Safety of the transradial approach to carotid stenting.

BACKGROUND: The multicenter prospective CREST-2 Registry (C2R) provides recent experience in performing carotid artery stenting (CAS) for interventionists to ensure safe performance of CAS. OBJECTIVE: To determine the periprocedural safety of CAS performed using a transradial approach relative to CAS performed using a transfemoral approach. METHODS: Patients with ≥70% asymptomatic and ≥50% symptomatic carotid stenosis, ≤80 years of age and at standard or high risk for carotid endarterectomy (CEA) are eligible for the C2R. The primary endpoint was a composite of severe access-related complications. Comparisons were made using propensity-score matched logistic regression. RESULTS: The mean age of the cohort was 67.6 ± 8.2 years and 1906 (35.1%) were female. Indications for CAS included 4063 (74.9%) for primary atherosclerosis. A total of 2868 (52.8%) cases underwent CAS for asymptomatic disease. Transradial access was used in 213 (3.9%) patients. The transradial cohort had lower use of general anesthesia (1.5% vs. 6.3%, p = 0.007) and higher use of distal embolic protection (96.7% vs. 89.4%, p = 0.0004). There were no significant differences between radial and femoral access groups in terms of a composite of major access-related complications (0% vs. 1.1%) or a composite of periprocedural stroke or death (3.3% vs. 2.4%; OR = 1.4 [confidence intervals 0.6, 3.1]; p = 0.42). CONCLUSION: We found no significant differences in rates of major access-related complications or periprocedural stroke or death with CAS performed using transradial compared to transfemoral access. Our results support incorporation of the transradial approach to clinical trials comparing CAS to other revascularization techniques.

Temporal Changes in Periprocedural Events in the Carotid Revascularization Endarterectomy Versus Stenting Trial.

BACKGROUND AND PURPOSE: Post-hoc, we hypothesized that over the recruitment period of the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST), increasing experience and improved patient selection with carotid stenting, and to a lesser extent, carotid endarterectomy would contribute to lower periprocedural event rates. METHODS: Three study periods with approximately the same number of patients were defined to span recruitment. Composite and individual rates of periprocedural stroke, myocardial infarction, and death rate were calculated separately by treatment assignment (carotid stenting/carotid endarterectomy). Temporal changes in unadjusted event rates, and rates after adjustment for temporal changes in patient characteristics, were assessed. RESULTS: For patients randomized to carotid stenting, there was no significant temporal change in the unadjusted composite rates that declined from 6.2% in the first period, to 4.9% in the second, and 4.6% in the third (P=0.28). Adjustment for patient characteristics attenuated the rates to 6.0%, 5.9%, and 5.6% (P=0.85). For carotid endarterectomy-randomized patients, both the composite and the combined stroke and death outcome decreased between periods 1 and 2 and then increased in period 3. CONCLUSIONS: The hypothesized temporal reduction of stroke+death events for carotid stenting-treated patients was not observed. Further adjustment for changes in patient characteristics between periods, including the addition of asymptomatic patients and a >50% decrease in proportion of octogenarians enrolled, resulted in practically identical rates. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.

Carotid artery stenting: acute and long-term results.

The objective of this study was to evaluate the safety and efficacy of carotid artery stenting (CAS) in high-risk patients. Carotid endarterectomy (CEA) has been shown to be more effective than medical therapy but has limitations. CAS may be a reasonable alternative, particularly in high-risk patients. The authors evaluated prospectively the safety and efficacy of CAS in 299 consecutive patients who underwent CAS of 343 extracranial carotid arteries. Of the patients enrolled, 210 (70%) would have been excluded from the major trials of CEA, and 84 (28%) were referred by vascular surgeons. This series represents a very high-risk group that included patients with unstable angina, previous ipsilateral CEA, contralateral carotid occlusion, and other severe comorbid illnesses. Seventy-four (25%) patients were aged 80 years or more. All patients had independent neurologic examination before and after the procedure. Three hundred seventy-six stents were deployed in 343 arteries. Procedural success was 99%. Mean stenosis was 75 +/- 12% before and 7 +/- 8% after the procedure. Ninety-two patients had coronary intervention. Only 56 (19%) patients were North American Symptomatic Carotid Endarterectomy Trial (NASCET) eligible. During the initial hospitalization and 30 days post-CAS, there were two (0.6%) major and seven (2.3%) minor strokes. There were no myocardial infarctions or deaths during or within 30 days of CAS. None of the NASCET-eligible patients had a stroke. At a mean follow-up period of 26 +/- 13 months, eight (2.7%) patients had asymptomatic restenosis. No additional major strokes or neurologic deaths occurred. In conclusion, CAS is feasible, can be performed even in high-risk patients, and is associated with a low restenosis rate.