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.).

Management of vascular risk factors in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST).

BACKGROUND: The Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) is a multicenter randomized trial of stenting versus endarterectomy in patients with symptomatic and asymptomatic carotid disease. This study assesses management of vascular risk factors. METHODS AND RESULTS: Management was provided by the patient's physician, with biannual monitoring results collected by the local site. Therapeutic targets were low-density lipoprotein, cholesterol <100 mg/dL, systolic blood pressure <140 mm Hg, fasting blood glucose <126 mg/dL, and nonsmoking status. Optimal control was defined as achieving all 4 goals concurrently. Generalized estimating equations were used to compare risk factors at baseline with those observed in scheduled follow-up visits for up to 48 months. In the analysis cohort of 2210, significant improvements in risk-factor control were observed across risk factors for all follow-up visits compared with baseline. At 48 months, achievement of the low-density lipoprotein cholesterol goal improved from 59.1% to 73.6% (P<0.001), achievement of the systolic blood pressure goal improved from 51.6% to 65.1% (P<0.001), achievement of the glucose goal improved from 74.9% to 80.7% (P=0.0101), and nonsmoking improved from 74.4% to 80.9% (P<0.0001). The percentage with optimal risk-factor control also improved significantly, from 16.7% to 36.2% (P<0.001), but nearly 2 of 3 study participants did not achieve optimal control during the study. CONCLUSIONS: Site-based risk-factor control improved significantly in the first 6 months and over the long term in CREST but was often suboptimal. Intensive medical management should be considered for future trials of carotid revascularization. CLINICAL TRIAL REGISTRATION URL: ClinicalTrials.gov. Unique identifier: NCT00004732.

Differential outcomes of carotid stenting and endarterectomy performed exclusively by vascular surgeons in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST).

OBJECTIVE: Outcomes in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) did not differ between carotid artery stenting (CAS) and carotid endarterectomy (CEA) for the composite primary end point of stroke, myocardial infarction (MI), or death during the periprocedural period or ipsilateral stroke within 4 years. Rigorous credentialing and training of interventionists, including vascular surgeons, were 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 end point 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 vs CEA for the composite primary end point and also for stroke and death. RESULTS: Among 2502 randomized patients, 1321 (53%) were symptomatic and 1181 (47%) were asymptomatic. For procedures performed exclusively by vascular surgeons, the primary end point did not differ between CAS and CEA at 4-year follow-up (6.2% vs 5.6%, respectively; hazard ratio [HR], 1.30; 95% confidence interval [CI], 0.70-2.41; P = .41) In this subgroup, the periprocedural stroke and death rates were higher after CAS than CEA for symptomatic patients (6.1% vs 1.3%; P = .01). Asymptomatic patients also had slightly higher stroke and death rates after CAS (2.6% vs 1.1%; P = .20), although this difference did not reach statistical significance. Conversely, cranial nerve injuries (0.0% vs 5.0%; P < .001) were less frequent after CAS than CEA. The MI rates were slightly lower after CAS (1.3% vs 2.6%; P = .24). In performing CAS, vascular surgeons had outcomes for the periprocedural primary end point comparable to the 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 end point compared with other surgeons (HR, 0.73; 95% CI, 0.42-1.27). CONCLUSIONS: When performed by surgeons, CAS and CEA have similar net outcomes, 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 rates 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. ClinicalTrials.gov identifier: NCT0000473.

Suprarenal stent perforation after endovascular abdominal aortic aneurysm repair.

A 66-year-old man with an abdominal aortic aneurysm previously repaired with an endovascular stent graft presented to our facility with worsening midabdominal and back pain. Previous postoperative surveillance computed tomography scans were unremarkable, showing excellent stent-wall apposition and a shrinking aneurysm sac; however, imaging done on his arrival identified a contained rupture at the level of the celiac artery containing a perforating suprarenal stent. We repaired this rupture with a surgeon-modified fenestrated stent graft. To our knowledge, this is the first reported case of penetration of the native aorta by a suprarenal stent in the absence of infection or trauma.

The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST): stenting versus carotid endarterectomy for carotid disease.

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; P=0.51). Symptomatic status and sex did not modify the treatment effect, but an interaction with age and treatment was detected (P=0.02). Outcomes were slightly better after CAS for patients aged <70 years and better after CEA for patients aged >70 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%, P=0.012; and myocardial infarction 1.1% versus 2.3%, P=0.032). CONCLUSIONS: In CREST, CAS and CEA had similar short- and longer-term outcomes. During the periprocedural period, there was higher risk of stroke with CAS and higher risk of myocardial infarction with CEA. Clinical Trial Registration-www.clinicaltrials.gov. Unique identifier: NCT00004732.

Duplex scan for deep vein thrombosis--defining who needs an examination of the contralateral asymptomatic leg.

OBJECTIVES: Determine the prevalence and clinical significance of deep venous thrombosis (DVT) in the asymptomatic contralateral extremity of patients referred to the vascular laboratory with unilateral symptoms and DVT confirmed by duplex scan. METHOD: From December 2003 to October 2006, a total of 4813 patients were referred to our vascular laboratory for unilateral venous duplex scans. We prospectively studied 239 patients who were found to have acute DVT and had unilateral symptoms. Contralateral examinations were performed and demographic data, including risk factors for DVT, were entered into a computerized database. RESULTS: Of the 239 patients, 133 (55.6%) had a major DVT (popliteal vein or above) and 106 (44.4%) had a calf vein DVT. The majority were outpatients (195, 81.6%) and the rest were inpatients (44, 18.4%). The contralateral leg was normal in 192 (80.3%) patients, whereas 47 (19.7%) patients had some evidence of venous thrombosis. These thromboses consisted of acute major DVT (18/47, 38.3%), acute calf vein DVT (14/47, 29.8%), and less clinically significant chronic or superficial thrombus (15/47 (31.9%). All 18 patients with major contralateral DVT had underlying risk factor for thrombosis: active malignancy (12/18), recent surgery (4/18), or trauma (2/18). Patients with asymptomatic contralateral calf vein involvement often had thrombotic risk factors (10/14) but occasionally did not (4/14). Patients with an active malignancy were significantly more likely to have DVT in the asymptomatic leg (18/47, 38.3%) than were patients without cancer (23/192, 12%; both P < .0001). Inpatients were much more likely to have contralateral asymptomatic thrombosis (15/44, 34.1%) than outpatients (31/195, 15.9%; both P < .006). If treatment had been based on the findings in the symptomatic leg, all but 2 of the 239 patients would have been adequately treated. These two patients had multiple thrombotic risk factors that should have precluded ordering of a unilateral examination. CONCLUSIONS: 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.