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 dinical 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.