Safety of low-dose heparin for intracranial stent-assisted angioplasty: a randomized controlled pilot study.
OBJECTIVE
To access the safety of low-dose heparin in comparison to a high-dose regimen in patients undergoing intracranial stent-assisted angioplasty.


METHODS
Sixty-four consecutive patients (53 men; mean age 54 years) undergoing stent-assisted angioplasty of 70 intracranial arterial stenoses were randomized to receive either low-dose (2000-U bolus+500 U/h) or high-dose (3000-U bolus+800 U/h) intravenous heparin during the procedure. The activated clotting time (ACT) was measured. The groups were compared for the following primary endpoints until hospital discharge: target lesion acute thrombosis, intracranial hemorrhage (ICH), and death.


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).


CONCLUSIONS
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.
Gao
Feng
F
Department of Neurology and Neuroradiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Du
Bin
B
Xu
Xiao-Tong
XT
Wang
Yong-Jun
YJ
Jiang
Wei-Jian
WJ
D000328:Adult; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006493:Heparin / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007275:Injections, Intravenous; D020765:Intracranial Arterial Diseases / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D020300:Intracranial Hemorrhages / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010351:Patient Discharge; D010865:Pilot Projects; D011446:Prospective Studies; D018570:Risk Assessment; D015607:Stents; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome
D000925:Anticoagulants; D006493:Heparin