Adv Ther (2013) 30:845 853 DOI 10.1007/s25-013-0058-8 ORIGINAL RESEARCH Comparison of Carotid Artery Stenting and Carotid Endarterectomy in Patients with Symptomatic Carotid Artery Stenosis: A Single Center Study M. Hakan Taş Ziya Şimşek Abdurrahim Colak Yavuzer Koza Pinar Demir Recep Demir Ugur Kaya Ibrahim Halil Tanboga Fuat Gundogdu Serdar Sevimli To view enhanced content go to www.advancesintherapy.com Received: August 19, 2013 / Published online: October 9, 2013 Ó Springer Healthcare 2013 ABSTRACT Introduction: Carotid artery stenting (CAS) is believed to be an alternative to carotid endarterectomy (CEA); however, recent studies have demonstrated an increase of complications with stenting that does not reflect our experience. We thus wanted to compare the periprocedural and 1-year follow-up outcomes of CAS with those of CEA among patients with symptomatic extracranial carotid stenosis in a population from eastern Turkey. M. H. Taş (&) Z. Şimşek Y. Koza P. Demir I. H. Tanboga F. Gundogdu S. Sevimli Department of Cardiology, Faculty of Medicine, Atatürk University, 25240 Erzurum, Turkey e-mail: mhakantas@gmail.com A. Colak U. Kaya Department of Cardiovascular Surgery, Faculty of Medicine, Atatürk University, Erzurum, Turkey R. Demir Department of Neurology, Faculty of Medicine, Atatürk University, Erzurum, Turkey Enhanced content for Advances in Therapy articles is available on the journal web site: www.advancesintherapy.com Methods: The hospital records of all patients who underwent carotid artery revascularization were retrospectively reviewed. Patients were divided into two groups based on the type of carotid revascularization performed, namely CEA or CAS. Comparisons were made with respect to 30-day and 1-year outcomes of transient ischemic attack (TIA), myocardial infarction (MI), stroke, and all-cause death rates. Composite endpoints for both groups were also analyzed. Results: Thirty-two CEA and 33 CAS procedures were performed for symptomatic occlusive carotid disease. Baseline characteristics were similar between both groups except for the incidence of diabetes mellitus. No significant differences were found with respect to 30-day mortality, MI, and neurologic morbidity endpoints for CEA and CAS procedures. In the postprocedural 1-year follow-up, only TIA was observed to be significantly higher in the CAS group; the other endpoints did not differ significantly. One-year composite endpoints did not differ between both groups (log-rank P = 0.300). Conclusion: In our trial of patients with symptomatic carotid artery stenosis, no
846 Adv Ther (2013) 30:845 853 significant difference could be shown in periprocedural outcomes, postprocedural outcomes except TIA, and in composite endpoints between the CEA and CAS groups. CAS is a safe and efficacious alternative for the treatment of symptomatic carotid artery stenosis. Keywords: Cardiology; Carotid artery stenting; Carotid endarterectomy; Carotid stenosis; Stroke INTRODUCTION Stroke is the third most common cause of mortality and an increasing cause of concern worldwide [1]. Substantial stenosis of the carotid artery is one of the major risk factors for ischemic stroke [2]. The treatment goal in carotid artery stenosis is to reduce the risk of stroke. Carotid endarterectomy (CEA) was first used in the 1950s and marked a turning point in this area. In the 1980s balloon angioplasty of carotid stenosis was performed with a similar safety to CEA. In 1995, carotid angioplasty and stenting (CAS) came to prominence [2]. Large, randomized trials have established CEA as the standard treatment for symptomatic, severe carotid artery stenosis [3]. CAS has been increasingly used as a possible alternative treatment to CEA because of a desire to avoid the risks from neck incision and decrease the risks of general anesthesia. According to recent studies there has been a general awareness that despite its advantages, CAS is associated with higher morbidity than CEA. This has been reported in at least two large, randomized studies [4 6]. While these studies were very well conceived, they failed to take into account operator experience and the number of cases (volume) treated at a center. These findings also do not reflect those achieved by many experienced neurointerventionists and/or cardiologists. Many randomized clinical trials have been conducted to determine the answers to questions, such as: is CAS as safe as endarterectomy and could it provide long-term protection from stroke? However, the answers to these questions are still unclear. In this study, we aimed to compare the periprocedural and 1-year follow-up outcomes of CAS with those of CEA among patients from eastern Turkey with symptomatic extracranial carotid stenosis. METHODS The hospital records of all patients who underwent carotid artery revascularization at the Department of Cardiology, Atatürk University between May 2011 and May 2012 were retrospectively reviewed. For inclusion in this single-center, observational study, either CEA or CAS performed angiographically for symptomatic internal carotid artery (ICA) stenosis of C50% was reviewed for analysis. Patients treated with combined CEA and coronary artery bypass grafting were excluded from the study. Clinical data were collected from the medical records and pooled for analysis. CEA and CAS procedures were performed by experienced cardiovascular surgeons and cardiologists at the Atatürk University [7]. All patients underwent duplex ultrasonography (DUS) preoperatively. After DUS revealed a hemodynamically significant stenosis, patients underwent diagnostic carotid angiogram and diffusion-weighted magnetic resonance imaging to further evaluate patient anatomy and suitability for CAS or CEA (Fig. 1a) [8]. The severity of stenosis was determined angiographically according to the North
Adv Ther (2013) 30:845 853 847 Fig. 1 a Significant stenosis could be seen on the angiographic image; b a filter used for cerebral protection; c digital subtraction angiography image of stent-implanted segment American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria [3]. All patients were counseled by a multidisciplinary board (cardiologist, cardiovascular surgeon, neurologist and radiologist) on the risks and benefits of both treatment modalities. All patients were examined clinically by an independent neurologist before and at 1 day after surgery or intervention. During the time period of this study, our hospital was not participating in any CAS or CEA clinical trials. Patients were excluded from CAS if they had inadequate femoral arterial access both in their right and left sides, unfavorable aortic arch anatomy, severely calcified carotid lesions, or lesions with fresh thrombus. Patients with totally stenosed ICA were excluded from CAS and CEA procedures. CAS was performed in patients at high risk for conventional CEA. The high-risk criteria included patients with one or more medical comorbidities, such as myocardial infarction (MI) or stroke in the previous 3 months. CAS was also the preferred technique for revascularization in patients having tracheostomy, history of ipsilateral neck irradiation, ipsilateral radical neck dissection or CEA. Patients were divided into two groups based on the type of carotid revascularization performed, namely CEA or CAS. Comparisons between the two groups were made with respect to preprocedural risk factors, 30-day and 1-year outcomes of transient ischemic attack (TIA), MI, stroke, and all-cause death rates. All carotid stenting procedures were performed in the catheter laboratory with routine use of cerebral protection devices, either an Angioguard Ò filter (Cordis, Johnson & Johnson Interventional Systems, New Jersey, USA) or a MoMa Ò ultraproximal protection device (Medtronic Invatec, Roncadelle, Italy). Carotid stenting was performed with 7 10/ 30 mm Cristallo Ideale Carotid Self-Expanding Stent-System (Medtronic, Invatec, Roncadelle, Italy). Carotid artery stenting was performed by experienced operators as described in detail previously (Fig. 1a c) [9]. Selection of emboli protection device was determined by assessment of the intracerebral circulation. In the absence of adequate cerebral collateralization, a filter protection device was preferred to preserve blood flow to the brain
848 Adv Ther (2013) 30:845 853 [10]. Dual antiplatelet treatment (aspirin and clopidogrel) was given for 1 month; after this time, clopidogrel was usually discontinued. CEA procedures were performed under general anesthesia. Selective shunting was used based on stump pressures\40 mmhg, measured during the procedure. All patients received patch closure with a saphenous vein patch graft. All patients received aspirin postoperatively indefinitely. Primary endpoints of the study were identified as TIA, MI, stroke and all-cause death rates. A composite endpoint was identified as the sum of TIA, MI, stroke and all-cause deaths. Death was defined as death from any cause. MI was defined as new pathologic Q waves in two or more contiguous electrocardiograph leads. TIA was defined as a contralateral neurologic event resolved within 24 h from its onset, and stroke was defined as any contralateral neurologic deficit that was present for more than 24 h. The study conformed to the principles of the Declaration of Helsinki and was approved by the Atatürk University Medical Faculty Ethics Committee. The analysis in this article is based on previously collected data and does not involve any new studies of human or animal subjects performed by any of the authors. Statistical Analysis Data were analyzed using the Statistical Package for Social Sciences, ver. 20.0 (SPSS Inc., Chicago, IL, USA). Comparison of continuous variables was assessed using the Student s t test or Mann Whitney U test, while comparison of categorical variables was assessed using the Chi Square or Fisher s exact test. A comparison of the composite endpoint (stroke, MI and all-cause death) was assessed using Kaplan Meier survival analysis with log-rank test. A P value of \0.05 was considered statistically significant. RESULTS In total, 65 patients were identified of whom 32 underwent CEA and 33 underwent CAS procedures. Thirty-two CEA procedures were performed by vascular surgeons and 33 CAS procedures were performed by cardiologists during the time period being evaluated. The mean (standard deviation [SD]) age of patients who underwent CEA was 69.81 ± 11.07 and 81% of the patients were male. The mean (SD) age of patients who underwent CAS was 71.51 ± 10.31 and 75% of the patients were male. All of the operations and CAS were performed for symptomatic occlusive carotid disease: amaurosis fugax, n = 11; TIA, n = 51; and stroke, n = 3. Baseline characteristics were similar between both treatment groups, as shown in Table 1. Statistically significant differences between the two groups were found for the incidence of diabetes mellitus (CAS 33% vs. CEA 62%; P\0.05). Comparing the CAS to the CEA group, mean (SD) baseline serum low-density lipoprotein levels (125.45 ± 33.33 vs. 133.87 ± 27.91 mg/dl, respectively; P\0.05) and glucose levels (120.09 ± 40.60 vs. 157.18 ± 72.84 mg/dl; P\0.05) were significantly higher in the CEA group, while serum high-density lipoprotein levels (35.00 ± 6.29 vs. 37.34 ± 9.68 mg/dl, respectively; P\0.05) were significantly lower in the CAS group. Triglyceride levels (190.45 ± 89.55 vs. 209.93 ± 131.53 g/dl, respectively; P = 0.143) and preprocedural creatinine levels (1.05 ± 0.22 vs. 1.18 ± 0.29 mg/dl, respectively; P = 0.199) were similar between the CAS and CEA groups.
Adv Ther (2013) 30:845 853 849 Table 1 Baseline characteristics of patients treated with carotid endarterectomy or carotid stenting Variable CAS (n 5 33) CEA (n 5 32) P value Age, mean ± SD 71.51 ± 10.31 69.81 ± 11.07 0.421 Male gender 25 (75%) 26 (81%) 0.086 Qualifying events Amaurosis fugax 5 (15%) 6 (19%) 0.699 TIA 25 (76%) 26 (82%) 0.590 Stroke 3 (9%) 0.081 Diabetes mellitus 11 (33%) 20 (62%) <0.05 Hypertension 25 (76%) 21 (66%) 0.369 Smoker 20 (61%) 25 (78%) 0.126 CAD 23 (70%) 16 (50%) 0.105 Previous myocardial infarction 13 (39%) 9 (28%) 0.337 Previous CABG 5 (15%) 5 (16%) 0.958 Previous PTCA 15 (45%) 14 (43%) 0.890 Atrial fibrillation 5 (15%) 4 (12.5%) 0.748 HDL, mean ± SD (mg/dl) 35.00 ± 6.29 37.34 ± 9.68 <0.05 LDL, mean ± SD (mg/dl) 125.45 ± 33.33 133.87 ± 27.91 <0.05 Triglycerides, mean ± SD 190.45 ± 89.55 209.93 ± 131.53 0.143 Creatinine, mean ± SD (mg/dl) 1.05 ± 0.22 1.18 ± 0.29 0.199 Glucose, mean ± SD (mg/dl) 120.09 ± 40.60 157.18 ± 72.84 <0.05 Preprocedural medication Aspirin 25 (76%) 32 (100%) 0.157 Clopidogrel 23 (70%) 19 (59%) 0.389 Antihypertensive 25 (76%) 21 (65%) 0.496 Statin 33 (100%) 32 (100%) 0.989 Significant values are in bold CABG coronary artery bypass graft, CAD coronary artery disease, HDL high-density lipoprotein, LDL low-density lipoprotein, PTCA percutaneous transluminal coronary angioplasty, SD standard deviation Angiographic severity of stenosis and modified Rankin Scale scores were similar in both groups (Table 2). The total 30-day perioperative TIA and death rates for CEA were similar at 6.2% (n = 2). Stroke and periprocedural MI was not observed (Table 2). In the CAS group, MI and death were not observed, but TIA and stroke rates were 9.0% (n = 3) and 6.0% (n = 2), respectively. No significant differences were found with respect to 30-day mortality and neurologic morbidity endpoints (Table 3). In the postprocedural 1-year follow-up, stroke, MI and death rates were 9.3% (n = 3),
850 Adv Ther (2013) 30:845 853 Table 2 Angiographic lesion severity and modified Rankin Scale scores of the patients according to treatment group CAS, n (%) CEA, n (%) P value Angiographic lesion severity 60 69% 1 (3.0) 70 79% 4 (12.1) 80 89% 16 (48.5) 23 (71.9) 0.530 90 99% 12 (36.4) 9 (28.1) 0.530 Modified Rankin Scale score 0 1 19 (57.5) 22 (68.5) 0.076 2 3 14 (42.5) 10 (31.5) 0.076 CAS carotid artery stenting, CEA carotid endarterectomy Table 3 Rate of transient ischemic attack, myocardial infarction, stroke and death within periprocedural (30-day) and postprocedural (1-year) periods in the carotid endarterectomy or stenting groups Variable CAS, n (%) CEA, n (%) P value Periprocedural TİA 3 (9.0) 2 (6.2) 0.721 MI 0 0 Stroke 2 (6.0) 0 0.081 Death 0 2 (6.2) 0.072 Postprocedural TIA 3 (9.0) 0 <0.05 MI 2 (6.0) 2 (6.2) 0.963 Stroke 2 (6.0) 3 (9.3) 0.357 Death 1 (3,0) 3 (9.3) 0.137 Composite endpoint 8 (24) 8 (25) 0.300 Significant value is in bold CAS carotid artery stenting, CEA carotid endarterectomy, MI myocardial infarction, TIA transient ischemic attack 6.0% (n = 2), and 9.3% (n = 3), respectively, in the CEA group. TIA was not observed during this period. In the CAS group, TIA, MI, stroke, and death rates were 9.0% (n = 3), 6.0% (n = 2), 6% (n = 2), and 3.0% (n = 1), respectively. When both groups were analyzed, only TIA was significantly higher in the CAS group, while the other endpoints did not differ significantly (Table 3). In the Kaplan Meier curves, the 1-year composite endpoint rate did not differ between the CEA and CAS groups according to the calendar period of admission (log-rank P = 0.300) (Fig. 2). DISCUSSION In our retrospective study, we analyzed outcomes in patients with severe and symptomatic carotid artery stenosis that was treated with either CEA or CAS. We have shown that periprocedural and postprocedural death, stroke, and MI rates were not significantly different among the two procedures. However, postprocedural TIA rates were significantly higher in the CAS group. These TIAs were seen in patients with thrombus burden. However, all of the ischemic attacks were limited and patients improved rapidly. Our study showed that despite a higher incidence of TIA, CAS can be an interesting alternative to CEA. We could not demonstrate a significant difference between CAS and CEA with respect to the risk of stroke or other major adverse events in our high-risk patients at 1 year, according to composite endpoints. However in the CEA group, stroke and death rates were higher than in the CAS group, although this difference did not reach a significant level. Also, many of these patients had co-existing conditions that are recognized to be associated with an increased risk of death. Our 30-day TIA, stroke and death rates in both treatment groups are comparable with previous large trials for both CEA and CAS. In
Adv Ther (2013) 30:845 853 851 Fig. 2 Kaplan Meier estimates for the composite endpoint (the sum of transient ischemic attack, myocardial infarction, stroke and all-cause deaths) according to the carotid endarterectomy or stenting group. CAS carotid artery stenting, CEA carotid endarterectomy the ARCHeR trial, which included high-risk patients, Gray et al. reported a combined 30-day stroke and death rate of 6.9% [11]. In the CAVATAS trial, investigators studied the outcomes among 504 patients randomly assigned to undergo CEA or endovascular therapy; they did not find a significant difference between the procedures in the incidence of stroke at 3 years. Also, in this trial the endovascular treatment lacked protection against emboli and consisted of balloon angioplasty in almost three-quarters of the patients [12]. In the ACAS trial, patients with 60% or greater asymptomatic carotid artery stenosis had a 2.3% perioperative stroke and death rate, including 1.2% angiography-related stroke rate [13]. An update of the NASCET trial in patients with stenosis of 70% or greater found that postoperative mortality was 0.6% and the stroke and death rate was 5.8%, while in contrast, among patients with 50 60% symptomatic carotid artery stenosis, postoperative mortality was 1.2% and the stroke and death rate was 6.7% [14]. The CREST trial reported no significant difference in the risk of stroke, MI or death between CAS and CEA. The incidence of periprocedural stroke was higher in the CAS group than in the CEA group [15]. Conversely, the incidence of periprocedural MI was higher in the CEA group than in the CAS group. The Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) and the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) trials reported poorer outcomes with stenting than with endarterectomy [5, 6]. The EVA-3S and SPACE studies included symptomatic carotid artery stenosis patients, as in our study, although these studies differed from ours in the rate at which emboli protection devices were used. Specific emboli protection devices were used in the EVA-3S trial in 92% of patients and in 27% of patients in the SPACE trial. We used emboli protection devices in all patients in our study. This could be the reason for the non-inferiority result in our CAS group, unlike these other studies. The most important limitations of our study were the retrospective nature of data evaluation, the low number of patients and the relatively short follow-up. The small
852 Adv Ther (2013) 30:845 853 number of events and low patient numbers mean that subtle differences between the two groups were likely to be missed. Also, another limitation of our study was that it was performed at a single center. CONCLUSION In our trial of patients with severe, symptomatic carotid artery stenosis, no significant difference could be shown in periprocedural or postprocedural outcomes at 1-year follow-up between patients who underwent CAS and CEA, except for the incidence of TIA. Therefore, CAS is a safe and efficacious alternative for the treatment of symptomatic carotid artery stenosis. Our findings somewhat contradict those of large trials that have shown that management of carotid stenosis is almost exclusively done by CEA. Our study reflects, however, the opinions of many experienced interventionists (cardiologists and neuroradiologists) who believe that interventional therapy when performed by experienced operators in high-volume centers can be an effective measure. ACKNOWLEDGMENTS No funding or sponsorship was received for this study or publication of this article. Dr. Taş is the guarantor for this article, and takes responsibility for the integrity of the work as a whole. Conflict of interest. M. Hakan Taş, Ziya Şimşek, Abdurrahim Colak, Yavuzer Koza, Pinar Demir, Recep Demir, Ugur Kaya, Ibrahim Halil Tanboga, Fuat Gundogdu and Serdar Sevimli declare that they have no conflicts of interest. Compliance with ethics guidelines. The study conformed to the principles of the Helsinki Declaration of 1975, as revised in 2000 and was approved by the Atatürk University Medical Faculty Ethics Committee. The analysis in this article is based on previously collected data and does not involve any new studies of human or animal subjects performed by any of the authors. REFERENCES 1. Rosamond W, Flegal K, Friday G, et al. Heart disease and stroke statistics 2007 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2007;115:e69 171. 2. Boztosun B, Can MM, Kocabay G. Carotid endarterectomy versus stenting: where do we stand today? Turk Kardiyol Dern Ars. 2012;40: 642 9. 3. North American Symptomatic Carotid Endarterectomy Trial Collaborators. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med. 1991;325:445 53. 4. Sheffet AJ, Roubin G, Howard G, et al. Design of the carotid revascularization endarterectomy vs. stenting trial (CREST). Int J Stroke. 2010;5:40 6. 5. Mas JL, Hotelier G, Beyssen B, et al. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med. 2006;355:1660 71. 6. SPACE Collaborative Group. 30 Day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised noninferiority trial. Lancet. 2006;368:9 47 (Erratum, Lancet 2006;368: 8). 7. Brott TG, Halperin JL, Abbara S, et al. 2011 ASA/ ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/ SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease: executive summary. Catheter Cardiovasc Interv. 2013;81:E76. 8. Lövblad KO, Plüschke W, Remonda L, et al. Diffusion-weighted MRI for monitoring neurovascular interventions. Neuroradiology. 2000;42:134 8.
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