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 preventing reocclusion after urokinase thrombolysis in patients with acute myocardial infarction (AMI). The study involved 137 consecutive patients with AMI and a time from the onset of symptoms < or = 6 hours, treated with urokinase (1,000,000 U intravenous bolus followed by 1,000,000 U slow-drip infusion over 12 hours). Immediately after thrombolysis, patients were allocated to treatment with defibrotide (group D: day 0, 3.6 g by intravenous infusion in 12 hours; days +1 to +6, 800 mg tid intravenously; days +7 to +10/+12, 400 mg tid intramuscularly), or heparin (group H: day 0, 1000 IU/hour infused over 12 hours; days +1 to +10/+12, 5000 IU tid subcutaneously). Coronary angiography was done, whenever possible, at +10/+12 days. The following parameters were assessed: (a) noninvasive estimate of myocardial reperfusion, through the analysis of CPK time-activity curves; (b) incidence of infarct-related artery (IRA) patency (TIMI scores 2-3) at coronary angiography. 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 versus 43% of group H patients (p = 0.07). No statistically significant differences were found in the proportion of patients with indirect signs of early reperfusion (63% in group D versus 52% in group H patients).(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes