Testing devices for the prevention and treatment of stroke and its complications

We are entering a challenging but exciting period when many new interventions may appear for stroke based on the use of devices. Hopefully these will lead to improved outcomes at a cost that can be afforded in most parts of the world. Nevertheless, it is vital that lessons are learnt from failures in the development of pharmacological interventions (and from some early device studies), including inadequate preclinical testing, suboptimal trial design and analysis, and underpowered studies. The device industry is far more disparate than that seen for pharmaceuticals; companies are very variable in size and experience in stroke, and are developing interventions across a wide range of stroke treatment and prevention. It is vital that companies work together where sales and marketing are not involved, including in understanding basic stroke mechanisms, prospective systematic reviews, and education of physicians. Where possible, industry and academics should also work closely together to ensure trials are designed to be relevant to patient care and outcomes. Additionally, regulation of the device industry lags behind that for pharmaceuticals, and it is critical that new interventions are shown to be safe and effective rather than just feasible. Phase IV postmarketing surveillance studies will also be needed to ensure that devices are safe when used in the ‘real-world’ and to pick up uncommon adverse events

Guidelines for management of ischaemic stroke and transient ischaemic attack 2008

This article represents the update of the European Stroke Initiative Recommendations for Stroke Management. These guidelines cover both ischaemic stroke and transient ischaemic attacks, which are now considered to be a single entity. The article covers referral and emergency management, Stroke Unit service, diagnostics, primary and secondary prevention, general stroke treatment, specific treatment including acute management, management of complications, and rehabilitation

How I Interpreted the Randomised Trials of Carotid Angioplasty/stenting versus Endarterectomy

AbstractCarotid endarterectomy (CEA) for carotid stenosis is effective in preventing ipsilateral carotid territory ischaemic stroke. Paradoxically however, it causes a stroke (the event it is trying to prevent) in about 5% or more of cases. If carotid angioplasty/stenting (CAS) is to have a place in the management of patients with carotid stenosis (beyond those who are not suitable for CEA), it has to demonstrate that it is also effective and safe.Limited data from 12 randomised trials comparing CAS with CEA (the current “gold standard”) in a total of 3227 patients with carotid stenosis (90% symptomatic) question the safety of CAS and suggest that it may cause more non-fatal, procedural strokes than CEA despite similar mortality rates and a much lower immediate local complication rate (eg cranial neuropathy). However, the published trials are rather heterogeneous (clinically and methodologically), none is large enough to provide robust and convincing data and long-term follow-up is very limited. Accordingly, it remains unknown whether CAS is effective in preventing recurrent stroke among patients with carotid stenosis, or whether it is safe.More data (from at least another 3,000 patients) are needed from the ongoing randomised trials before it can reliably be concluded whether CAS is inferior to, non-inferior to, or more effective than, CEA. More importantly, it will be possible to determine which patients should be treated preferentially with CAS, which patients with CEA, and which patients should not undergo either revascularisation procedure

Carotid artery stent placement is safe in the very elderly (>= 80 years)

Background: Carotid artery stent (CAS) placement is an alternative to carotid endarterectomy (CEA) for stroke prevention. Clinical adoption of CAS depends on its safety and efficacy compared to CEA. There are conflicting reports in the literature regarding the safety of CAS in the elderly. To address these safety concerns, we report our single-center 13-year CAS experience in very elderly (≥80 years of age) patients. Methods: Between 1994 and 2007, 816 CAS procedures were performed at the Ochsner Clinic Foundation. Very elderly patients, those ≥80 years of age, accounted for 126 (15%) of all CAS procedures. Independent neurologic examination was performed before and after the CAS procedure. Results: The average patient age was 82.9 ± 2.9 years. Almost one-half (44%) were women and 40% were symptomatic from their carotid stenoses. One-third of the elderly patients met anatomic criteria for high surgical risk as their indication for CAS. The procedural success rate was 100% with embolic protection devices used in 50%. The 30-day major adverse coronary or cerebral events (MACCE) rate was 2.7% (n = 3) with all events occurring in the symptomatic patient group [death = 0.9% (n = 1), myocardial infarction = 0%, major (disabling) stroke = 0.9% (n = 1), and minor stroke = 0.9% (n = 1)]. Conclusion: Elderly patients, ≥80 years of age, may undergo successful CAS with a very low adverse event rate as determined by an independent neurological examination. We believe that careful case selection and experienced operators were keys to our success