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. 2019 Mar 15;15(6):1747493019833017.
doi: 10.1177/1747493019833017. Online ahead of print.

Angioplasty in asymptomatic carotid artery stenosis vs. endarterectomy compared to best medical treatment: One-year interim results of SPACE-2

T Reiff  1 , H H Eckstein  2 , U Mansmann  3 , O Jansen  4 , G Fraedrich  5 , H Mudra  6 , D Böckler  7 , M Böhm  8 , H Brückmann  9 , E S Debus  10 , J Fiehler  11 , W Lang  12 , K Mathias  13 , E B Ringelstein  14 , J Schmidli  15 , R Stingele  16 , R Zahn  17 , T Zeller  18 , A Hetzel  19 , U Bodechtel  20 , A Binder  21 , J Glahn  22 , W Hacke  1 , P A Ringleb  1
Affiliations

Angioplasty in asymptomatic carotid artery stenosis vs. endarterectomy compared to best medical treatment: One-year interim results of SPACE-2

T Reiff et al. Int J Stroke. .

Abstract

Background: Treatment of individuals with asymptomatic carotid artery stenosis is still handled controversially. Recommendations for treatment of asymptomatic carotid stenosis with carotid endarterectomy (CEA) are based on trials having recruited patients more than 15 years ago. Registry data indicate that advances in best medical treatment (BMT) may lead to a markedly decreasing risk of stroke in asymptomatic carotid stenosis. The aim of the SPACE-2 trial (ISRCTN78592017) was to compare the stroke preventive effects of BMT alone with that of BMT in combination with CEA or carotid artery stenting (CAS), respectively, in patients with asymptomatic carotid artery stenosis of ≥70% European Carotid Surgery Trial (ECST) criteria.

Methods: SPACE-2 is a randomized, controlled, multicenter, open study. A major secondary endpoint was the cumulative rate of any stroke (ischemic or hemorrhagic) or death from any cause within 30 days plus an ipsilateral ischemic stroke within one year of follow-up. Safety was assessed as the rate of any stroke and death from any cause within 30 days after CEA or CAS. Protocol changes had to be implemented. The results on the one-year period after treatment are reported.

Findings: It was planned to enroll 3550 patients. Due to low recruitment, the enrollment of patients was stopped prematurely after randomization of 513 patients in 36 centers to CEA (n = 203), CAS (n = 197), or BMT (n = 113). The one-year rate of the major secondary endpoint did not significantly differ between groups (CEA 2.5%, CAS 3.0%, BMT 0.9%; p = 0.530) as well as rates of any stroke (CEA 3.9%, CAS 4.1%, BMT 0.9%; p = 0.256) and all-cause mortality (CEA 2.5%, CAS 1.0%, BMT 3.5%; p = 0.304). About half of all strokes occurred in the peri-interventional period. Higher albeit statistically non-significant rates of restenosis occurred in the stenting group (CEA 2.0% vs. CAS 5.6%; p = 0.068) without evidence of increased stroke rates.

Interpretation: The low sample size of this prematurely stopped trial of 513 patients implies that its power is not sufficient to show that CEA or CAS is superior to a modern medical therapy (BMT) in the primary prevention of ischemic stroke in patients with an asymptomatic carotid stenosis up to one year after treatment. Also, no evidence for differences in safety between CAS and CEA during the first year after treatment could be derived. Follow-up will be performed up to five years. Data may be used for pooled analysis with ongoing trials.

Keywords: Asymptomatic carotid artery stenosis; best medical treatment; carotid artery stenting; carotid endarterectomy; disease-free survival; epidemiology; primary prevention; prospective study; stroke.

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Figures

Figure 1.
Figure 1.
Randomization and follow-up of the study patients within one year. All patients included in intention-to-treat analysis. PAOD: Peripheral arterial occlusive disease; CHD: coronary heart disease; ASA: acetylsalicylic acid; CAS: carotid artery stenting; BMT: best medical treatment; CEA: carotid endarterectomy.
Figure 2.
Figure 2.
Kaplan–Meier estimates of cumulative incidence (%) for major outcomes within one year. (a) Major secondary endpoint. (b) Any stroke. (c) Any stroke after day 30 up to one year.** (d) Ipsilateral stroke.** (e) Any death. (f) Restenosis ≥ 70%ECST in CEA and CAS. (g) Ipsilateral TIA.** (h) Disabling stroke.** CAS: carotid artery stenting; BMT: best medical treatment; CEA: carotid endarterectomy; CI: confidence interval; HR: hazard ratio. ** After intervention for CEA/CAS and after randomization for BMT.
See this image and copyright information in PMC

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