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.)
Background and Purpose-Carotid artery stenosis causes up to 10% of all ischemic strokes. Carotid endarterectomy (CEA) was introduced as a treatment to prevent stroke in the early 1950s. Carotid stenting (CAS) was introduced as a treatment to prevent stroke in 1994. Methods-The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is a randomized trial with blinded end point adjudication. Symptomatic and asymptomatic patients were randomized to CAS or CEA. The primary end point was the composite of any stroke, myocardial infarction, or death during the periprocedural period and ipsilateral stroke thereafter, up to 4 years. Results-There was no significant difference in the rates of the primary end point between CAS and CEA (7.2% versus 6.8%; hazard ratio, 1.11; 95% CI, 0.81 to 1.51; Pϭ0.51). Symptomatic status and sex did not modify the treatment effect, but an interaction with age and treatment was detected (Pϭ0.02). Outcomes were slightly better after CAS for patients aged Ͻ70 years and better after CEA for patients aged Ͼ70 years. The periprocedural end point did not differ for CAS and CEA, but there were differences in the components, CAS versus CEA (stroke 4.1% versus 2.3%, Pϭ0.012; and myocardial infarction 1.1% versus 2.3%, Pϭ0.032). Conclusions-In
Objective Outcomes in CREST did not differ between carotid artery stenting (CAS) and carotid endarterectomy (CEA) for the composite primary endpoint of stroke, myocardial infarction (MI), or death during the periprocedural period or ipsilateral stroke within four years. Rigorous credentialing and training of interventionists, including vascular surgeons, was required for the randomization phase of CREST. Because the lead-in phase of CREST had suggested higher perioperative risks after CAS performed by vascular surgeons, the purpose of this analysis was to examine differences in outcomes after randomization between CAS and CEA performed by vascular surgeons. Methods CREST is a prospective randomized controlled trial with blinded endpoint adjudication. Vascular surgeons performed 237 (21%) of the CAS procedures and 765 (65%) of the CEA procedures among 2320 patients who received their assigned treatment. Proportional hazards analyses were used to estimate the relative efficacy of CAS versus CEA for the composite primary endpoint and also for stroke and death. Results Among 2502 randomized patients, 1321 (53%) were symptomatic and 1181 (47%) asymptomatic. For procedures performed exclusively by vascular surgeons, the primary endpoint did not differ between CAS and CEA at four-year follow-up (6.2% vs 5.6%, respectively; hazard ratio [HR], 1.30; 95% confidence interval [CI], 0.70–2.41; P=0.41). In this subgroup, the periprocedural stroke and death rates were higher after CAS than CEA for symptomatic (6.1% vs 1.3%; P=0.01) patients. Asymptomatic patients also had slightly higher stroke and death rates after CAS (2.6% vs 1.1%; P=0.20), although this difference did not reach a level of statistical significance. Conversely, cranial nerve injuries (0.0% vs 5.0%; P<.001) were less frequent after CAS than CEA. MI rates were also slightly lower after CAS (1.3% vs 2.6%; P=0.24). In performing CAS, vascular surgeons had outcomes for the periprocedural primary endpoint comparable to outcomes of all interventionists (HR, 0.99; 95% CI, 0.50–2.00) after adjusting for age, sex, and symptomatic status. Vascular surgeons also had similar results after CEA for the periprocedural primary endpoint compared to other surgeons (HR, 0.73; 85%, 0.42–1.27). Conclusion CAS and CEA have similar net outcomes when performed by surgeons, although the periprocedural risks vary (lower stroke with CEA and lower MI with CAS). These data suggest that appropriately trained vascular surgeons may safely offer both CEA and CAS for the prevention of stroke. The remarkably low stroke and death rate after CEA performed by vascular surgeons in CREST, particularly among symptomatic patients, represent the best outcomes ever reported after carotid interventions from a randomized controlled trial.
This is the largest study to examine the use of the Endologix AFX unibody stent-graft for the treatment of AIOD. Use of the AFX stent-graft appears to be a safe and effective endovascular treatment for complex AIOD.
Inpatients have a very high incidence of clinically silent contralateral thrombosis (34%) and should usually undergo bilateral examinations. Patients with active malignancy have a 38% incidence of asymptomatic contralateral clot and should always have a bilateral study. Outpatients with unilateral symptoms and no associated risk factors for thrombosis can safely undergo unilateral examinations and should be adequately treated according to the unilateral findings. Algorithms to select patients for limited studies should include screening data for active malignancy, recent trauma or surgery, pregnancy, hormone therapy, or history of thrombophilia.
Short-term results indicate that the Zenith Alpha thoracic endovascular graft appears safe and effective for the treatment of BTAIs. This low-profile device enables complete percutaneous repair in a large percentage of patients and can achieve high rates of technical success and very low rates of aortic injury-related mortality within 30 days.
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