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(Stroke. 2007;38:330.)
© 2007 American Heart Association, Inc.

Original Contributions

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

Martin Barth, MD; Hans-Holger Capelle, MD; Stephan Weidauer, MD; Christel Weiss, MD; Elke Münch, MD; Claudius Thomé, MD; Thomas Luecke, MD; Peter Schmiedek, MD; Hidetoshi Kasuya, MD Peter Vajkoczy, MD

From the Department of Neurosurgery (M.B., H.-H.C., C.T., P.S., P.V.), the Institute for Biomedical Statistics (C.W.), and the Institute for Anesthesiology and Intensive Care Medicine (E.M., T.L.), University Hospital Mannheim, Faculty for Clinical Medicine of the Karl-Ruprecht-University of Heidelberg, Mannheim, Germany; the Department of Neuroradiology (S.W.), Johann-Wolfgang-Goethe University of Frankfurt, Germany; and the Department of Neurosurgery (H.K.), Tokyo Women’s Medical University, Tokyo, Japan.

Correspondence to Peter Vajkoczy, MD, Department of Neurosurgery, University Hospital Mannheim, Faculty for Clinical Medicine of the Karl-Ruprecht-University of Heidelberg, Theodor-Kutzer-Ufer 1–3, D-68167 Mannheim, Germany. E-mail peter.vajkoczy{at}nch.ma.uni-heidelberg.de

Background and Purpose— 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.

Methods— 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.

Results— 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).

Conclusions— Implantation of NPRIs reduces the incidence of cerebral vasospasm and delayed ischemic deficits and improves clinical outcome after severe subarachnoid hemorrhage.

Key Words: nicardipine prolonged-release implants • SAH • stroke • vasospasm

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