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Longmore R.B.,University of Missouri - Kansas City | Yeh R.W.,Massachusetts General Hospital | Kennedy K.F.,University of Missouri - Kansas City | Anderson H.V.,University of Houston | And 5 more authors.
Circulation: Cardiovascular Interventions | Year: 2011

Background-Carotid artery stenting (CAS) and carotid endarterectomy (CEA) are alternative strategies for stroke prevention in patients with atherosclerotic carotid disease. Although randomized clinical trials are the gold standard for assessing the relative benefits of different treatments, observational research is necessary for determining "real-world" effectiveness. Current recommendations limit the application of CAS to high-risk patients, undermining the ability to "balance" the characteristics of patients treated with either approach. We compared the clinical profiles of patients referred for CAS versus CEA in a large national database. Methods and Results-Clinical characteristics of 12 701 patients referred for CAS or CEA in the National Cardiovascular Data Registry-Carotid Artery Revascularization and Endarterectomy were compared for 44 clinical and demographic variables. To investigate the comparability of CAS and CEA patients, we stratified the cohort into quintiles of the propensity score for referral for CAS. Among 8069 patients referred for CAS and 4632 referred for CEA, the CAS patients had significantly more comorbidities. Whereas the propensity model balanced most covariates, the pooled standardized differences (≥10%) suggested persistent imbalance for ischemic heart disease, recent myocardial infarction, and restenosis of prior CAS/CEA, all of which were more common in the CAS group. After stratification of propensity scores by quintile, CEA patients comprised only 14% of the upper 2 quintiles. Conclusions-Characteristics of patients referred for CAS differ markedly from those referred for CEA. Because of extreme clinical disparities between these patients, generalizable comparative effectiveness analyses of observational data will be difficult. © 2011 American Heart Association, Inc. Source

Vivo R.P.,University of Texas Medical Branch | Krim S.R.,Ochsner Heart and Vascular Institute | Krim N.R.,Montefiore Medical Center | Zhao X.,Duke Clinical Research Institute | And 6 more authors.
Circulation: Heart Failure | Year: 2012

Background-Although individuals of Hispanic ethnicity are at high risk for developing heart failure (HF), little is known about differences between Hispanic HF patients stratified by left ventricular ejection fraction (EF). We compared characteristics, quality of care, and outcomes between Hispanic and non-Hispanic white patients hospitalized for HF with preserved EF (PEF) or reduced EF (REF). Methods and Results-From 247 hospitals in Get With The Guidelines-Heart Failure between 2005-2010, 6117 Hispanics were compared with 71 859 non-Hispanic whites. Forty-six percent of Hispanics had PEF (EF>40%), whereas 54% had REF (EF<40%); 55% and 45% of non-Hispanic whites had PEF and REF, respectively. Relative to non-Hispanic whites, Hispanics with PEF or REF were more likely to be younger and to have diabetes, hypertension, and overweight/obesity. In multivariate analysis, a lower mortality risk was observed among Hispanics with PEF (odds ratio, 0.50; 95% confidence interval, 0.31- 0.81; P<0.005) but not in Hispanics with REF (odds ratio, 0.94; 95% confidence interval, 0.62-1.43; P<0.784) compared with non-Hispanic whites. In all groups, composite performance improved within the study period (Hispanics PEF: 75.2-95.1%; non-Hispanic whites PEF: 79.0 -92.7%; Hispanics REF: 67.7- 88.4%; non-Hispanic whites REF: 60.8 - 85.6%, P<0.0001). Conclusions-Hispanic HF patients with PEF had better in-hospital survival than non-Hispanic whites with PEF. Inpatient mortality was similar between groups with REF. Quality of care was similar and improved over time irrespective of ethnicity, highlighting the potential benefit of performance improvement programs in promoting equitable care. © 2012 American Heart Association, Inc. Source

Subherwal S.,Duke University | Patel M.R.,Duke University | Chiswell K.,Duke University | Tidemann-Miller B.A.,Duke University | And 9 more authors.
Circulation | Year: 2014

Background-Tremendous advances have occurred in therapies for peripheral vascular disease (PVD); until recently, however, it has not been possible to examine the entire clinical trial portfolio of studies for the treatment of PVD (both arterial and venous disease). Methods and Results-We examined interventional trials registered in ClinicalTrials.gov from October 2007 through September 2010 (n=40 970) and identified 676 (1.7%) PVD trials (n=493 arterial only, n=170 venous only, n=13 both arterial and venous). Most arterial studies investigated lower-extremity peripheral artery disease and acute stroke (35% and 24%, respectively), whereas most venous studies examined deep vein thrombosis/pulmonary embolus prevention (42%) or venous ulceration (25%). A placebo-controlled trial design was used in 27% of the PVD trials, and 4% of the PVD trials excluded patients >65 years of age. Enrollment in at least 1 US site decreased from 51% of trials in 2007 to 41% in 2010. Compared with noncardiology disciplines, PVD trials were more likely to be double-blinded, to investigate the use of devices and procedures, and to have industry sponsorship and assumed funding source, and they were less likely to investigate drug and behavioral therapies. Geographic access to PVD clinical trials within the United States is limited to primarily large metropolitan areas. Conclusions-PVD studies represent a small group of trials registered in ClinicalTrials.gov, despite the high prevalence of vascular disease in the general population. This low number, compounded by the decreasing number of PVD trials in the United States, is concerning and may limit the ability to inform current clinical practice of patients with PVD. © 2014 American Heart Association, Inc. Source

Nedeltchev K.,Triemli Hospital | Pattynama P.M.,Erasmus Medical Center | Biaminoo G.,Gruppo Villa Maria Endovascular | Diehm N.,University of Bern | And 6 more authors.
Catheterization and Cardiovascular Interventions | Year: 2010

Background: Endovascular therapy has emerged as a promising alternative to open surgery for stroke prevention in patients with obstructive disease of the supra-aortic arteries. Although most previous studies have used similar safety and efficacy endpoints, differences in definitions, timing of assessments, and standards of reporting have hampered direct comparisons across various trials. Methods and results: The DEFINE group, an informal collaboration of multidisciplinary physicians, involved in the therapy of patients with obstructive disease of the supra-aortic arteries in Europe and the United States reviewed the current literature and, after extensive correspondence and meetings, proposed the definitions outlined in the present manuscript. Three meetings including all authors of the manuscript, along with representatives of the United States Food and Drug Administration (FDA) and commercial device manufacturers were held in Barcelona, Spain, in May 2008, in Munich, Germany, in July 2008, and in New York in November 2008. The proposed definitions encompass baseline clinical and anatomic characteristics, clinical and radiologic outcomes, complications, standards of reporting, and timing of assessment. Conclusions: Considering the broad consensus between the multidisciplinary scientific members and the regulatory authorities, the proposed definitions are expected to find adoption in future clinical investigations. These definitions can be applied to both endovascular and open surgery trials and will allow reliable comparisons between these two revascularization methods. © 2010 Wiley-Liss, Inc. Source

Vivo R.P.,University of California at Los Angeles | Krim S.R.,Ochsner Heart and Vascular Institute | Liang L.,Duke Clinical Research Institute | Neely M.,Duke Clinical Research Institute | And 7 more authors.
Journal of the American Heart Association | Year: 2014

Background-The degree to which outcomes following hospitalization for acute heart failure (HF) vary by racial and ethnic groups is poorly characterized. We sought to compare 30-day and 1-year rehospitalization and mortality rates for HF among 4 race/ethnic groups. Methods and Results-Using the Get With The Guidelines-HF registry linked with Medicare data, we compared 30-day and 1-year outcomes between racial/ethnic groups by using a multivariable Cox proportional hazards model adjusting for clinical, hospital, and socioeconomic status characteristics. We analyzed 47 149 Medicare patients aged ≥65 years who had been discharged for HF between 2005 and 2011: there were 39 213 whites (83.2%), 4946 blacks (10.5%), 2347 Hispanics (5.0%), and 643 Asians/Pacific Islanders (1.4%). Relative to whites, blacks and Hispanics had higher 30-day and 1-year unadjusted readmission rates but lower 30-day and 1-year mortality; Asians had similar 30-day readmission rates but lower 1-year mortality. After risk adjustment, blacks had higher 30-day and 1-year CV readmission than whites but modestly lower short- and long-term mortality; Hispanics had higher 30-day and 1-year readmission rates and similar 1-year mortality than whites, while Asians had similar outcomes. When socioeconomic status data were added to the model, the majority of associations persisted, but the difference in 30-day and 1-year readmission rates between white and Hispanic patients became nonsignificant. Conclusions-Among Medicare patients hospitalized with HF, short- and long-term readmission rates and mortality differed among the 4 major racial/ethnic populations and persisted even after controlling for clinical, hospital, and socioeconomic status variables. © 2014 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell. Source

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