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      Predictors of Long‐term Clinical Endpoints in Patients With Refractory Angina

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          Abstract

          Background

          Clinical outcomes in patients with refractory angina (RA) are poorly characterized and variably described. Using the Duke Database for Cardiovascular Disease (DDCD), we explored characteristics that drive clinical endpoints in patients with class II to IV angina stabilized on medical therapy.

          Methods and Results

          We explored clinical endpoints and associated costs of patients who underwent catheterization at Duke University Medical Center from 1997 to 2010 for evaluation of coronary artery disease (CAD) and were found to have advanced CAD ineligible for additional revascularization, and were clinically stable for a minimum of 60 days. Of 77 257 cardiac catheterizations performed, 1908 patients met entry criteria. The 3‐year incidence of death; cardiac rehospitalization; and a composite of death, myocardial infarction, stroke, cardiac rehospitalization, and revascularization were 13.0%, 43.5%, and 52.2%, respectively. Predictors of mortality included age, ejection fraction (EF), low body mass index, multivessel CAD, low heart rate, diabetes, diastolic blood pressure, history of coronary artery bypass graft surgery, cigarette smoking, history of congestive heart failure (CHF), and race. Multivessel CAD, EF<45%, and history of CHF increased risk of mortality; angina class and prior revascularization did not. Total rehospitalization costs over a 3‐year period per patient were $10 185 (95% CI 8458, 11912) in 2012 US dollars.

          Conclusions

          Clinically stable patients with RA who are medically managed have a modest mortality, but a high incidence of hospitalization and resource use over 3 years. These findings point to the need for novel therapies aimed at symptom mitigation in this population and their potential impact on health care utilization and costs.

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          Most cited references23

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          National and regional trends in heart failure hospitalization and mortality rates for Medicare beneficiaries, 1998-2008.

          It is not known whether recent declines in ischemic heart disease and its risk factors have been accompanied by declines in heart failure (HF) hospitalization and mortality. To examine changes in HF hospitalization rate and 1-year mortality rate in the United States, nationally and by state or territory. From acute care hospitals in the United States and Puerto Rico, 55,097,390 fee-for-service Medicare beneficiaries hospitalized between 1998 and 2008 with a principal discharge diagnosis code for HF. Changes in patient demographics and comorbidities, HF hospitalization rates, and 1-year mortality rates. The HF hospitalization rate adjusted for age, sex, and race declined from 2845 per 100,000 person-years in 1998 to 2007 per 100,000 person-years in 2008 (P < .001), a relative decline of 29.5%. Age-adjusted HF hospitalization rates declined over the study period for all race-sex categories. Black men had the lowest rate of decline (4142 to 3201 per 100,000 person-years) among all race-sex categories, which persisted after adjusting for age (incidence rate ratio, 0.81; 95% CI, 0.79-0.84). Heart failure hospitalization rates declined significantly faster than the national mean in 16 states and significantly slower in 3 states. Risk-adjusted 1-year mortality decreased from 31.7% in 1999 to 29.6% in 2008 (P < .001), a relative decline of 6.6%. One-year mortality rates declined significantly in 4 states but increased in 5 states. The overall HF hospitalization rate declined substantially from 1998 to 2008 but at a lower rate for black men. The overall 1-year mortality rate declined slightly over the past decade but remains high. Changes in HF hospitalization and 1-year mortality rates were uneven across states.
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            The problem of chronic refractory angina; report from the ESC Joint Study Group on the Treatment of Refractory Angina.

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              VEGF gene therapy fails to improve perfusion of ischemic myocardium in patients with advanced coronary disease: results of the NORTHERN trial.

              Despite the promise of proangiogenic gene therapy most clinical trials have failed to show benefit for the primary end point analysis. The NOGA angiogenesis Revascularization Therapy: assessment by RadioNuclide imaging (NORTHERN) trial was a double-blind, placebo-controlled study of intramyocardial vascular endothelial growth factor (VEGF165) gene therapy versus placebo, involving seven sites across Canada, designed to overcome major limitations of previous proangiogenic gene therapy trials. A total of 93 patients with refractory Canadian Cardiovascular Society (CCS) class 3 or 4 anginal symptoms were randomized to receive 2,000 microg of VEGF plasmid DNA or placebo (buffered saline) delivered via the endocardial route using an electroanatomical NOGA guidance catheter. There was no difference between the VEGF-treated and the placebo groups in the primary end point of change in myocardial perfusion from baseline to 3 or 6 months, assessed by single photon emission tomography (SPECT) imaging, although a significant reduction in the ischemic area was seen in both groups. Also, similar improvements in exercise treadmill time and anginal symptoms were seen in the VEGF and the placebo groups at 3 and 6 months, although again there were no differences between these groups. Despite the intramyocardial administration of a high "dose" of plasmid DNA using a percutaneous guidance catheter system, there was no benefit of VEGF gene therapy at 3 or 6 months for any of the end points studied.
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                Author and article information

                Journal
                J Am Heart Assoc
                J Am Heart Assoc
                ahaoa
                jah3
                Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
                Blackwell Publishing Ltd
                2047-9980
                February 2015
                30 January 2015
                : 4
                : 2
                : e001287
                Affiliations
                Duke Clinical Research Institute, Durham, NC (T.J.P., S.B., K.J.A., L.K.S., M.O., E.L.E., P.K.S., J.H.A.)
                Program for Advanced Coronary Disease, Duke Medicine, Durham, NC (M.O.)
                Author notes
                Correspondence to: Thomas J. Povsic, MD, PhD, Duke Clinical Research Institute, Duke Medicine, 2400 Pratt Street, Durham, NC 27705. E‐mail: thomas.povsic@ 123456duke.edu .
                Article
                jah3765
                10.1161/JAHA.114.001287
                4345862
                25637344
                a7f1c878-1132-4708-a9ed-28f126a323d6
                © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

                This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                : 28 July 2014
                : 19 October 2014
                Categories
                Original Research
                Coronary Heart Disease

                Cardiovascular Medicine
                angina,chronic ischemic heart disease,coronary artery disease,outcomes,refractory angina,resource use

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