Sunday, April 21, 2013

High-Dose Simvastatin for Aneurysmal Subarachnoid Hemorrhage: A Multicenter, Randomized, Controlled

imageBACKGROUND: Experimental evidence has indicated the benefit of simvastatin in the treatment of subarachnoid hemorrhage. However, no clinical data are available to answer whether a high-dose regimen is more effective than a normal-dose regimen, even though the biochemical actions and related neuroprotective mechanisms are thought to be dose related. OBJECTIVE: To determine whether 80 mg simvastatin daily (high dose) over 3 weeks initiated within 96 hours of the ictus will reduce the incidence of delayed ischemic deficits after subarachnoid hemorrhage compared with 40 mg simvastatin daily (normal dose), leading to improvements in clinical outcomes and thus cost-effectiveness. METHODS: The study design is a randomized, controlled, double-blind clinical trial (www.ClinicalTrials.gov ; identifier: NCT01077206). Two hundred forty patients with aneurysmal subarachnoid hemorrhage (presenting within 96 hours of the ictus) from 6 neurosurgical centers are being recruited over 3 years. The primary outcome measure is the presence of delayed ischemic deficits. Secondary outcome measures include modified Rankin Disability Score at 3 months and cost-effectiveness analysis. EXPECTED OUTCOMES: This will be the first study to clarify whether high-dose simvastatin is better than normal-dose simvastatin for patients with acute aneurysmal subarachnoid hemorrhage in terms of neurological outcomes and cost-effectiveness. DISCUSSION: In the present trial, we compare high-dose and normal-dose simvastatin; we know that another ongoing phase III multicenter trial (Simvastatin in Aneurysmal Subarachnoid Haemorrhage; http://www.stashtrial.com/home.html ) is comparing normal-dose and no simvastatin. When the results are interpreted together, the research question of a possible beneficial effect of high-dose simvastatin in acute aneurysmal subarachnoid hemorrhage could be answered. ABBREVIATIONS: DID, delayed ischemic deficit CBF, cerebral blood flow SAH, subarachnoid hemorrhage





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High-Dose Simvastatin for Aneurysmal Subarachnoid Hemorrhage: A Multicenter, Randomized, Controlled

imageBACKGROUND: Experimental evidence has indicated the benefit of simvastatin in the treatment of subarachnoid hemorrhage. However, no clinical data are available to answer whether a high-dose regimen is more effective than a normal-dose regimen, even though the biochemical actions and related neuroprotective mechanisms are thought to be dose related. OBJECTIVE: To determine whether 80 mg simvastatin daily (high dose) over 3 weeks initiated within 96 hours of the ictus will reduce the incidence of delayed ischemic deficits after subarachnoid hemorrhage compared with 40 mg simvastatin daily (normal dose), leading to improvements in clinical outcomes and thus cost-effectiveness. METHODS: The study design is a randomized, controlled, double-blind clinical trial (www.ClinicalTrials.gov ; identifier: NCT01077206). Two hundred forty patients with aneurysmal subarachnoid hemorrhage (presenting within 96 hours of the ictus) from 6 neurosurgical centers are being recruited over 3 years. The primary outcome measure is the presence of delayed ischemic deficits. Secondary outcome measures include modified Rankin Disability Score at 3 months and cost-effectiveness analysis. EXPECTED OUTCOMES: This will be the first study to clarify whether high-dose simvastatin is better than normal-dose simvastatin for patients with acute aneurysmal subarachnoid hemorrhage in terms of neurological outcomes and cost-effectiveness. DISCUSSION: In the present trial, we compare high-dose and normal-dose simvastatin; we know that another ongoing phase III multicenter trial (Simvastatin in Aneurysmal Subarachnoid Haemorrhage; http://www.stashtrial.com/home.html ) is comparing normal-dose and no simvastatin. When the results are interpreted together, the research question of a possible beneficial effect of high-dose simvastatin in acute aneurysmal subarachnoid hemorrhage could be answered. ABBREVIATIONS: DID, delayed ischemic deficit CBF, cerebral blood flow SAH, subarachnoid hemorrhage





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High-Dose Simvastatin for Aneurysmal Subarachnoid Hemorrhage: A Multicenter, Randomized, Controlled

imageBACKGROUND: Experimental evidence has indicated the benefit of simvastatin in the treatment of subarachnoid hemorrhage. However, no clinical data are available to answer whether a high-dose regimen is more effective than a normal-dose regimen, even though the biochemical actions and related neuroprotective mechanisms are thought to be dose related. OBJECTIVE: To determine whether 80 mg simvastatin daily (high dose) over 3 weeks initiated within 96 hours of the ictus will reduce the incidence of delayed ischemic deficits after subarachnoid hemorrhage compared with 40 mg simvastatin daily (normal dose), leading to improvements in clinical outcomes and thus cost-effectiveness. METHODS: The study design is a randomized, controlled, double-blind clinical trial (www.ClinicalTrials.gov ; identifier: NCT01077206). Two hundred forty patients with aneurysmal subarachnoid hemorrhage (presenting within 96 hours of the ictus) from 6 neurosurgical centers are being recruited over 3 years. The primary outcome measure is the presence of delayed ischemic deficits. Secondary outcome measures include modified Rankin Disability Score at 3 months and cost-effectiveness analysis. EXPECTED OUTCOMES: This will be the first study to clarify whether high-dose simvastatin is better than normal-dose simvastatin for patients with acute aneurysmal subarachnoid hemorrhage in terms of neurological outcomes and cost-effectiveness. DISCUSSION: In the present trial, we compare high-dose and normal-dose simvastatin; we know that another ongoing phase III multicenter trial (Simvastatin in Aneurysmal Subarachnoid Haemorrhage; http://www.stashtrial.com/home.html ) is comparing normal-dose and no simvastatin. When the results are interpreted together, the research question of a possible beneficial effect of high-dose simvastatin in acute aneurysmal subarachnoid hemorrhage could be answered. ABBREVIATIONS: DID, delayed ischemic deficit CBF, cerebral blood flow SAH, subarachnoid hemorrhage





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Role of Endoscopic Third Ventriculostomy and Ventriculoperitoneal Shunt in Idiopathic Normal Pressur

imageBACKGROUND: Currently, the most common treatment for idiopathic normal pressure hydrocephalus (INPH) is a ventriculoperitoneal shunt (VPS), generally with programmable valve implantation. Endoscopic third ventriculostomy (ETV) is another treatment option, and it does not require prosthesis implantation. OBJECTIVE: To compare the functional neurological outcome in patients after 12 months of treatment with INPH by using 2 different techniques: ETV or VPS. METHODS: Randomized, parallel, open-label trial involving the study of 42 patients with INPH and a positive response to the tap test, from January 2009 to January 2012. ETV was performed with a rigid endoscope with a 30° lens (Minop, Aesculap), and VPS was performed with a fixed-pressure valve (PS Medical, Medtronic). The outcome was assessed 12 months after surgery. The neurological function outcomes were based on the results of 6 clinical scales: mini-mental, Berg balance, dynamic gait index, functional independence measure, timed up and go, and normal pressure hydrocephalus. RESULTS: There was a statistically significant difference between the 2 groups after 12 months of follow-ups, and the VPS group showed better improvement results (ETV = 50%, VPS = 76.9%). CONCLUSION: Compared with ETV, VPS is a superior method because it had better functional neurological outcomes 12 months after surgery. ABBREVIATIONS: BERG, Berg balance scale DGI, dynamic gait index EI, Evans index ETV, endoscopic third ventriculostomy FIM, functional independence measure INPH, idiopathic normal pressure hydrocephalus MMSE, Mini-Mental State Examination NPH Scale, NPH Japanese Scale TT, tap test TUG, timed up and go VPS, ventriculoperitoneal shunt





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The Durability of Carotid Endarterectomy: Long-term Results for Restenosis and Stroke

BACKGROUND: Carotid endarterectomy is a low-risk treatment for carotid occlusive disease. Recent clinical trials have suggested that carotid angioplasty may be a viable alternative. One important issue that has not been evaluated is the long-term recurrent stenosis rate after either intervention. OBJECTIVE: To examine the risk of recurrent stenosis after carotid endarterectomy and to provide long-term data on the durability of carotid endarterectomy. METHODS: A total of 1335 sequential patients were followed up prospectively with annual carotid ultrasonography. All patients were maintained on antiplatelet therapy, and arteriotomies were closed with a patch graft. Operations were performed under general anesthesia with electroencephalographic monitoring and selective shunting. There were no changes in surgical technique during this study. RESULTS: Two-thirds of the patients were men; the mean age was 70 years. Approximately 60% were symptomatic. The 90-day perioperative morbidity and mortality rate was 0.9% (0.4% stroke and 0.5% death). Five patients (0.4%) developed recurrent stenosis >70% over a mean follow-up of 15.8 years. Twelve patients (0.9%) had documentation of late stroke in the ipsilateral carotid distribution. The mean follow-up was 15.8 years. CONCLUSION: Carotid endarterectomy is an extremely safe treatment for carotid stenosis with very low perioperative complications and low rates of recurrent stenosis or late stroke. When endarterectomy is compared with angioplasty, in addition to periprocedural complications, the durability of both interventions needs to be considered, given the risks and costs of repeat interventions. ABBREVIATIONS: CAS, carotid artery stenting CEA, carotid endarterectomy CREST, Carotid Revascularization Endarterectomy Versus Stenting Trial ICSS, International Carotid Stenting Study NASCET, North American Symptomatic Carotid Endarterectomy Trial





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