Carotid Revascularization Using Endarterectomy or Stenting Systems (CaRESS):4-Year Outcomes

Abstract

¤ ¤Purpose: To examine the 4-year outcomes from Carotid Revascularization using Endarterectomy or Stenting Systems (CaRESS) in light of the current reimbursement guidelines for carotid artery stenting (CAS) from the Centers for Medicare and Medicaid Services (CMS).Methods: CaRESS was designed as a prospective, nonrandomized comparative cohort study of a broad-risk population of symptomatic and asymptomatic patients with carotid stenosis. In all, 397 patients (247 men; mean age 71 years, range 43-89) were enrolled and underwent carotid endarterectomy (CEA; n5254) or protected CAS (n5143). More than 90% of patients had .75% stenosis; two thirds were asymptomatic. The primary endpoints included (1) all-cause mortality, (2) any stroke, and (3) myocardial infarction (MI), as well as the composite endpoints of (4) death and any nonfatal stroke and (5) death, nonfatal stroke, and MI. The secondary endpoints were restenosis, repeat angiography, and carotid revascularization. All patients were classified with respect to surgical risk, symptom status, and stenosis grade based on criteria published by the CMS. In addition, separate analyses were performed comparing genders and octogenarians to those ,80 years old.Results: No significant differences in the primary outcome measures were found between the CEA and CAS groups in the 4-year analysis. The incidences of any stroke at 4 years were 9.6% for CEA and 8.6% for CAS (p50.444); when combined with death, the composite death/nonfatal stroke rates were 26.5% for CEA versus 21.8% for CAS (p50.361). The composite endpoint of death, nonfatal stroke, and MI at 4 years was 27.0% in CEA versus 21.7% in CAS (p50.273) patients. The secondary endpoints of restenosis (p50.014) and repeat angiography (p50.052) were higher in the CAS arm. There were no differences in any of the subgroups stratified according the CMS guidelines or in the gender comparison. Four-year incidences of death/nonfatal stroke and death/nonfatal stroke/MI were higher in the CEA arm among patients ,80 years of age (p50.049 and p50.030, respectively). There were no significant differences between these incidences in the octogenarian subgroup.

Unprotected Carotid Artery Stenting in Symptomatic Patients with High-Grade Stenosis: Results and Long-Term Follow-Up in a Single-Center Experience

“…38 The results should probably be independent of the use of cerebral protective devices. In our series, the 1-year mortality rate was 2.7%.…”

Temporal trends in safety of carotid endarterectomy in asymptomatic patients

“…Operator experience ranged from a minimum of 2 years' experience 25 to 50 CEAs per year with a ,3% stroke or death rate. 27 The demographics of patients in all the trials were similar with an average age of 64-72 years and 65%-70% of participants were male. Medical treatment consisted of aspirin alone in Veterans Affairs; aspirin and discussion of risk factors in Asymptomatic Carotid Atherosclerosis Study (ACAS); aspirin, statins, and antihypertensives to varying degrees in ACST and Carotid Revascularization Endarterectomy versus Stenting Trial (CREST); and was not stated in General Anaesthesia Versus Local Anaesthesia for Carotid Surgery (GALA) and Carotid Revascularization Using Endarterectomy or Stenting Systems (CaRESS).…”

“…Five were randomized controlled trials and the sixth was a high-quality cohort study. 27 The number of endarterectomies ranged from 170 to 1,405 per study. Operator experience ranged from a minimum of 2 years' experience 25 to 50 CEAs per year with a ,3% stroke or death rate.…”

“…20 Data from 4 randomized controlled trials were not included because fewer than 100 CEAs in asymptomatic patients were performed during each study [21][22][23][24] (range 7-84), leaving 6 research trials. 3,4,[25][26][27][28] Fortyseven registries were reported in 17 separate publications.…”

Restenosis After Carotid Artery Stenting Versus Endarterectomy: The Jury is Still Out!

“…3 For this reason, 2,3 the high proportion of ''baseline'' post-CEA restenotic lesions in the CAS arm of CaRESS is likely to have driven (and can explain the finding of) an apparently higher CAS restenosis rate in the overall study population at 4 years (14.7% versus 5.9%, p50.014). 1 The CAVATAS (Carotid and Vertebral Artery Transluminal Angioplasty Study) trial 4 (413 patients with carotid artery stenosis randomized to endovascular treatment or CEA) reported that significant (.70%) restenosis was more common after endovascular treatment than after CEA, both at 1 year (10.5% versus 2.5%, p,0.001) and at 5 years (30.7% versus 10.5%, p,0.0001). In CAVATAS, stenting was performed in only 22% of patients allocated to endovascular treatment, whereas angioplasty alone did not always lead to appropriate dilation of the carotid lesion.…”