Influence of Site and Operator Characteristics on Carotid Artery Stent Outcomes Analysis of the CAPTURE 2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) Clinical Study

ObjectivesThe aim of this study was to analyze the CAPTURE 2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) study for physician- or site-related variables associated with differential outcomes for carotid artery stenting (CAS).BackgroundThe CAPTURE 2 trial is an ongoing, prospective, nonrandomized, independently adjudicated, multicenter clinical study enrolling high-surgical-risk patients undergoing CAS.MethodsIn this assessment of the CAPTURE 2 study, the American Heart Association carotid endarterectomy guideline limits were used to define acceptable site and physician CAS outcomes; therefore, the resulting population of nonoctogenarian, asymptomatic subjects in this analysis is confined to 3,388 (of the total 5,297) subjects treated at 180 U.S. hospitals by 459 operators between March 2006 and January 2009.ResultsThe rates of death, stroke, and myocardial infarction and death and stroke (DS) at 30 days were 3.5% and 3.3%, respectively, for the full CAPTURE 2 study cohort and 2.9% and 2.7%, respectively, for the asymptomatic, nonoctogenarian subgroup. In this subgroup, two-thirds of sites (118 of 180, 66%) had no DS events. Within the remaining sites, an inverse relationship between event rates and hospital patient volume as well as between event rates and individual operator volume was observed. The DS rates trended lower for interventional cardiologists compared with other specialties.ConclusionsOutcomes from the largest prospectively gathered, independently adjudicated, multicenter CAS study indicate that CAS can be safely performed in a variety of hospital settings by physicians with various specialties. The most important determinant of perioperative CAS outcomes was both site and operator CAS volume. A threshold of 72 cases was found to be necessary for consistently achieving a DS rate below 3% in this later-phase single arm study; background era and non-study operator experience will affect this determination.(Second Phase of “Carotid RX ACCULINK/RX ACCUNET Post-Approval Trial to Uncover Unanticipated or Rare Events”; NCT00302237

First clinical trial of nitinol self-expanding everolimus-eluting stent implantation for peripheral arterial occlusive disease

BackgroundA novel self-expanding drug-eluting stent was designed to slowly release everolimus to prevent restenosis following peripheral arterial intervention. The purpose of the first-in-human Superficial Femoral Artery Treatment with Drug-Eluting Stents (STRIDES) trial was to evaluate the safety and efficacy of this device for the treatment of symptomatic superficial femoral and proximal popliteal arterial occlusive disease.Methods and ResultsOne hundred four patients were enrolled at 11 European investigative centers in a prospective, nonrandomized, single-arm trial. The patients had severe symptomatic vascular disease, including a significant proportion of patients with critical limb ischemia (17%), diabetes (39%), and single-vessel outflow (26%). The mean lesion length was 9.0 ± 4.3 cm. Ninety-nine percent of patients were available for 12-month follow-up, including duplex imaging in 90% and arteriography in 83%. Clinical improvement, defined as a sustained decrease in Rutherford-Becker clinical category, was achieved in 80% of patients. Primary patency (freedom from ≥50% in-stent restenosis) was 94 ± 2.3% and 68 ± 4.6% at 6 and 12 months, respectively. Plain radiographic examination of 122 implanted devices at 12 months revealed no evidence for stent fracture.ConclusionsThe everolimus-eluting self-expanding nitinol stent can be successfully implanted in patients with severe peripheral arterial disease with favorable outcomes and clinical improvements observed in the majority of patients

Impact of tricuspid regurgitation on survival in patients with heart failure: a large electronic health record patient-level database analysis.

AIMS: More evidence is needed to quantify the association between tricuspid regurgitation (TR) and mortality in patients with heart failure (HF). METHODS AND RESULTS: Between 2008-2017, using the Optum longitudinal database, a patient-level database that integrates multiple US-based electronic health and claim records from several health care providers, we identified 435 679 patients with new HF diagnosis and both an assessment of the left ventricular ejection fraction and at least 1 year of history. TR was graded as mild, moderate or severe and classified as prevalent (at the time of the initial HF diagnosis) or incident (subsequent new cases thereafter). For prevalent TR, the analysis was performed using a Cox proportional hazards model with adjustment for patient covariates. Incident TR was modelled as a time-updated covariate, as were other non-fatal events during follow-up. Prevalence of mild, moderate and severe TR at baseline was 10.1%, 5.1% and 1.4%, respectively. Over a median follow-up of 1.5 years, 121 273 patients (27.8%) died and prevalent TR was independently associated with survival. Compared to patients with no TR at baseline, the adjusted hazard ratios for mortality were 0.99 [95% confidence interval (CI) 0.97-1.01], 1.17 (95% CI 1.14-1.20) and 1.34 (95% CI 1.28-1.39) for mild, moderate and severe TR, respectively. In the 363 270 patients free from TR at baseline, incident TR (at least mild, at least moderate, or severe) developed during follow-up in 12.1%, 5.1% and 1.1%, respectively. Adjusted mortality hazard ratios for such new cases were 1.48 (95% CI 1.44-1.52), 1.92 (95% CI 1.86-1.99) and 2.44 (95% CI 2.32-2.57), respectively. Findings were consistent across all patient subgroups based on age, gender, rhythm, associated comorbidities, prior cardiac surgery, B-type natriuretic peptide/N-terminal pro-B-type natriuretic peptide, and left ventricular ejection fraction. CONCLUSIONS: In this large contemporary patient-level database of almost half-million US patients with HF, TR was associated with a marked increases in mortality risk overall and in all subgroups. Future randomized controlled trials will evaluate the impact of TR correction on clinical outcomes and the causal relationship between TR and mortality

Thirty-Day Outcomes for Carotid Artery Stenting in 6320 Patients From 2 Prospective, Multicenter, High-Surgical-Risk Registries

Background— The American Heart Association has established guidelines for acceptable 30-day death and stroke rates for patients with severe carotid disease undergoing standard-risk carotid endarterectomy: <3% for asymptomatic lesions and <6% for symptomatic lesions. To date, carotid artery stenting has not demonstrated these outcomes in multicenter, prospective assessments of high-surgical-risk patients. Methods and Results— Data from 2 prospective, multicenter (280 US sites, 672 operators), postmarket surveillance studies in high-surgical-risk patients were analyzed: 2145 patients from the Emboshield and Xact Post Approval Carotid Stent Trial (EX) and 4175 patients from the Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events (C2). Both studies had pre- and postprocedure neurological evaluation and independent adjudication of neurological events. The overall 30-day death and stroke rate was 4.1% (95% CI, 3.3% to 5.0%) for EX and 3.4% (95% CI, 2.9% to 4.0%) for C2. In the population comparable with American Heart Association guidelines (<80 years), the combined 30-day death and stroke rate was 5.3% (95% CI, 3.6% to 7.4%) for symptomatic patients and 2.9% (95% CI, 2.4% to 3.4%) for asymptomatic patients, independent of unfavorable risk factors (anatomic or physiologic); in patients ≥80 years, this rate was 10.5% (95% CI, 6.3% to 16.0%) and 4.4% (95% CI, 3.3% to 5.7%), respectively. In subjects with anatomic features unfavorable for surgery, the 30-day death and stroke rates were 1.7% (95% CI, 0.0% to 8.9%) and 2.7% (95% CI, 1.3% to 4.9%) for symptomatic and asymptomatic cohorts, respectively, independent of age. Conclusions— Outcomes for carotid artery stenting in nonoctogenarian high-surgical-risk patients have improved since the pivotal Food and Drug Administration approval trials, and have achieved American Heart Association standards in both symptomatic and asymptomatic lesions

Carotid Artery Stenting in Octogenarians Periprocedural Stroke Risk Predictor Analysis From the Multicenter Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events (CAPTURE 2) Clinical Trial

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 ≥80 years old. Methods— Symptomatic patients with ≥50% stenosis and asymptomatic patients with ≥80% 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 ≥80 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 ≥80 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 ≥80 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

CAPTURE 2 risk-adjusted stroke outcome benchmarks for carotid artery stenting with distal embolic protection

Many medical procedures undergo rapid evolution and process of care improvements after introduction. National outcome standards are useful to help physicians, institutions, and other stakeholders evaluate the quality of their programs and take action when suboptimal outcomes are identified. The purpose of this analysis was to derive contemporary risk-adjusted stroke rates from a large, contemporary, independently assessed outcome database within 30 days after carotid artery stenting (CAS) in the United States. The second phase of carotid ACCULINK/ACCUNET post approval trial to uncover rare events (CAPTURE 2) is an ongoing prospective, multicenter, clinical trial conducted to assess CAS outcomes in the general practice setting after device approval for high surgical risk patients (symptomatic with >50% stenosis or asymptomatic with >80% stenosis). A neurologist examined the patients before the procedure, at 1 day and 30 days after CAS. The primary endpoint was a composite of death, any stroke, or myocardial infarction (MI) within the periprocedural period. Strokes and neurologic events suspected to be strokes were adjudicated by an independent clinical events adjudication committee. Logistic regression analysis including stepwise logistic and multivariable modeling was performed to determine clinical predictors of periprocedural stroke outcome and generate a parsimonious model that could be used for a clinical standard. Five thousand two hundred ninety-seven consecutive patients (5297) had CAS performed by 459 physicians at 186 sites before the data cutoff of January 10, 2009. The 30-day rate of stroke was 2.7% (95% confidence interval [CI], 2.3–3.2). Multivariable predictors of periprocedural stroke included age, symptomatic status, and dwell time of embolic protection device. A parsimonious model P i = 1/(1+e −(−3.83 + 0.51 × (symptomatic) + 0.31 × (age ≥80) + 0.62 × (age ≥80 × symptomatic)), including symptomatic and octogenarian status and the term of the interaction of the two, was established based on consideration of clinical predictors, clinical interaction, and practicability. CAS outcomes in patients at high surgical risk have comparable periprocedural outcomes to published randomized trials of endarterectomy for patients at standard surgical risk. A model is presented for calculating a contemporary national standard for risk-adjusted stroke rates. Quality improvement measures could be based on relative performance to this benchmark and could improve overall outcomes for patients undergoing CAS