Safety and Efficacy of Low-dose Heparin During Intracranial Angioplasty and Stent Placement
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Purpose:
To compare intra-operative two doses of heparin regimen (low dose verses high dose), and to evaluate safety and efficacy of low-dose heparin in patients undergoing intracranial angioplasty and stent placement.
Year Started:
2005
Year Finished:
2009
Design:
Randomized, double-blind, controlled, single-center trial.
Inclusion Criteria
Patients who are undergoing intracranial angioplasty and stenting attributed to symptomatic intracranial arterial stenosis of >50% confirmed by digital subtraction angiography.
Patient Involvement:
Patients are being randomly assigned to two groups, low-dose group who receive 2000 IU heparin intravenous bolus plus 500 IU/hr and high-dose group who receive 3000 IU heparin intravenous bolus plus 800 IU/hr after placement of an arterial sheath during intracranial angioplasty and stenting procedure.
Primary Outcome:
Efficacy end point will be the thrombo-embolic complications within 24 hour and safety end point will be intracranial bleeding complications within 24 hour of intracranial angioplasty and stenting procedure.
Secondary Outcome:
Intra-operative activated clotting time (ACT) and bleeding complications at puncture site.
Results:
The overall angioplasty success rate was 93% (65/70 lesions). Stents were placed in 94.7% (36/38) and 90.6% (29/32) of patients in the low-dose and high-dose groups, respectively (p = 0.65). The primary endpoint occurred in 6% (2/33) of patients in the low-dose group versus 16% (5/31) of patients in the high-dose group (p = 0.25). Two patients, 1 patient in each group, experienced acute target lesion thrombosis during the procedure (p = NS); ICH occurred in 5 patients: 1 in the low-dose group and 4 in high-dose group (3.0% versus 12.9%, p = 0.19). In conclusion, the use of a low-dose heparin regimen did not increase the incidence of target lesion thrombosis or ICH in this small pilot trial. Intraoperative low-dose heparin seems to be safe for patients undergoing intracranial stent-assisted angioplasty, but these data should be confirmed in a larger trial.
Source of Information:
Presented at the 2006 International Stroke Conference [February 2006].
Correspondence with trial coordinator.
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This information last updated on: 11/2/2009
Reviewed on: 10/05/2009.
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