Angioplastie Carotidienne - Carotid Angioplasty & Stenting

1. Yadav, J. S., M. H. Wholey, et al. (2004). "Protected carotid-artery stenting versus endarterectomy in high-risk patients." N Engl J Med 351(15): 1493-501
2. Mas, JL et al. (2004). "Carotid angioplasty and stenting with and without cerebral protection: clinical alert from the Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis (EVA-3S) trial." Stroke 35(1): e18-20
3. Hobson, RW et al. (2004). "Carotid artery stenting is associated with increased complications in octogenarians: 30-day stroke and death rates in the CREST lead-in phase." J Vasc Surg 40(6): 1106-11
4. Brooks, WH et al. (2004). "Carotid angioplasty and stenting versus carotid endarterectomy for treatment of asymptomatic carotid stenosis: a randomized trial in a community hospital." Neurosurgery 54(2): 318-24; discussion 324-5
5. (2003). "Carotid revascularization using endarterectomy or stenting systems (CARESS): phase I clinical trial." J Endovasc Ther 10(6): 1021-30
6. Roubin, GS et al. (2001). "Immediate and late clinical outcomes of carotid artery stenting in patients with symptomatic and asymptomatic carotid artery stenosis: a 5-year prospective analysis." Circulation 103(4): 532-7
7. Brooks, WH et al. (2001). "Carotid angioplasty and stenting versus carotid endarterectomy: randomized trial in a community hospital." J Am Coll Cardiol 38(6): 1589-95
8. (2001). "Endovascular versus surgical treatment in patients with carotid stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomised trial." Lancet 357(9270): 1729-37.
9. Alberts MJ (2001). Results of a Multicenter Prospective Randomized Trial of Carotid Artery Stenting vs. Carotid Endarterectomy 3. Stroke : (32):325-d
10. Link, JC et al. (2000). "[Carotid endarterectomy and carotid stenting. A pilot study of a prospective, randomized and controlled comparison]." Radiologe 40(9): 813-20
11. Naylor AR.et al. (1998). "Randomized study of carotid angioplasty and stenting versus carotid endarterectomy: a stopped trial." J Vasc Surg 28(2): 326-34

1. Yadav, J. S., M. H. Wholey, et al. (2004). "Protected carotid-artery stenting versus endarterectomy in high-risk patients." N Engl J Med 351(15): 1493-501.
BACKGROUND: Carotid endarterectomy is more effective than medical management in the prevention of stroke in patients with severe symptomatic or asymptomatic atherosclerotic carotid-artery stenosis. Stenting with the use of an emboli-protection device is a less invasive revascularization strategy than endarterectomy in carotid-artery disease. METHODS: We conducted a randomized trial comparing carotid-artery stenting with the use of an emboli-protection device to endarterectomy in 334 patients with coexisting conditions that potentially increased the risk posed by endarterectomy and who had either a symptomatic carotid-artery stenosis of at least 50 percent of the luminal diameter or an asymptomatic stenosis of at least 80 percent. The primary end point of the study was the cumulative incidence of a major cardiovascular event at 1 year--a composite of death, stroke, or myocardial infarction within 30 days after the intervention or death or ipsilateral stroke between 31 days and 1 year. The study was designed to test the hypothesis that the less invasive strategy, stenting, was not inferior to endarterectomy. RESULTS: The primary end point occurred in 20 patients randomly assigned to undergo carotid-artery stenting with an emboli-protection device (cumulative incidence, 12.2 percent) and in 32 patients randomly assigned to undergo endarterectomy (cumulative incidence, 20.1 percent; absolute difference, -7.9 percentage points; 95 percent confidence interval, -16.4 to 0.7 percentage points; P=0.004 for noninferiority, and P=0.053 for superiority). At one year, carotid revascularization was repeated in fewer patients who had received stents than in those who had undergone endarterectomy (cumulative incidence, 0.6 percent vs. 4.3 percent; P=0.04). CONCLUSIONS: Among patients with severe carotid-artery stenosis and coexisting conditions, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy.

2. Mas, J. L., G. Chatellier, et al. (2004). "Carotid angioplasty and stenting with and without cerebral protection: clinical alert from the Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis (EVA-3S) trial." Stroke 35(1): 18-20.
BACKGROUND AND PURPOSE: Whether cerebral protection during carotid angioplasty and stenting (CAS) is associated with a lower risk of periprocedural stroke or death remains to be established. We report on 80 patients randomized in the CAS arm of the Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis trial comparing CAS (with or without cerebral protection) with carotid surgery in patients with recently symptomatic, severe carotid stenosis. SUMMARY OF REPORT: The Safety Committee recommended stopping unprotected CAS, because the 30-day rate of stroke was 3.9 (0.9 to 16.7) times higher than that of CAS with cerebral protection (4/15 versus 5/58). CONCLUSIONS: Although this result was not based on a randomized comparison of unprotected versus protected CAS, it suggests that the use of cerebral protection devices during CAS reduces periprocedural strokes.

3. Hobson, R. W., 2nd, V. J. Howard, et al. (2004). "Carotid artery stenting is associated with increased complications in octogenarians: 30-day stroke and death rates in the CREST lead-in phase." J Vasc Surg 40(6): 1106-11.
BACKGROUND: A heightened risk of stroke and death among octogenarians undergoing carotid artery stenting (CAS) has been reported. The multicenter Carotid Revascularization Endarterectomy vs. Stent Trial (CREST) supported by the National Institute of Neurological Disorders, National Institutes of Health, compares the efficacy of carotid endarterectomy (CEA) and CAS in an ongoing clinical trial. This effort also includes a "lead-in" phase of symptomatic (>50% stenosis) and asymptomatic (>70% stenosis) patients. The protocol calls for patients to receive aspirin and clopidogrel before and 30-days after CAS and to be examined by a study neurologist preprocedure, at 24-hours, and at 30-day. The occurrence of stroke and death was reviewed by an independent clinical events committee. METHODS: The association of age and periprocedural stroke and death was examined in 749 lead-in patients undergoing CAS (30.7% symptomatic, 69.3% asymptomatic). Patients were separated into four age categories: less than 60, 60 to 69, 70 to 79, and 80 years or older, and the proportion of patients with stroke and death during the 30-day periprocedural period was calculated for each category. RESULTS: An increasing proportion of patients suffered stroke and death with increasing age (P =.0006); 2 (1.7%) of 120 patients under age 60, 3 (1.3%) of 229 aged 60 to 69, 16 (5.3%) of 301 aged 70 to 79, and 12 (12.1%) of 99 patients aged 80 years and older. These increasingly high complication rates at older ages were not mediated by adjustment for symptomatic status, use of antiembolic devices, gender, percentage of carotid stenosis, or the presence of distal arterial tortuosity. CONCLUSIONS: Interim results from the lead-in phase of CREST show that the periprocedural risk of stroke and death after CAS increases with age in the course of a credentialing registry. This effect is not mediated by potential confounding factors. Randomized trial data are needed to compare the CAS versus CEA periprocedural risk of stroke and death by age. Pending results from randomized studies, care should be taken when CAS is performed in older patient populations.

4. Brooks, W. H., R. R. McClure, et al. (2004). "Carotid angioplasty and stenting versus carotid endarterectomy for treatment of asymptomatic carotid stenosis: a randomized trial in a community hospital." Neurosurgery 54(2): 318-24; discussion 324-5.
OBJECTIVE: Carotid endarterectomy (CEA) is effective in reducing the risk of stroke in individuals with more than 60% carotid stenosis. Carotid angioplasty and stenting (CAS) has been proffered as effective and used in treating individuals with asymptomatic carotid stenosis despite the absence of proven clinical equivalency. This randomized trial was designed to explore the hypothesis that CAS is equivalent to CEA for treating asymptomatic carotid stenosis. METHODS: A total of 85 individuals presenting with asymptomatic carotid stenosis of more than 80% were selected randomly for CAS or CEA and followed up for 48 months. RESULTS: Stenosis decreased to an average of 5% after CAS. The patency of the reconstructed artery remained satisfactory regardless of the technique, as determined by carotid ultrasonography. No major complications such as cerebral ischemia or death occurred. Procedural complications associated with CAS (n = 5) were hypotension and/or bradycardia; those concomitant with CEA (n = 3) were cervical nerve injury or complications related to general anesthesia (n = 4). Both procedures were well tolerated in the context of pain and discomfort. Hospital stay was similar in the two groups (mean, 1.1 versus 1.2 d). The occurrence of complications associated with CAS or CEA prolonged hospitalization by 3 days (mean, 4.0 versus 4.5 d). Return to full activity was achieved within 1 week by more than 85% of patients; all returned to their usual lifestyle by 2 weeks. Although hospital charges were slightly higher for CAS, costs were similar. CONCLUSION: CAS and CEA may be equally effective and safe in treating individuals with asymptomatic carotid stenosis.

5. (2003). "Carotid revascularization using endarterectomy or stenting systems (CARESS): phase I clinical trial." J Endovasc Ther 10(6): 1021-30.
PURPOSE: To determine whether carotid stenting with embolic protection is equivalent to carotid endarterectomy (CEA) in a broad risk population of patients with symptomatic and asymptomatic carotid stenosis. METHODS: A prospective, multicenter Phase I trial was conducted comparing standard CEA to carotid stenting systems (CSS) in patients with symptomatic (> or =50%) and asymptomatic (> or =75%) carotid stenosis. Patients were enrolled using selection criteria reflective of broad clinical practice. The enrollment ratio at each clinical site was designed to be 2:1 (CEA to CSS) to achieve a planned enrollment of 450 patients: 300 in the CEA arm and 150 in the CSS cohort, which would ensure adequate precision with a coefficient of variation < or =0.35. The primary endpoint for comparison was 30-day all-cause mortality and nonfatal stroke. RESULTS: Between April 2001 and December 2002, 14 clinical sites enrolled 439 patients, of which 397 (247 men; mean age 71 years, range 44-89) were treated: 254 with CEA and 143 patients with CSS (ratio 1.8 to 1.0). More than 90% of patients had >75% stenosis; approximately 68% of patients were asymptomatic. There were no significant differences in baseline patient characteristics between the treatment groups with the exception of a more frequent history of prior CEA (30% CSS versus 11% for CEA, p<0.0001) and prior carotid stent placement in the CSS group (6% versus 0% for CEA, p=0.0002). There was no significant difference in the 30-day combined all-cause mortality and stroke rate by Kaplan-Meier estimate between CEA (2%) and CSS (2%). There was no significant difference in the secondary endpoint of combined 30-day all-cause mortality, stroke, and myocardial infarction between CEA (3%) and CSS (2%). CONCLUSIONS: This study suggests that the 30-day risk of stroke or death following carotid stenting with cerebral protection is equivalent to standard carotid endarterectomy in a broad risk population of patients with carotid stenosis.

6. Roubin, G. S., G. New, et al. (2001). "Immediate and late clinical outcomes of carotid artery stenting in patients with symptomatic and asymptomatic carotid artery stenosis: a 5-year prospective analysis." Circulation 103(4): 532-7.
BACKGROUND: Carotid stenting is a less invasive percutaneous procedure than carotid endarterectomy for the treatment of carotid stenosis. Reports suggest that it can be performed with periprocedural complication rates similar to those of carotid endarterectomy. The purpose of this study was to determine short- and long-term outcomes in the largest prospective cohort of carotid stenting patients. METHODS AND RESULTS: This study followed 528 consecutive patients (604 hemispheres/arteries) undergoing carotid stenting. There was a 0.6% (n=3) fatal stroke rate and 1% (n=5) nonstroke death rate at 30 days. The major stroke rate was 1% (n=6), and the minor stroke rate was 4.8% (n=29). The overall 30-day stroke and death rate was 7.4% (n=43). Over the 5-year study period, the 30-day minor stroke rate improved from 7.1% (n=7) for the first year to 3.1% (n=5) for the fifth year (P:<0.05 for trend). The best predictor of 30-day stroke and death was age >/=80 years. After the 30-day period, the incidence of fatal and nonfatal stroke was 3.2% (n=31). On Kaplan-Meier analysis, the 3-year freedom from ipsilateral or fatal stroke was 92+/-1%. CONCLUSIONS: Experience from a single group of operators demonstrates that carotid stenting can be performed with an acceptable 30-day complication rate. Late follow-up also demonstrates a low rate of fatal and nonfatal stroke. These results suggest that carotid stenting may be comparable to carotid endarterectomy, and it underscores the clinical equipoise and premise for the National Institute of Health-supported, randomized Carotid Revascularization Endarterectomy Versus Stent Trial comparing carotid stenting with carotid endarterectomy.

7. Brooks, W. H., R. R. McClure, et al. (2001). "Carotid angioplasty and stenting versus carotid endarterectomy: randomized trial in a community hospital." J Am Coll Cardiol 38(6): 1589-95.
OBJECTIVES: The goal of this study was to determine whether carotid angioplasty and stenting (CAS) is equivalent to carotid endarterectomy (CEA) in patients with symptomatic carotid stenosis >70% by a randomized, controlled trial in a community hospital. BACKGROUND: Carotid angioplasty and stenting has been suggested to be as effective as CEA for treatment of symptomatic carotid artery stenosis. METHODS: A total of 104 patients presenting with cerebrovascular ischemia ipsilateral to carotid stenosis were selected randomly for CEA or carotid stenting and followed for two years. RESULTS: Stenosis decreased to an average of 5% after CAS. The patency of the reconstructed artery remained satisfactory regardless of the technique as determined by sequential ultrasound. One death occurred in the CEA group (1/51); one transient ischemic attack occurred in the CAS group (1/53); no individual sustained a stroke. The perception of procedurally related pain/discomfort was similar. Hospital stay was similar, although the CAS group tended to be discharged earlier (mean = 1.8 days vs. 2.7 days). Complications associated with CAS prolonged hospitalization when compared with those sustaining a CEA-related complication (mean = 5.6 days vs. 3.8 days). Return to full activity was achieved within one week by 80% of the CAS group and 67% of the patients receiving CEA. Hospital charges were slightly higher for CAS. CONCLUSIONS: Carotid stenting is equivalent to CEA in reducing carotid stenosis without increased risk for major complications of death/stroke. Because of shortened hospitalization and convalescence, CAS challenges CEA as the preferred treatment of symptomatic carotid stenosis if a reduction in costs can be achieved.

8. (2001). "Endovascular versus surgical treatment in patients with carotid stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomised trial." Lancet 357(9270): 1729-37.
BACKGROUND: Percutaneous transluminal angioplasty and stenting (endovascular treatment) can be used to treat carotid stenosis, but risks and benefits are uncertain. We therefore compared endovascular treatment with conventional carotid surgery. METHODS: In a multicentre clinical trial, we randomly assigned 504 patients with carotid stenosis to endovascular treatment (n=251) or carotid endarterectomy (n=253). For endovascular patients treated successfully, we used stents in 55 (26%) and balloon angioplasty alone in 158 (74%). An independent neurologist followed up patients. Analysis was by intention to treat. FINDINGS: The rates of major outcome events within 30 days of first treatment did not differ significantly between endovascular treatment and surgery (6.4% vs 5.9%, respectively, for disabling stroke or death; 10.0% vs 9.9% for any stroke lasting more than 7 days, or death). Cranial neuropathy was reported in 22 (8.7%) surgery patients, but not after endovascular treatment (p<0.0001). Major groin or neck haematoma occurred less often after endovascular treatment than after surgery (three [1.2%] vs 17 [6.7%], p<0.0015). At 1 year after treatment, severe (70-99%) ipsilateral carotid stenosis was more usual after endovascular treatment (25 [14%] vs seven [4%], p<0.001). However, no substantial difference in the rate of ipsilateral stroke was noted with survival analysis up to 3 years after randomisation (adjusted hazard ratio=1.04, 95% CI 0.63-1.70, p=0.9). INTERPRETATION: Endovascular treatment had similar major risks and effectiveness at prevention of stroke during 3 years compared with carotid surgery, but with wide CIs. Endovascular treatment had the advantage of avoiding minor complications.

9. Alberts MJ (2001). 3Results of a Multicenter Prospective Randomized Trial of Carotid Artery Stenting vs. Carotid Endarterectomy 3. Stroke : (32):325-d.
BACKGROUND: Carotid artery stenosis (CAS) is a common etiology for ischemic stroke. While carotid endarterectomy (CEA) is a safe and effective treatment for CAS, endovascular therapy using carotid stenting may be a reasonable alternative. This multicenter study was designed to determine if carotid stenting was equivalent to CEA in patients with symptomatic CAS. METHODS: Patients with symptomatic CAS of 60-99% by cerebral angiogram were prospectively randomized to CEA or carotid stenting. All enrolled patients were reviewed by a multidisciplinary team that included neurologists, surgeons, and interventionalists. Patients in the stent group were treated with the WALLSTENT endoprosthesis and received aspirin 325 mg bid and ticlopidine 250 mg bid for 4 weeks. Neurologic assessments were performed 24 hrs post-procedure, then at 1, 6 and 12 months. The primary end-point was ipsilateral stroke, procedure-related death, or vascular death within 1 year. P-values are from 2-sided Fisher's Exact Test. RESULTS: A total of 219 patients were enrolled; 107 in the stent group (mean age 66.5, 66% male) and 112 in the CEA group (mean age 70, 62% male). The mean baseline degree of stenosis was 76% in the stent group vs 75% in the CEA group. 65% of stent patients had a TIA vs 68% in the CEA group. Median follow-up days for stent and CEA patients were 354 and 341, respectively. The primary end-point rate at approximately one year was 12.1% in the stent group vs. 3.6% for CEA (p = 0.022). The rate of any major stroke was 3.7% for stent vs. 0.9% for CEA (p = 0.204). A post-stent angiogram showed that 97% of patients had less than 30% stenosis. The 30 day peri-procedure complication rate (any stroke or death) was 12.1% for stents and 4.5% for CEA (p = 0.049). The 2 day peri-procedure complication rate was 7.5% for stents and 1.8% for CEA (p=0.055). Other common peri-procedure complications of stenting were severe bradycardia (7%) and groin hematoma (4%). CONCLUSIONS: This study did not find that carotid stenting was equivalent to CEA in patients with symptomatic CAS. Based on these data and a futility analysis, the study was terminated before the planned maximum of 700 patients were enrolled.

10. Link, J., C. Manke, et al. (2000). "[Carotid endarterectomy and carotid stenting. A pilot study of a prospective, randomized and controlled comparison]." Radiologe 40(9): 813-20.
INTRODUCTION: A prospective, randomized and controlled trial is conducted to compare carotid endarterectomy and carotid stenting in high grade symptomatic carotid artery stenoses. METHODS: According to the study design symptomatic patients with a angiographically high-grade (> or = 70%) internal carotid artery stenosis are included. Pre- and postinterventional diagnostics during the hospitalization period includes neurological assessment, duplex sonography of the cervical and cerebral arteries and magnetic resonance imaging of the brain. Follow-up examinations are scheduled after 1, 6 and 12 months and consist of a neurological assessment and duplex sonography. After 12 months selective angiography and magnetic resonance imaging of the brain will be performed additionally. During a period of 9 months up to now 23/137 patients treated for a carotid artery stenosis were included in the study, 11 patients underwent surgery and 12 patients carotid stenting. RESULTS: Carotid stenting and endarterectomy was primarily successful without residual stenosis > 30% in each patient without the occurrence of stroke or death. In 18 follow-up examinations (neurological assessment including duplex sonography) of 13 patients (13 follow-up examinations after 30 days, 5 after 6 months) no relevant restenosis and no stroke occurred. CONCLUSION: As of yet, carotid stenting was a safe procedure. Due to the small number of patients a definitive conclusion can not be drawn.

11. Naylor, A. R., A. Bolia, et al. (1998). "Randomized study of carotid angioplasty and stenting versus carotid endarterectomy: a stopped trial." J Vasc Surg 28(2): 326-34.
BACKGROUND: Carotid angioplasty (CA) has been suggested to be a safer and more cost-effective alternative to carotid endarterectomy (CEA) in the management of symptomatic severe internal carotid artery (ICA) disease. METHODS: The study was conducted as a prospective consecutive randomized trial of CEA versus CA for symptomatic severe ICA disease in a university teaching hospital. All patients were assessed before and after surgery by a neurologist. The study consisted of 23 patients with focal carotid territory symptoms and severe ICA stenosis (> 70%) who were randomized to either CEA or CA. However, only 17 had received their allocated treatment before trial suspension. CEA with patching or CA with stenting were used as interventions. The main outcome measures were death or disabling or nondisabling stroke within 30 days. RESULTS: All 10 CEA operations proceeded without complication, but 5 of the 7 patients who underwent CA had a stroke (P=.0034), 3 of which were disabling at 30 days. CONCLUSIONS: After referral, the Data Monitoring Committee invoked the stopping rule and the trial was suspended. The investigators and the Ethics Committee subsequently concluded that the trial could not be restarted--even in an amended format-primarily because of problems with informed consent. We review many of the ethical dilemmas encountered in the performance of this study. If future trials do suggest a selected role for CA, it is essential that both the inclusion and the exclusion criteria are fully documented.