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

Where Next after SPACE and EVA-3S: ‘The Good, the Bad and the Ugly!’

SPACE and EVA-3S are the latest to publish outcomes in recently symptomatic patients who were randomised to carotid endarterectomy (CEA) or angioplasty and stenting (CAS). Contrary to expectations, both found that CAS was not ‘as good as’ CEA, while EVA-3S found CEA to be statistically superior. Not surprisingly, these trials have aroused considerable controversy and many in the pro-CAS lobby have simply dismissed them as being methodologically flawed and unrepresentative of contemporary CAS practice. However, to simply dismiss SPACE and EVA-3S as maverick trials is unacceptable. Unlike the landmark ‘symptomatic’ and ‘asymptomatic’ studies, the history of randomised trials comparing CAS and CEA has been characterised by repeated trial suspension (because of excess risk in the CAs cohort) and a systematic failure to achieve randomisation targets (thereby preventing any prospect of a statiscally meaningful outcome) amid a milieu of corporate and individual conflicts of interest. SPACE and EVA-3S have certainly informed the dabate but they have not resolved it. Two trials are actively randomising recently symptomatic patients (ICSS in Europe and CREST in North America). Both require our support so that future guidelines are ‘evidence based’ rather than ‘marker driven’