Thrombolysis for Acute Myocardial Infarction: Drug Review

David K. Cundiff

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In This Article

Complications of Thrombolysis

Bleeding is the most serious and potentially fatal complication of thrombolysis for AMI.[27,29,30,31,32,33] While the initial randomized trials comparing thrombolysis with control treatment for AMI had CNS bleeding rates of 0.2% to 1%, averaging 0.5%,[27] more recent studies comparing thrombolysis with angioplasty have reported CNS bleeding from thrombolysis in up to 2% of the cases.[30] In a recent meta-analysis of randomized studies of thrombolysis vs angioplasty, hemorrhagic stroke rate (0.1% versus 1.1%, P < .001, for angioplasty and thrombolysis respectively) significantly exceeded the CNS bleeding rate for thrombolysis in the earlier randomized studies.[34] Systemic hemorrhage occurs more commonly in patients with major vascular punctures. When thrombolysis was followed by angioplasty in one study, the hematocrit dropped 11.7 ± 6.5 points from baseline to nadir and blood transfusion not related to bypass surgery was required in 18% of the patients.[35] Perhaps, contributing to the "early hazard" effect, thrombolysis increases the incidence of myocardial rupture to about 0.5%.[25,27,36,37] Hemorrhagic cardiac tamponade[8,38] and splenic bleeding[39] also occur with increased frequency.

Immunologic complications of thrombolysis include anaphylaxis, occurring rarely, and immune complex disease, typically causing chills and fever. These happen only with SK or agents with a SK moiety, including anistreplase (anisoylated plasminogen- SK activator complex). Hypotension, usually transient, occurs in about 10% of patients with SK and anistreplase.[27]

According to the NRMI-1 during 1990 through 1993, 35.1% of patients with AMI received thrombolysis, with 56% of those getting t-PA.[23] Of the more than 2 million people with acute coronary events admitted each year to hospitals in the United States,[40] a diagnostic evaluation confirms an AMI in 30% to 50%.[1] Since about 35% of AMI patients receive thrombolysis,[23] from 210,000 to 350,000 receive thrombolysis for AMI in the United States each year. With a treatment-related mortality of thrombolysis for AMI of about 1%, this translates to 2100 to 3500 deaths per year from complications of this treatment.

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