Safety and Efficacy of Low-dose Heparin During Intracranial Angioplasty and Stent Placement "SELHIAS "

Completed

Phase N/A Results

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.