William Brooks

Stenting versus Endarterectomy for Treatment of Carotid-Artery Stenosis

BACKGROUND Carotid-artery stenting and carotid endarterectomy are both options for treating carotid-artery stenosis, an important cause of stroke. METHODS We randomly assigned patients with symptomatic or asymptomatic carotid stenosis to undergo carotid-artery stenting or carotid endarterectomy. The primary composite end point was stroke, myocardial infarction, or death from any cause during the periprocedural period or any ipsilateral stroke within 4 years after randomization. RESULTS For 2502 patients over a median follow-up period of 2.5 years, there was no significant difference in the estimated 4-year rates of the primary end point between the stenting group and the endarterectomy group (7.2% and 6.8%, respectively; hazard ratio with stenting, 1.11; 95% confidence interval, 0.81 to 1.51; P=0.51). There was no differential treatment effect with regard to the primary end point according to symptomatic status (P=0.84) or sex (P=0.34). The 4-year rate of stroke or death was 6.4% with stenting and 4.7% with endarterectomy (hazard ratio, 1.50; P=0.03); the rates among symptomatic patients were 8.0% and 6.4% (hazard ratio, 1.37; P=0.14), and the rates among asymptomatic patients were 4.5% and 2.7% (hazard ratio, 1.86; P=0.07), respectively. Periprocedural rates of individual components of the end points differed between the stenting group and the endarterectomy group: for death (0.7% vs. 0.3%, P=0.18), for stroke (4.1% vs. 2.3%, P=0.01), and for myocardial infarction (1.1% vs. 2.3%, P=0.03). After this period, the incidences of ipsilateral stroke with stenting and with endarterectomy were similarly low (2.0% and 2.4%, respectively; P=0.85). CONCLUSIONS Among patients with symptomatic or asymptomatic carotid stenosis, the risk of the composite primary outcome of stroke, myocardial infarction, or death did not differ significantly in the group undergoing carotid-artery stenting and the group undergoing carotid endarterectomy. During the periprocedural period, there was a higher risk of stroke with stenting and a higher risk of myocardial infarction with endarterectomy. (ClinicalTrials.gov number, NCT00004732.)

CAROTID ANGIOPLASTY AND STENTING VERSUS CAROTID ENDARTERECTOMY: RANDOMIZED TRIAL IN A COMMUNITY HOSPITAL

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.

Carotid angioplasty and stenting versus carotid endarterectomy for treatment of asymptomatic carotid stenosis: a randomized trial in a community hospital.

OBJECTIVECarotid 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. METHODSA 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. RESULTSStenosis 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. CONCLUSIONCAS and CEA may be equally effective and safe in treating individuals with asymptomatic carotid stenosis.

Safety of Stenting and Endarterectomy by Symptomatic Status in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)

Background and Purpose— The safety of carotid artery stenting (CAS) and carotid endarterectomy (CEA) has varied by symptomatic status in previous trials. The Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) data were analyzed to determine safety in symptomatic and asymptomatic patients. Methods— CREST is a randomized trial comparing safety and efficacy of CAS versus CEA in patients with high-grade carotid stenoses. Patients were defined as symptomatic if they had relevant symptoms within 180 days of randomization. The primary end point was stroke, myocardial infarction, or death within the periprocedural period or ipsilateral stroke up to 4 years. Results— For 1321 symptomatic and 1181 asymptomatic patients, the periprocedural aggregate of stroke, myocardial infarction, and death did not differ between CAS and CEA (5.2% versus 4.5%; hazard ratio, 1.18; 95% CI, 0.82 to 1.68; P=0.38). The stroke and death rate was higher for CAS versus CEA (4.4% versus 2.3%; hazard ratio, 1.90; 95% CI, 1.21 to 2.98; P=0.005). For symptomatic patients, the periprocedural stroke and death rates were 6.0%±0.9% for CAS and 3.2%±0.7% for CEA (hazard ratio, 1.89; 95% CI, 1.11 to 3.21; P=0.02). For asymptomatic patients, the stroke and death rates were 2.5%±0.6% for CAS and 1.4%±0.5% for CEA (hazard ratio, 1.88; 95% CI, 0.79 to 4.42; P=0.15). Rates were lower for those aged <80 years. Conclusions— There were no significant differences between CAS versus CEA by symptomatic status for the primary CREST end point. Periprocedural stroke and death rates were significantly lower for CEA in symptomatic patients. However, for both CAS and CEA, stroke and death rates were below or comparable to those of previous randomized trials and were within the complication thresholds suggested in current guidelines for both symptomatic and asymptomatic patients.

Long-Term Results of Stenting Versus Endarterectomy for Carotid-Artery Stenosis

BACKGROUND In the Carotid Revascularization Endarterectomy versus Stenting Trial, we found no significant difference between the stenting group and the endarterectomy group with respect to the primary composite end point of stroke, myocardial infarction, or death during the periprocedural period or any subsequent ipsilateral stroke during 4 years of follow-up. We now extend the results to 10 years. METHODS Among patients with carotid-artery stenosis who had been randomly assigned to stenting or endarterectomy, we evaluated outcomes every 6 months for up to 10 years at 117 centers. In addition to assessing the primary composite end point, we assessed the primary end point for the long-term extension study, which was ipsilateral stroke after the periprocedural period. RESULTS Among 2502 patients, there was no significant difference in the rate of the primary composite end point between the stenting group (11.8%; 95% confidence interval [CI], 9.1 to 14.8) and the endarterectomy group (9.9%; 95% CI, 7.9 to 12.2) over 10 years of follow-up (hazard ratio, 1.10; 95% CI, 0.83 to 1.44). With respect to the primary long-term end point, postprocedural ipsilateral stroke over the 10-year follow-up occurred in 6.9% (95% CI, 4.4 to 9.7) of the patients in the stenting group and in 5.6% (95% CI, 3.7 to 7.6) of those in the endarterectomy group; the rates did not differ significantly between the groups (hazard ratio, 0.99; 95% CI, 0.64 to 1.52). No significant between-group differences with respect to either end point were detected when symptomatic patients and asymptomatic patients were analyzed separately. CONCLUSIONS Over 10 years of follow-up, we did not find a significant difference between patients who underwent stenting and those who underwent endarterectomy with respect to the risk of periprocedural stroke, myocardial infarction, or death and subsequent ipsilateral stroke. The rate of postprocedural ipsilateral stroke also did not differ between groups. (Funded by the National Institutes of Health and Abbott Vascular Solutions; CREST ClinicalTrials.gov number, NCT00004732.).

Carotid angioplasty with stenting versus endarterectomy: 10-year randomized trial in a community hospital.

OBJECTIVES This single-center, randomized, clinical trial was designed to determine the 10-year comparative efficacy and durability of carotid angioplasty and stenting (CAS) versus carotid endarterectomy (CEA) in preventing ipsilateral ischemic stroke in symptomatic and asymptomatic patients with high-grade carotid artery stenosis. BACKGROUND Modern clinical trials with short-term follow-up indicate CAS and CEA are equivalent in reducing the risk for ipsilateral ischemic stroke secondary to carotid stenosis. A paucity of data exists regarding long-term outcomes. METHODS Patients of all surgical risks with symptomatic and asymptomatic carotid stenosis (>70%) were randomly selected for CEA or CAS and followed a minimum of 10 years. RESULTS Long-term follow-up was achieved in 173 patients (91%). Eighty-seven (50.2%) died within this period, most commonly of nonvascular causes. No difference in the risk of stroke ipsilateral to the treated artery was noted among treatment groups (p > 0.05). Restenosis determined by sequential ultrasound was assessed only in the CAS group (3.3%) and remained asymptomatic. The combined risk of fatal or nonfatal heart attack over the 10-year period was highest in individuals with symptomatic versus asymptomatic stenosis (27.5% vs. 11.0%; hazard ratio [HR]: 2.32, 95% confidence interval [CI]: 1.298 to 4.146, p = 0.005) and was higher in all patients treated with CEA (HR: 2.27, 95% CI: 1.35 to 3.816, p = 0.002). CONCLUSIONS Long-term protection against ipsilateral stroke provided by CAS and CEA did not differ in this trial. The 10-year risk of fatal/nonfatal myocardial infarction was highest in all patients harboring symptomatic carotid stenosis at enrollment. The risk of fatal/nonfatal heart attack was significantly more prevalent in those symptomatic or asymptomatic patients randomized to CEA.

Intravascular Frequency-Domain Optical Coherence Tomography Assessment of Atherosclerosis and Stent-Vessel Interactions in Human Carotid Arteries

BACKGROUND AND PURPOSE: Carotid artery–related stroke is largely an embolic disease that has been correlated with inflammation, plaque rupture, and thrombus formation in “vulnerable” atherosclerotic plaque. Nevertheless, current guidelines for carotid revascularization in asymptomatic patients rely on the calculation of stenosis for risk assessment, a parameter that has been viewed with increasing skepticism. Intravascular OCT is an imaging technique that offers high axial resolution (10 μm), allowing an unprecedented micron-level assessment of human carotid plaque morphology. This observational article reports the first successful use of the newest iteration of this technology, FDOCT without balloon occlusion to assess human carotid artery disease and carotid stent-vessel interaction in vivo. MATERIALS AND METHODS: Four patients with asymptomatic carotid artery disease and ambiguous noninvasive and/or angiographic data underwent carotid FDOCT to assess risk and to formulate a treatment strategy. RESULTS: Findings include the unexpected demonstration of TCFAs, plaque rupture, thrombus, inflammation, and marked tissue prolapse through stent struts in patients without high-risk factors by conventional criteria, as well as low-risk features in a patient with a high-risk noninvasive study. The procedures were performed without safety issues or special accommodations for vessel occlusion. CONCLUSIONS: The present study demonstrates the technical feasibility of FDOCT in cervical carotid arteries. As such, this technology holds the promise of not only clarifying ambiguous data in individual patients but of providing data that might call for a future paradigm shift in the assessment of asymptomatic carotid artery disease.

Intravascular Frequency-Domain Optical Coherence Tomography Assessment of Carotid Artery Disease in Symptomatic and Asymptomatic Patients

OBJECTIVES The goal of this study was to investigate carotid plaque characteristics in symptomatic versus asymptomatic patients with the use of nonocclusive optical coherence tomography (OCT). BACKGROUND The identification of asymptomatic patients with carotid disease who are at risk of stroke remains a challenge. There is an increasing awareness that plaque characteristics may best risk-stratify this population. We hypothesized that OCT, a new high-resolution (∼ 10 μm) imaging modality, might be useful for the identification of low-risk versus high-risk carotid plaque features and help us to understand the relationship between carotid diameter stenosis and plaque morphology to ischemic stroke. METHODS Fifty-three patients undergoing diagnostic carotid angiography were studied with OCT. Data analysis was carried out by imaging experts who were unaware of the clinical characteristics of the study population. RESULTS Plaque with American Heart Association type VI complicated features was more common in symptomatic than asymptomatic patients (74.1% vs. 36.4%, p = 0.02). This was largely driven by differences in the incidence of thin-cap fibroatheroma with rupture (40.7% vs. 13.6%, p = 0.056) and thrombus (67.7% vs. 36.4%, p = 0.034). Conversely, non-type VI plaques were more common in asymptomatic than symptomatic patients (63.6% vs. 25.9%, p = 0.02). No association between the degree of stenosis and plaque morphology was identified. CONCLUSIONS This retrospective analysis of carotid OCT data supports the hypothesis that the evaluation of carotid plaque characteristics with this high-resolution imaging technique has the potential to alter the understanding and treatment of carotid artery disease.

Frequency-Domain Optical Coherence Tomography Assessment of Human Carotid Atherosclerosis Using Saline Flush for Blood Clearance without Balloon Occlusion

SUMMARY FD-OCT is a new imaging technique that allows unprecedented in vivo microlevel assessment of human carotid plaque morphologic patterns and stent-vessel interactions. Prior reports describing the use of this technique have used balloon occlusion of the target vessel or iodinated contrast media to facilitate imaging. We report, for the first time, in vivo FD-OCT imaging of human carotid arteries without the use of iodinated contrast material or balloon occlusion techniques.

Optical coherence tomography of the intracranial vasculature and Wingspan stent in a patient

Summary A 67-year-old man with medically refractory vertebrobasilar insufficiency and short segment occlusions of the intracranial vertebral arteries was treated with angioplasty and stent placement. Fifteen hours after the procedure the patient developed symptoms of posterior fossa ischemia and repeat angiography showed thrombus formation within the stent which was treated with thrombolytic and aggressive antiplatelet therapy. Angiography revealed lysis of the clot, but concerns regarding the mechanism of the thrombotic phenomenon prompted frequency-domain optical coherence tomography (FDOCT) assessment. FDOCT provided excellent visualization of the stent and vessel wall interactions, as well as excluding residual flow-limiting stenosis, obviating the need for further intervention. The potential utility of FDOCT in the evaluation of intracranial atherosclerotic disease and additional intracranial applications are discussed.