Carotid Artery Stenting in Octogenarians

Abstract

on behalf of the CAPTURE 2 Investigators and Executive Committee Background and Purpose-Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events (CAPTURE 2) is an ongoing prospective, nonrandomized, multicenter clinical trial enrolling patients undergoing carotid artery stenting.The aim of this analysis is to identify risk predictors for periprocedural stroke in patients Ն80 years old. Methods-Symptomatic patients with Ն50% stenosis and asymptomatic patients with Ն80% stenosis were enrolled.Patients' neurological status was assessed by an independent neurologist before as well as 24 hours and 30 days postprocedure. All strokes and suspected strokes were adjudicated by an independent committee. Logistic regression analysis was conducted to identify baseline demographic, lesion, procedural, or comorbidity parameters associated with outcomes in patients Ն80 years of age. Results-As of January 10, 2009, 5297 patients underwent carotid artery stenting in 186 US CAPTURE 2 clinical centers and 1166 were Ն80 years old. Octogenarians were similar to nonoctogenarians in terms of gender and symptomatic status but had fewer of certain risk factors (prior myocardial infarction or carotid endarterectomy, diabetes, smoking history) and more cardiac arrhythmia and renal insufficiency. For the overall cohort, death/stroke rate was 3.3%; stroke rate was 2.7% (0.8% major, 1.9% minor). Death/stroke rates were significantly higher for octogenarians than nonoctogenarians (4.5% versus 3.0%) as were stroke rates (3.8% versus 2.4%). Symptomatic status, embolic protection device dwell time, and lesion length were risk predictors for periprocedural stroke in octogenarians. Conclusions-Patients Ն80 years old have higher periprocedural event rates than nonoctogenarians. Age, symptomatic status, and lesion length should be considered when identifying appropriate candidates for the procedure. (Stroke. 2010; 41:757-764.)

Relationship Between Physician and Hospital Procedure Volume and Mortality After Carotid Artery Stenting Among Medicare Beneficiaries

“…One of the major strengths of this study is that we were able to evaluate and adjust for important clinical and procedural factors, such as high surgical risk status 31 and symptomatic status, 32 which have been associated with poor outcomes after CAS. In using mortality as the outcome, we selected the hardest and most reliable end point.…”

Immediate and late outcomes of stenting for severe extracranial internal carotid artery stenosis in octogenarian patients

“…In our study, age was not an important factor in determining the incidence of permanent neurologic deficits during the periprocedural period. Similarly, in other monocentric studies, there is no evidence of a causal link between perioperative neurologic complications and advanced age (Bacharach et al., 2010; Chrysant, Prabhu, Tebow, & Snowden, 2009), although several RCTs showed an increased incidence of complications in octogenarians (Chaturvedi, Matsumura, Gray, Xu, & Verta, 2010; Hobson et al., 2004). …”

Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel Meeting on the ACCULINK and ACCUNET Carotid Artery Stent System

“…No hypothesis of noninferiority was prespecified for octogenarian patients. Although octogenarians were included in the randomization phase of CREST, published outcome data in CEA were sparse (eg, octogenarians were excluded from landmark randomized CEA studies, including the North American Symptomatic Carotid Endarterectomy Trial and the Asymptomatic Carotid Atherosclerosis Study) and outcomes in CAS patients identified octogenarian status as a predictor of adverse outcomes, 12 which raised concerns regarding the lack of clinical equipoise between CAS and CEA for this patient population in CREST. Therefore, before data unblinding, a prespecified noninferiority analysis for nonoctogenarians was agreed on with the FDA and added to the Statistical and Analytic Plan.…”

“…Since 2002, the device has had regulatory approval in Europe and has been commercialized in Ͼ85 countries, with no 12,[15][16][17][18] Since conducting ARCHeR, rates of 30-day DSMI with the ACCULINK/ ACCUNET system have been noticeably reduced; specifically, 30-day DSMI rates for ARCHeR, CAPTURE, and CAPTURE 2 were 8.3%, 6.1%, and 3.5%, respectively. These studies, representing Ͼ180 sites and 450 operators in the United States, established the safety and effectiveness of the device for patients at high surgical risk in nontrial clinical settings.…”

“…12 The regulatory pathway was bound by the typical standards imposed by the FDA in PMA studies including good clinical practice (GCP) standards for the design, conduct, performance and reporting of clinical trials, 13 including biomedical research (BiMo) audits -on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research for credibility and accuracy. …”