Phase 2b Trial: Nicardipine Implants Show Promise in Reducing Vasospasm After Aneurysmal Subarachnoid Hemorrhage – JAMA Neurology

Study Design and Population: This single-masked, multicenter, randomized clinical trial involved 41 patients with World Federation of Neurological Surgeons grade 3 or 4 aneurysmal subarachnoid hemorrhage (aSAH) from six neurovascular centers in Germany and Austria. The patients were randomized to either receive localized nicardipine release implants during microsurgical aneurysm repair plus standard care or standard care alone.

Main Findings: The incidence of moderate to severe angiographic vasospasm (aVS) between days 7 and 9 after aSAH was significantly lower in the implant group (20%) compared to the control group (58%; P = .02). Additionally, fewer patients in the implant group required vasospasm rescue therapy (10% vs. 58%; P = .002). However, at 52 weeks, no significant difference was observed in favorable outcomes between the groups (84% in the implant group vs. 67% in the control group; P = .27).

Implications for Practice: Nicardipine implants show promise in reducing vasospasm-related complications following aSAH, suggesting a potential benefit for early postoperative management. However, their impact on long-term clinical outcomes requires further investigation in larger phase 3 trials to determine the overall benefit and cost-effectiveness of this intervention.

Reference: Wessels L et al. (2024). Localized Nicardipine Release Implants for Prevention of Vasospasm After Aneurysmal Subarachnoid Hemorrhage: A Randomized Clinical Trial. JAMA Neurology. http://doi.org/10.1001/jamaneurol.2024.2564