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Intra-arterial Thrombolysis: PROACT II
PROACT II trial (pro-urokinase) is positive for primary endpoint
- Significant improvement of outcome
- Significant increase in recanalization rate
- Effect mostly found in patients with NIHSS between 10 and 20
- Approval not granted because of study size and neutral secondary endpoints
In the PROACT I (Prolyse in Acute Cerebral Thromboembolism I) trial, intra-arterial thrombolytic therapy using
pro-urokinase was compared with intra-arterial infusion of saline in a blinded session. In that trial recanalization
was higher with pro-urokinase. In the larger PROACT II trial, a total of 150 patients were randomized to receive
either intra-arterial pro-urokinase or low dose i.v. heparin.
In this trial, patients had to have angiographicaly proven M1 or M2 occlusion. More than 400 angiograms were done to
select 150 patients eligible for randomization, a rate that could be lower if TCD or MRA were used as a screening tool.
The primary endpoint was the modified Rankin Scale 0 to 2 as opposed to 3 to 6. The absolute difference was 15 points,
25 % of the Heparin patients reached this independent outcome compared with 40% in the actively treated arm. In addition,
the recanalization rate was, not surprisingly, significantly higher in the actively treated group and reached almost
70 %. Approval was not granted by the FDA, and a larger trial, PROACT III is in preparation.
Patients have been treated with intra-arterial rt-PA but this method of administration has no regulatory approval and no clear dosing recommendation.
References:
Furlan et al. JAMA 1999; 282 (21): 2003-2011. |
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© 2005 Boehringer Ingelheim GmbH, Germany. All rights reserved.
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