Joseph Massaro.

Our trial was designed to detect a two-thirds decrease in the risk of recurrent events in the closure group, which is an ambitious objective. Thus, it did not have the charged capacity to detect a smaller decrease in the event rate. The insignificant craze toward a higher rate of the principal end result in the medical-therapy group was driven by the lower price of TIAs in the closure group. TIA is normally a much less precise end point than stroke. We included defined and individually adjudicated TIAs as an end point strictly, because these events may be caused by paradoxical embolism and because the needed sample size would have been prohibitively large if stroke have been used as the only end point.26,27 The 2-year price of stroke was low and virtually identical in the closure and medical-therapy groups, suggesting that a much larger sample will be required if stroke were the only end stage and a follow-up interval longer than 24 months would be unlikely to show a significant difference in stroke outcomes.Previous observational research comparing the outcomes of medical operation with those of medical therapy have already been subject to the limitations imposed by baseline distinctions between the treatment groups and treatment-selection and survivor biases12,14-18; prospective, randomized trials might decrease these limitations. In this randomized trial, we hypothesized that the advantages of surgical treatment would be maximized by performing medical procedures within 48 hours after randomization, as the risk of embolism has been reported to be high through the first week after analysis particularly.4,6,19 The rate of embolism in the conventional-treatment group was similar compared to that reported in other studies,6,11,12 and the rate of embolism in the early-surgery group was markedly reduced, in comparison with conventional treatment, needlessly to say from our prior observational study.12 Therefore, we suggest that early medical procedures is a valuable therapeutic option to prevent embolism.

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