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Preventive angioplasty in myocardial infarction.

The Authors Reply: Smith and White hypothesize, on the basis of their previous analysis, that preterm birth had a substantial influence on the primary outcome in our study and that this obscures any potential effect of the method of delivery. In our study, the primary outcome occurred significantly less often in infants of women who underwent randomization at term than in infants of women who underwent randomization before term (odds ratio, 0.41; 95% CI, 0.21 to 0.81; P = 0.01). However, the test of the interaction between gestational age at randomization and treatment group did not reach statistical significance (P = 0.18). Therefore, the statistical analysis involving the subgroup of women who underwent randomization at term was not justified in the main article. We are considering Smith and White’s suggestion regarding secondary analyses involving women who delivered at full-term (with adjustment for potential confounders), as well as a more detailed analysis involving women who underwent randomization at full-term gestation. The former would not be an intention-to-treat analysis and would need to be interpreted with caution. In response to Keane: we assumed that planned vaginal delivery was the standard of care, and therefore the trial was designed to test the superiority of planned cesarean delivery in reducing the probability of the primary outcome. The smallest clinically important difference to justify planned cesarean delivery was set at a relative risk of 0.5 (i.e., a reduction in the probability of the primary outcome from 4% to 2%). The confidence interval for the odds ratio (0.77 to 1.74) excludes by some margin the value of 0.5, since the odds ratio is a good estimate of the relative risk for such rare outcomes. Taking a Bayesian perspective with a noninformative prior distribution for the relative risk, one could state that the probability that the relative risk is 0.5 or less (i.e., that planned cesarean delivery is sufficiently superior to justify its routine adoption) is 0.00003. The protocol was reviewed by an expert panel for the funding agency, the Canadian Institutes of Health Research, and the manuscript underwent peer review before publication. In neither review was the idea raised that the trial should have been designed as a noninferiority study.