Stroke Review. Advances in Interventional Neuroradiology 2004

The year 2004 in interventional neuroradiology has been distinguished by the steady accumulation of evidence to validate the efficacy of therapeutic procedures, such as carotid angioplasty and stenting (CAS) for cerebrovascular atherosclerosis. There is increasing momentum to design trials that will validate the role of endovascular therapy in the treatment of acute stroke and other cerebrovascular disorders. Practice patterns continue to evolve as evidence-based principles are applied to interventional therapy. In September 2004, the US Food and Drug Administration approved the use of stents for the treatment of atherosclerotic disease of the carotid bifurcation. This approval was based on data from the industry-supported Acculink for Revascularization of Carotids in High Risk patients (ARCHeR)1 registry and the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial.2 ARCHeR showed a 10% complication rate for CAS in 581 high-risk patients compared with a 15% complication rate derived from the carotid endarterectomy (CEA) literature. SAPPHIRE was a randomized control trial (RCT) comparing CAS to CEA in 334 high-risk patients. Primary end points were the cumulative incidence of death, stroke, or myocardial infarction within 30 days and death or ipsilateral stroke between 31 days and 1 year. The overall rate of primary end points was 39% lower in the CAS group, and CAS resulted in complication rates for all adverse events ≤CEA in both symptomatic and asymptomatic patients. The authors believe they have proven their hypothesis that CAS with distal protection is not inferior to CEA in high-risk patients. Criticisms of the study include the large proportion of asymptomatic patients, bias favoring CAS due to unequal randomization, the inclusion of many patients with recurrent stenoses after prior CEA, small sample size, and controversial end points, such as myocardial infarction and cranial nerve palsy.3 The evidence is also …