DEFIBROTIDE VERSUS HEPARIN IN THE PREVENTION OF CORONARY REOCCLUSION AFTER THROMBOLYSIS IN ACUTE MYOCARDIAL-INFARCTION

A multicenter controlled study versus heparin was conducted to explore the activity of defibrotide, a polydesoxyribonucleotide drug, in prev enting reocclusion after urokinase thrombolysis in patients with acute myocardial infarction (AMI). The study involved 137 consecutive patie nts with AMI and a time from the onset of symptoms less-than-or-equal- to 6 hours, treated with urokinase (1,000,000 U intravenous bolus foll owed by 1,000,000 U slow-drip infusion over 12 hours). Immediately aft er thrombolysis, patients were allocated to treatment with defibrotide (group D: day 0, 3.6 g by intravenous infusion in 12 hours; days +1 t o +6, 800 mg tid intravenously; days +7 to +10/+12, 400 mg tid intramu scularly), or heparin (group H: day 0, 1000 IU/hour infused over 12 ho urs; days +1 to +10/+12, 5000 IU tid subcutaneously). Coronary angiogr aphy was done, whenever possible, at +10/+12 days. The following param eters were assessed: (a) non-invasive estimate of myocardial reperfusi on, through the analysis of CPK time-activity curves; (b) incidence of infarct-related artery (IRA) patency (TIMI scores 2-3) at coronary an giography. A total of 125 patients had a complete enzymatic curve (63 in group D and 62 in group H) and 106 had coronary angiography as well . IRA patency (the main end point) was observed in 63% of group D vers us 43% of group H patients (p = 0.07). No statistically significant di fferences were found in the proportion of patients with indirect signs of early reperfusion (63% in group D versus 52% in group H patients). Combining the findings of CPK curve analysis and coronary angiographi c data, the D group showed a trend towards a minor proportion of patie nts with reocclusion of a possibly patent IRA (28% vs. 47%) and a grea ter proportion of patients with ''late reperfusion'' of a possibly occ luded IRA (44% vs. 37%), in comparison to the H group. These prelimina ry data suggest that defibrotide is equal, if not more effective than heparin, in combination with urokinase, in achieving IRA patency in pa tients with AMI.