Impact of Time of Presentation on the Care and Outcomes of Acute Myocardial Infarction

1. Impact of Time of Presentation on the Care and Outcomes of Acute Myocardial Infarction Hani Jneid, Gregg C. Fonarow, Christopher P. Cannon, Igor F. Palacios,Teoman Kilic, George V. Moukarbel, Andrew O. Maree, Kenneth A LaBresh, Li Liang, L. Kristin Newby, Gerald Fletcher, Laura Wexler, Eric Peterson; for the Get With The Guidelines Steering Committee and Investigators From the Massachusetts General Hospital and Harvard Medical School, Boston, MA (Drs Jneid, Palacios, Kilic, Moukarbel, and Maree); UCLA Medical Center, Los Angeles, CA (Dr Fonarow); TIMI Group and BWH, Boston, MA (Dr Cannon); Masspro, Inc., Waltham, Massachusetts, USA (Dr. LaBresh); Duke Clinical Research Institute and Duke University Medical Center, Durham, NC (Drs Liang, Newby, and Peterson); Mayo Clinic, Jacksonville, FL (Dr. Fletcher); University of Cincinnati College of Medicine, Cincinnati, OH (Dr Wexler) Jneid, H. et al. Circulation May 2008.

2. Background • Acute myocardial infarction (AMI) remains a leading cause of death in the United States. Its associated mortality and morbidity can be altered however by proven, effective therapies. • Healthcare providers have been working to improve the consistency and timely delivery of evidence-based treatments. Despite these efforts, studies continue to demonstrate quality gaps in AMI care in routine clinical practice. Jneid, H. et al. Circulation May 2008.

3. Background • Recently, several studies found that patients presenting on weekends or during “off-hours” (weekday nights, weekends, and holidays) were less likely to receive guideline-based medications and/or timely reperfusion after AMI. • However, these studies have been inconsistent in their findings and have been in part limited by reflecting non-contemporary clinical practices, regional results and selected MI patients. Jneid, H. et al. Circulation May 2008.

4. Aims of this Study • To conduct a comprehensive analysis of the influence of regular vs. off-hour AMI presentation on subsequent care and outcomes using the American Heart Association’s Get With The Guidelines-Coronary Artery Disease (GWTG-CAD) national database. • More specifically, we examined differences in reperfusion strategies, timeliness of reperfusion, use of invasive procedures, early medical treatments and in-hospital mortality among AMI patients admitted during regular vs. off-hours. • We corroborated our findings in patients with ST-segment myocardial infarction (STEMI) and non-ST-segment myocardial infarction (NSTEMI), in age and sex subgroups, and using an alternative definition for arrival time. Jneid, H. et al. Circulation May 2008.

5. Methods Data Source and Study Sample • The primary data source was the Get with the Guidelines-Coronary artery disease (GWTG-CAD) database , which contained data on a total of 93,595 AMI patients treated at 379 hospitals between July 2000 and September 2005 admissions. • We excluded patients with missing or invalid arrival dates/times (n= 4,568), and transfer-in patients (n= 26,213)in whom initial treatments could not be ascertained with accuracy. • The final study population included included 62,814 AMI patients. Jneid, H. et al. Circulation May 2008.

6. Methods Data Collection and Measures • Arrival time (regular vs. off-hours) was the primary independent variable. • Regular hours were defined as weekdays (Monday through Friday) 7:00 AM to 7:00 PM. Off-hours were defined as weeknights (7:00 PM to 7:00 AM), weekends and holidays. • Holidays included: New Year (December 31st and January 1st), Christmas holiday (December 24th and 25th), Memorial day, Independence, Labor and Thanksgiving days. Jneid, H. et al. Circulation May 2008.

7. Methods Data Collection and Measures • The primary study outcome was in-hospital mortality. • Secondary outcomes included rates of: a) Quality of Care measures: - acute medical therapies (aspirin and beta blocker within 24 h) - reperfusion therapies in the STEMI cohort (fibrinolytic therapy, PCI, any reperfusion) - timeliness of reperfusion in the STEMI cohort (door-to- balloon within 90 min, and door-to-needle within 30 min) b) Invasive procedures (catheterization, PCI, CABG, revascularization) Jneid, H. et al. Circulation May 2008.

8. Methods Statistical Analyses For the descriptive analysis: • patients’ sociodemographic • medical history variables • baseline clinical characteristics • invasive procedures • Quality of Care (QOC) are measures • in-hospital mortality were compared among patients arriving during off-hours vs. regular hours. • Multivariable logistic regression analyses, using the Generalized Estimating Equations (GEE) method, were performed to determine whether off-hour arrival independently influenced each measure and outcome. Jneid, H. et al. Circulation May 2008.

9. The adjusted covariates inlcuded: age, sex, race, body mass index, insurance type, systolic BP, cardiac diagnosis, initial ECG with diagnostic ST-segment elevation or LBBB, diabetes, hypertension, hyperlipidemia, smoking, renal insufficiency, COPD, heart failure, stroke, peripheral artery disease, and previous MI To assess the generalizability of our findings, we repeated the analysis using an alternative definition by re-classifing patients’ hospital arrival time into weekends (from 6:00 PM on Friday until 7:00 AM on Monday) and holidays vs. weekdays (from 7:00 AM on Monday until 6:00 PM on Friday). MethodsStatistical Analysis • Subgroup analyses were performed by sex and age (subdivided into 3 intervals: < 55 yr, 55-75 yr and > 75 yr). Jneid, H. et al. Circulation May 2008.

10. Results • Of all AMI patients (n= 62,814), 54.1% (n= 33,982) arrived during off-hours. • Of the overall AMI cohort, 20,279 (32.3%) patients had STEMI, defined as having an initial ECG on arrival showing diagnostic ST-segment elevation or left bundle branch block (LBBB). • The remaining 67.7% of AMI patients constituted the NSTEMI cohort (n= 42,535). Jneid, H. et al. Circulation May 2008.

11. Results Socio-Demographic Characteristics Jneid, H. et al. Circulation May 2008, Table 1..

12. Results Medical History Jneid, H. et al. Circulation May 2008, Table 1.

13. Results Clinical Characteristics Jneid, H. et al. Circulation May 2008, Table 1.

14. Results Early Medical Therapies * Overall AMI patients Jneid, H. et al. Circulation May 2008, Table 2..

15. Results Reperfusion and Timeliness of Reperfusion DTB: Door-To-Balloon; DTN: Door-To-Needle. * STEMI Patients only Jneid, H. et al. Circulation May 2008, Table 2..

16. Results Invasive Procedures Jneid, H. et al. Circulation May 2008.

17. Results In-hospital Mortality in the Overall AMI Cohort Jneid, H. et al. Circulation May 2008, figure 1.

18. Results In-hospital Mortality in the STEMI Cohort In-hospital Mortality in the NSTEMI Cohort Jneid, H. et al. Circulation May 2008, figure 1.

19. Results Adjusted Odds Ratios for Early Medical Therapies in Patients Arriving during Off-hours vs. Regular hours * Overall AMI patients Jneid, H. et al. Circulation May 2008.Table 3.

20. Results Adjusted Odds Ratios for ReperfusionTherapies in Patients Arriving during Off-hours vs. Regular hours DTB: Door-To-Balloon; DTN: Door-To-Needle. * STEMI Patients only Jneid, H. et al. Circulation May 2008. Table 3.

21. Results Adjusted Odds Ratios for InvasiveTherapies in Patients Arriving during Off-hours vs. Regular hours Jneid, H. et al. Circulation May 2008, Table 3.

22. Results In-hospital Mortality across Age Subgroups with respect to Hospital Arrival Time 12.0% (1,371) 12.2% (1,247) In-hospital Mortality (%) 5.2% (647) 4.8% (520) 2.1% (133) 2.3% (117) Jneid, H. et al. Circulation May 2008, figure 2..

23. Results In-Hospital Mortality in Men and Women with Respect to Arrival time 8.7% (1,051) 8.9% (912) 6.0% (1,094) 6.2% (968) In-hospital Mortality (%) Jneid, H. et al. Circulation May 2008, figure 2..

24. Conclusions • In this large cohort study of 62,814 patients with AMI from the multicenter GWTG-CAD database, we found that arrival during off-hours was associated with slightly lower rates of primary PCI and revascularization during the initial hospitalization, and significantly longer Door-to-Balloon times. • There were no measurable differences in in-hospital mortality in the overall AMI cohort, and in the STEMI and NSTEMI subpopulations. • Similar observations were made across most age and sex subgroups and using an alternative definition for arrival time (weekends/holidays vs. weekdays). Jneid, H. et al. Circulation May 2008.

25. Conclusions Healthcare providers should continue to work to enhance the healthcare system during regular and off-hours and reduce existing disparities in cardiac care through multifaceted initiatives aiming to improve the timely delivery of evidence-based therapies. Jneid, H. et al. Circulation May 2008.

26. AUTHORS: Hani Jneid, Gregg C. Fonarow, Christopher P. Cannon, Igor F. Palacios,TeomanKilic, George V. Moukarbel, Andrew O. Maree, Kenneth A LaBresh, Li Liang, L. Kristin Newby, Gerald Fletcher, Laura Wexler, Eric Peterson; for the Get With The Guidelines Steering Committee and Investigators From the Massachusetts General Hospital and Harvard Medical School, Boston, MA (Drs Jneid, Palacios, Kilic, Moukarbel, and Maree); UCLA Medical Center, Los Angeles, CA (Dr Fonarow); TIMI Group and BWH, Boston, MA (Dr Cannon); Masspro, Inc., Waltham, Massachusetts, USA (Dr. LaBresh); Duke Clinical Research Institute and Duke University Medical Center, Durham, NC (Drs Liang, Newby, and Peterson); Mayo Clinic, Jacksonville, FL (Dr. Fletcher); University of Cincinnati College of Medicine, Cincinnati, OH (Dr Wexler) Jneid, H. et al. Circulation May 2008

27. This analysis and publication is supported by a grant from the Council on Clinical Cardiology of the American Heart Association. The GWTG-CAD program is funded in part by the Merck Schering Plough partnership. Data collection and management was performed by Outcome, Inc (Cambridge, MA). The analysis of registry data was preformed at Duke Clinical Research Institute (Durham, NC), which also receives funding from the American Heart Association. Funding/Support Jneid, H. et al. Circulation May 2008

28. Dr. Hani Jneid has received a database research seed grant from the Council on Clinical Cardiology. Dr. Gregg C. Fonarow serves as chair of the American Heart Association's Get With the Guidelines Steering Committee. Dr. Christopher Cannon serves as the chair of the American Heart Association's Get With the Guidelines Steering Science Sub-Committee. Dr. Eric Peterson is the Associated Director of the Duke Clinical Research Institute, which also receives funding from the American Heart Association. Disclosures Jneid, H. et al. Circulation May 2008

29. Publication ahead of Print Reference Jneid H, Fonarow GC, Cannon CP, Palacios IF, Kilic T, Moukarbel GV, Maree AO, LaBresh KA, Liang L, Newby LK, Fletcher G, Wexler L, Peterson E, for the Get With the Guidelines Steering Committee and Investigators Impact of Time of Presentation on the Care and Outcomes of Acute Myocardial Infarction. Circulation 2008: published online before print April 21, 2008, 10.1161/CIRCULATIONAHA.107.752113