Brain Hemorrhage After Thrombolysis: Good or Bad?

Intracranial bleeding is the most feared complication of thrombolytic therapy in acute stroke. The risk of brain hemorrhage is the main argument of the European authorities not to approve recombinant tissue plasminogen activator (rtPA), and the fear of hurting patients with rtPA explains its limited use in North America. The common argument is, “Treatment with rt-PA may have some beneficial effect, but that is traded off by a considerable risk of symptomatic hemorrhage.” This argument is false and based on misunderstanding and misconception. The misunderstanding: There is no such trade-off. The National Institute of Neurological Disorders and Stroke (NINDS) rtPA Stroke Study Group observed 2 patients (0.6%) with symptomatic and 1 patient (0.3%) with fatal hemorrhages in the placebo group (n=312) and 20 patients (6.4%) with symptomatic and 9 patients (2.9%) with fatal hemorrhages in the rtPA group (n=312).1 Despite this supposed excess in risks caused by rtPA treatment (odds ratios [OR], 10.6 and 9.2), rtPA treatment significantly reduced the risk for disability and death (modified Rankin Scale >1 at 12 months after stroke) from 73% to 59% (reduction for death alone: 28% to 24%).2 In both European Cooperative Acute Stroke Studies (ECASS) 1 and 2, rtPA increased the risk for parenchymal hematomas (OR, 3.0 and 4.2), but reduced the overall risk for disability and death by 6% and 8% (NS).3,4⇓ A similar observation—an overall risk reduction for disability and death despite an increased risk for intracranial hemorrhages—was made in the Multicenter Acute Stroke Trials (MAST) -Europe and -Italy. Why …