Published Online
on December 21, 2006

A more recent version of this article appeared on February 1, 2007

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Submitted on July 31, 2006
Revised on September 15, 2006
Accepted on September 25, 2006

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; and Peter Vajkoczy MD^*

From the Department of Neurosurgery (M.B., H.-H.K., 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.

^* To whom correspondence should be addressed. E-mail: peter.vajkoczy{at}nch.ma.uni-heidelberg.de.

Background and Purpose--The purpose of this study was to investigate the effect of nicardipineprolonged-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: nicardipineprolonged-release implants • SAH • stroke • vasospasm

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