Effect of nicardipine prolonged-release implants on cerebral vasospasm and clinical outcome after severe aneurysmal subarachnoid hemorrhage : A prospective, randomized, double-blind phase IIa study

• Published in: Stroke (1970) 2007-02, Vol.38 (2), p.330-336
• Main Authors: BARTH, Martin, CAPELLE, Hans-Holger, WEIDAUER, Stephan, WEISS, Christel, MÜNCH, Elke, THOME, Claudius, LUECKE, Thomas, SCHMIEDEK, Peter, KASUYA, Hidetoshi, VAJKOCZY, Peter
• Format: Article
• Language: English
• Subjects: Adult; Biological and medical sciences; Cardiovascular system; Delayed-Action Preparations - administration & dosage; Double-Blind Method; Drug Implants; Female; Humans; Intracranial Aneurysm - diagnostic imaging; Intracranial Aneurysm - drug therapy; Intracranial Aneurysm - epidemiology; Medical sciences; Middle Aged; Neurology; Neuropharmacology; Neuroprotective agent; Nicardipine - administration & dosage; Pharmacology. Drug treatments; Prospective Studies; Radiography; Subarachnoid Hemorrhage - diagnostic imaging; Subarachnoid Hemorrhage - drug therapy; Subarachnoid Hemorrhage - epidemiology; Time Factors; Treatment Outcome; Vascular diseases and vascular malformations of the nervous system; Vasodilator agents. Cerebral vasodilators; Vasospasm, Intracranial - diagnostic imaging; Vasospasm, Intracranial - drug therapy; Vasospasm, Intracranial - epidemiology
• ISSN: 0039-2499; 1524-4628
• DOI: 10.1161/01.STR.0000254601.74596.0f

The purpose of this study was to investigate the effect of nicardipine prolonged-release implants (NPRIs) on cerebral vasospasm and clinical outcome after severe subarachnoid hemorrhage. Thirty-two patients with severe subarachnoid hemorrhage and undergoing aneurysm clipping were included into this single center, randomized, double-blind trial. Sixteen patients received NPRIs implanted into the basal cisterns in direct contact to the exposed proximal blood vessels; in 16 control patients, the basal cisterns were opened and washed out only without leaving implants. Angiography was performed preoperatively and at day 8+/-1. Computed tomography imaging was analyzed for the incidence of territorial infarcts unrelated to surgery. Patient outcome was assessed using the modified Rankin and National Institute of Health Stroke scales. The incidence of angiographic vasospasm in proximal vessel segments was significantly reduced after implantation of NPRIs (73% control versus 7% NPRIs). Significant differences occurred also for the majority of distal vessel segments. Computed tomography scans revealed a lower incidence of delayed ischemic lesions (47% control versus 14% NPRIs). The NPRI group demonstrated more favorable modified Rankin and National Institute of Health Stroke scales as well as a significantly lower incidence of deaths (38% control versus 6% NPRIs). Implantation of NPRIs reduces the incidence of cerebral vasospasm and delayed ischemic deficits and improves clinical outcome after severe subarachnoid hemorrhage.