Nicardipine release implants may prevent angiographic vasospasm after subarachnoid haemorrhage

In the treatment of patients with aneurysmal subarachnoid haemorrhage (aSAH), placing nicardipine release implants during microsurgical aneurysm repair appears to reduce the incidence of moderate to severe angiographic vasospasm and improve clinical outcomes, according to data from a phase 2b study.

The study included 41 consecutive patients with World Federation of Neurological Surgeons grade 3 or 4 aSAH due to a ruptured anterior circulation aneurysm requiring microsurgical aneurysm repair. During the procedure, the patients were randomly assigned to receive 10 implants of nicardipine at 4 mg each plus standard of care (implant group, n=21, mean age 53.6 years, 67 percent female) or aneurysm repair alone plus standard of care (control group, n=20, mean age 54.9 years, 85 percent female).

The incidence of moderate to severe cerebral angiographic vasospasm between days 7 and 9 after aneurysm rupture, the primary study endpoint, was ascertained using digital subtraction angiography.

Among the 39 patients who were included in the primary efficacy analysis, moderate to severe angiographic vasospasm occurred in four of 20 patients in the implant group and in 11 of 19 patients in the control group (20 percent vs 58 percent; p=0.02). As such, fewer patients in the implant group than in the control group required vasospasm rescue therapy (10 percent vs 58 percent; p=0.002).

Between days 13 and 15 following aneurysm rupture, new cerebral infarcts occurred in 10 percent of patients in the implant group as opposed to 32 percent in the control group, although the difference was not statistically significant (p=0.13). Likewise, the proportion of patients who had favourable outcomes at week 52 was only numerically greater in the implant vs the control group (84 percent vs 67 percent; p=0.27).

The frequency of adverse events was similar between the two groups.