution because of limited power.¹ We estimate that for the North American subset, there is only 42% power to detect aprotinin-associated mortality differences, compared with 94% power for the entire sample. Survival analysis demonstrated significant differences in both . . . [Full Text of this Article]

Dennis T. Mangano, PhD, MD
dtb@iref.org
Ischemia Research and Education Foundation
San Bruno, Calif

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