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  • Simvastatin in aneurysmal subarachnoid haemorrhage (STASH) trial: a clinical phase 111 randomised placebo controlled trial - the results

    Final Number:
    204

    Authors:
    Carole L Turner MSc; Christopher Smith; Gordon D Murray; Peter J. Hutchinson PhD, FRCS (SN); Peter J. Kirkpatrick FRCS

    Study Design:
    Clinical Trial

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2014 Annual Meeting

    Introduction: Prevention of cerebral vasospasm is the target of modern drug therapy, candidates of which include statins. The results of phase 11 studies have shown promise in this arena1. STASH is an international multicentre randomised controlled phase 111 trial designed to assess the effects of Simvastatin 40mg on the long and short term outcome of patients who have suffered from an acute aneurysmal subarachnoid haemorrhage (SAH).

    Methods: All grades of SAH patients with a radiological proven aneurysm were eligible. Patients were randomized to receive Simvastatin 40mg or placebo for up to 21 days. Primary outcome was the modified Rankin Disability Score (mRS) at 6 months. Secondary outcome measures included the SF-36 short form questionnaire at 6 months, the incidence and duration of delayed ischemic deficit (DID) and associated rescue therapy, the incidence and severity of sepsis, length of intensive care and total acute hospital stay, and discharge destination. Primary analysis was an ordinal regression of the mRS following the intention to treat (ITT) principle.

    Results: 803 patients (252 male, 551 female) were recruited with mean age 50 yrs (range 21 – 67). 676 (85%) from UK centres and 127 (15%) from non-UK centres. 588 patients (73%) were WFNS grade 1-2 on admission and 84% had a CT scan Fisher Grade 3 or 4. 515 patients (64%) were coiled. 6 month outcome data is available for 782 (97%) of which 560 (72%) were mRS 0-2 at 6 months. DID was confirmed in 131 (16.3%), and the overall mortality at 6 months was 9% (n = 72). Mean length of hospital stay was 20 days and ITU stay 12 days. 471 (59%) were discharged directly home and 102 (13%) were discharged to rehabilitation centres.

    Conclusions: Primary outcome, secondary outcome measures and subgroup analyses will be presented from the ITT population.

    Patient Care: We have high confidence that this study will provide a definitive statement on the role of statins in this acute setting.

    Learning Objectives: STASH is the largest randomised controlled trial in this cohort of patients and by the conclusion of this session we feel that participants will be able to establish if statins are an effective method of treating acute SAH patients.

    References: 1 Tseng M-Y, Czosnyka M, Richards H, Pickard JD, Kirkpatrick PJ. Effects of acute treatment with Pravastatin on cerebral vasospasm, autoregulation and delayed ischemic deficits after aneurysmal subarachnoid hemorrhage. A phase 11 randomised placebo-controlled trial. Stroke 2005; 36:1627-1632.

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