Background The burden of stroke is truly significant and it is imperative that a change to a more mature approach to its prevention is pursued further by all concerned. Randomised trials comparing carotid artery stenting (CAS) with carotid endarterectomy (CEA) have been plagued with difficulties and a clear consensus cannot be established. We aimed to determine the success, safety and long-term durability of CAS in stroke prevention for all-comers managed with mandatory neuroprotection and a tailored approach.
Methods We selected from the Cotignola CAS registry all procedures with intention-to-treat by stenting under protection with a distal filter or a proximal occlusion device. 1515 procedures were identified spanning the period April 1999 to September 2007. Indications included symptomatic stenoses of 50% or greater (366, 24%) and asymptomatic stenoses of 80% or greater (1149, 76%).
Results Mean age was 72 ± 8 years (236 ⩾80 years, 17%); 418 women (30%). Filter devices were used in 1327 (88%) and proximal occlusion in 188 (12%) cases. CAS was successful in 99.8% of cases. The 30-day all stroke/death rate was 1.6% (minor stroke 11 (0.7%), major stroke nine (0.6%), death five (0.3%)); with a risk of 1.2% for asymptomatic and 2.7% for symptomatic groups (p = 0.043, 95% CI 1.003 to 5.2). Risk was 1.5% and 2.1% for patients aged 79 years or less and 80 years or greater (p = 0.5); with no events for patients under 60 years. Symptomatic octogenarians had a higher risk than other groups (odds ratio (OR) 3.8, 95% CI 1.055 to 13.9): asymptomatic 79 years or less 1.2%, asymptomatic 80 years or older 1.2%, symptomatic 79 years or less 2.3% and symptomatic 80 years and older 4.5%. The risk for men and women in asymptomatic (1.2% and 1.2%, p = 0.9) and symptomatic (3.2% and 1.2%, p = 0.3) groups were comparable. Multivariate analysis did not show the above factors to be independent predictors. In a model wherein age and symptomatic status were combined, symptomatic octogenarians were shown to be an independent predictor of adverse outcome (OR 4.2, 95% CI 1.2 to 14.8). Kaplan–Meier analyses (mean follow-up 8.66 ± 0.05 years) showed no difference for all stroke/neuro-deaths between symptomatic octogenarians and other patients (p = 0.9). 7-year freedom from stroke/neuro-deaths was 94% and 93% for asymptomatic and symptomatic groups (p = 0.001).
Conclusion Well-conducted applicable randomised trials are essential in establishing equivalence or superiority of new therapeutic interventions. Until such evidence is available, the results from this large cohort show that carotid stenting in the “real world” setting can achieve results well below the CEA reference bar of 6% and 3% for 30-day complications in symptomatic and asymptomatic patients, respectively. The data reflect the reality of day-to-day decision-making influenced by knowledge from experience, randomised trials and prospective registries. These results underscore that with experienced operators, built on a philosophy of dedicated training and a tailored strategy, carotid stenting is an effective procedure.