A randomized, placebo-controlled trial of intravenous recombinant tissue-type plasminogen activator and emergency coronary angioplasty in patients with acute myocardial infarction

• Published in: Circulation (New York, N.Y.) N.Y.), 1987-02, Vol.75 (2), p.420-428
• Main Authors: TOPOL, E. J, O'NEILL, W. W, LANGBURD, A. B, WALTON, J. A. JR, BOURDILLON, P. D. V, BATES, E. R, GRINES, C. L, SCHORK, A. M, KLINE, E, PITT, B
• Format: Article
• Language: English
• Subjects: Angioplasty, Balloon; Biological and medical sciences; Blood. Blood coagulation. Reticuloendothelial system; Clinical Trials as Topic; Coronary Vessels; Double-Blind Method; Emergency Medical Services; Female; Humans; Male; Medical sciences; Middle Aged; Myocardial Infarction - therapy; Pharmacology. Drug treatments; Pilot Projects; Random Allocation; Recombinant Proteins - therapeutic use; Tissue Plasminogen Activator - therapeutic use
• ISSN: 0009-7322; 1524-4539
• DOI: 10.1161/01.CIR.75.2.420

To determine the role of tissue-type plasminogen activator (t-PA) and immediate percutaneous transluminal coronary angioplasty (PTCA) in treating patients with evolving transmural myocardial infarction, 50 patients received t-PA (1.25 mg/kg iv over 3 hrs) or placebo according to 3:1 double-blind randomization 3.8 +/- 1.1 hr after onset of symptoms. At emergency coronary arteriography, patency of the infarct-related vessel was demonstrated in 32 of 38 (84%) patients receiving t-PA vs two of 12 (17%) receiving placebo (p less than .001). Of the 32 patients with recanalization after t-PA, 28 had a residual stenosis of at least 50% and underwent randomization a second time to immediate (n = 15) or no PTCA (n = 13). Immediate PTCA of the infarct-related vessel was successful in all 15 patients, with reduction of the residual diameter stenosis from 80.8 +/- 8.2% to 32.5 +/- 15.6% (p less than .001). The incidence of postinfarction angina (greater than or equal to 20 min of chest discomfort and reversible electrocardiographic changes) and reinfarction (documented by recurrent creatine kinase isoenzyme elevation) was reduced in the patients receiving t-PA and PTCA (2/15) compared with that in patients receiving t-PA alone (7/13; p = .006). At 1 week there was no difference in patency of the infarct-related vessel (12/15 t-PA and PTCA vs 9/13 t-PA only) or in global ventricular functional change between the two groups (0.5 +/- 10.4 SD/chord for t-PA and PTCA vs -2.1 +/- 8.2 SD/chord for t-PA only).