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Small Unruptured Aneurysm Verification-prevention Effect against Growth of Cerebral Aneurysm Study Using Statin
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- YOSHIDA Kazumichi
- Department of Neurosurgery, Kyoto University Graduate School of Medicine
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- UWANO Ikuko
- Division of Ultra-High Field MRI, Institute for Biomedical Sciences, Iwate Medical University
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- SASAKI Makoto
- Division of Ultra-High Field MRI, Institute for Biomedical Sciences, Iwate Medical University
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- TAKAHASHI Osamu
- St. Luke's International University Graduate School of Public Health
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- SAKAI Nobuyuki
- Department of Neurosurgery, Kobe City Medical Centre General Hospital
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- TSURUTA Wataro
- Department of Endovascular Neurosurgery, Toranomon Hospital
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- NAKASE Hiroyuki
- Department of Neurosurgery, Nara Medical University
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- OGASAWARA Kuniaki
- Department of Neurosurgery, Iwate Medical University
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- OSATO Toshiaki
- Department of Neurosurgery, Nakamura Memorial Hospital
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- TAKAHASHI Jun C.
- Department of Neurosurgery, National Cerebral and Cardiovascular Center
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- KINOUCHI Hiroyuki
- Department of Neurosurgery, Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi
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- HATANO Taketo
- Department of Neurosurgery, Stroke Center, Kokura Memorial Hospital
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- MIYAMOTO Susumu
- Department of Neurosurgery, Kyoto University Graduate School of Medicine
Bibliographic Information
- Published
- 2021
- Resource Type
- journal article
- DOI
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- 10.2176/nmc.oa.2021-0017
- Publisher
- The Japan Neurosurgical Society
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Description
<p>Several basic experimental studies have demonstrated that statins have beneficial effects for intracranial aneurysm (IA). Clinical studies on unruptured IAs, however, remain limited to four retrospective studies that have reached different conclusions. This study was the first open-label, multicenter, randomized controlled trial to assess the preventive effects of atorvastatin. Patients with unruptured small saccular IAs were randomly assigned to statin and control groups. The primary endpoint was a composite of aneurysm growth of ≥0.5 mm, new bleb formation confirmed from magnetic resonance (MR) angiography, and rupture. Enrollment was prematurely terminated due to unexpectedly slow enrollment. Of 231 patients (275 target IAs), 110 patients (128 IAs) were randomly assigned to the statin group and 121 patients (147 IAs) to the control group. After excluding 22 dropout patients, 107 IAs in the 93 statin group patients and 140 IAs in the 116 control group patients were finally analyzed. No significant differences of basic characteristics were evident between groups, except for significantly higher systolic pressure in the statin group (P = 0.03). The primary endpoint occurred in 28 IAs (20.0%) in the control group and in 17 IAs (15.9%) in the statin group. No aneurysm rupture was confirmed in either group. Significant beneficial effects of statin for IAs were not demonstrated for the primary endpoint (log-rank P = 0.359). This randomized trial did not establish any preventive effects of atorvastatin for unruptured small IAs. Further studies of larger cohorts are required to clarify the efficacy of statins for patients with unruptured IAs.</p> <p>Clinical trial registration: UMIN000005135</p>
Journal
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- Neurologia medico-chirurgica
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Neurologia medico-chirurgica 61 (7), 442-451, 2021
The Japan Neurosurgical Society
