14769
document
A prospective , placebo-controlled , randomized trial of intravenous streptokinase and angioplasty versus lone angioplasty therapy of acute myocardial infarction . BACKGROUND The value of routine administration of intravenous thrombolytic agents during percutaneous transluminal coronary angioplasty ( PTCA ) therapy of acute myocardial infarction ( MI ) has not been determined . Therefore , we prospectively randomized 122 patients with evolving MI to PTCA therapy with or without adjunctive intravenous streptokinase therapy . METHODS AND RESULTS Patients with ECG ST segment elevation who presented within 4 hours of symptom onset , had no contraindication to thrombolytic therapy , and were not in cardiogenic shock were enrolled . They were treated immediately with intravenous heparin ( 10,000 units ) and oral aspirin ( 325 mg ) and randomized to treatment with placebo or streptokinase ( 1.5 M units ) administered intravenously over 30 minutes . Patients then were taken immediately to the catheterization laboratory , and those with suitable coronary anatomy underwent immediate PTCA . Subsequent clinical course , serial radionuclide ventriculography , and 6-month repeat angiography were analyzed . A total of 106 patients were treated with PTCA . Use of PTCA was similar for placebo ( 92 % ) and streptokinase ( 83 % ) groups . Angioplasty was successful in 95 % of patients , with no difference in placebo ( 93 % ) and streptokinase ( 98 % ) groups . Serial radionuclide ventriculography demonstrated no difference in 24-hour ( 52 +/- 12 % versus 50 +/- 12 % ) or 6-week ( 51 +/- 12 % versus 51 +/- 13 % ) ejection fraction values for placebo and streptokinase groups , respectively . Contrast ventriculography demonstrated improvement in immediate ( 54 +/- 12 % ) versus 6-month ( 60 +/- 15 % , p < 0.05 ) values for the overall group . No differences in 6-month values were present ( 58 +/- 15 % versus 62 +/- 15 % , p = NS ) for placebo and streptokinase groups , respectively . Coronary angiography was performed in 75 % of the 90 patients eligible for restudy . Arterial patency was 87 % at 6 months , and coronary restenosis was present in 38 % of patients . No differences in chronic patency or restenosis were detected for the two treatment groups . Although adjunctive intravenous streptokinase therapy did not improve outcome , it did complicate the hospital course . Hospitalization was longer ( 9.3 +/- 5.0 versus 7.7 +/- 4.4 days , p = 0.046 ) and more costly ( $ 25,191 +/- 15,368 versus $ 19,643 +/- 7,250 , p < 0.02 ) . Transfusion rate was higher ( 39 % versus 8 % , p = 0.0001 ) and need for emergency coronary bypass surgery was greater ( 10.3 % versus 1.6 % , p = 0.03 ) for the streptokinase-treated patients . CONCLUSIONS Adjunctive intravenous streptokinase therapy does not enhance early preservation of ventricular function , improve arterial patency rates , or lower restenosis rates after PTCA therapy of acute MI . Hospital course is longer , more expensive , and more complicated . For these reasons , PTCA therapy of acute MI should not be routinely performed with adjunctive intravenous streptokinase therapy .
14770
Intervention_Control
placebo-controlled
14771
Intervention_Pharmacological
streptokinase
14772
Intervention_Physical
angioplasty versus lone angioplasty therapy
14773
Intervention_Pharmacological
thrombolytic agents
14774
Intervention_Physical
percutaneous transluminal coronary angioplasty ( PTCA ) therapy
14775
Intervention_Physical
PTCA therapy
14776
Intervention_Physical
intravenous streptokinase therapy
14777
Intervention_Physical
thrombolytic therapy
14778
Intervention_Pharmacological
intravenous heparin
14779
Intervention_Pharmacological
oral aspirin
14780
Intervention_Control
placebo
14781
Intervention_Pharmacological
streptokinase
14782
Intervention_Physical
PTCA
14783
Intervention_Control
placebo
14784
Intervention_Pharmacological
streptokinase
14785
Intervention_Pharmacological
streptokinase
14786
Intervention_Pharmacological
streptokinase
14787
Intervention_Pharmacological
streptokinase
14788
Intervention_Physical
Coronary angiography
14789
Intervention_Pharmacological
streptokinase
14790
Intervention_Pharmacological
streptokinase therapy
14791
Intervention_Pharmacological
streptokinase therapy
14792
Outcome_Other
ejection fraction values
14793
Outcome_Physical
Contrast ventriculography
14794
Outcome_Other
6-month values
14795
Outcome_Physical
Coronary angiography
14796
Outcome_Physical
Arterial patency
14797
Outcome_Physical
coronary restenosis
14798
Outcome_Physical
chronic patency or restenosis
14799
Outcome_Other
Hospitalization
14800
Outcome_Other
costly
14801
Outcome_Other
Transfusion rate
14802
Outcome_Physical
ventricular function
14803
Participant_Condition
evolving MI to PTCA therapy
14804
Participant_Condition
ECG ST segment elevation
14805
Participant_Condition
treated with PTCA