Results of the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) study to treat symptomatic stenoses at 2 years: a multinational, prospective, randomised trial

Eckstein, H.‐H.; Ringleb, Peter; Allenberg, Jens-Rainer; Berger, Jürgen; Fraedrich, Gustav; Hacke, Werner; Hennerici, Michael G.; Stingele, Robert; Fiehler, Jens; Zeumer, H.; Jansen, Olav

doi:10.1016/s1474-4422(08)70196-0

Cited by 748 publications

(561 citation statements)

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“…Unfortunately, thus far, gender issues regarding the comparison of CEA and CAS were not yet fully explored in the SPACE study where women were anyway underrepresented (28 %) [44,45].…”

Section: Endovascular Therapymentioning

confidence: 99%

Gender differences in patients with carotid stenosis

Stoberock¹,

Debus²,

Atlihan³

et al. 2016

Vasa

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PrevalenceAccording to the "North American Symptomatic Carotid Artery Trial" (NASCET) a significant stenosis of the internal carotid artery is defined as a loss of lumen of at least 50 %. A distinction is made between moderate (50 -70 %) and high-grade stenosis (≥ 70 %).In a meta-analysis of 29 studies involving 22,636 patients, the pooled prevalence of moderate stenosis was 4.2 % (95 % CI 3.1 -5.7 %). In a meta-analysis of 4 studies with 6518 patients, the prevalence of high-grade stenosis was 1.7 % (95 % CI 0.7 -3.9 %) [4].Carotid stenosis is more common in men than in women: 7 -9 % of men > 65 years-old have at least a 50 % stenosis compared to 5 -7 % of age-matched women [4,5]. In a meta-analysis of 8 studies, the prevalence in patients < 70 years-old was 4.8 % (95 % CI 3.1 -7.3 %) for men and 2.2 % (95 % CI 0.9 -4.9 %) for women [3,4]. In patients > 70 years-old, it was 12.5 % (95 % CI 7.4 -20.3 %) for men, and 6.9 % (95 % CI 4.0 -11.5 %) for women [3,4]. Epidemiology and risk factors for strokeAlthough the prevalence for carotid stenosis is higher in men, the risk of stroke is higher in women. In Western societies, one out of every 5 women and one out of every 6 men will suffer from a stroke during their lifetime [5]. Mul- Review Gender differences in patients with carotid stenosisKonstanze Stoberock 1 , Eike Sebastian Debus 1 , Gülsen Atlihan 1 , Günter Daum 1 , Axel Larena-Avellaneda 1 , Sandra Eifert 2 , and Sabine Wipper 1 1 University Heart Center, Hamburg, Germany 2 University Heart Center, Leipzig, Germany Summary: This overview analyses gender differences in prevalence, epidemiology, risk factors and therapy in patients with carotid stenosis in a systematic review. Ischemic stroke is a leading cause of death in Western society, where about 20% of cases are triggered by a carotid stenosis or occlusion, which occurs more frequently in men than in women. The stroke-protective effect of carotid endarterectomy is greater in men. Men have lower peri-procedural stroke and death rates. Particularly men with carotid stenosis and a life expectancy of at least 5 years benefit from surgical treatment. Also, the recurrence rate of ipsilateral stroke 5 years after initial surgery is lower in men than in women. It is not yet fully clarified whether there are significant gender differences regarding the outcome after endovascular versus surgical treatment. Gender differences in the outcome of carotid artery repair may be caused by biological, anatomical (smaller vessel diameter in women) or hormonal differences as well as a protracted development of atherosclerotic changes in women and different plaque morphology. Moreover, women are on average older at the time of surgery and their surgical treatment is often delayed. To reduce the risk of stroke and to improve treatment outcome especially for women, further research on gender differences and their causes is mandatory and promising.

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“…Unfortunately, thus far, gender issues regarding the comparison of CEA and CAS were not yet fully explored in the SPACE study where women were anyway underrepresented (28 %) [44,45].…”

Section: Endovascular Therapymentioning

confidence: 99%

Gender differences in patients with carotid stenosis

Stoberock¹,

Debus²,

Atlihan³

et al. 2016

Vasa

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“…In addition, several randomized clinical trials (SPACE, CREST, International Carotid Stenting Study [ICSS]) comparing CAS to CEA also did not show a significant impact of sex on the outcome of patients undergoing CAS. 10,14,20 A meta-analysis of individual patient data recently performed by the Carotid Stenting Trialists Collaboration, taken from the randomized trials ICSS, EVA-3S, and SPACE, comparing short-term outcome after CAS vs endarterectomy for symptomatic carotid stenosis, did not show a significant impact of sex on the outcome of patients undergoing each therapy. 21 In contrast to the trials mentioned above, the EVA-3S trial showed a significantly worse outcome of men undergoing CAS compared with women, which was mainly caused by a lower risk of stroke or death in men undergoing CEA compared with women.…”

Section: Outcome In Women Vs Men Undergoing Carotid Artery Stentingmentioning

confidence: 99%

Carotid Artery Stenting in Clinical Practice: Does Sex Matter? Results From the Carotid Artery Stenting Registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK)

Werner

Zeymer

Mark

et al. 2012

Clinical Cardiology

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Background:Carotid artery stenting (CAS) is increasingly used for treatment of severe carotid artery stenosis, but only few procedural risk factors for complications of CAS are clearly defined yet. A possible impact of the patient's gender on the outcome of patients undergoing CAS has not been investigated properly and only little information about this topic is available so far.Methods:We analysed data of the German prospective, multicenter CAS Registry of the Arbeitsgemeinschaft leitende kardiologische Krankenhausärzte.Results:From July 1996 to May 2009 5130 patients underwent CAS at 35 German hospitals and were enrolled into the prospective ALKK CAS Registry. Therefrom 1443 (28.1%) patients were female. There was no significant time‐related difference in the proportion of women undergoing CAS over the years. Women undergoing CAS were significantly older than men (73 years vs. 70 years, p < 0.01) and had a longer in hospital stay in comparison to men (p < 0.01). The majority of patients treated with CAS was between 60 and 80 years of age (∼73%). No significant differences between women and men could be found regarding in‐hospital events like death (0.5% vs. 0.5%, p = 0.99), major or minor stroke (1.7% vs. 1.6%, p = 0.97; 1.0% vs. 1.6%, p = 0.12), TIA (2.8% vs. 2.6%, p = 0.64), amaurosis fugax (0.3% vs. 0.5%, p = 0.25) , intracranial bleeding (0.5% vs. 0.3%, p = 0.43), myocardial infarction (0.1% vs. 0.0%, p = 0.48) or all non‐fatal strokes and all death (3.0% vs. 3.4%, p = 0.47). 30 day event rates did not show gender related differences in the combined endpoint of the outcome of patients undergoing CAS, as well (♀ n = 31/882 [3.5%] vs. ♂ n = 109/2273 [4.8%], p = 0.12).Conclusion:Our results do not suggest any gender‐related differences in success rates and complications in CAS. In clinical practice approximately 30% of patients treated with CAS are women.The institutions and people who participated in the ALKK CAS Registry are listed in Zahn et al.16 The authors have no funding, financial relationships, or conflicts of interest to disclose.

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“…The clinical durability of CEA and CAS beyond 5 years cannot be clearly determined from available studies. 45,171 Restenosis after CEA has been reported in 5% to 10% of cases when assessed by postoperative ultrasonography but consistently in fewer than 5% of cases when patching was used in recent series. 63,176,[276][277][278][279][280][281] Hemodynamically significant recurrent stenosis rates of 5% to 7% have been reported in multicenter trials.…”

Section: Durability Of Carotid Revascularizationmentioning

confidence: 99%

“…After 1 year of followup in the SPACE trial, 4.6% of patients who underwent CEA and 10.7% of those undergoing CAS had developed 70% recurrent stenosis as assessed by ultrasound (p50.0009). 45 Although limited data suggest that CAS is noninferior to CEA in patients with various comorbidities, available data are insufficient to justify a recommendation favoring one procedure over the other in patients with carotid stenosis and occlusion of the contralateral carotid artery. Restenosis is generally benign and does not require revascularization except when it leads to recurrent ischemic symptoms or progresses to preocclusive severity.…”

Section: Durability Of Carotid Revascularizationmentioning

confidence: 99%