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Based on the time for developing identifiable restenosis and on efficacy analysis,>50%restenosis developed in 11 operated vessels(16%)in the treated group and in 10 arteries(14%)in the placebo group,yielding an observed risk increase of 14%(95%CI,-52%to 167%,P>0.2).By intention-to- treat analysis,>50%restenosis developed in 16 of 90 operated vessels in treated patients and in 10 of 85 arteries in patients receiving placebo (26%for the treated group and 12%for the placebo group;P=0.18,Mantel- Haenszel statistic),representing an observed risk increase of 110%(CI,-5% to 365%).Similar differences were observed for>20%restenosis and for the comparison of patients rather than operated vessels by either intention- to-treat or efficacy analyses.Conclusions:Because therapy not only failed to reduce carotid restenosis but may have actually increased its frequency,treatment with aspirin plus dipyridamole probably has no clinically important benefit on restenosis in patients having carotid endarterectomy. |
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