Summary of U.S. clinical trials program for evaluation of anistreplase.

Because the reestablishment of coronary blood flow is believed to be central to the benefit of thrombolytic therapy, the U.S. evaluation program of anistreplase has focused on reperfusion, patency, and reocclusion comparisons with approved thrombolytic regimens, including (1) intracoronary streptokinase (completed) (TEAM-I), (2) intravenous streptokinase (completed) (TEAM-II), and (3) intravenous tissue plasminogen activator complex or alteplase (tPA, ongoing) (TEAM-III). The TEAM trials have established that anistreplase possesses similar reperfusion efficacy to intracoronary streptokinase, if given within 4 h, but is much easier to administer; comparisons with currently approved intravenous agents, streptokinase, and tissue plasminogen activator (tPA) have been completed and are being analyzed or are underway; reocclusion and reinfarction rates are low; safety is good, and similar to that of streptokinase; and mortality rates have been low with treatment, consistent with beneficial reports from randomized trials. Based on overall efficacy, ease of administration, and safety, anistreplase has been shown to be a promising agent for treatment of acute myocardial infarction.