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 statistically 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'.
Naylor
A Ross
AR
The Department of Vascular Surgery at Leicester Royal Infirmary, Leicester, UK. ross.naylor@uhl-tr.nhs.uk
D017130:Angioplasty / Q000009:adverse effects; D016893:Carotid Stenosis / Q000150:complications / Q000401:mortality / Q000601:surgery*; D016265:Conflict of Interest; D016894:Endarterectomy, Carotid / Q000009:adverse effects; D004992:Ethics, Medical; D006801:Humans; D015337:Multicenter Studies as Topic; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents; D020521:Stroke / Q000209:etiology; D016896:Treatment Outcome