Long-term outcomes of the conformable TAG thoracic endoprosthesis in a prospective multicenter trial.

BACKGROUND: The Gore conformable TAG thoracic endoprosthesis (CTAG) was engineered to enhance conformability in the thoracic aorta and has demonstrated greater deployment accuracy and wall apposition than the original TAG device. The Food and Drug Administration approved the CTAG in 2011 based on the 1-year results of the pivotal trial for the CTAG device. In the present report, we have documented the outcomes for those patients through 5 years. METHODS: The CTAG aneurysm study was a prospective, multicenter trial that assessed the safety and effectiveness of the CTAG device as treatment of descending thoracic aortic aneurysms. Follow-up imaging assessments consisted of radiographs and computed tomography at annual intervals through 5 years. A core imaging laboratory was used to assess the aneurysm size, device integrity, and endoleaks. RESULTS: A total of 66 patients were enrolled (51 pivotal arm patients and 15 continued access patients) from October 2009 through September 2011. The baseline characteristics, procedural characteristics, and outcomes through 2 years were reported previously. Through 5 years, five patients (7.6%) had required device-related reintervention (one type Ia endoleak or contained rupture of the descending thoracic aorta, one type Ib endoleak, two indeterminate endoleaks, and one thoracic aortic pseudoaneurysm). Four patients (6.1%) had died of aneurysm-related causes, with one death occurring within 30 days of the index procedure. A total of 24 patients (36.3%) had died during the 5-year study period. Seven patients (10.6%) had experienced stroke or transient ischemic attack through 5 years, with one early stroke (postoperative day 28). Prosthesis or intercomponent migration was observed in six patients (9.1%) through 5 years; however, no patient had developed a type III junctional endoleak. No stent-graft fracture or compression was observed through 5 years. At 5 years, 14 patients (50.0%) showed sac regression, 5 (17.9%) showed sac expansion, and 9 (32.1%) showed sac stability using on a 5-mm threshold for change. CONCLUSIONS: Thoracic endovascular aortic repair with the CTAG device was associated with low rates of aneurysm-related mortality and reintervention through 5 years. Proximal endoleak was rare, and most patients showed sac regression or stability at 5 years after the initial thoracic endovascular aortic repair.

Correlates of Incident Cognitive Impairment in the REasons for Geographic and Racial Differences in Stroke (REGARDS) Study.

OBJECTIVE: To identify approximately 500 cases of incident cognitive impairment (ICI) in a large, national sample adapting an existing cognitive test-based case definition and to examine relationships of vascular risk factors with ICI. METHOD: Participants were from the REGARDS study, a national sample of 30,239 African-American and White Americans. Participants included in this analysis had normal cognitive screening and no history of stroke at baseline, and at least one follow-up cognitive assessment with a three-test battery (TTB). Regression-based norms were applied to TTB scores to identify cases of ICI. Logistic regression was used to model associations with baseline vascular risk factors. RESULTS: We identified 495 participants with ICI of 17,630 eligible participants. In multivariable modeling, income (OR 1.83 CI 1.27,2.62), stroke belt residence (OR 1.45 CI 1.18,1.78), history of transient ischemic attack (OR 1.90 CI 1.29,2.81), coronary artery disease(OR 1.32 CI 1.02,1.70), diabetes (OR 1.48 CI 1.17,1.87), obesity (OR 1.40 CI 1.05,1.86), and incident stroke (OR 2.73 CI 1.52,4.90) were associated with ICI. CONCLUSIONS: We adapted a previously validated cognitive test-based case definition to identify cases of ICI. Many previously identified risk factors were associated with ICI, supporting the criterion-related validity of our definition.

Dietary contributors to glycemic load in the REasons for Geographic and Racial Differences in Stroke study.

OBJECTIVE: High dietary glycemic load (GL) has been associated with an increased risk for chronic diseases, including type 2 diabetes, coronary heart disease, and selected cancers. The aim of this study was to identify the main food and food group contributors to dietary GL in a representative sample of US adults to inform future interventions. METHODS: Participants were from the REGARDS (REasons for Geographic and Racial Differences in Stroke) study, a longitudinal cohort of 30 239 community-dwelling black and white women and men ages ≥45 y from throughout the United States. Diet was assessed with a food frequency questionnaire. The amount of each carbohydrate food, and its glycemic index, were used to calculate GL values for each carbohydrate food reported. These were totaled to estimate the mean total daily GL for each participant. Individual carbohydrate foods also were collapsed into 18 carbohydrate food groups, and the portion of the total GL contributed by each carbohydrate food and food group was determined. Analyses were conducted overall, by race/sex groups, and by region. RESULTS: Sweetened beverages were the main contributors to GL overall (12.14 median percentage [median %] of daily GL), by far the largest contributors in black men (17.79 median %) and black women (16.43 median %), and major contributors in white men (12.02 median %) and white women (11.22 median %). Other important contributors to GL overall and in all race/sex groups and regions included breads, starchy side dishes, and cereals. CONCLUSIONS: In this US cohort of white and black adults, sweetened beverages were major contributors to GL overall, especially in black participants. This information may help to inform future interventions targeting reduction in dietary GL.

Performance of the NINDS-CSN 5-minute protocol in a national population-based sample.

In 2006, the National Institute of Neurological Disorders and Stroke-Canadian Stroke Network (NINDS-CSN) Vascular Cognitive Impairment Harmonization Standards recommended a 5-Minute Protocol as a brief screening instrument for vascular cognitive impairment (VCI). We report demographically adjusted norms for the 5-Minute Protocol and its relation to other measures of cognitive function and cerebrovascular risk factors. We performed a cross-sectional analysis of 7199 stroke-free adults in the REasons for Geographic And Racial Differences in Stroke (REGARDS) study on the NINDS-CSN 5-Minute Protocol score. Total scores on the 5-Minute Protocol were inversely correlated with age and positively correlated with years of education, and performance on the Six-Item Screener, Word List Learning, and Animal Fluency (all p-values <.001). Higher cerebrovascular risk on the Framingham Stroke Risk Profile (FSRP) was associated with lower total 5-Minute Protocol scores (p <.001). The 5-Minute Protocol also differentiated between participants with and without confirmed stroke and with and without stroke symptom histories (p <.001). The NINDS-CSN 5-Minute Protocol is a brief, easily administered screening measure that is sensitive to cerebrovascular risk and offers a valid method of screening for cognitive impairment in populations at risk for VCI.

Self-reported sleep duration in relation to incident stroke symptoms: nuances by body mass and race from the REGARDS study.

BACKGROUND: To determine, among employed persons with low risk for obstructive sleep apnea (OSA), if sleep duration is associated with incident stroke symptoms, independent of body mass index (BMI), and if sleep duration mediates racial differences in stroke symptoms. METHODS: In 2008, 5666 employed participants (US blacks and whites, ≥45 years) from the longitudinal and nationally representative Reasons for Geographic And Racial Differences in Stroke study self-reported their average sleep duration. Participants had no history of stroke, transient ischemic attack, or stroke symptoms and were at low risk for OSA. After the sleep assessment, self-reported stroke symptoms were collected at 6-month intervals, up to 3 years (M = 751 days). Interval-censored, parametric survival models were conducted to estimate hazard ratios predicting time from sleep duration measurement (<6, 6-6.9, 7-7.9 [reference], 8-8.9, ≥9 hours) to first stroke symptom. Adjusted models included demographics, stroke risk factors, psychological symptoms, health behaviors, and diet. RESULTS: During follow-up, 224 participants reported 1 or more stroke symptoms. In the unadjusted model, short sleep (<6 hours) significantly predicted increased risk of stroke symptoms but not in adjusted models. Stratification by BMI revealed a significant association between short sleep duration and stroke symptoms only for normal BMI persons in unadjusted (hazard ratio: 2.93, 95% confidence interval: 1.38-6.22) and fully adjusted models (hazard ratio: 4.19, 95% confidence interval: 1.62-10.84). The mediating effect of sleep duration on the relationship between race and stroke symptoms was borderline significant in normal weight participants. CONCLUSIONS: Among middle-aged to older employed individuals of normal weight and low risk of OSA, self-reported short sleep duration is prospectively associated with increased risk of stroke symptoms.

Age differences in the association of obstructive sleep apnea risk with cognition and quality of life.

Using a sample of 2925 stroke-free participants drawn from a national population-based study, we examined cross-sectional associations of obstructive sleep apnea (OSA) risk with cognition and quality of life and whether these vary with age, while controlling for demographics and comorbidities. Included participants from the REasons for Geographic And Racial Differences in Stroke (REGARDS) study were aged 47-93 years. OSA risk was categorized as high or low based on responses to the Berlin Sleep Questionnaire. Cognitive function was assessed with standardized fluency and recall measures. Depressive symptoms were assessed with the four-item Center for Epidemiologic Studies Depression Scale. Health-related quality of life (HRQoL) was assessed with the Medical Outcomes Study Short Form-12 (SF-12). Multivariate analyses of covariance (mancova) statistics were applied separately to the cognitive and quality of life dependent variables while accounting for potential confounders (demographics, comorbidities). In fully adjusted models, those at high risk for OSA had significantly lower cognitive scores (Wilks' lambda = 0.996, F3,2786  = 3.31, P < 0.05) and lower quality of life [depressive symptoms and HRQoL] (Wilks' lambda = 0.989, F3,2786  = 10.02, P < 0.0001). However, some of the associations were age-dependent. Differences in cognition and quality of life between those at high and low obstructive sleep apnea risk were most pronounced during middle age, with attenuated effects after age 70 years.

Dietary Patterns Derived Using Exploratory and Confirmatory Factor Analysis are Stable and Generalizable Across Race, Region, and Gender Subgroups in the REGARDS Study.

BACKGROUND: Examining diet as a whole using dietary patterns as exposures is a complementary method to using single food or nutrients in studies of diet and disease, but the generalizability of intake patterns across race, region, and gender in the United States has not been established. OBJECTIVE: To employ rigorous statistical analysis to empirically derive dietary patterns in a large bi-racial, geographically diverse population and examine whether results are stable across population subgroups. DESIGN: The present analysis utilized data from 21,636 participants in the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study who completed the Block 98 food frequency questionnaire. We employed exploratory factor analysis and confirmatory factor analyses on 56 different food groups iteratively and examined differences by race, region, and sex to determine the optimal factor solution in our sample. RESULTS: Five dietary patterns emerged: the "Convenience" pattern was characterized by mixed dishes; the "Plant-based" pattern by fruits, vegetables, and fish; the "Sweets/Fats" pattern by sweet snacks, desserts, and fats and oils; the "Southern" pattern by fried foods, organ meat, and sweetened beverages; and the "Alcohol/Salads" pattern by beer, wine, liquor, and salads. Differences were most pronounced in the Southern pattern with black participants, those residing in the Southeast, and participants not completing high school having the highest scores. CONCLUSION: Five meaningful dietary patterns emerged in the REGARDS study and showed strong congruence across race, sex, and region. Future research will examine associations between these patterns and health outcomes to better understand racial disparities in disease and inform prevention efforts.

Medication adherence and stroke/TIA risk in treated hypertensives: results from the REGARDS study.

BACKGROUND: The extent to which low medication adherence in hypertensive individuals contributes to disparities in stroke and transient ischemic attack (TIA) risk is poorly understood. METHODS: Investigators examined the relationship between self-reported medication adherence and blood pressure (BP) control (<140/90 mm Hg), Framingham Stroke Risk Score, and physician-adjudicated stroke/TIA incidence in treated hypertensive subjects (n = 15,071; 51% black; 57% in Stroke Belt) over 4.9 years in the national population-based REGARDS cohort study. RESULTS: Mean systolic BP varied from 130.8 ± 16.2 mm Hg in those reporting high adherence to 137.8 ± 19.5 mm Hg in those reporting low adherence (P for trend < .0001). In logistic regression models, each level of worsening medication adherence was associated with significant and increasing odds of inadequately controlled BP (≥140/90 mm Hg; score = 1, odds ratio [95% confidence interval], 1.20 [1.09-1.30]; score = 2, 1.27 [1.08-1.49]; score = 3 or 4, 2.21 [1.75-2.78]). In hazard models using systolic BP as a mediator, those reporting low medication adherence had 1.08 (1.04-1.14) times greater risk of stroke and 1.08 (1.03-1.12) times greater risk of stroke or TIA. CONCLUSION: Low medication adherence was associated with inadequate BP control and an increased risk of incident stroke or TIA.

Report of stroke-like symptoms predicts incident cognitive impairment in a stroke-free cohort.

OBJECTIVE: The present study characterizes the relationship between report of stroke symptoms (SS) or TIA and incident cognitive impairment in the large biracial cohort of the Reasons for Geographic and Racial Differences in Stroke (REGARDS) Study. METHODS: The REGARDS Study is a population-based, biracial, longitudinal cohort study that has enrolled 30,239 participants from the United States. Exclusion of those with baseline cognitive impairment, stroke before enrollment, or incomplete data resulted in a sample size of 23,830. Participants reported SS/TIA on the Questionnaire for Verifying Stroke-free Status at baseline and every 6 months during follow-up. Incident cognitive impairment was detected using the Six-item Screener, which was administered annually. RESULTS: Logistic regression found significant association between report of SS/TIA and subsequent incident cognitive impairment. Among white participants, the odds ratio for incident cognitive impairment was 2.08 (95% confidence interval: 1.81, 2.39) for those reporting at least one SS/TIA compared with those reporting no SS/TIA. Among black participants, the odds ratio was 1.66 (95% confidence interval: 1.45, 1.89) using the same modeling. The magnitude of impact was largest among those with fewer traditional stroke risk factors, particularly among white participants. CONCLUSIONS: Report of SS/TIA showed a strong association with incident cognitive impairment and supports the use of the Questionnaire for Verifying Stroke-free Status as a quick, low-cost instrument to screen for people at increased risk of cognitive decline.

Adherence to a Mediterranean diet and risk of incident cognitive impairment.

OBJECTIVE: We sought to determine the relationship of greater adherence to Mediterranean diet (MeD) and likelihood of incident cognitive impairment (ICI) and evaluate the interaction of race and vascular risk factors. METHODS: A prospective, population-based, cohort of individuals enrolled in the Reasons for Geographic and Racial Differences in Stroke (REGARDS) Study 2003-2007, excluding participants with history of stroke, impaired cognitive status at baseline, and missing data on Food Frequency Questionnaires (FFQ), was evaluated. Adherence to a MeD (scored as 0-9) was computed from FFQ. Cognitive status was evaluated at baseline and annually during a mean follow-up period of 4.0 ± 1.5 years using Six-item-Screener. RESULTS: ICI was identified in 1,248 (7%) out of 17,478 individuals fulfilling the inclusion criteria. Higher adherence to MeD was associated with lower likelihood of ICI before (odds ratio [lsqb]OR[rsqb] 0.89; 95% confidence interval [lsqb]CI[rsqb] 0.79-1.00) and after adjustment for potential confounders (OR 0.87; 95% CI 0.76-1.00) including demographic characteristics, environmental factors, vascular risk factors, depressive symptoms, and self-reported health status. There was no interaction between race (p = 0.2928) and association of adherence to MeD with cognitive status. However, we identified a strong interaction of diabetes mellitus (p = 0.0134) on the relationship of adherence to MeD with ICI; high adherence to MeD was associated with a lower likelihood of ICI in nondiabetic participants (OR 0.81; 95% CI 0.70-0.94; p = 0.0066) but not in diabetic individuals (OR 1.27; 95% CI 0.95-1.71; p = 0.1063). CONCLUSIONS: Higher adherence to MeD was associated with a lower likelihood of ICI independent of potential confounders. This association was moderated by presence of diabetes mellitus.

Generic medications and blood pressure control in diabetic hypertensive subjects: results from the REasons for Geographic And Racial Differences in Stroke (REGARDS) study.

OBJECTIVE: To investigate temporal improvements in blood pressure (BP) control in subjects with diabetes and policy changes regarding generic antihypertensives. RESEARCH DESIGN AND METHODS: In a cross-sectional study we used logistic regression models to investigate the temporal relationship between access to generic antihypertensive medications and BP control (<130/80 mmHg) in 5,375 subjects (mean age, 66 ± 9 years; 61% African American) with diabetes and hypertension (HTN) enrolled in the national Results from the REasons for Geographic And Racial Differences in Stroke (REGARDS) cohort study between 2003 and 2007. At enrollment, BP was measured and medications in the home determined by medication label review by a trained professional. Generic antihypertensive medication status was ascertained from the U.S. Food and Drug Administration. RESULTS: The percentage of subjects accessing generically available antihypertensive medications increased significantly from 66% in 2003 to 81% in 2007 (P < 0.0001), and the odds of achieving a BP <130/80 mmHg in 2007 was 66% higher (odds ratio 1.66 [95% CI 1.30-2.10]) than in 2003. Nevertheless, <50% of participants achieved this goal. African American race, male sex, limited income, and medication nonadherence were significant predictors of inadequate BP control. There was no significant relationship between access to generic antihypertensives and BP control when other demographic factors were included in the model (0.98 [0.96-1.00]). CONCLUSIONS: Among African American and white subjects with HTN and diabetes, BP control remained inadequate relative to published guidelines, and racial disparities persisted. Although access to generic antihypertensives increased, this was not independently associated with improved BP control, suggesting that poor BP control is multifactorial.

High sodium:potassium intake ratio increases the risk for all-cause mortality: the REasons for Geographic And Racial Differences in Stroke (REGARDS) study.

Increased dietary Na intake and decreased dietary K intake are associated with higher blood pressure. It is not known whether the dietary Na:K ratio is associated with all-cause mortality or stroke incidence and whether this relationship varies according to race. Between 2003 and 2007, the REasons for Geographic And Racial Differences in Stroke (REGARDS) cohort enrolled 30 239 black and white Americans aged 45 years or older. Diet was assessed using the Block 98 FFQ and was available on 21 374 participants. The Na:K ratio was modelled in race- and sex-specific quintiles for all analyses, with the lowest quintile (Q1) as the reference group. Data on other covariates were collected using both an in-home assessment and telephone interviews. We identified 1779 deaths and 363 strokes over a mean of 4·9 years. We used Cox proportional hazards models to obtain multivariable-adjusted hazard ratios (HR). In the highest quintile (Q5), a high Na:K ratio was associated with all-cause mortality (Q5 v. Q1 for whites: HR 1·22; 95 % CI 1·00, 1·47, P for trend = 0·084; for blacks: HR 1·36; 95 % CI 1·04, 1·77, P for trend = 0·028). A high Na:K ratio was not significantly associated with stroke in whites (HR 1·29; 95 % CI 0·88, 1·90) or blacks (HR 1·39; 95 % CI 0·78, 2·48), partly because of the low number of stroke events. In the REGARDS study, a high Na:K ratio was associated with all-cause mortality and there was a suggestive association between the Na:K ratio and stroke. These data support the policies targeted at reduction of Na from the food supply and recommendations to increase K intake.