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Maron D.J.,Vanderbilt University | Hartigan P.M.,Veterans Affairs Cooperative Studies Program Coordinating Center | Neff D.R.,Sharp Corporation | Weintraub W.S.,Christiana Care Health System | Boden W.E.,Samuel ratton Veterans Affairs Medical Center
American Journal of Cardiology | Year: 2013

In the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) study, a revascularization strategy trial with optimal medical therapy in both arms, the low-density lipoprotein (LDL) cholesterol goal was 60 to 85 mg/dl; this was revised to <70 mg/dl in 2004. COURAGE patients (n = 2,287) were titrated with increasing statin doses to achieve the initial LDL cholesterol goal using a prespecified protocol. Ezetimibe was not available when study enrollment began in 1999 but became available after approval in 2003. After maximizing statin dose, ezetimibe was added to reach the LDL cholesterol goal in 34% of patients (n = 734). Median baseline LDL cholesterol was higher in patients who received ezetimibe than in those who did not (109 vs 96 mg/dl). At baseline, 18% of patients who would later receive ezetimibe had LDL cholesterol <85 mg/dl, and 8% had LDL cholesterol <70 mg/dl. On maximum tolerated statin (with or without other lipid-lowering drugs), 40% had LDL cholesterol <85 mg/dl and 23% had LDL cholesterol <70 mg/dl before starting ezetimibe. At the final study visit, 68% of ezetimibe patients achieved LDL cholesterol <85 mg/dl, and 46% achieved LDL cholesterol <70 mg/dl. Using Cox regression analysis, the most significant factors associated with achieving LDL cholesterol goals were lower baseline LDL cholesterol, average statin dose, and ezetimibe use. In conclusion, after maximizing statin dose, the addition of ezetimibe results in a substantial increase in the percentage of patients who reach LDL cholesterol goal, a key component of optimal medical therapy. © 2013 Published by Elsevier Inc. All rights. Source


Kaafarani H.M.A.,Tufts Medical Center | Kaufman D.,Veterans Affairs Cooperative Studies Program Coordinating Center | Reda D.,Veterans Affairs Cooperative Studies Program Coordinating Center | Itani K.M.F.,Veterans Affairs Boston Healthcare System | And 2 more authors.
Journal of Surgical Research | Year: 2010

Background: Surgical site infection (SSI) after ventral incisional hernia repair (VIH) can result in serious consequences. We sought to identify patient, procedure, and/or hernia characteristics that are associated with SSI in VIH. Methods: Between 2004 and 2006, patients were randomized in four Veteran Affairs (VA) hospitals to undergo laparoscopic or open VIH. Patients who developed SSI within eight weeks postoperatively were compared to those who did not. A bivariate analysis for each factor and a multiple logistic regression analysis were performed to determine factors associated with SSI. The variables studied included patient characteristics and co-morbidities (e.g., age, gender, race, ethnicity, body mass index, ASA classification, diabetes, steroid use), hernia characteristics (e.g., size, duration, number of previous incisions), procedure characteristics (e.g., open versus laparoscopic, blood loss, use of postoperative drains, operating room temperature) and surgeons' experience (resident training level, number of open VIH previously performed by the attending surgeon). Antibiotic prophylaxis, anticoagulation protocols, preparation of the skin, draping of the wound, body temperature control, and closure of the surgical site were all standardized and monitored throughout the study period. Results: Out of 145 patients who underwent VIH, 21 developed a SSI (14.5%). Patients who underwent open VIH had significantly more SSIs than those who underwent laparoscopic VIH (22.1% versus 3.4%; P = 0.002). Among patients who underwent open VIH, those who developed SSI had a recorded intraoperative blood loss greater than 25 mL (68.4% versus 40.3%; P = 0.030), were more likely to have a drain placed (79.0% versus 49.3%; P = 0.021) and were more likey to be operated on by surgeons with less than 75 open VIH case experience (52.6% versus 28.4%; P = 0.048). Patient and hernia characteristics were similar between the two groups. In a multiple logistic regression analysis, the open surgical technique was associated with SSI (OR 8.03, 95% CI 2.03, 31.72; P = 0.003) while controlling for the VA medical center where the procedure was performed (P = 0.041). Conclusion: Open surgical technique and the medical center rather than patient co-morbidities or hernia characteristics are associated with the formation of postoperative SSI in VIH. © 2010 Elsevier Inc. All rights reserved. Source


Mancini G.B.J.,University of British Columbia | Hartigan P.M.,Veterans Affairs Cooperative Studies Program Coordinating Center | Shaw L.J.,Emory University | Berman D.S.,University of California at Los Angeles | And 12 more authors.
JACC: Cardiovascular Interventions | Year: 2014

Objectives The aim of this study was to determine the relative utility of anatomic and ischemic burden of coronary artery disease for predicting outcomes. Background Both anatomic burden and ischemic burden of coronary artery disease determine patient prognosis and influence myocardial revascularization decisions. When both measures are available, their relative utility for prognostication and management choice is controversial. Methods A total of 621 patients enrolled in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial with baseline quantitative nuclear single-photon emission computed tomography (SPECT) and quantitative coronary angiography were studied. Several multiple regression models were constructed to determine independent predictors of the endpoint of death, myocardial infarction (MI) (excluding periprocedural MI) and non-ST-segment elevation acute coronary syndromes (NSTE-ACS). Ischemic burden during stress SPECT, anatomic burden derived from angiography, left ventricular ejection fraction, and assignment to either optimal medical therapy (OMT) + percutaneous coronary intervention (PCI) or OMT alone were analyzed. Results In nonadjusted and adjusted regression models, anatomic burden and left ventricular ejection fraction were consistent predictors of death, MI, and NSTE-ACS, whereas ischemic burden and treatment assignment were not. There was a marginal (p = 0.03) effect of the interaction term of anatomic and ischemic burden for the prediction of clinical outcome, but separately or in combination, neither anatomy nor ischemia interacted with therapeutic strategy to predict outcome. Conclusions In a cohort of patients treated with OMT, anatomic burden was a consistent predictor of death, MI, and NSTE-ACS, whereas ischemic burden was not. Importantly, neither determination, even in combination, identified a patient profile benefiting preferentially from an invasive therapeutic strategy. © 2014 by the American College of Cardiology Foundation. Source


Maron D.J.,Vanderbilt University | Boden W.E.,State University of New York at Buffalo | O'Rourke R.A.,South Texas Veterans Health Care System Audie Murphy Campus | Hartigan P.M.,Veterans Affairs Cooperative Studies Program Coordinating Center | And 20 more authors.
Journal of the American College of Cardiology | Year: 2010

Objectives: This paper describes the medical therapy used in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial and its effect on risk factors. Background: Most cardiovascular clinical trials test a single intervention. The COURAGE trial tested multiple lifestyle and pharmacologic interventions (optimal medical therapy) with or without percutaneous coronary intervention in patients with stable coronary disease. Methods: All patients, regardless of treatment assignment, received equivalent lifestyle and pharmacologic interventions for secondary prevention. Most medications were provided at no cost. Therapy was administered by nurse case managers according to protocols designed to achieve predefined lifestyle and risk factor goals. Results: The patients (n = 2,287) were followed for 4.6 years. There were no significant differences between treatment groups in proportion of patients achieving therapeutic goals. The proportion of smokers decreased from 23% to 19% (p = 0.025), those who reported <7% of calories from saturated fat increased from 46% to 80% (p < 0.001), and those who walked ≥150 min/week increased from 58% to 66% (p < 0.001). Body mass index increased from 28.8 ± 0.13 kg/m2 to 29.3 ± 0.23 kg/m2 (p < 0.001). Appropriate medication use increased from pre-randomization to 5 years as follows: antiplatelets 87% to 96%; beta-blockers 69% to 85%; renin-angiotensin-aldosterone system inhibitors 46% to 72%; and statins 64% to 93%. Systolic blood pressure decreased from a median of 131 ± 0.49 mm Hg to 123 ± 0.88 mm Hg. Low-density lipoprotein cholesterol decreased from a median of 101 ± 0.83 mg/dl to 72 ± 0.88 mg/dl. Conclusions: Secondary prevention was applied equally and intensively to both treatment groups in the COURAGE trial by nurse case managers with treatment protocols and resulted in significant improvement in risk factors. Optimal medical therapy in the COURAGE trial provides an effective model for secondary prevention among patients with chronic coronary disease. (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation; NCT00007657). © 2010 American College of Cardiology Foundation. Source


Maron D.J.,Vanderbilt University | Maron D.J.,Vanderbilt Heart and Vascular Institute | Boden W.E.,State University of New York at Buffalo | Spertus J.A.,University of Missouri - Kansas City | And 11 more authors.
Journal of the American College of Cardiology | Year: 2011

Objectives: Our purpose was to clarify the clinical utility of identifying metabolic syndrome (MetS) in patients with coronary artery disease (CAD). Background: It is uncertain whether MetS influences prognosis in patients with CAD and whether the risk associated with MetS exceeds the risk associated with the sum of its individual components. Methods: In a post hoc analysis, we compared the incidence of death or myocardial infarction (MI) in stable CAD patients in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial according to the presence (+) or absence (-) of MetS and diabetes: Group A, -MetS/-diabetes; Group B, +MetS/-diabetes; Group C, -MetS/+diabetes; and Group D, +MetS/+diabetes. We explored which MetS components best predicted adverse outcomes and whether MetS had independent prognostic significance beyond its individual components. Results: Of 2,248 patients, 61% had MetS and 34% diabetes. Risk for death or MI increased from Group A (14%) to Group D (25%, p < 0.001). Hypertension (hazard ratio [HR]: 1.30; 95% confidence interval [CI]: 0.98 to 1.71; p = 0.07), low high-density lipoprotein cholesterol (HR: 1.26; 95% CI: 1.03 to 1.55; p = 0.03), and elevated glucose (HR: 1.17; 95% CI: 0.96 to 1.47; p = 0.11) most strongly predicted death or MI. MetS was associated with an increased risk of death or MI (unadjusted HR: 1.41; 95% CI: 1.15 to 1.73; p = 0.001). However, after adjusting for its individual components, MetS was no longer significantly associated with outcome (HR: 1.15; 95% CI: 0.79 to 1.68; p = 0.46). Allocation to initial percutaneous coronary intervention did not affect the incidence of death or MI within any group. Conclusions: Among stable CAD patients in the COURAGE trial, the presence of MetS identified increased risk for death or MI, but MetS did not have independent prognostic significance after adjusting for its constituent components. The addition of early percutaneous coronary intervention to optimal medical therapy did not significantly reduce the risk of death or MI regardless of MetS or diabetes status. (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation [COURAGE]; NCT00007657) © 2011 American College of Cardiology Foundation. Source

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