75928
document
Veterans Administration Cooperative Study on antiplatelet agents in diabetic patients after amputation for gangrene : II . Effects of aspirin and dipyridamole on atherosclerotic vascular disease rates . We report the results of a randomized multicenter clinical trial on the effects of aspirin plus dipyridamole versus placebo on major vascular end points in 231 non-insulin-dependent diabetic men with either a recent amputation for gangrene or active gangrene . Primary end points were death from atherosclerotic vascular disease plus amputation of the opposite extremity for gangrene . There were 24 atherosclerotic deaths in the drug treatment group ( 21.8 % ) and 23 in the placebo group ( 19.0 % ) . There were 22 patients in the drug treatment group ( 20.0 % ) and 29 patients in the placebo group ( 24.0 % ) with opposite-side amputations . Survival curve analyses revealed little difference between these groups for major vascular end points , total mortality , all amputations , or myocardial infarctions . The most noteworthy group difference was observed for cerebrovascular end points ( strokes and transient ischemic attacks ) , with an incidence of 8.2 % ( 9 patients ) in the drug treatment group and 19.0 % ( 23 patients ) in the placebo group . We conclude from this study that antiplatelet agents have no effect on the primary vascular end points , vascular deaths and/or amputation of the opposite extremity , in this population . Similarly , no effects were seen on secondary vascular end points , except for a suggestion of protection versus strokes and transient ischemic attacks . However , this finding must be interpreted with caution , since it is a secondary end point and was found only after multiple analyses of the data .
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Intervention_Pharmacological
antiplatelet agents
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Intervention_Pharmacological
aspirin
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Intervention_Pharmacological
dipyridamole
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Intervention_Pharmacological
aspirin plus dipyridamole
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Intervention_Control
placebo
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Intervention_Control
placebo
75935
Outcome_Physical
atherosclerotic vascular disease rates
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Outcome_Physical
vascular end points
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Outcome_Mortality
death
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Outcome_Mortality
atherosclerotic deaths
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Outcome_Physical
opposite-side amputations
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Outcome_Physical
vascular end points
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Outcome_Mortality
total mortality
75942
Outcome_Physical
amputations
75943
Outcome_Physical
myocardial infarctions
75944
Outcome_Physical
cerebrovascular end points
75945
Outcome_Physical
strokes and transient ischemic attacks
75946
Outcome_Mortality
vascular deaths
75947
Outcome_Physical
amputation of the opposite extremity
75948
Outcome_Physical
protection versus strokes and transient ischemic attacks
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Participant_Condition
diabetic
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Participant_Condition
amputation
75951
Participant_Condition
gangrene
75952
Participant_Sample-size
231
75953
Participant_Condition
non-insulin-dependent diabetic
75954
Participant_Condition
gangrene
75955
Participant_Condition
gangrene