Carotid-Stenosis Repair: SPACE for Another CEA vs. Stenting Trial

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Summary and Comment

Carotid-Stenosis Repair: SPACE for Another CEA vs. Stenting Trial

The SPACE trial failed to demonstrate the noninferiority of carotid stenting to endarterectomy, and stenting was associated with slightly more ipsilateral ischemic strokes at 30 days.

In a partly industry-funded, randomized trial conducted in Germany, Austria, and Switzerland, researchers compared carotid endarterectomy (CEA; the standard treatment for severe, symptomatic carotid stenosis) with carotid stenting. The trial, known as SPACE, was designed to assess the noninferiority of stenting, the same goal as that of the EVA-3S trial (see Journal Watch Cardiology Oct 18 2006).

The 1200 SPACE subjects had $≥$ 70% carotid-artery stenosis on duplex ultrasound and were randomized within 180 days after experiencing a transient ischemic attack (TIA) or moderate ischemic stroke. An embolic-protection device was used in 27% of the stenting group. Of 35 trial centers, 26 recruited fewer than 50 patients each, and 11 recruited fewer than 10; only 3 centers recruited more than 100 patients each. An additional 10 centers were excluded because they did not meet quality standards; the report does not provide the rejection criteria.

Incidence of the primary endpoint — ipsilateral stroke or death at 30 days — was slightly higher in the stenting group than in the CEA group (6.84% vs. 6.34%; P=0.09 for noninferiority), due entirely to a nonsignificant difference in ipsilateral stroke (6.51% vs. 5.14%). Unlike in other trials, SPACE’s primary endpoint included all events lasting longer than 24 hours, even those that were fully reversible shortly afterwards. The rate of ischemic events with persistent deficits or disabling stroke was 4.0% in the stenting group and 2.9% in the CEA group (odds ratio, 1.39; a nonsignificant difference).

Comment: SPACE failed to demonstrate the periprocedural noninferiority of carotid-artery stenting to CEA; endpoint differences were small and nonsignificant. The exclusion of 10 originally planned centers and limited operator experience at many of the included centers raise questions about the generalizability of the findings. Unfortunately, because of their own limitations, upcoming trials are unlikely to resolve the CEA versus stenting debate. However, continuous quality reporting from centers that perform CEA and carotid stenting might help patients and their physicians to choose the best treatment for symptomatic carotid stenosis that requires repair. For now, carotid stenting seems prudent only for patients with high surgical risk.

— Beat J. Meyer, MD

Published in Journal Watch Cardiology October 18, 2006

Citation(s):

The SPACE Collaborative Group. 30-day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: A randomised non-inferiority trial. Lancet 2006 Oct 7; 368:1239-47.