IPO-V2 - A PROSPECTIVE, MULTICENTER, RANDOMIZED, COMPARATIVE CLINICALINVESTIGATION OF THE EFFECTS OF SULODEXIDE IN PREVENTING CARDIOVASCULAR ACCIDENTS IN THE 1ST YEAR AFTER ACUTE MYOCARDIAL-INFARCTION

Objectives. This study was conducted to assess the efficacy of sulodex ide, a glycosaminoglycan compound with antithrombotic properties, in p reventing death and thromboembolic events after acute myocardial infar ction. Background. Antithrombotic therapy has been found to play an im portant role in the prevention of cardiovascular events and death afte r acute myocardial infarction. Glycosaminoglycan-containing compounds, including sulodexide, show profibrinolytic and antithrombotic propert ies that render them suitable for use in patients after infarction. Me thods. A total of 3,986 patients who had recovered from acute myocardi al infarction were randomized to receive either the standard therapy r outinely administered at each study center, excluding antiplatelet and anticoagulant drugs (control group, 1,970 patients), or the standard therapy plus sulodexide (treated group, 2,016 patients). Between 7 and 10 days after the episode of acute myocardial infarction, sulodexide was administered as a single daily 600-lipoprotein-lipase-releasing un it (LRU) intramuscular injection for the 1st month, followed by oral c apsules of 500 LRU twice daily. Patients were evaluated for greater-th an-or-equal-to 12 months. Results. At the end of the study, 140 deaths (7.1%) were recorded in the control group and 97 (4.8%) in the sulode xide group (32% risk reduction, p = 0.0022, chi-square test). A total of 90 patients (4.6%) in the control group had a further infarction, c ompared with 66 (3.3%) in the sulodexide group (28% risk reduction. p = 0.035). Furthermore, a reduction in left ventricular thrombus format ion (evaluated by echocardiography) was observed in the sulodexide gro up (n = 12; 0.6%), compared with values in the control group (n = 25; 1.3%) (53% risk reduction, p = 0.027). Sulodexide was well tolerated a nd devoid of significant adverse events. All significant results were confirmed by ''actual treatment'' analyses. Conclusions. The study pro vides evidence that long-term therapy with sulodexide started early af ter an episode of acute myocardial infarction is associated with reduc tions in total mortality, rate of reinfarction and mural thrombus form ation.