SITE-SPECIFIC INTRACORONARY THROMBOLYSIS WITH UROKINASE-COATED HYDROGEL BALLOONS - ACUTE AND FOLLOW-UP-STUDIES IN 95 PATIENTS

Conventional balloon angioplasty in the presence of intracoronary thro mbus is associated with an elevated risk for acute myocardial infarcti on, emergency bypass surgery and death, The purpose of this study was to assess the safety and efficacy of a new technique to treat thrombus -containing stenoses consisting of the local delivery of urokinase dir ectly to the site of intraluminal clot with hydrogel-coated balloons. Ninety-five patients with angiographically apparent intracoronary thro mbus were treated with urokinase-coated hydrogel balloons either prior to (n = 74) or following (n = 21) conventional balloon angioplasty. C linical diagnoses for the study group included acute myocardial infarc tion in 50 patients, postinfarction angina in 23 patients, and unstabl e angina in 22 patients. All hydrogel balloons were initially coated w ith urokinase by immersing the inflated balloon in a concentrated Abbo kinase solution (50,000 units/ml) for 60 s, All patients were subseque ntly treated with drug-coated balloons using a balloon:artery ratio of I:1, a mean of 2.2 +/- 1.2 inflations, and a mean total inflation tim e of 7.5 +/- 4.9 min. Use of urokinase-coated balloons resulted in ang iographic disappearance of intracoronary thrombus in 78 patients, impr ovement in 14, and no change in the remaining 3 patients. Following hy drogel balloon use for the entire 95 patients, TIMI flow increased fro m 1.4 +/- 1.2 to 2.9 +/- 0.4, minimal lumen diameter increased from 0. 4 +/- 0.4 to 2.0 +/- 0.6 mm, and thrombus score decreased from 2,0 +/- 0.9 to 0,2 +/- 0.6 (all P < 0.01). Procedural and early in-hospital c omplications were noted in 7 of the 95 patients (7,4%) and included ab rupt closure in 3 patients, distal embolization in 1 patient, no reflo w in ? patient, sidebranch occlusion in 1 patient, and late closure in 1 patient. Two of;he 3 patients with abrupt closure and the single pa tient with late closure required intracoronary stenting to maintain ve ssel patency, Two of these 7 patients sustained small myocardial infar ctions, although no patient required emergency bypass surgery or exper ienced a procedural death. Late clinical follow-up (mean = 8.3 +/- 6,6 months; range = 2 wk to 29 mo) demonstrated adverse recurrent events in 29 of the 95 patients (30.5%), including death (n = 5), myocardial infarction (n = 2), and recurrence of angina (n = 22). The results of this study suggest that intracoronary thrombolysis can be safely and r apidly achieved by using limited quantities of urokinase delivered dir ectly to the site of intraluminal clot with hydrogel balloons. Use of this technique may result in improved acute outcomes in comparison wit h conventional techniques currently being used to treat thrombus-conta ining stenoses. (C) 1997 Wiley-Liss, Inc.