Coronary Artery Disease: Spertus JA

Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA. · Duke University Medical Center, Durham, NC, USA. · Circulation. · Pubmed #19131581 No free full text.

Abstract: The American College of Cardiology Foundation (ACCF), Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, and the American Association for Thoracic Surgery, along with key specialty and subspecialty societies, conducted an appropriateness review of common clinical scenarios in which coronary revascularization is frequently considered. The clinical scenarios were developed to mimic common situations encountered in everyday practice and included information on symptom status, extent of medical therapy, risk level as assessed by noninvasive testing, and coronary anatomy. Approximately 180 clinical scenarios were developed by a writing committee and scored by a separate technical panel on a scale of 1 to 9. Scores of 7 to 9 indicate that revascularization was considered appropriate and likely to improve health outcomes or survival. Scores of 1 to 3 indicate revascularization was considered inappropriate and unlikely to improve health outcomes or survival. The mid range (4 to 6) indicates a clinical scenario for which the likelihood that coronary revascularization would improve health outcomes or survival was considered uncertain. For the majority of the clinical scenarios, the panel only considered the appropriateness of revascularization irrespective of whether this was accomplished by percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG). In a select subgroup of clinical scenarios in which revascularization is generally considered appropriate, the appropriateness of PCI and CABG individually as the primary mode of revascularization was considered. In general, the use of coronary revascularization for patients with acute coronary syndromes and combinations of significant symptoms and/or ischemia was viewed favorably. In contrast, revascularization of asymptomatic patients or patients with low-risk findings on noninvasive testing and minimal medical therapy were viewed less favorably. It is anticipated that these results will have an impact on physician decision making and patient education regarding expected benefits from revascularization and will help guide future research.

Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA, Masoudi FA, Brindis RG, Beckman KJ, Chambers CE, Ferguson TB, Garcia MJ, Grover FL, Holmes DR, Klein LW, Limacher M, Mack MJ, Malenka DJ, Park MH, Ragosta M, Ritchie JL, Rose GA, Rosenberg AB, Shemin RJ, Weintraub WS, Wolk MJ, Allen JM, Douglas PS, Hendel RC, Peterson ED. · Division of Cardiology, Duke University Medical Center, Durham, NC, USA. · Catheter Cardiovasc Interv. · Pubmed #19127535 No free full text.

Abstract: The American College of Cardiology Foundation (ACCF), Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, and the American Association for Thoracic Surgery, along with key specialty and subspecialty societies, conducted an appropriateness review of common clinical scenarios in which coronary revascularization is frequently considered. The clinical scenarios were developed to mimic common situations encountered in everyday practice and included information on symptom status, extent of medical therapy, risk level as assessed by noninvasive testing, and coronary anatomy. Approximately 180 clinical scenarios were developed by a writing committee and scored by a separate technical panel on a scale of 1 to 9. Scores of 7 to 9 indicate that revascularization was considered appropriate and likely to improve health outcomes or survival. Scores of 1 to 3 indicate revascularization was considered inappropriate and unlikely to improve health outcomes or survival. The mid range (4 to 6) indicates a clinical scenario for which the likelihood that coronary revascularization would improve health outcomes or survival was considered uncertain. For the majority of the clinical scenarios, the panel only considered the appropriateness of revascularization irrespective of whether this was accomplished by percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG). In a select subgroup of clinical scenarios in which revascularization is generally considered appropriate, the appropriateness of PCI and CABG individually as the primary mode of revascularization was considered. In general, the use of coronary revascularization for patients with acute coronary syndromes and combinations of significant symptoms and/or ischemia was viewed favorably. In contrast, revascularization of asymptomatic patients or patients with low-risk findings on noninvasive testing and minimal medical therapy were viewed less favorably. It is anticipated that these results will have an impact on physician decision making and patient education regarding expected benefits from revascularization and will help guide future research.

Douglas PS, Khandheria B, Stainback RF, Weissman NJ, Peterson ED, Hendel RC, Stainback RF, Blaivas M, Des Prez RD, Gillam LD, Golash T, Hiratzka LF, Kussmaul WG, Labovitz AJ, Lindenfeld J, Masoudi FA, Mayo PH, Porembka D, Spertus JA, Wann LS, Wiegers SE, Brindis RG, Douglas PS, Hendel RC, Patel MR, Peterson ED, Wolk MJ, Allen JM, Anonymous00094, Anonymous00095, Anonymous00096, Anonymous00097, Anonymous00098, Anonymous00099, Anonymous00100, Anonymous00101. · No affiliation provided · J Am Coll Cardiol. · Pubmed #18342240 No free full text.

Abstract: The American College of Cardiology Foundation (ACCF) and the American Society of Echocardiography (ASE) together with key specialty and subspecialty societies, conducted an appropriateness review for stress echocardiography. The review assessed the risks and benefits of stress echocardiography for several indications or clinical scenarios and scored them on a scale of 1 to 9 (based upon methodology developed by the ACCF to assess imaging appropriateness). The upper range (7 to 9) implies that the test is generally acceptable and is a reasonable approach, and the lower range (1 to 3) implies that the test is generally not acceptable and is not a reasonable approach. The midrange (4 to 6) indicates a clinical scenario for which the indication for a stress echocardiogram is uncertain. The indications for this review were drawn from common applications or anticipated uses, as well as from current clinical practice guidelines. Use of stress echocardiography for risk assessment in patients with coronary artery disease (CAD) was viewed favorably, while routine repeat testing and general screening in certain clinical scenarios were viewed less favorably. It is anticipated that these results will have a significant impact on physician decision making and performance, reimbursement policy, and will help guide future research.

Douglas PS, Khandheria B, Stainback RF, Weissman NJ, Peterson ED, Hendel RC, Stainback RF, Blaivas M, Des Prez RD, Gillam LD, Golash T, Hiratzka LF, Kussmaul WG, Labovitz AJ, Lindenfeld J, Masoudi FA, Mayo PH, Porembka D, Spertus JA, Wann LS, Wiegers SE, Brindis RG, Douglas PS, Patel MR, Wolk MJ, Allen JM, Anonymous00125, Anonymous00126, Anonymous00127, Anonymous00128, Anonymous00129, Anonymous00130, Anonymous00131, Anonymous00132. · Duke University Medical Center, Durham, NC, USA. · Circulation. · Pubmed #18316491 links to  free full text

Abstract: The American College of Cardiology Foundation (ACCF) and the American Society of Echocardiography (ASE) together with key specialty and subspecialty societies, conducted an appropriateness review for stress echocardiography. The review assessed the risks and benefits of stress echocardiography for several indications or clinical scenarios and scored them on a scale of 1 to 9 (based upon methodology developed by the ACCF to assess imaging appropriateness). The upper range (7 to 9) implies that the test is generally acceptable and is a reasonable approach, and the lower range (1 to 3) implies that the test is generally not acceptable and is not a reasonable approach. The midrange (4 to 6) indicates a clinical scenario for which the indication for a stress echocardiogram is uncertain. The indications for this review were drawn from common applications or anticipated uses, as well as from current clinical practice guidelines. Use of stress echocardiography for risk assessment in patients with coronary artery disease (CAD) was viewed favorably, while routine repeat testing and general screening in certain clinical scenarios were viewed less favorably. It is anticipated that these results will have a significant impact on physician decision making and performance, reimbursement policy, and will help guide future research.

Douglas PS, Khandheria B, Stainback RF, Weissman NJ, Peterson ED, Hendel RC, Stainback RF, Blaivas M, Des Prez RD, Gillam LD, Golash T, Hiratzka LF, Kussmaul WG, Labovitz AJ, Lindenfeld J, Masoudi FA, Mayo PH, Porembka D, Spertus JA, Wann LS, Wiegers SE, Brindis RG, Douglas PS, Hendel RC, Patel MR, Peterson ED, Wolk MJ, Allen JM, Anonymous00137, Anonymous00138, Anonymous00139, Anonymous00140, Anonymous00141, Anonymous00142, Anonymous00143, Anonymous00144, Anonymous00145, Anonymous00146. · Duke University Medical Center, Durham, NC, USA. · Catheter Cardiovasc Interv. · Pubmed #18314889 No free full text.

Abstract: The American College of Cardiology Foundation (ACCF) and the American Society of Echocardiography (ASE) together with key specialty and subspecialty societies, conducted an appropriateness review for stress echocardiography. The review assessed the risks and benefits of stress echocardiography for several indications or clinical scenarios and scored them on a scale of 1 to 9 (based upon methodology developed by the ACCF to assess imaging appropriateness). The upper range (7 to 9) implies that the test is generally acceptable and is a reasonable approach, and the lower range (1 to 3) implies that the test is generally not acceptable and is not a reasonable approach. The midrange (4 to 6) indicates a clinical scenario for which the indication for a stress echocardiogram is uncertain.The indications for this review were drawn from common applications or anticipated uses, as well as from current clinical practice guidelines. Use of stress echocardiography for risk assessment in patients with coronary artery disease (CAD) was viewed favorably, while routine repeat testing and general screening in certain clinical scenarios were viewed less favorably. It is anticipated that these results will have a significant impact on physician decision making and performance, reimbursement policy, and will help guide future research.

Mommersteeg PM, Denollet J, Spertus JA, Pedersen SS. · Center of Research on Psychology in Somatic Diseases, Tilburg University, The Netherlands. · Am Heart J. · Pubmed #19185627 No free full text.

Abstract: BACKGROUND: Patient-perceived health status is receiving increased recognition as a patient-centered outcome in chronic heart failure (CHF) and coronary artery disease (CAD), but poor health status is also associated with adverse prognosis. In this systematic review, we examined current evidence on the influence of health status on prognosis in CHF and CAD. METHODS: We conducted a search of PubMed using a set of a priori-defined search terms, the Web of Science for newly cited articles, and the reference lists of eligible articles, resulting in 34 articles. RESULTS: Poor physical health status was a significant predictor for adverse health outcomes in patients with CHF and CAD. In CHF, poor physical health status seemed to be a stronger predictor of hospitalization than mortality. Little evidence was found that poor mental health status is associated with adverse prognosis in CHF and CAD. A disease-specific measure was a better predictor in CHF, but not in CAD. The majority of studies adjusted for an objective measure of disease severity. Neither the index event nor time to follow-up appeared to influence the predictive value of health status. CONCLUSIONS: Poor physical health status is associated with adverse CAD and CHF prognosis. Heterogeneity across studies makes definitive conclusions difficult as to which components of health status may be detrimental to patients' health, and how health status as a potential risk factor should be assessed, monitored, and intervened upon in clinical practice.

Wyrwich KW, Spertus JA, Kroenke K, Tierney WM, Babu AN, Wolinsky FD, Anonymous00052. · Department of Research Methodology, Saint Louis University, St Louis, MO 63103, USA. · Am Heart J. · Pubmed #15077075 No free full text.

Abstract: BACKGROUND: The purpose of the study was to develop clinically important difference (CID) standards for patients with coronary artery disease and congestive heart failure that identify small, moderate, and large intraindividual changes with time in a modified version of the Chronic Heart Failure Questionnaire (CHQ) and the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36, version 2). Prior work in ascertaining important difference standards for the CHQ have centered on patient-perceived changes. No important difference standards for the SF-36 have been published for patients with heart disease. This development of CIDs would facilitate the use of health status measures in daily clinical decision-making. METHODS: We used a modification of the RAND Appropriateness Method to assemble and guide a 9-member consensus panel of physicians with substantial experience in using the CHQ or the SF-36 among patients with heart disease. RESULTS: On the basis of their own experience using these measures and an extensive review of articles describing the development and use of these instruments, the expert panel achieved consensus on small, medium, and large clinically relevant changes in scores for the CHQ and SF-36. The CID standards established by this panel were slightly higher than the minimal important difference standards previously established for the CHQ using patient-perceived changes. CONCLUSIONS: The CID standards established by this expert panel provide an important and useful tool for determining whether routine clinical health status assessments will benefit patients and enhance physicians' decision-making capacity in clinical settings.

Zhang Z, Weintraub WS, Mahoney EM, Spertus JA, Booth J, Nugara F, Stables RH, Vaccarino V. · Department of Medicine, Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia 30306, USA. · Am J Cardiol. · Pubmed #14969611 No free full text.

Abstract: Information on the relative benefit of coronary artery bypass grafting (CABG) versus stent-assisted percutaneous coronary intervention (PCI) for improvement of cardiac-related health status in women and how it compares with men is limited. The Stent or Surgery trial compared randomly assigned CABG and stent-assisted PCI in 206 women and 782 men with multivessel disease. We examined longitudinal changes at 6 and 12 months from baseline by gender and treatment in 3 subscales of the Seattle Angina Questionnaire (SAQ): physical limitation, angina frequency, and quality of life. At the time of revascularization, women were older, more severely ill, and tended to have lower SAQ scores than men. At 6 months, SAQ scores after both procedures improved significantly in both genders, with greater improvement achieved with CABG. After adjustment for other factors, in men, CABG was associated with a 54.7% greater improvement in physical limitation compared with PCI, 31.3% greater improvement in angina frequency, and 18.3% greater improvement in quality of life. In women, these relative differences were 11.6%, 43.2%, and 39.3%, respectively. At 1 year, men continued to show greater improvement with CABG in all 3 dimensions (50.6%, 19.7%, and 15.3%, respectively), but in women the relative differences decreased substantially (1.6%, 11.1%, and 0.6%, respectively) due to a greater later improvement after PCI (p = 0.049 for the interaction among treatment, gender, and follow-up for the quality of life domain). Although CABG may be superior to PCI in men, in women, at 1 year after intervention, both procedures appear equally effective.

Zhang Z, Mahoney EM, Stables RH, Booth J, Nugara F, Spertus JA, Weintraub WS. · Division of Cardiology, Emory University School of Medicine, Atlanta, Ga 30306, USA. · Circulation. · Pubmed #12975252 links to  free full text

Abstract: BACKGROUND: Functional status and quality of life are important outcomes in the evaluation of revascularization approaches for symptomatic coronary artery disease. Few data are available regarding the comparative improvement in disease-specific health status after CABG versus percutaneous coronary intervention (PCI) in the era of coronary stenting. METHODS AND RESULTS: Cardiac-specific health status was evaluated at baseline and at 6 and 12 months after intervention with the Seattle Angina Questionnaire (SAQ) in patients randomized to stent-assisted PCI (n=488) versus CABG (n=500) in the Stent or Surgery trial. Scores for physical limitation, angina frequency, and quality of life improved significantly for both treatment groups at 6 months (range of improvement from 13.6 to 34.7 points) and 12 months (14.3 to 38.2 points; all P<0.001). CABG patients had greater improvement than those assigned to PCI, although the magnitude of the difference decreased over time (difference at 6 months, 4.03 to 6.48 points; 12 months, 2.05 to 2.93 points). A component of this reduction is accounted for by PCI-arm patients who required repeat intervention. Differences between treatment groups were greatest for the 6-month angina frequency scores (difference=6.48 points; 95% CI 3.96 to 8.99). Overall, treatment satisfaction was high and did not differ significantly between groups. CONCLUSIONS: Both CABG and stent-assisted PCI dramatically improved cardiac-related health status in patients with multivessel disease at 6- and 12-month follow-up. During the first postprocedure year, patients' angina burden and physical limitations were alleviated to a greater extent with CABG.

Borkon AM, Muehlebach GF, House J, Marso SP, Spertus JA. · Mid America Heart Institute, Kansas City, Missouri, USA. · Ann Thorac Surg. · Pubmed #12440603 No free full text.

Abstract: BACKGROUND: Selection of the optimum mode of coronary revascularization should not only be directed by technical outcomes, but should also consider patients' postprocedural health status, including symptoms, functionality, and quality of life. METHODS: Health status was analyzed and compared after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) using the Seattle Angina Questionnaire (SAQ). The SAQ was administered to 475 patients (252 PCI and 223 CABG) preprocedure and then monthly for 6 months and again at 1 year. Differences in baseline characteristics were controlled by multivariable risk adjustment, and outcomes over time were compared using repeated-measures analysis of variance. RESULTS: In-hospital, 6-and 12-month clinical outcomes were not different; however, 25% of PCI patients required at least one reintervention during the study period, compared with only 1% of CABG patients (p < 0.001). Although physical function decreased for CABG patients at 1 month (p < 0.001), it improved and was better than the PCI group by 12 months (p = 0.008). Relief of angina was greater for CABG than PCI when analyzed over time (p < 0.001), principally due to the adverse effects of restenosis in the PCI group. Multivariable analysis confirmed that CABG independently conferred greater angina relief compared with PCI (p < 0.001). At 12 months postprocedure, quality of life had improved to a greater extent for CABG than PCI (p = 0.004). CONCLUSIONS: Over 12 months of follow-up, health status was improved to a greater extent for CABG patients than for PCI patients, primarily due to the adverse influence of restenosis after PCI.

Spertus JA, Dewhurst TA, Dougherty CM, Nichol P, McDonell M, Bliven B, Fihn SD. · Department of Medicine, Section of Cardiology, Mid America Heart Institute, University of Missouri, Kansas City, Mo 64111, USA. · Am Heart J. · Pubmed #11773925 No free full text.

Abstract: OBJECTIVE: Our purpose was to determine the efficacy of health status measurement in quantifying improvements in quality of care provided by an "angina clinic." STUDY DESIGN: In a pretest-posttest, nonequivalent control group design in the outpatient clinics of a Veterans Affairs Medical Center, 535 patients with coronary disease were followed up, without intervention, for 3 months and were defined as the "usual-care" group. Concurrently, a clinical trial that optimized the antianginal medications of 100 patients with chronic, stable coronary disease was conducted and defined as the "angina clinic" group. The 3-month change in scores for the Seattle Angina Questionnaire, a valid, reliable, and responsive disease-specific health status measure for patients with coronary disease, was used as the main outcome measure. RESULTS: After baseline differences between groups were controlled, the "angina clinic" conferred substantial improvement on patient symptom control (3-month benefit in angina frequency +9.4, P <.001; in angina stability +14.7, P <.001), treatment satisfaction (+8.6, P <.001), quality of life (+6.8, P <.001), and physical limitations resulting from coronary disease (+3.6, P =.047). Only the changes in physical limitation were not clinically significant. CONCLUSION: Disease-specific health status measures can provide valuable insights into the quality of care associated with innovations in health care delivery. These results suggest that patients in a clinical trial optimizing antianginal medications had greater improvements in symptom control, treatment satisfaction, and quality of life compared with similar patients receiving "usual care" in a general medicine clinic.

Spertus JA, Jones PG, Coen M, Garg M, Bliven B, O'Keefe J, March RJ, Horvath K. · Section of Cardiology, Mid America Heart Institute/University of Missouri--Kansas City 64111, USA. · Am J Med. · Pubmed #11583635 No free full text.

Abstract: PURPOSE: To describe differences in health status (symptoms, physical function, and quality of life) between continued medical management and transmyocardial revascularization with a carbon dioxide laser in patients with severe, symptomatic, inoperable coronary artery disease. SUBJECTS AND METHODS: This prospective, multicenter trial randomized 98 patients to transmyocardial revascularization and 99 to continued medical therapy. Health status was assessed with the Seattle Angina Questionnaire and the Short Form-36 at baseline and at 3, 6, and 12 months. A new analytic technique, the benefit statistic, was developed to facilitate interpretability of disease-specific health status assessments over time. RESULTS: Of the 99 patients assigned to medical therapy, 59 (60%) subsequently underwent transmyocardial revascularization. By an intention-to-treat analysis, patients initially randomized to transmyocardial revascularization had 44% of their angina eliminated versus 21% for the medical treatment group (difference = 23%; 95% confidence interval [CI], 11% to 34%). Differences in the benefits of transmyocardial revascularization on physical limitations (33% vs 11% in the medical arm [difference = 23%; 95% CI, 15% to 31%]) and quality of life (47% vs 20% in the medical arm [difference = 26%; 95% CI, 18% to 35%]) were similarly large. These benefits were apparent at 3 months and sustained throughout the 1 year of follow-up. An efficacy analysis that excluded patients who crossed over from the medical treatment to transmyocardial revascularization arm suggested greater treatment benefits. CONCLUSIONS: Transmyocardial revascularization may offer a valuable palliative alternative to patients with severe limitations in health status for whom no standard revascularization options exist.

Spertus JA, Dewhurst T, Dougherty CM, Nichol P. · Department of Cardiology, University of Missouri-Kansas City School of Medicine, Kansas City, MO 64111, USA. · Am Heart J. · Pubmed #11275919 No free full text.

Abstract: OBJECTIVE: Our purpose was to test the hypothesis that converting patients with stable angina to long-acting antianginal medications would improve their functional status, symptom control, treatment satisfaction, and quality of life. METHODS AND RESULTS: A single-blind randomized trial of 100 patients with stable coronary artery disease was performed in the outpatient clinic of a Veterans Affairs Health System. Outpatients with chronic stable angina taking at least 2 antianginal medications were studied. Patients were randomized to one of two treatments: optimal adjustment of their usual antianginal medications or conversion to solely long-acting medications (long-acting diltiazem +/- nitroglycerin patches +/- atenolol) with subsequent optimization. The primary outcome was the 3-month change in Seattle Angina Questionnaire scores. Although no differences in physical limitation scores were noted, patients randomized to receive long-acting medications had improved symptom control (3-month improvement in anginal stability [19.1 vs 5.6, P =.02] and anginal frequency [17.8 vs 5.5, P =.006]), more treatment satisfaction (3-month improvement of 8.2 vs 3.0, P =.057), and better quality of life (3-month improvement of 11.2 vs 5.6, P =.09) compared with patients whose pretrial medications were optimized. The improvement in symptom control was statistically significant. CONCLUSION: Converting patients with chronic, stable angina to long-acting antianginal medications resulted in substantial improvements in symptom control with a trend toward better treatment satisfaction and quality of life.

Boden WE, O'Rourke RA, Teo KK, Maron DJ, Hartigan PM, Sedlis SP, Dada M, Labedi M, Spertus JA, Kostuk WJ, Berman DS, Shaw LJ, Chaitman BR, Mancini GB, Weintraub WS, Anonymous00061. · VA Western New York Health Care System, Buffalo General Hospital, and the University at Buffalo, Buffalo, NY, USA. · Am J Cardiol. · Pubmed #19576311 No free full text.

Abstract: The main results of the Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial revealed no significant differences in the primary end point of all-cause mortality or nonfatal myocardial infarction [MI] or major secondary end points (composites of death/MI/stroke; hospitalization for acute coronary syndromes [ACSs]) during a median 4.6-year follow-up in 2,287 patients with stable coronary artery disease randomized to optimal medical therapy (OMT) with or without percutaneous coronary intervention (PCI). We sought to assess the impact of PCI when added to OMT on major prespecified tertiary cardiovascular outcomes (time to first event), namely cardiac death and composites of cardiac death/MI, cardiac death/MI/hospitalization for ACS, cardiac death/MI/stroke, MI/stroke, or cardiac death/MI/ACS/stroke, during study follow-up. There were no significant differences between treatment arms for the composite of cardiac death or MI (15% in PCI + OMT group vs 14.2% in OMT group, hazard ratio 1.07, 95% confidence interval 0.86 to 1.33, p = 0.62) or in any of the major prespecified composite cardiovascular events during long-term follow-up, even after excluding periprocedural MI as an outcome of interest. Overall, cause-specific cardiovascular outcomes paralleled closely the primary and secondary composite outcomes of the trial as a whole. In conclusion, compared with an initial management strategy of OMT alone, addition of PCI did not decrease the incidence of major cardiovascular outcomes including cardiac death or the composite of cardiac death/MI/ACS/stroke in patients with stable coronary artery disease.

Arnold SV, Spertus JA, Jones PG, Xiao L, Cohen DJ. · Saint Luke's Mid America Heart Institute, Kansas City, MO, USA. · Am Heart J. · Pubmed #19464415 No free full text.

Abstract: BACKGROUND: Both angina and dyspnea are prevalent symptoms among post-myocardial infarction (MI) patients. Given their frequent overlap, little is known about the degree to which these symptoms provide independent information in this population. METHODS: Using the multicenter Prospective Registry Evaluating Myocardial Infarction: Events and Recovery (PREMIER), 1,835 patients were administered the Rose Dyspnea Scale (scores range 0-4; higher scores indicate worse dyspnea), Seattle Angina Questionnaire (SAQ; lower scores indicate worse angina), and 12-item Short Form physical component (PCS; lower scores indicate worse physical health status) at 1 and 12 months post-MI. Multivariable regression was used to examine the association between dyspnea and quality of life (QOL) in both cross-sectional and longitudinal analyses as well as its association with rehospitalizations and mortality. RESULTS: At 1-month follow-up, 863 patients (47%) reported dyspnea, and 340 (19%) noted moderate to severe dyspnea. After adjusting for sociodemographic and clinical factors including SAQ angina frequency, higher dyspnea scores remained strongly associated with worse QOL in both cross-sectional (1-U dyspnea increase = 2.5-point PCS decrease and 2.4-point SAQ QOL decrease) and longitudinal analyses (1-U dyspnea increase from 1 month to 1 year = 3.8-point PCS decrease and 3.5-point SAQ QOL decrease), and with increased risk of 1-year rehospitalization (hazard ratio 1.15/1 U of dyspnea, 95% CI 1.07-1.24) and 3-year mortality (hazard ratio 1.34/1 U of dyspnea, 95% CI 1.19-1.51; P < .001 for all analyses). CONCLUSIONS: Among post-MI patients, dyspnea is common and strongly associated with impaired QOL, more frequent rehospitalization, and reduced survival--independent of both clinical factors and angina. These findings suggest that dyspnea is an important component of disease-specific health status for post-MI patients, and its assessment should be strongly considered in both research studies and clinical practice.

Wang TY, Xiao L, Alexander KP, Rao SV, Kosiborod MN, Rumsfeld JS, Spertus JA, Peterson ED. · Duke Clinical Research Institute, 2400 Pratt St, Room 0311, Terrace Level, Durham, NC 27705, USA. · Circulation. · Pubmed #18981304 No free full text.

Abstract: BACKGROUND: Bleeding among patients with acute myocardial infarction (AMI) is associated with worse long-term outcomes. Although the mechanism underlying this association is unclear, a potential explanation is that withholding antiplatelet therapies long beyond resolution of the bleeding event may contribute to recurrent events. METHODS AND RESULTS: We examined medication use at discharge, 1, 6, and 12 months after AMI among 2498 patients in the Prospective Registry Evaluating Myocardial Infarction: Events and Recovery (PREMIER) registry. Bleeding was defined as non-coronary artery bypass graft-related Thrombolysis of Myocardial Infarction major/minor bleeding or transfusion among patients with baseline hematocrit > or =28%. Logistic regression was used to evaluate the association between bleeding during the index AMI hospitalization and medication use. In-hospital bleeding occurred in 301 patients (12%) with AMI. Patients with in-hospital bleeding were less likely to be discharged on aspirin or thienopyridine (adjusted odds ratio=0.45; 95% CI, 0.31 to 0.64; and odds ratio=0.62; 95% CI, 0.42 to 0.91, respectively). At 1 month after discharge, although patients with in-hospital bleeding remained significantly less likely to receive aspirin (odds ratio=0.68; 95% CI, 0.50 to 0.92), use of thienopyridines in the 2 groups started to become similar. By 1 year, antiplatelet therapy use was similar among patients with and without bleeding. Postdischarge cardiology follow-up was associated with greater antiplatelet therapy use than either primary care or no clinical follow-up. CONCLUSIONS: Patients whose index AMI is complicated by bleeding are less likely to be treated with antiplatelet therapies during the first 6 months after discharge. Early reassessment of antiplatelet eligibility may represent an opportunity to reduce the long-term risk of adverse outcomes associated with bleeding.

Weintraub WS, Spertus JA, Kolm P, Maron DJ, Zhang Z, Jurkovitz C, Zhang W, Hartigan PM, Lewis C, Veledar E, Bowen J, Dunbar SB, Deaton C, Kaufman S, O'Rourke RA, Goeree R, Barnett PG, Teo KK, Boden WE, Anonymous00069, Mancini GB. · Christiana Care Health System, Newark, DE 19718, USA. · N Engl J Med. · Pubmed #18703470 links to  free full text

Abstract: BACKGROUND: It has not been clearly established whether percutaneous coronary intervention (PCI) can provide an incremental benefit in quality of life over that provided by optimal medical therapy among patients with chronic coronary artery disease. METHODS: We randomly assigned 2287 patients with stable coronary disease to PCI plus optimal medical therapy or to optimal medical therapy alone. We assessed angina-specific health status (with the use of the Seattle Angina Questionnaire) and overall physical and mental function (with the use of the RAND 36-item health survey [RAND-36]). RESULTS: At baseline, 22% of the patients were free of angina. At 3 months, 53% of the patients in the PCI group and 42% in the medical-therapy group were angina-free (P<0.001). Baseline mean (+/-SD) Seattle Angina Questionnaire scores (which range from 0 to 100, with higher scores indicating better health status) were 66+/-25 for physical limitations, 54+/-32 for angina stability, 69+/-26 for angina frequency, 87+/-16 for treatment satisfaction, and 51+/-25 for quality of life. By 3 months, these scores had increased in the PCI group, as compared with the medical-therapy group, to 76+/-24 versus 72+/-23 for physical limitation (P=0.004), 77+/-28 versus 73+/-27 for angina stability (P=0.002), 85+/-22 versus 80+/-23 for angina frequency (P<0.001), 92+/-12 versus 90+/-14 for treatment satisfaction (P<0.001), and 73+/-22 versus 68+/-23 for quality of life (P<0.001). In general, patients had an incremental benefit from PCI for 6 to 24 months; patients with more severe angina had a greater benefit from PCI. Similar incremental benefits from PCI were seen in some but not all RAND-36 domains. By 36 months, there was no significant difference in health status between the treatment groups. CONCLUSIONS: Among patients with stable angina, both those treated with PCI and those treated with optimal medical therapy alone had marked improvements in health status during follow-up. The PCI group had small, but significant, incremental benefits that disappeared by 36 months. (ClinicalTrials.gov number, NCT00007657.)

Shaw LJ, Berman DS, Maron DJ, Mancini GB, Hayes SW, Hartigan PM, Weintraub WS, O'Rourke RA, Dada M, Spertus JA, Chaitman BR, Friedman J, Slomka P, Heller GV, Germano G, Gosselin G, Berger P, Kostuk WJ, Schwartz RG, Knudtson M, Veledar E, Bates ER, McCallister B, Teo KK, Boden WE, Anonymous00009. · Emory University School of Medicine, Atlanta, GA 30306, USA. · Circulation. · Pubmed #18268144 links to  free full text

Abstract: BACKGROUND: Extent and severity of myocardial ischemia are determinants of risk for patients with coronary artery disease, and ischemia reduction is an important therapeutic goal. The Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) nuclear substudy compared the effectiveness of percutaneous coronary intervention (PCI) for ischemia reduction added to optimal medical therapy (OMT) with the use of myocardial perfusion single photon emission computed tomography (MPS). METHODS AND RESULTS: Of the 2287 COURAGE patients, 314 were enrolled in this substudy of serial rest/stress MPS performed before treatment and 6 to 18 months (mean=374+/-50 days) after randomization using paired exercise (n=84) or vasodilator stress (n=230). A blinded core laboratory analyzed quantitative MPS measures of percent ischemic myocardium. Moderate to severe ischemia encumbered > or = 10% myocardium. The primary end point was > or = 5% reduction in ischemic myocardium at follow-up. Treatment groups had similar baseline characteristics. At follow-up, the reduction in ischemic myocardium was greater with PCI+OMT (-2.7%; 95% confidence interval, -1.7%, -3.8%) than with OMT (-0.5%; 95% confidence interval, -1.6%, 0.6%; P<0.0001). More PCI+OMT patients exhibited significant ischemia reduction (33% versus 19%; P=0.0004), especially patients with moderate to severe pretreatment ischemia (78% versus 52%; P=0.007). Patients with ischemia reduction had lower unadjusted risk for death or myocardial infarction (P=0.037 [risk-adjusted P=0.26]), particularly if baseline ischemia was moderate to severe (P=0.001 [risk-adjusted P=0.08]). Death or myocardial infarction rates ranged from 0% to 39% for patients with no residual ischemia to > or = 10% residual ischemia on follow-up MPS (P=0.002 [risk-adjusted P=0.09]). CONCLUSIONS: In COURAGE patients who underwent serial MPS, adding PCI to OMT resulted in greater reduction in ischemia compared with OMT alone. Our findings suggest a treatment target of > or = 5% ischemia reduction with OMT with or without coronary revascularization.

Singh M, Gersh BJ, Li S, Rumsfeld JS, Spertus JA, O'Brien SM, Suri RM, Peterson ED. · Division of Cardiovascular Diseases, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA. · Circulation. · Pubmed #18172033 links to  free full text

Abstract: BACKGROUND: Current risk models predict in-hospital mortality after either coronary artery bypass graft surgery or percutaneous coronary interventions separately, yet the overlap suggests that the same variables can define the risks of alternative coronary reperfusion therapies. Our goal was to seek a preprocedure risk model that can predict in-hospital mortality after either percutaneous coronary intervention or coronary artery bypass graft surgery. METHODS AND RESULTS: We tested the ability of the recently validated, integer-based Mayo Clinic Risk Score (MCRS) for percutaneous coronary intervention, which is based solely on preprocedure variables (age, creatinine, ejection fraction, myocardial infarction < or = 24 hours, shock, congestive heart failure, and peripheral vascular disease), to predict in-hospital mortality among 370,793 patients in the Society of Thoracic Surgeons database undergoing isolated coronary artery bypass graft surgery from 2004 to 2006. For the Society of Thoracic Surgeons coronary artery bypass graft surgery population studied, the median age was 66 years (quartiles 1 to 3, 57 to 74 years), with 37.2% of patients > or = 70 years old. A high prevalence of comorbid conditions, including diabetes mellitus (37.1%), hypertension (80.5%), peripheral vascular disease (15.3%), and renal disease (creatinine > or = 1.4 mg/dL; 11.8%), was present. A strong association existed between the MCRS and the observed mortality in the Society of Thoracic Surgeons database. The in-hospital mortality ranged between 0.3% (95% confidence interval 0.3% to 0.4%) with a score of 0 on the MCRS and 33.8% (95% confidence interval 27.3% to 40.3%) with an MCRS score of 20 to 24. The discriminatory ability of the MCRS was moderate, as measured by the area under the receiver operating characteristic curve (C-statistic = 0.715 to 0.784 among various subgroups); performance was inferior to the Society of Thoracic Surgeons model for most categories tested. CONCLUSIONS: This model, which is based on 7 preprocedure risk variables, may be useful for providing patients with individualized, evidence-based estimates of procedural risk as part of the informed consent process before percutaneous or surgical revascularization.

Block RC, Harris WS, Reid KJ, Sands SA, Spertus JA. · Department of Community and Preventive Medicine, University of Rochester School of Medicine and Dentistry, Rochester, Box 644, 601 Elmwood Avenue, NY 14642, United States. robert · Atherosclerosis. · Pubmed #17875307 No free full text.

Abstract: BACKGROUND: Increased blood levels of the omega-3 fatty acids (FA) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have been inversely associated with risk for sudden cardiac death, but their relationship with acute coronary syndromes (ACS) is unclear. OBJECTIVE: We hypothesized that the EPA+DHA content of blood cell membranes, as a percent of total FAs, is reduced in ACS patients relative to matched controls. METHODS: We measured the content of EPA+DHA in 768 ACS patients and 768 age-, sex- and race-matched controls. The association with ACS case status of blood cell EPA+DHA [both by a 1 unit change and by category (low, <4%; intermediate 4.1-7.9%; and high, > or =8%)] was assessed using multivariate conditional logistic regression models adjusting for matching variables and smoking status, alcohol use, diabetes, body mass index, serum lipids, education, family history of coronary artery disease, personal histories of myocardial infarction and hypertension, and statin, aspirin, and other antiplatelet drug use. RESULTS: The combined groups had a mean age of 61+/-12 years, 66% were male, and 92% were Caucasian. The EPA+DHA content was 20% lower in cases than controls (3.4+/-1.6 vs. 4.25+/-2.0%, p<0.001). The multivariable-adjusted odds for case status was 0.77 (95% CI 0.70 to 0.85, p<0.001) for a 1 unit increase in EPA+DHA content. Compared with the lowest EPA+DHA group, the odds ratio for an ACS event was 0.58 (95% CI 0.42-0.80), in the intermediate EPA+DHA group and was 0.31 (95% CI 0.14-0.67; p for trend <0.0001) in the highest EPA+DHA group. CONCLUSIONS: Odds for ACS case status increased incrementally as the EPA+DHA content decreased suggesting that low EPA+DHA may be associated with increased risk for ACS.

Decker C, Huddleston J, Kosiborod M, Buchanan DM, Stoner C, Jones A, Banerjee S, Spertus JA. · Mid America Heart Institute of Saint Lukes Hospital, and School of Nursing, University of Missouri-Kansas City, Kansas City, Missouri, USA. · Am J Cardiol. · Pubmed #17398186 No free full text.

Abstract: Complementary and alternative medicine (CAM) use is common in patients with cardiovascular disease. Although numerous efforts have sought to understand CAM types and the prevalence of CAM, whether patients preferentially use CAM instead of evidence-based therapies is unknown. Self-reported use of CAM and evidence-based therapies in a prospective registry of hospitalized patients with acute coronary syndrome from March 1, 2001 to October 31, 2002 were examined. Poisson regression models were used to assess whether CAM use was independently associated with lower rates of aspirin, beta-blocker, and statin use in 596 patients with established coronary artery disease (CAD). Overall, CAM use was 19% in patients with CAD. Higher proportions of patients who used CAM were non-Caucasian (31% vs 12%), uninsured (12% vs 7%), economically burdened (58% vs 29%), and had depression (13% vs 6%, p<0.05 for all). Patients who used CAM were more likely to use beta blockers (64% vs 46%, p=0.008) and as likely to use aspirin (73% vs 74%, p=0.90) and statins (71% vs 68%, p=0.76) as non-CAM users. Adjusting for demographic and clinical factors did not change results (CAM users: RR 1.27, 95% confidence interval [CI] 1.01 to 1.60 for using beta blockers, RR 0.97, 95% CI 0.85 to 1.11 for using aspirin, and RR 1.05, 95% CI 0.87 to 1.28 for using statins). In conclusion, although CAM users with established CAD have worse socioeconomic status than nonusers, we found no evidence that they were less compliant with evidence-based therapies.

Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS, Anonymous00175. · Western New York Veterans Affairs Healthcare Network and Buffalo General Hospital-SUNY, Buffalo, NY 14203, USA. · N Engl J Med. · Pubmed #17387127 links to  free full text

Abstract: BACKGROUND: In patients with stable coronary artery disease, it remains unclear whether an initial management strategy of percutaneous coronary intervention (PCI) with intensive pharmacologic therapy and lifestyle intervention (optimal medical therapy) is superior to optimal medical therapy alone in reducing the risk of cardiovascular events. METHODS: We conducted a randomized trial involving 2287 patients who had objective evidence of myocardial ischemia and significant coronary artery disease at 50 U.S. and Canadian centers. Between 1999 and 2004, we assigned 1149 patients to undergo PCI with optimal medical therapy (PCI group) and 1138 to receive optimal medical therapy alone (medical-therapy group). The primary outcome was death from any cause and nonfatal myocardial infarction during a follow-up period of 2.5 to 7.0 years (median, 4.6). RESULTS: There were 211 primary events in the PCI group and 202 events in the medical-therapy group. The 4.6-year cumulative primary-event rates were 19.0% in the PCI group and 18.5% in the medical-therapy group (hazard ratio for the PCI group, 1.05; 95% confidence interval [CI], 0.87 to 1.27; P=0.62). There were no significant differences between the PCI group and the medical-therapy group in the composite of death, myocardial infarction, and stroke (20.0% vs. 19.5%; hazard ratio, 1.05; 95% CI, 0.87 to 1.27; P=0.62); hospitalization for acute coronary syndrome (12.4% vs. 11.8%; hazard ratio, 1.07; 95% CI, 0.84 to 1.37; P=0.56); or myocardial infarction (13.2% vs. 12.3%; hazard ratio, 1.13; 95% CI, 0.89 to 1.43; P=0.33). CONCLUSIONS: As an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy. (ClinicalTrials.gov number, NCT00007657 [ClinicalTrials.gov].).

Boden WE, O'rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk W, Knudtson M, Dada M, Casperson P, Harris CL, Spertus JA, Shaw L, Chaitman BR, Mancini GB, Berman DS, Gau G, Weintraub WS, Anonymous00242. · VA Connecticut Healthcare System, West Haven, Connecticut, USA. · Am J Cardiol. · Pubmed #17223420 No free full text.

Abstract: Major improvements in medical therapy and percutaneous coronary intervention for coronary artery disease (CAD) have emerged during the previous 2 decades, but no randomized trial in patients with stable CAD has been powered to compare these 2 strategies for the hard clinical end points of death or myocardial infarction (MI), and previous studies have not evaluated the effect of coronary stents and intensive medical therapy on cardiac events during long-term follow-up. Between 1999 and 2004, 2,287 patients with documented myocardial ischemia and angiographically confirmed CAD were randomized to the Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial, with a principal hypothesis that a strategy of percutaneous coronary intervention plus intensive, guideline-driven medical therapy would be superior to a strategy of intensive medical therapy alone. The primary end point was a composite of all-cause mortality or acute MI (time to first event) during a 2.5- to 7-year (median 5) follow-up. Baseline characteristics were a mean age of 62 +/- 5 years, 85% men, and 86% Caucasian. Mean duration of angina before randomization was 26 months (average 10 episodes/week), and 29% of patients were smokers, 67% had hypertension, 38% had previous MI, 71% had dyslipidemia, 34% had diabetes, 27% had previous revascularization, and 69% had multivessel CAD. Approximately 55% of patients met established criteria for the metabolic syndrome. In conclusion, baseline characteristics of the COURAGE trial study population indicate a highly symptomatic group of patients with CAD who have a significant duration and frequency of antecedent angina pectoris and a high prevalence of cardiac risk factors.

Zhang Z, Mahoney EM, Spertus JA, Booth J, Nugara F, Kolm P, Stables RH, Weintraub WS. · Christiana Care Center for Outcomes Research, Christiana Care Health System, Newark, DE 19713, USA. · Am Heart J. · Pubmed #17161069 No free full text.

Abstract: BACKGROUND: Relative outcomes of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) may differ between younger and older patients. There are no data comparing the age-related CABG versus PCI outcomes in the stent era. METHODS: The SoS trial compared CABG (n = 500) and stent-assisted PCI (n = 488). The impact of treatment assignment on 1-year outcomes was evaluated by age < or = 65 years (n = 295, CABG; n = 298, PCI) and > 65 years (n = 205, CABG; n = 190, PCI). RESULTS: One-year procedural outcomes were similar between treatment groups regardless of age, with the exception of more repeat revascularizations after PCI (age < or = 65, 16.1% vs 4.8%; age > 65, 19.5% vs 3.4%; both P < .001). Six and 12-month Seattle Angina Questionnaire scores improved from baseline in both age and treatment groups. However, CABG was associated with greater improvement in physical limitation, angina frequency, and quality of life in younger patients at 6 and 12 months (12-month difference in improvement between CABG and PCI: 5.6, 4.8, and 3.9 points for 3 domains), whereas in the elderly a significant benefit of CABG observed at 6 months did not persist at 12 months (12-month difference: 0.9, 1.9, and 1.4). One-year costs were significantly higher after CABG regardless of age. CONCLUSIONS: Although PCI and CABG result in similar rates in clinical outcomes irrespective of age, younger patients reported more health status benefits from CABG as compared with PCI, whereas in older patients the 2 approaches resulted in similar 1-year health status benefits.

Boden WE, O'rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk W, Knudtson M, Dada M, Casperson P, Harris CL, Spertus JA, Shaw L, Chaitman BR, Mancini GB, Berman DS, Weintraub WS, Anonymous00055. · VA Connecticut Healthcare System, West Haven, CT, USA. · Am Heart J. · Pubmed #16781214 No free full text.

Abstract: BACKGROUND: Major improvements in medical therapy and percutaneous coronary intervention (PCI) for coronary heart disease have occurred during the past decade, but no randomized trial has compared these 2 strategies for the "hard" clinical end points of death or myocardial infarction nor have earlier studies incorporated the use of coronary stents and aggressive multifaceted medical therapy during long-term follow-up. METHODS: The COURAGE trial is a multicenter study of patients with documented myocardial ischemia and angiographically confirmed single or multivessel coronary artery disease who are randomized to a strategy of PCI plus intensive medical therapy or intensive medical therapy alone. Medical therapy in both groups is guideline-driven and includes: aspirin, clopidogrel, simvastatin (low-density lipoprotein cholesterol target 60-85 mg/dL), long-acting metoprolol and/or amlodipine, lisinopril or losartan, and long-acting nitrates, as well as lifestyle interventions. The primary end point is a composite of all-cause mortality or acute myocardial infarction, and there will be 85% power to detect an absolute 4.6% (relative 22%) difference between strategies. The principal hypothesis is that PCI plus aggressive medical therapy (projected event rate 16.4%) will be superior to aggressive medical therapy alone (projected event rate 21%) during a 2.5- to 7-year (median of 5 years) follow-up. CONCLUSIONS: COURAGE is the largest prospective randomized trial of PCI versus intensive medical therapy to date and will define the incremental benefits of PCI in the setting of contemporary optimal medical therapy for chronic coronary heart disease. A total of 2287 patients have been enrolled, and follow-up will conclude in June 2006.