Small Unruptured Aneurysm Verification-prevention Effect against Growth of Cerebral Aneurysm Study Using Statin

Kazumichi YOSHIDA; Ikuko UWANO; Makoto SASAKI; Osamu TAKAHASHI; Nobuyuki SAKAI; Wataro TSURUTA; Hiroyuki NAKASE; Kuniaki OGASAWARA; Toshiaki OSATO; Jun C. TAKAHASHI; Taketo HATANO; Hiroyuki KINOUCHI; Susumu MIYAMOTO; On behalf of the SUAVe-PEGASUS trial Investigators

doi:10.2176/nmc.oa.2021-0017

Original Articles

Small Unruptured Aneurysm Verification-prevention Effect against Growth of Cerebral Aneurysm Study Using Statin

Kazumichi YOSHIDA, Ikuko UWANO, Makoto SASAKI, Osamu TAKAHASHI, Nobuyuki SAKAI, Wataro TSURUTA, Hiroyuki NAKASE, Kuniaki OGASAWARA, Toshiaki OSATO, Jun C. TAKAHASHI, Taketo HATANO, Hiroyuki KINOUCHI, Susumu MIYAMOTO, On behalf of the SUAVe-PEGASUS trial Investigators

Author information

Kazumichi YOSHIDA
Department of Neurosurgery, Kyoto University Graduate School of Medicine
Ikuko UWANO
Division of Ultra-High Field MRI, Institute for Biomedical Sciences, Iwate Medical University
Makoto SASAKI
Division of Ultra-High Field MRI, Institute for Biomedical Sciences, Iwate Medical University
Osamu TAKAHASHI
St. Luke's International University Graduate School of Public Health
Nobuyuki SAKAI
Department of Neurosurgery, Kobe City Medical Centre General Hospital
Wataro TSURUTA
Department of Endovascular Neurosurgery, Toranomon Hospital
Hiroyuki NAKASE
Department of Neurosurgery, Nara Medical University
Kuniaki OGASAWARA
Department of Neurosurgery, Iwate Medical University
Toshiaki OSATO
Department of Neurosurgery, Nakamura Memorial Hospital
Jun C. TAKAHASHI
Department of Neurosurgery, National Cerebral and Cardiovascular Center
Taketo HATANO
Department of Neurosurgery, Stroke Center, Kokura Memorial Hospital
Hiroyuki KINOUCHI
Department of Neurosurgery, Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi
Susumu MIYAMOTO
Department of Neurosurgery, Kyoto University Graduate School of Medicine
On behalf of the SUAVe-PEGASUS trial Investigators

Keywords: cerebral aneurysm, small unruptured aneurysm, statin, randomized study

JOURNAL OPEN ACCESS

2021 Volume 61 Issue 7 Pages 442-451

DOI https://doi.org/10.2176/nmc.oa.2021-0017

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Details

Abstract

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.

Clinical trial registration: UMIN000005135

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