8384
document
Benefits , morbidity , and mortality associated with long-term administration of oral anticoagulant therapy to patients with peripheral arterial bypass procedures : a prospective randomized study . BACKGROUND The benefits of the long-term administration of oral anticoagulant therapy remain unclear in patients with lower extremity arterial bypass surgery . We studied the effect of warfarin plus aspirin therapy ( WASA ) versus aspirin therapy alone ( ASA ) on patient mortality , morbidity and bypass patency rates in a randomized clinical trial . METHODS In a multicenter , prospective , nonmasked clinical trial , 831 patients who underwent peripheral arterial bypass surgery were compared in a long-term treatment program of WASA ( target international normalized ratio of 1.4 to 2.8 ; 325 mg/day ) with ASA ( 325 mg/day ) . The primary end point was bypass patency , and mortality and morbidity were the secondary endpoints . RESULTS There were 133 deaths in the WASA group ( 31.8 % ) and 95 deaths in the ASA group ( 23.0 % ; risk ratio , 1.41 ; 95 % confidence interval , 1.09 to 1.84 ; P =.0001 ) . Major hemorrhagic events occurred more frequently in the WASA group ( WASA , n = 35 ; ASA , n = 15 ; P =.02 ) . In the prosthetic bypass group , there was no significant difference in patency rate in the 8-mm bypass subgroup , but there was a significant difference in patency rate in the 6-mm bypass subgroup ( femoral-popliteal ; 71.4 % in the WASA group versus 57.9 % in the ASA group ; P =.02 ) . In the vein bypass group , patency rate was unaffected ( 75.3 % in the WASA group versus 74.9 % in the ASA group ) . CONCLUSION The long-term administration of warfarin therapy when combined with aspirin therapy has only a few selected indications for improvement of bypass patency and is associated with an increased risk of morbidity and mortality .
8385
Intervention_Pharmacological
oral anticoagulant therapy
8386
Intervention_Physical
oral anticoagulant therapy
8387
Intervention_Pharmacological
warfarin plus aspirin therapy ( WASA )
8388
Intervention_Pharmacological
aspirin therapy alone ( ASA )
8389
Intervention_Pharmacological
WASA
8390
Intervention_Pharmacological
ASA
8391
Intervention_Physical
WASA
8392
Intervention_Physical
ASA
8393
Intervention_Physical
WASA
8394
Intervention_Physical
ASA
8395
Intervention_Physical
WASA
8396
Intervention_Physical
ASA
8397
Intervention_Physical
WASA
8398
Intervention_Physical
warfarin therapy
8399
Outcome_Other
Benefits
8400
Outcome_Physical
morbidity
8401
Outcome_Mortality
mortality
8402
Outcome_Mortality
patient mortality
8403
Outcome_Physical
morbidity
8404
Outcome_Physical
bypass patency rates
8405
Outcome_Physical
bypass patency
8406
Outcome_Mortality
mortality
8407
Outcome_Physical
morbidity
8408
Outcome_Mortality
deaths
8409
Outcome_Mortality
deaths
8410
Outcome_Physical
Major hemorrhagic events
8411
Outcome_Other
patency rate
8412
Outcome_Other
patency rate
8413
Outcome_Other
patency rate
8414
Outcome_Other
bypass patency
8415
Outcome_Physical
morbidity
8416
Outcome_Mortality
mortality
8417
Participant_Condition
patients with peripheral arterial bypass procedures :