Results for the primary endpoint of the study, 30-day mortality, are shown in Table 1. The incidence of 30-day mortality for accelerated infusion of Alteplase was 1.0% lower than for SK (IV) and 1.0% lower than for SK (SQ). The secondary endpoints of combined 30-day mortality or nonfatal stroke, and 24-hour mortality, as well as the safety endpoints of total stroke and intracerebral hemorrhage are also shown in Table 1. The incidence of combined 30-day mortality or nonfatal stroke for the Alteplase accelerated infusion was 1.0% lower than for SK (IV) and 0.8% lower than for SK (SQ).

Table 1

Subgroup analysis of patients by age, infarct location, time from symptom onset to thrombolytic treatment, and treatment in the U.S. or elsewhere showed consistently lower 30-day mortality for the Alteplase accelerated infusion group. For patients who were over 75 years of age, a predefined subgroup consisting of 12% of patients enrolled, the incidence of stroke was 4.0% for the Alteplase accelerated infusion group, 2.8% for SK (IV), and 3.2% for SK (SQ); the incidence of combined 30-day mortality or nonfatal stroke was 20.6%

for accelerated infusion of Alteplase, 21.5% for SK (IV), and 22.0% for SK (SQ). An angiographic substudy of the GUSTO trial provided data on infarct related artery patency. Table 2 presents 90-minute, 180-minute, 24-hour, and 5-7 day patency values by TIMI flow grade for the three treatment regimens. Reocclusion rates were similar for all three treatment regimens.

Table 2

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