2010 Late-Breaking Clinical Tria
l Abstracts and Clinical Science: Special Reports Abstracts
to explore the relationship between all AHRE and embolic events. Results: A total of 2582 patients were enrolled in 23 countries, between December 2004 and September 2008. Follow-up completed in June 2010, after a mean study duration of 43 months. The mean age of patients was 767 years and 42% were female. All patients had hypertension, 28% had diabetes mellitus, 15% had heart failure and 7% had prior stroke. The mean CHADS-2 score was 2.41. Only 7.5% of patients were started on oral anticoagulation during the study. Implanted devices detected AHRE in 60% of patients; adjudication confirmed that only 51% of these episodes were true atrial arrhythmias. The overall rate of the primary outcome composite of non-CNS systemic embolism and ischemic stroke was 0.72% per year. This risk correlated strongly with baseline stroke risk factors and was 1.06% per year in patients with a CHADS2 score or 1 and only 0.19% per year for those with a CHADS2 score1. The study has at least 80% power to detect a doubling of embolic risk with the presence of AHRE. Final results will be presented at the meeting.
Author Disclosures: J.S. Healey: Research Grant; Significant; St. Jude Medical. S.J. Connolly: St. Jude Medical. M.R. Gold: None. A. Capucci: None. C. Israel: None. I.C. van Gelder: None. C. Lau: None. C.A. Morillo: None. E. Fain: Employment; Significant; St Jude Medical. M. Carlson: ; St Jude Medical. S.H. Hohnloser: None.
Impact of Massachusetts Health Care Reform on Racial, Ethnic, and Socioeconomic Disparities in Cardiovascular Care
Michelle A Albert, Brigham & Womens Hosp, Boston, MA; Treacy S Silbaugh, Harvard Med Sch, Dept of Health Policy, Boston, MA; John Z Ayanian, Brigham & Womens Hosp, Boston, MA; Ann Lovett, Robert E Wolf, Harvard Med Sch, Dept of Health Care Policy, Boston, MA; Katya Zelevinsky, Harvard Med Sch, Dept of Public Policy, Boston, MA; Fred Resnic, Brigham & Womens Hosp, Boston, MA; Sharon-Lise Normand; Harvard Med Sch and Harvard Sch of Public Health, Boston, MA
Background: Because insurance status is positively associated with receipt of invasive cardiovascular procedures, we examined the impact of the 2006 Massachusetts (MA) Health Care Reform Act on coronary revascularization by race/ethnicity/education level and in-hospital mortality. Methods: Using a state database, we compared race/ethnic and educational differences in coronary revascularization [surgery (CABG), percutaneous interventionstent (PCI)] and in-hospital mortality among all MA residents 21–64 years old with a hospital discharge diagnosis of ischemic heart disease pre (November 1, 2004 to July 31, 2006) and post (December 1, 2006 to September 30, 2008) health reform. Results: Crude* logistic regression models controlled for age, sex, admission status and comorbidities and multivari- able models** additionally adjusted for education; Race/ethnic differences were noted for CABG-PCI procedures pre-reform with no significant change in these disparities post-reform. Increasing education (high school (HS), HS graduate, HS) was linked to increased coronary revascularization pre and post-reform (pboth0.01). Post-reform the odds of in-hospital mortality were lower for blacks and higher in Asians than whites. Conclusion: MA health reform has thus far not resulted in significant changes in observed race/ethnic/educational disparities in coronary revascularization. Blacks had lower odds of in-hospital mortality post-reform compared to whites.
ECG or ECG plus myocardial perfusion SPECT (ECGMPS) from 44 centers. Entry was limited to women with an interpretable ECG reporting 5 metabolic equivalents on the Duke activity status index. 6% of women failed to complete index testing or were lost during follow-up. The primary endpoint was 2-year incidence of major adverse CAD events (death or hospitalization for acute coronary syndrome or heart failure). A quality control laboratory deemed good- excellent quality in 96% of studies. Prelminary Results: For women randomized to ECG, results were normal in 62.3%, equivocal in 16.0%, and abnormal in 21.6%. The MPS results were normal in 90.5%, mildly abnormal in 3.2%, and moderate-severely abnormal in 6.3%. For the ECG arm, crossover MPS occured in 17.7% as compared to a 9.3% repeat MPS rate in the ECGMPS arm (p0.0001). Follow-up coronary angiography occured in 6% of women. The diagnostic sensitivity was 30.8% for the ECG and 75.0% for ECGMPS. The diagnostic specificity was 80.0% for the ECG and 76.9% for ECGMPS. Index testing costs were higher for those randomized to ECGMPS (averaging: $154 vs. $495 for the ECG vs. ECGMPS arms, p0.0001) yet follow-up costs were higher for the ECG arm ($180 [ECG] vs. $145 [ECGMPS], p0.008). Overall procedural costs averaged $338 for ECG and $643 for ECGMPS (p0.0001). At 2-years, CAD event-free survival was 98.0% for women randomized to exercise ECG vs. 97.7% for those randomized to ECGMPS (p0.76). Conclusions: A non-imaging strategy employing exercise ECG was equally effective, resulting in similar clinical outcomes, as ECGMPS. These data support initial ECG testing as equally effective and cost efficient as ECGMPS for women presenting for evaluation of suspected CAD capable of exercise.
Author Disclosures: L.J. Shaw: Research Grant; Significant; GE Healthcare. J.H. Mieres: GE Healthcare. R.H. Hendel: GE Healthcare. M. Gulati: Research Grant; Modest; GE Healthcare. E. Veledar: None. W.E. Boden: None. R. Hachamovitch: None. J.A. Arrighi: None. C. Bairey-Merz: None. R.J. Gibbons: None. N.K. Wenger: None. G.V. Heller: Research Grant; Significant; GE Healthcare.
21821 Benefits of Natriuretic Peptide Guided Heart Failure Therapy for Patients With Chronic Left Ventricular Systolic Dysfunction: Primary Results of the Pro-BNP Outpatient Tailored Chronic Heart Failure Therapy (PROTECT) Study
James Januzzi, Shafiq U Rehman, Asim A Mohammed, Anju Bhardwaj, Linda Barajas, Justine Barajas, Han-Na Kim, Aaron L Baggish, Rory B Weiner, Annabel A Chen-Tournoux, Jane E Marshall, Stephanie A Moore, William Carlson, Gregory D Lewis, Jordan Shin, Dorothy Sullivan, Kimberly Parks, Thomas Wang, Shawn A Gregory, Shanmugam Uthamalingam, Marc J Semigran; Massachusetts General Hosp, Boston, MA
Introduction: Lower values of amino-terminal pro-B type natriuretic peptide (NT-proBNP) predict favorable prognosis in patients with chronic heart failure (HF). Many HF therapies lower NT-proBNP values, but it is unclear whether titrating HF treatment with the goal of reducing NT-proBNP concentrations is superior to HF care based on standard clinical parameters. In the Pro-BNP Outpatient Tailored Chronic HF Therapy (PROTECT) Study (NCT00351390), we hypothesized NT-proBNP guided HF care would lead to better outcomes. Methods: In a prospective single-center trial, 151 subjects with HF due to left ventricular (LV) systolic dysfunction (ejection fraction 40%) were randomized to receive either standard HF care or standard HF care plus a goal to reduce NT-proBNP concentrations 1000 pg/mL. The primary endpoint was total cardiovascular events over a one-year period; secondary endpoints included effects of NT-proBNP guided care on patient quality of life (QOL; assessed with the Minnesota Living with HF Questionnaire) as well as cardiac structure and function, assessed via 2-dimensional echocardiography. Results: The mean age was 63 years, 87% were NYHA class II/III; the mean baseline LVEF was 279%. Through 10 months, subjects in the NT-proBNP arm had more office visits for HF care (P.05 versus the standard of care [SOC] arm), and at study completion were less likely than SOC patients to be taking loop diuretics (85 vs 96%; P.05) and more likely than SOC patients to be taking aldosterone antagonists (63 vs 45%; P.001). Those in the NT-proBNP arm had significant lowering of their NT-proBNP value (2344 vs 1125 pg/mL, P.01), with 44% 1000 pg/mL. SOC arm patients did not have a significant change in their NT-proBNP (1946 vs 1844 pg/mL, P.61). Compared to SOC, a significant reduction in the primary endpoint of total cardiovascular events was seen in the NT-proBNP arm (100 vs 58; P.009; OR0.44, 95% CI .22–.84; P.02), with particular effects on worsening HF and HF hospitalization (both P.003). Fewer patients in the NT-proBNP group had HF events (43.4% vs 29.3%; P.04). Greater improvements QOL and in echo parameters were seen in NT-proBNP patients. Conclusions: Among patients with chronic systolic HF, NT-proBNP guided HF therapy was superior to standard HF care.
Author Disclosures: M.A. Albert: None. T.S. Silbaugh: None. J.Z. Ayanian: None. A. Lovett: None. R.E. Wolf: None. K. Zelevinsky: None. F. Resnic: None. S. Normand: None.
Author Disclosures: J. Januzzi: Research Grant; Significant; Roche Dignostics, Siemens, Critical Diagnostics. Consultant/Advisory Board; Significant; Roche Diagnostics, Critical Diag- nostics. S.U. Rehman: None. A.A. Mohammed: None. A. Bhardwaj: None. L. Barajas: None. J. Barajas: None. H. Kim: None. A.L. Baggish: None. R.B. Weiner: None. A.A. Chen- Tournoux: None. J.E. Marshall: None. S.A. Moore: None. W. Carlson: None. G.D. Lewis: None. J. Shin: None. D. Sullivan: None. K. Parks: None. T. Wang: None. S.A. Gregory: None. S. Uthamalingam: None. M.J. Semigran: None.
23023 Comparative Effectiveness of Exercise Electrocardiography versus Exercise Electrocardiography Plus Myocardial Perfusion SPECT in Women With Suspected Coronary Artery Disease: Results From the What’s the Optimal Method for Ischemia Evaluation in Women Trial
Clinical Science: Special Reports II
Room S100c Abstracts 21854–21785
Leslee J Shaw, Emory Univ Sch of Med, Atlanta, GA; Jennifer H Mieres, Northshore-LIJ Hosp, Long Island, NY; Robert H Hendel, Univ of Miami Med Cntr, Miami, FL; Martha Gulati, Northwestern Univ, Chicago, IL; Emir Veledar, Emory Univ Sch of Med, Atlanta, GA; William E Boden, Univ of Buffalo, Buffalo, NY; Rory Hachamovitch, Cleveland Clinic Foundation, Cleveland, OH; James A Arrighi, Brown Univ, Providence, RI; C. Noel Bairey-Merz, Cedars-Sinai Med Cntr, Los Angeles, CA; Raymond J Gibbons, Mayo Clinic, Rochester, MN; Nanette K Wenger, Emory Univ Sch of Med, Atlanta, GA; Gary V Heller; Hartford Hosp, Hartford, CT
21854 Intracoronary versus Intravenous Abciximab in ST-Elevation Myocardial Infarction: Results of the CICERO Trial in Patients Undergoing Primary Percutaneous Coronary Intervention With Thrombus Aspiration
Background: Diagnostic testing in women with suspected coronary artery disease (CAD) has a limited evidence base with no available randomized trials to guide clinical decision making aimed at improving clinical outcomes. For women capable of performing exercise, evidence is lacking as to whether the addition of imaging provides an added clinical benefit over exercise electrocardiography (ECG) alone. Methods: A total of 825 women were randomized to exercise
Youlan L Gu, Marthe A Kampinga, Wouter G Wieringa, Marieke L Fokkema, Ad F van den Heuvel, Eng-Shiong Tan, Gabija Pundziute, Rik van der Werf, Siyrous Hoseyni Guyomi, Felix Zijlstra, Bart J de Smet; Univ Med Cntr Groningen, Univ of Groningen, Groningen, Netherlands
Background Administration of the glycoprotein IIb/IIIa inhibitor abciximab is an effective adjunctive treatment strategy during primary percutaneous coronary intervention (PCI) for ST-elevation