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Safety of Bolus vs Infusion Thrombolytic Therapy—Reply

John Eikelboom, MBBS; Shamir Mehta, MD
JAMA. 2001;285(16):2075. doi:10.1001/jama.285.16.2075.
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In Reply: Dr Graumlich suggests that an absolute excess of 2 intracranial hemorrhages per 1000 patients treated with bolus thrombolytic therapy is not clinically relevant. However, clinical relevance cannot be determined solely on the basis of the numbers of patients treated at a single institution. The total burden of disease in the general community must also be considered.

We estimate that the routine adoption of bolus thrombolytic therapy in place of standard infusion therapy will lead to an excess of approximately 1000 cases of intracranial hemorrhage each year in North America,1,2 more than 500 of which will be fatal.3 On a worldwide basis, this translates into thousands of avoidable cases and premature deaths each year with no benefit on reinfarction, other cardiovascular death, or nonhemorrhagic stroke. Irrespective of the alleged failure of hospital formulary committees in the United States to consider the public health implications of modest differences in efficacy or safety between new and established therapies, clinicians cannot ignore the potential impact of this uncommon but devastating complication on the health of their patients.


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