scholarly journals Successful implementation of best medical treatment for patients with asymptomatic carotid artery stenosis within a randomized controlled trial (SPACE-2)

2021 ◽  
Vol 3 (1) ◽  
Author(s):  
Tilman Reiff ◽  
Hans-Henning Eckstein ◽  
Ulrich Mansmann ◽  
Olav Jansen ◽  
Gustav Fraedrich ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Carotid Artery ◽  
Controlled Trial ◽  
Asymptomatic Carotid ◽  
Randomized Controlled ◽  
Cholesterol Levels ◽  
Best Medical Treatment ◽  
Asymptomatic Carotid Artery Stenosis ◽  
One Year ◽  
Hba1c Levels

Abstract Background Asymptomatic carotid artery stenosis (ACS) can be treated with carotid endarterectomy (CEA), carotid artery stenting (CAS), or best medical treatment (BMT) only. For all treatment options, optimization of vascular risk factors such as arterial hypertension, hyperlipidemia, smoking, obesity, and insufficient physical activity is essential. Data on adherence to BMT and lifestyle modification in patients with ACS are sparse. The subject of this investigation is the implementation and quality of risk factor adjustment in the context of a randomized controlled trial. Methods A total of 513 patients in the prematurely terminated, randomized, controlled, multicenter SPACE-2 trial (ISRCTN 78592017) were analyzed within one year after randomization into 3 groups (CEA, CAS, and BMT only) for implementation of prespecified BMT recommendations and lifestyle modifications. Measurement time points were the screening visit and visits after one month (D30), 6 months (M6), and one year (A1). Differences between groups and follow-up visits (FUVs) relative to the screening visit were investigated. Findings For all FUVs, a significant increase in statin medication (91% at A1; p < 0.0001) was demonstrated to be associated with a significant decrease (p < 0.01) in cholesterol levels (median 167 mg/dl at A1) and LDL cholesterol levels (median 93 mg/dl at A1). The lowest cholesterol levels were achieved by patients in the BMT group. Seventy-eight percent of all patients reached predefined target cholesterol levels (< 200 mg/dl), with significantly better rates in the BMT group (p = 0.036 at D30). Furthermore, a significant decrease in arterial blood pressure at all FUVs (p < 0.05) was associated with a significant increase in antihypertensive medication (96% at A1, p < 0.0001). However, only 28% of patients achieved the predefined treatment goal of a systolic blood pressure of ≤ 130 mmHg. Forty-two of a total of 100 smokers at the screening visit quit smoking within one year, resulting in a significant increase in nonsmokers at all FUVs (p < 0.0001). Recommended HbA1c levels (< 7%) were achieved in 82% without significant changes after one year. Only 7% of obese (BMI > 25) patients achieved sufficient weight reduction after one year without significant changes at all FUVs (median BMI 27 at A1; p = 0.1201). The BMT group showed significantly (p = 0.024) higher rates of adequate physical activity than the intervention groups. Furthermore, after one year, the BMT group showed a comparatively significantly better implementation of risk factor modification (77%; p = 0.027) according to the treating physician. Interpretation SPACE-2 demonstrated sustained improvement in the noninterventional management of vascular risk factors in patients treated in a clinical trial by general practitioners, internists and neurologists. The best implemented treatment targets were a reduction in cholesterol and HbA1c levels. In this context, a significant increase in statin use was demonstrated. Blood pressure control missed its target but was significantly reduced by intensification of antihypertensive medication. Patients on BMT only had better adjusted lipid parameters and were more physically active. However, all groups failed to achieve sufficient weight reduction. Due to insufficient patient recruitment, the results must be interpreted cautiously. Trial registration: ISRCTN Registry, ISRCTN78592017, Registered 16 June 2007, https://www.isrctn.com/search?q=78592017.

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

2019 ◽  
Vol 15 (6) ◽  
pp. 638-649 ◽  
Author(s):  
T Reiff ◽  
HH Eckstein ◽  
U Mansmann ◽  
O Jansen ◽  
G Fraedrich ◽  
...  
Keyword(s):  
Carotid Artery ◽  
Carotid Stenosis ◽  
Carotid Artery Stenosis ◽  
Artery Stenosis ◽  
Asymptomatic Carotid Stenosis ◽  
Asymptomatic Carotid ◽  
Best Medical Treatment ◽  
Asymptomatic Carotid Artery Stenosis ◽  
One Year ◽  
The One

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.

Issues to Be Addressed and Hopefully Resolved in the Carotid Revascularization Endarterectomy Versus Stenting Trial 2

Angiology ◽  
2015 ◽  
Vol 67 (5) ◽  
pp. 408-410 ◽  
Author(s):  
Wesley S. Moore
Keyword(s):  
Carotid Artery ◽  
Medical Treatment ◽  
Stroke Prevention ◽  
Carotid Artery Stenting ◽  
Controlled Trials ◽  
Asymptomatic Carotid Stenosis ◽  
Asymptomatic Carotid ◽  
Carotid Revascularization ◽  
Randomized Controlled ◽  
Best Medical Treatment

The superiority of carotid endarterectomy (CEA) plus best medical treatment (BMT) over BMT alone for the management of patients with asymptomatic carotid stenosis is based on randomized controlled trials that recruited patients up to 30 years ago. Best medical treatment has improved considerably since that time with respect to stroke prevention. Furthermore, a new carotid intervention has emerged during the last 2 decades and has gradually become established, that is, carotid artery stenting (CAS). Consequently, the efficacy of current BMT alone needs to be compared not only with CEA plus BMT but also with CAS plus BMT to determine which strategy achieves the optimal stroke prevention rates. This article highlights the purpose of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) 2 and discusses the issues that CREST-2 will hopefully provide answers to.

Optimal contemporary management of symptomatic and asymptomatic carotid artery stenosis

Vascular ◽  
2011 ◽  
Vol 19 (3) ◽  
pp. 117-120 ◽  
Author(s):  
Kosmas I Paraskevas ◽  
Dimitri P Mikhailidis ◽  
Wesley S Moore ◽  
Frank J Veith
Keyword(s):  
Carotid Artery ◽  
Carotid Artery Stenosis ◽  
Stroke Risk ◽  
Artery Stenosis ◽  
Asymptomatic Carotid ◽  
Symptomatic Carotid ◽  
Asymptomatic Patients ◽  
Best Medical Treatment ◽  
Asymptomatic Carotid Artery Stenosis ◽  
Contemporary Management

This commentary addresses the issue of optimal contemporary management of symptomatic and asymptomatic carotid artery stenosis. Based on current data, carotid endarterectomy (CEA) should be performed in the majority of patients with symptomatic carotid artery stenosis. Carotid artery stenting (CAS) should be reserved for a minority of these symptomatic patients, in whom CEA is contraindicated. In asymptomatic patients, all should be placed on best medical treatment (BMT). With the use of one or more of the proposed stroke risk stratification models or some as yet undetermined method, the identification of those asymptomatic individuals may be possible in whom stroke risk is higher than usual with BMT. This asymptomatic subgroup, which may be small and is yet to be determined with certainty, could be offered an invasive carotid procedure (either CAS or CEA).

Clinical considerations in the management of asymptomatic carotid artery stenosis

2011 ◽  
Vol 31 (6) ◽  
pp. E7 ◽  
Author(s):  
Philipp Taussky ◽  
Ricardo A. Hanel ◽  
Fredric B. Meyer
Keyword(s):  
Carotid Artery ◽  
Randomized Controlled Trials ◽  
Carotid Artery Stenosis ◽  
Risk Profile ◽  
Artery Stenosis ◽  
Controlled Trials ◽  
Asymptomatic Carotid ◽  
Randomized Controlled ◽  
Asymptomatic Carotid Artery Stenosis ◽  
Angioplasty And Stenting

Incidental findings pose considerable management dilemmas for the treating physician and psychological burden for the respective patient. With an aging population, more patients will be diagnosed with asymptomatic internal carotid artery stenosis. Patients will have to be counseled with regard to treatment options according to their individual risk profile and according to professionals' knowledge of evidence-based data derived from large randomized control trials. Treatment consensus has long been lacking for patients with asymptomatic carotid artery stenosis prior to any randomized controlled trials. Additionally, an individual's risk profile may be hard to assess according to knowledge gained from randomized controlled trials. Moreover, while earlier studies compared carotid endarterectomy and medical therapy, in the past years, a new therapeutic modality, carotid artery angioplasty and stenting, has emerged as a possible alternative. This has been evaluated in a recent randomized controlled trial, the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), which compared carotid endarterectomy with angioplasty and stenting in both symptomatic and asymptomatic patients. The following review summarizes current knowledge of the natural history, diagnosis, and treatment strategies to counsel patients with asymptomatic carotid artery stenosis.

Oxidative injury associated with stenting of asymptomatic carotid artery stenosis

VASA ◽  
2017 ◽  
Vol 46 (4) ◽  
pp. 268-274
Author(s):  
Erhan Saraçoğlu ◽  
Ertan Vuruşkan ◽  
Yusuf Çekici ◽  
Salih Kiliç ◽  
Halil Ay ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Carotid Artery ◽  
Oxidative Damage ◽  
Carotid Artery Stenosis ◽  
Artery Stenosis ◽  
Oxidative Stress Marker ◽  
Asymptomatic Carotid ◽  
Imaging Methods ◽  
Neurological Findings ◽  
Asymptomatic Carotid Artery Stenosis

Abstract. Background: After carotid artery stenting (CAS), neurological complications that cannot be explained with imaging methods may develop. In our study we aimed to show, using oxidative stress markers, isolated oxidative damage and resulting neurological findings following CAS in patients with asymptomatic carotid artery stenosis. Patients and methods: We included 131 neurologically asymptomatic patients requiring CAS. The neurological findings were evaluated using the modified Rankin Scale (mRS) prior to the procedure, one hour post-procedure, and two days after. Patients with elevated mRS scores but with or without typical hyperintense lesions observed on an MRI and with changes of oxidative stress marker levels at the time (Δtotal-thiol, Δtotal antioxidative status [TAS], and Δtotal oxidant status [TOS]) were evaluated. Results: In the neurological examination carried out one hour prior to the procedure, there were 92 patients with mRS = 0, 20 with mRS = 1, and 12 with mRS = 2. When Δtotal-thiol, ΔTAS, and ΔTOS values and the mRS were compared, it was observed that as the difference in oxidative parameters increased, clinical deterioration also increased proportionally (p = 0.001). Conclusions: We demonstrate a possible correlation between oxidative damage and neurological findings after CAS which could not be explained by routine imaging methods.

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