Significantly higher TIMI flow grade rates in RAPID II trial* |
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Benefits associated with early reperfusion, especially TIMI 3 flow |
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Smaller infarct size |
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Improved left ventricular function |
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Lower rate of reocclusion |
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Adverse events observed in RAPID II trial* |
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Percent of patients requiring transfusion (excluding those undergoing surgery) was 12.4% in the Retavase group, compared with 9.7% in the alteplase group (p=NS) |
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Of all hemorrhages, 4.4% and 3% were rated as severe or life-threatening in the Retavase and alteplase groups, respectively |
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*RAPID II trial, a multicenter, randomized study comparing the speed and completeness of coronary patency in patients treated with Retavase (n=157) or accelerated alteplase (n=146). This trial did not have sufficient power to detect differences in adverse events between the groups. |
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†Only the 90-minute assessment was mandatory, according to trial protocol. |
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Important Safety Information |
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Because thrombolytic therapy increases the risk of bleeding, including internal bleeding (such as intracranial, retroperitoneal, gastrointestinal, genitourinary, or respiratory), Retavase should be used only in those patients for whom its use is indicated in the prescribing information
(see "Indications" in the prescribing information). In addition, thrombolytic therapy increases the absolute risk of stroke, including hemorrhagic stroke, in patients of advanced age. Cholesterol embolism has been reported rarely in patients treated with thrombolytic agents. Coronary thrombolysis may result in arrhythmias associated with reperfusion (see "Warnings" in the prescribing information). |
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