Coronary Artery Disease: Weintraub WS

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.

Weintraub WS, Diamond GA. · No affiliation provided · N Engl J Med. · Pubmed #18367744 No free full text.

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Weintraub WS. · No affiliation provided · Circulation. · Pubmed #12777315 links to  free full text

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Weintraub WS. · Department of Cardiology and Christiana Center for Outcomes Research, Christiana Care Health Services, Newark, Delaware 19718, USA. · Am J Cardiol. · Pubmed #17719351 No free full text.

Abstract: The introduction of percutaneous transluminal coronary angioplasty (PTCA) revolutionized the surgical treatment of coronary artery disease. However, despite increased surgical experience and technical breakthroughs, restenosis occurs in 30%-50% of patients undergoing simple balloon angioplasty and in 10%-30% of patients who receive an intravascular stent. Animal and human data indicate that restenosis is a response to injury incurred during PTCA. The need for reintervention in a high percentage of patients due to restenosis remains an important limitation to the long-term success of PTCA. Stenting reduces initial elastic recoil and limits negative arterial remodeling; however, bare-metal stents may promote intimal hyperplasia by eliciting an immune and proliferative response. Consistent with these data, clinical studies suggest that drug-eluting stents, coated with anti-inflammatory or antiproliferative agents, reduce the risk for restenosis. Stenting represents a considerable cost burden. Treatment strategy should focus on selective use of expensive drug-eluting stents in populations where they have been found to be more clinically effective than bare-metal stents--patients who are at high risk for restenosis or who develop restenosis with bare-metal stents. Recent studies suggest that the pharmacologic management of restenosis is now feasible. Together, the judicious use of stents and oral pharmacotherapy promise to reduce the risk for restenosis, even among high-risk patients.

O'Rourke RA, Brundage BH, Froelicher VF, Greenland P, Grundy SM, Hachamovitch R, Pohost GM, Shaw LJ, Weintraub WS, Winters WL. · No affiliation provided · J Am Coll Cardiol. · Pubmed #10898458 No free full text.

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O'Rourke RA, Brundage BH, Froelicher VF, Greenland P, Grundy SM, Hachamovitch R, Pohost GM, Shaw LJ, Weintraub WS, Winters WL, Forrester JS, Douglas PS, Faxon DP, Fisher JD, Gregoratos G, Hochman JS, Hutter AM, Kaul S, Wolk MJ. · No affiliation provided · Circulation. · Pubmed #10880426 links to  free full text

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Weintraub WS, Kosinski A, Culler S. · Division of Cardiology, School of Medicine, Emory University Hospital, Atlanta, GA 30322, USA. · Am Heart J. · Pubmed #10539803 No free full text.

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Weintraub WS, Mahoney EM, Zhang Z, Chu H, Hutton J, Buxton M, Booth J, Nugara F, Stables RH, Dooley P, Collinson J, Stuteville M, Delahunty N, Wright A, Flather MD, De Cock E. · The Emory Centre for Outcomes Research, Department of Medicine, Emory University, 1256 Briarcliff Road, Suite 1 North, Atlanta, Georgia 30306, USA. · Heart. · Pubmed #15201249 links to  free full text

Abstract: OBJECTIVES: To compare initial and one year costs of coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) in the stent or surgery trial. DESIGN: Prospective, unblinded, randomised trial. SETTING: Multicentre study. PATIENTS: 988 patients with multivessel disease. INTERVENTIONS: CABG and stent assisted PCI. MAIN OUTCOME MEASURES: Initial hospitalisation and one year follow up costs. RESULTS: At one year mortality was 2.5% in the PCI arm and 0.8% in the CABG arm (p = 0.05). There was no difference in the composite of death or Q wave myocardial infarction (6.9% for PCI v 8.1% for CABG, p = 0.49). There were more repeat revascularisations with PCI (17.2% v 4.2% for CABG). There was no significant difference in utility between arms at six months or at one year. Quality adjusted life years were similar 0.6938 for PCI v 0.6954 for PCI, Delta = 0.00154, 95% confidence interval (CI) -0.0242 to 0.0273). Initial length of stay was longer with CABG (12.2 v 5.4 days with PCI, p < 0.0001) and initial hospitalisation costs were higher (7321 pounds sterling v 3884 pounds sterling for PCI, Delta = 3437 pounds sterling, 95% CI 3040 pounds sterling to 3848 pounds sterling). At one year the cost difference narrowed but costs remained higher for CABG (8905 pounds sterling v 6296 pounds sterling for PCI, Delta = 2609 pounds sterling, 95% CI 1769 pounds sterling to 3314 pounds sterling). CONCLUSIONS: Over one year, CABG was more expensive and offered greater survival than PCI but little added benefit in terms of quality adjusted life years. The additional cost of CABG can be justified only if it offers continuing benefit at no further increase in cost relative to PCI over several years.

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.

Bezanson JL, Deaton C, Craver J, Jones E, Guyton RA, Weintraub WS. · Scientific Research Solutions, Inc, Roswell, GA, USA. · Am J Crit Care. · Pubmed #11688605 No free full text.

Abstract: BACKGROUND: Older age has been associated with prolonged mechanical ventilation after coronary artery bypass surgery. Prolonged mechanical ventilation contributes to increased morbidity and mortality and to use of limited financial resources among older adults. OBJECTIVES: To examine selected physiological and pathophysiological variables ofpresurgicalpatients to predict duration of mechanical ventilation in older adults after coronary artery bypass surgery. METHODS: Nonrandomized study of a clinical database of 919 patients (> or =65 years old) who had coronary artery bypass surgery between October 1996 and December 1997. RESULTS: Median elapsed time after coronary artery bypass surgery until extubation was used to sort patients into 2 groups: group 1, 6 hours or fewer (n = 464); and group 2, more than 6 hours (n = 455). With stepwise logistic regression, the physiological model included age (odds ratio, 1.05; P<.001) and female sex (odds ratio, 1.48; P = .005) with weak discrimination by group (concordance statistic = 0.5880). The pathophysiological model, which included renal insufficiency (odds ratio, 3.28; P = .01), previous peripheral vascular surgery (odds ratio, 2.87; P = .03), nonelective preoperative clinical status (odds ratio, 2.8; P = .006), congestive heartfailure (odds ratio, 2.6; P<.001), and reoperation (odds ratio, 2.34; P = .007), showed moderate discrimination bygroup (concordance statistic =0.6755). CONCLUSION: Many older adults were easily extubated and had good outcomes. The variables comorbid conditions and severity of illness provided better discrimination between extubation groups than a physiological model provided. Both predictive models allowed limited discrimination between groups.

Cannon CP, Weintraub WS, Demopoulos LA, Vicari R, Frey MJ, Lakkis N, Neumann FJ, Robertson DH, DeLucca PT, DiBattiste PM, Gibson CM, Braunwald E, Anonymous00267. · Cardiovascular Division, Brigham and Women's Hospital, Boston, MA 02115, USA. · N Engl J Med. · Pubmed #11419424 links to  free full text

Abstract: BACKGROUND: There is continued debate as to whether a routine, early invasive strategy is superior to a conservative strategy for the management of unstable angina and myocardial infarction without ST-segment elevation. METHODS: We enrolled 2220 patients with unstable angina and myocardial infarction without ST-segment elevation who had electrocardiographic evidence of changes in the ST segment or T wave, elevated levels of cardiac markers, a history of coronary artery disease, or all three findings. All patients were treated with aspirin, heparin, and the glycoprotein IIb/IIIa inhibitor tirofiban. They were randomly assigned to an early invasive strategy, which included routine catheterization within 4 to 48 hours and revascularization as appropriate, or to a more conservative (selectively invasive) strategy, in which catheterization was performed only if the patient had objective evidence of recurrent ischemia or an abnormal stress test. The primary end point was a composite of death, nonfatal myocardial infarction, and rehospitalization for an acute coronary syndrome at six months. RESULTS: At six months, the rate of the primary end point was 15.9 percent with use of the early invasive strategy and 19.4 percent with use of the conservative strategy (odds ratio, 0.78; 95 percent confidence interval, 0.62 to 0.97; P=0.025). The rate of death or nonfatal myocardial infarction at six months was similarly reduced (7.3 percent vs. 9.5 percent; odds ratio, 0.74; 95 percent confidence interval, 0.54 to 1.00; P<0.05). CONCLUSIONS: In patients with unstable angina and myocardial infarction without ST-segment elevation who were treated with the glycoprotein IIb/IIIa inhibitor tirofiban, the use of an early invasive strategy significantly reduced the incidence of major cardiac events. These data support a policy involving broader use of the early inhibition of glycoprotein IIb/IIIa in combination with an early invasive strategy in such patients.

Puskas JD, Thourani VH, Marshall JJ, Dempsey SJ, Steiner MA, Sammons BH, Brown WM, Gott JP, Weintraub WS, Guyton RA. · Division of Cardiothoracic Surgery, Carlyle Fraser Heart Center, Crawford Long Hospital of Emory University, Atlanta, Georgia 30365, USA. · Ann Thorac Surg. · Pubmed #11383786 No free full text.

Abstract: BACKGROUND: This retrospective study compared clinical outcomes and resource utilization in patients having off-pump coronary artery bypass grafting (OPCAB) versus conventional coronary artery bypass grafting (CABG). Angiographic patency was documented in the OPCAB group. METHODS: From April 1997 through November 1999, OPCAB was performed in 200 consecutive patients, and the results were compared with those in a contemporaneous matched control group of 1,000 patients undergoing CABG. Patients were matched according to age, sex, preexisting disease (renal failure, diabetes, pulmonary disease, stroke, hypertension, peripheral vascular disease, previous myocardial infarction, and primary or redo status. Follow-up in the OPCAB patients was 93% and averaged 13.4 months. RESULTS: Hospital death (1.0%), postoperative stroke (1.5%), myocardial infarction (1.0%), and re-entry for bleeding (1.5%) occurred infrequently in the OPCAB group. There were reductions in the rates of transfusion (33.0% versus 70.0%; p < 0.001) and deep sternal wound infection (0% versus 2.2%; p = 0.067) in the OPCAB group compared with the CABG group. Angiographic assessment of 421 grafted arteries was performed in 167 OPCAB patients (83.5%) prior to hospital discharge. All but five were patent (98.8%) (93.3% FitzGibbon A, 5.5% FitzGibbon B, 1.2% FitzGibbon O). All 163 internal mammary artery grafts were patent. Off-pump coronary artery bypass grafting reduced postoperative hospital stay from 5.7 +/- 5.3 days in the CABG group to 3.9 +/- 2.6 days (p < 0.001), with a decrease in hospital cost of 15.0% (p < 0.001). CONCLUSIONS: Off-pump coronary artery bypass grafting reduces hospital cost, postoperative length of stay, and morbidity compared with CABG on cardiopulmonary bypass. Off-pump coronary bypass grafting is safe, cost effective, and associated with excellent graft patency and clinical outcomes.

Weintraub WS, Becker ER, Mauldin PD, Culler S, Kosinski AS, King SB. · Division of Cardiology, School of Medicine, Health Policy and Management, and Biometry, Medical University of South Carolina, USA. · Am J Cardiol. · Pubmed #11018194 No free full text.

Abstract: The Emory Angioplasty versus Surgery Trial (EAST) was a randomized trial that compared, by intention to treat, the clinical outcome and costs of percutaneous transluminal coronary angioplasty (PTCA) and coronary bypass grafting (CABG) for multivessel coronary artery disease. We present the findings of the economic analysis of EAST through 8 years of follow-up and compare the cost and outcomes of patients randomized in EAST versus patients eligible but not randomized (registry patients). Charges were assessed from hospital UB82 and UB92 bills and professional charges from the Emory Clinic. Hospital charges were reduced to cost through step-down accounting methods. All costs and charges were inflated to 1997 dollars. Costs were assessed for initial hospitalization and for cumulative costs of the initial hospitalization and additional revascularization procedures up to 8 years. Total 8-year costs were $46,548 for CABG and $44,491 for PTCA (p = 0.37). Cost of CABG in the eligible registry group showed a pattern similar to that for randomized patients, but total cost of PTCA was lower for registry patients than for randomized patients. Thus, the primary procedural costs of CABG are more than those for PTCA; this cost advantage, given the limits of measurement, is largely or even completely lost for randomized patients over the course of 8 years because of additional procedures after a first revascularization by PTCA.

King SB, Kosinski AS, Guyton RA, Lembo NJ, Weintraub WS. · Emory University School of Medicine, Department of Medicine, Atlanta, Georgia, USA. · J Am Coll Cardiol. · Pubmed #10758949 No free full text.

Abstract: OBJECTIVES: To evaluate the long-term outcome of patients randomized to coronary bypass surgery or coronary angioplasty. BACKGROUND: The Emory Angioplasty versus Surgery Trial (EAST) is a single center randomized comparison of a strategy of initial coronary angioplasty (n = 198) or coronary bypass surgery (n = 194) for patients with multivessel coronary artery disease. The primary end point (death, myocardial infarction or a large ischemic defect at 3 years) was not different, and repeat revascularization was significantly greater in the angioplasty group. Subsequently, the National Heart, Lung and Blood Institute supported a five-year extension of the trial. METHODS: After the three year anniversary visit, annual questionnaires, telephone contact and examination of medical records were accomplished until death or the eight year anniversary in 100% of the patients surviving at 3 years. RESULTS: Survival at 8 years is 79.3% in the angioplasty group and 82.7% in the surgical group (p = 0.40). Patients with proximal left anterior descending stenosis and those with diabetes tended to have better late survival with surgical intervention although not reaching statistical significance. After the first 3 years, repeat interventions remained relatively equal for both treatment groups. CONCLUSIONS: Long-term survival is not significantly different between angioplasty and surgery, and late (three to eight year) revascularization procedures were infrequent. Patients without treated diabetes had similar survival in both groups.

Alazraki NP, Krawczynska EG, Kosinski AS, DePuey EG, Ziffer JA, Taylor AT, Pettigrew RI, Vansant JP, Shaw LJ, Weintraub WS, King SB. · Department of Radiology, Rollins School of Public Health, Emory University School of Medicine, Atlanta, Georgia, USA. · Am J Cardiol. · Pubmed #10606106 No free full text.

Abstract: The aim of this study was to investigate the relation between reversible thallium single-photon emission computed tomography (SPECT) myocardial perfusion defects at 1-year after revascularization and quantitative indexes in Emory Angioplasty versus Surgery Trial (EAST) and outcomes 3 years after revascularization in 336 patients. EAST was a randomized controlled trial assessing cardiac outcomes for angioplasty versus bypass surgery for patients with multivessel coronary artery disease. During this prospective trial, a substudy included the evaluation of the prognostic value of reversible defects on quantitative thallium SPECT. At 1-year after revascularization, 336 patients underwent SPECT thallium-201 stress myocardial perfusion and 3-hour delayed imaging. Subsequent events, percutaneous transluminal coronary angioplasty, coronary artery bypass graft surgery, myocardial infarction, and death, were recorded at 3 years. A stress-induced reversible thallium-201 defect was defined using a quantitative index of a reversibility score >30% and severity score >500. Reversible defects were observed more frequently in the percutaneous transluminal coronary angioplasty than in the coronary artery bypass graft surgery treatment groups (46% vs 27%, p <0.001). A total of 123 patients had stress-induced, reversible thallium defects and more events than patients with other perfusion results (freedom from all events was 81.3% vs 94% [p <0.001], and freedom from myocardial infarction and death 88.3% vs 95.5% [p = 0.031]). Quantitative thallium SPECT at 1 year after revascularization risk stratifies patients as to their likelihood of major cardiac outcomes.

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.

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, Shaw RE, Merz CN, Brindis RG, Klein LW, Nallamothu B, Douglas PS, Krone RJ, McKay CR, Block PC, Hewitt K, Weintraub WS, Peterson ED, Anonymous00293. · Emory Program in Cardiovascular Outcomes Research and Epidemiology, 1256 Briarcliff Rd NE, Suite 1-N, Emory University School of Medicine, Atlanta, GA 30306, USA. · Circulation. · Pubmed #18378615 links to  free full text

Abstract: BACKGROUND: Although populations referred for coronary angiography are increasingly diverse, there is limited information on coronary artery disease (CAD) prevalence and in-hospital mortality other than for predominately white male patients. METHODS AND RESULTS: We examined gender and ethnic differences in CAD prevalence and in-hospital mortality in a prospective cohort of patients referred for angiographic evaluation of stable angina (n=375,886) or acute coronary syndromes (ACS; unstable angina or myocardial infarction, n=450,329) at 388 US hospitals participating in the American College of Cardiology-National Cardiovascular Data Registry, an angiographic registry. Univariable and multivariable (with covariates that included risk factors, symptoms, and comorbidities) logistic regression models were used to estimate significant CAD, defined as > or = 70% stenosis, and in-hospital mortality. Within stable angina and ACS cohorts, 7% of patients were black, 2% were Hispanic, 0.3% were Native American, 1% were Asian, and 90% were white, respectively. In stable angina, the risk-adjusted OR for significant CAD was 0.34 for women compared with men (P<0.0001), with black women having the lowest risk-adjusted odds (P<0.0001) compared with other females. Among ACS patients, the risk-adjusted OR of significant CAD was 0.47 for women compared with men (P<0.0001); similarly, black women had the lowest risk-adjusted odds (P<0.0001) compared with other females. Higher in-hospital mortality was reported for white women presenting with stable angina (P<0.00001). White women had a 1.34-fold (95% CI 1.21 to 1.48) higher risk-adjusted odds ratio for mortality than white men with stable angina (P<0.0001), with higher rates noted for white women who were older or had significant CAD (both P<0.0001). Lower utilization of elective coronary revascularization, aspirin, and glycoprotein IIb/IIIa inhibitors (all P<0.0001) may have contributed to higher in-hospital mortality for white women. In ACS, higher in-hospital mortality was reported for Hispanic (P=0.015) and white (P<0.0001) women; however, neither white (P=0.51) or Hispanic (P=0.13) women had higher in-hospital risk-adjusted mortality. CONCLUSIONS: The likelihood for significant CAD at coronary angiography and for in-hospital mortality varied significantly by ethnicity and gender. Future clinical practice guidelines should be tailored to gender subsets of the population, in particular for black women, to improve the efficient use of angiographic laboratories and to target at-risk populations of women and men.

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.

Brener SJ, Milford-Beland S, Roe MT, Bhatt DL, Weintraub WS, Brindis RG, Anonymous00074. · Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH 44195, USA. · Am Heart J. · Pubmed #18082505 No free full text.

Abstract: BACKGROUND: Multivessel (MV) coronary artery disease (CAD) frequently exists in patients presenting with non-ST-elevation (NSTE) acute coronary syndromes (ACSs). Although an early invasive strategy improves outcome in these patients, there are limited data on culprit-only, single-vessel (SV) percutaneous coronary intervention (PCI) or MV PCI in the NSTE ACS setting. METHODS: To identify the predictors of SV versus MV PCI in patients with ACS and compare their outcomes up to hospital discharge, we analyzed the records of 105,866 patients undergoing PCI with ACS and MV CAD from 402 centers reported to the American College of Cardiology National Cardiovascular Database Registry between 2000 and 2004. Demographic, clinical, and angiographic characteristics of the patients were used to create a propensity score for SV versus MV PCI. RESULTS: Single-vessel PCI was performed in 68% (72,048 patients), whereas the remaining 32% (33,818 patients) had MV PCI. Factors independently associated with the performance of SV versus MV PCI were presentation with NSTE infarction (vs unstable angina), adjusted odds ratio (OR) of 1.29 (95% CI 1.24-1.34); being older, adjusted OR of 1.09 (95% CI 1.08-1.11) per decade; and presence of total occlusion, adjusted OR of 1.25 (95% CI 1.16-1.36). The c-statistic for the model was 0.70. Procedural success was achieved in 91% of SV PCI and 88% of MV PCI (P < .001). Inhospital mortality was 1.3% and 1.2%, respectively (P = .09; adjusted OR 1.11 [95% CI 0.97-1.27], P = .13). Rates of morbidity, such as bleeding, development of renal failure, or nonfatal cardiogenic shock, were similar for both groups. CONCLUSIONS: In patients with MV CAD, presenting with ACS and selected for PCI, performance of MV PCI appears to be associated with at least as successful an inhospital outcome as SV PCI.

Mehta SK, Frutkin AD, Milford-Beland S, Klein LW, Shaw RE, Weintraub WS, Krone RJ, Anderson HV, Kutcher MA, Marso SP, Anonymous00077. · Department of Cardiology, The Mid America Heart Institute, Kansas City, Missouri, USA. · Am J Cardiol. · Pubmed #17884373 No free full text.

Abstract: In clinical trials, the use of a distal embolic protection device (EPD) during saphenous vein graft (SVG) percutaneous intervention (PCI) decreases the incidence of major adverse events. However, the frequency of EPD use during SVG PCI in clinical practice is unknown. We evaluated 19,546 SVG PCI procedures in the American College of Cardiology-National Cardiovascular Data Registry from January 1, 2004, through March 30, 2006. EPD use was the primary outcome. Univariate and multivariable analyses were used to assess for characteristics associated with EPD use and to determine the association between EPD use and 2 outcomes: no-reflow and in-hospital mortality. EPDs were used in 22% of patients who underwent SVG PCI. Characteristics independently associated with EPD use were age (odds ratio [OR] 1.04, p = 0.03), male gender (OR 1.12, p = 0.02), older grafts (p <0.001 for the group), longer lesions (OR 1.16, p <0.001), and American College of Cardiology/American Heart Association class C lesions (OR 1.41, p <0.001). Patients were less likely to receive an EPD if they had class <3 grade flow according to Thrombolysis in Myocardial Infarction classification (p <0.001) or previously treated lesions (OR 0.55, p <0.001). There was a weak correlation between annual hospital PCI volume and EPD use (r = 0.2, p <0.001). Nineteen percent of centers did not use EPDs and 41% used them in <10% of cases. EPD use was independently associated with a lower incidence of no-reflow (OR 0.68, p = 0.032), but not in-hospital mortality (1.0% vs 0.9%, p = NS). In conclusion, in current practice, EPDs are used in <25% of SVG PCI procedures.

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].).

Greenland P, Bonow RO, Brundage BH, Budoff MJ, Eisenberg MJ, Grundy SM, Lauer MS, Post WS, Raggi P, Redberg RF, Rodgers GP, Shaw LJ, Taylor AJ, Weintraub WS, Anonymous00384, Anonymous00385, Anonymous00386. · No affiliation provided · J Am Coll Cardiol. · Pubmed #17239724 No free full text.

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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.