© 2008, American Heart Association. All rights reserved. Impact of Time of Presentation on the Care and Outcomes of Acute Myocardial Infarction Hani Jneid,

© 2008, American Heart Association. All rights reserved.

Impact of Time of Presentation on the Care and Impact of Time of Presentation on the Care and Outcomes of Acute Myocardial InfarctionOutcomes 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.


BackgroundBackground

• Acute myocardial infarction (AMI) remains a leading cause of Acute myocardial infarction (AMI) remains a leading cause of death in the United States. Its associated mortality and death in the United States. Its associated mortality and morbidity can be altered however by proven, effective morbidity can be altered however by proven, effective therapies. therapies.

• Healthcare providers have been working to improve the Healthcare providers have been working to improve the consistency and timely delivery of evidence-based consistency and timely delivery of evidence-based treatments. Despite these efforts, studies continue to treatments. Despite these efforts, studies continue to demonstrate quality gaps in AMI care in routine clinical demonstrate quality gaps in AMI care in routine clinical practice. practice.



BackgroundBackground

• Recently, several studies found that patients presenting on Recently, several studies found that patients presenting on weekends or during “off-hours” (weekday nights, weekends, weekends or during “off-hours” (weekday nights, weekends, and holidays) were less likely to receive guideline-based and holidays) were less likely to receive guideline-based medications and/or timely reperfusion after AMI. medications and/or timely reperfusion after AMI.

• However, these studies have been inconsistent in their However, these studies have been inconsistent in their findings and have been in part limited by reflecting non-findings and have been in part limited by reflecting non-contemporary clinical practices, regional results and selected contemporary clinical practices, regional results and selected MI patients. MI patients.



• To conduct a comprehensive analysis of the influence of regular vs. To conduct a comprehensive analysis of the influence of regular vs. off-hour AMI presentation on subsequent care and outcomes using off-hour AMI presentation on subsequent care and outcomes using the American Heart Association’s the American Heart Association’s Get With The Guidelines-Coronary Get With The Guidelines-Coronary Artery Disease (GWTG-CAD) national Artery Disease (GWTG-CAD) national database. database.

• More specifically, we examined differences in reperfusion strategies, More specifically, we examined differences in reperfusion strategies, timeliness of reperfusion, use of invasive procedures, early medical timeliness of reperfusion, use of invasive procedures, early medical treatments and in-hospital mortality among AMI patients admitted treatments and in-hospital mortality among AMI patients admitted during regular vs. off-hours. during regular vs. off-hours.

• We corroborated our findings in patients with ST-segment We corroborated our findings in patients with ST-segment myocardial infarction (STEMI) and non-ST-segment myocardial myocardial infarction (STEMI) and non-ST-segment myocardial infarction (NSTEMI), in age and sex subgroups, and using an infarction (NSTEMI), in age and sex subgroups, and using an alternative definition for arrival time. alternative definition for arrival time.

Aims of this StudyAims of this Study



MethodsMethodsData Source and Study SampleData Source and Study Sample

• The The primary data source primary data source was the Get with the Guidelines-Coronary artery disease (GWTG-CAD) database , which contained data on a was the Get with the Guidelines-Coronary artery disease (GWTG-CAD) database , which contained data on a total of total of 93,595 AMI patients treated at 379 hospitals between July 2000 and September 200593,595 AMI patients treated at 379 hospitals between July 2000 and September 2005 admissions. admissions.

• WWe excluded patients with missing or invalid arrival dates/timese excluded patients with missing or invalid arrival dates/times (n= (n= 4,5684,568)), and transfer-in patients, and transfer-in patients (n= (n= 26,21326,213)) in whomin whom initial initial treatments could not be ascertained with accuracy.treatments could not be ascertained with accuracy.

• The The final study populationfinal study population included included included 62,814 AMI patientsincluded 62,814 AMI patients..



MethodsMethodsData Collection and Measures Data Collection and Measures

• Arrival time (regular vs. off-hours) was the primary independent variable. 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 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. to 7:00 AM), weekends and holidays.

• HolidaysHolidays included: New Year (December 31 included: New Year (December 31stst and January 1 and January 1stst), Christmas holiday (December 24), Christmas holiday (December 24thth and 25th), Memorial day, and 25th), Memorial day, Independence, Labor and Thanksgiving days. Independence, Labor and Thanksgiving days.



MethodsMethodsData Collection and Measures Data Collection and Measures

• The primary study outcome was in-hospital mortality. The primary study outcome was in-hospital mortality.

• Secondary outcomes included rates of:Secondary outcomes included rates of: a) Quality of Care measures:a) Quality of Care measures:

- acute medical therapies (aspirin and beta blocker within - acute medical therapies (aspirin and beta blocker within 24 h)24 h)

- reperfusion therapies in the STEMI cohort (fibrinolytic - reperfusion therapies in the STEMI cohort (fibrinolytic therapy, PCI, any reperfusion)therapy, PCI, any reperfusion)

- timeliness of reperfusion in the STEMI cohort (door-to-- timeliness of reperfusion in the STEMI cohort (door-to- balloon within 90 min, and door-to-needle within 30 balloon within 90 min, and door-to-needle within 30 min)min) b) Invasive procedures (catheterization, PCI, CABG, b) Invasive procedures (catheterization, PCI, CABG, revascularization)revascularization)



Statistical AnalysesStatistical AnalysesFor the descriptive analysisFor the descriptive analysis::

– patients’ sociodemographic patients’ sociodemographic – medical history variables medical history variables – baseline clinical characteristics baseline clinical characteristics – invasive procedures invasive procedures – QQuality of uality of CCare (QOC) areare (QOC) are measures measures – in-hospital mortality were compared among patients arriving in-hospital mortality were compared among patients arriving

during off-hours vs. regular hours. during off-hours vs. regular hours.

• Multivariable logistic regression analyses, using the Generalized Multivariable logistic regression analyses, using the Generalized Estimating EquationsEstimating Equations (GEE) (GEE) method, were performed to method, were performed to determine whether off-hour arrival independently influenced determine whether off-hour arrival independently influenced each measure and outcome.each measure and outcome.

MethodsMethods



MethodsStatistical Analysis

• 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).

• Subgroup analyses were performed by sex and age (subdivided into 3 intervals: < 55 yr, 55-75 yr and > 75 yr).



• Of all AMI patients (n= 62,814), Of all AMI patients (n= 62,814), 54.1% (n= 33,982) arrived 54.1% (n= 33,982) arrived during off-hours.during off-hours.

• Of the overall AMI cohort, Of the overall AMI cohort, 20,279 (32.3%) patients had STEMI20,279 (32.3%) patients had STEMI, , defined as having an initial ECG on arrival showing diagnostic defined as having an initial ECG on arrival showing diagnostic ST-segment elevation or left bundle branch block (LBBB). ST-segment elevation or left bundle branch block (LBBB).

• The remaining 67.7% of AMI patients constituted the NSTEMI The remaining 67.7% of AMI patients constituted the NSTEMI cohort (n= 42,535).cohort (n= 42,535).

ResultsResults



ResultsResultsSocio-Demographic Characteristics

DescriptionRegular hours

(N= 28,832)% (n)

Off-hours (N =33,982)

% (n)P value

Age, mean (SD), yr 68.2 ±14.4 67.6 ±14.7 < 0.0001

Male 60.8 (17,524) 60.3 (20,494) 0.23

Caucasian 75.1 (21,654) 73.3 (24,921)

< 0.0001

African American 6.7 (1,934) 7.4 (2,523)

Asian 4.0 (1,150) 4.1 (1,404)

Hispanic 6.8 (1,945) 6.9 (2,328)

American Indian 0.2 (46) 0.2 (61)

Other 1.9 (541) 2.3 (764)

Unknown 5.4 (1,562) 5.8 (1,981)

BMI, mean (SD), kg/m2 28.0±6.5 (25,713) 28.1±6.5 (30,078) 0.0001

Health insurance

Medicare 43.4 (12,498) 41.6 (14,119) < 0.0001

Medicaid 5.7 (1,646) 6.1 (2,059) 0.03

No insurance/UTD 6.7 (1,916) 6.9 (2,333) 0.16

Other insurance 38.3 (11,035) 38.0 (12,917) 0.80

Jneid, H. et al. Circulation May 2008, Table 1..


ResultsResults


(N= 28,832)% (n)

Off-hours (N =33,982)

% (n)P value

Hypertension 62.1 (17,896) 61.7 (20,956) 0.30

Hyperlipidemia 31.3 (9,033) 31.7 (10,782) 0.26

Diabetes 30.1 (8,670) 31.5 (10,690) 0.0001

Previous MI 19.8 (5,697) 21.3 (7,226) < 0.0001

Angina 10.4 (2,984) 10.2 (3,476) 0.63

Heart failure 15.5 (4,472) 16.8 (5,707) < 0.0001

Chronic renal insufficiency 10.8 (3,117) 11.0 (3,730) 0.50

Renal dialysis 2.3 (649) 2.2 (755) 0.81

Atrial fibrillation 8.6 (2,470) 8.1 (2,752) 0.03

Stroke 8.6 (2,472) 8.5 (2,898) 0.85

COPD 13.1 (3,781) 13.2 (4,493) 0.68

PVD 8.8 (2,536) 8.5 (2,884) 0.17

Adult history of smoking 26.6 (7,667) 28.8 (9,802) < 0.0001

Medical History

Jneid, H. et al. Circulation May 2008, Table 1.


ResultsResultsClinical Characteristics


(N= 28,832)% (n)

Off-hours (n =33,982)

% (n)P value

STEMI diagnosis 31.6 (9,122) 32.8 (11,157) 0.001

SBP, mean (SD), mmHg 123±28 123±28 0.76

DBP, mean (SD), mmHg 67±16 67±17 0.27

Total Cholesterol, mean (SD), mg/dl 175±48 176±48 0.04

Ejection fraction, mean (SD), % 47±15 47±15 0.38



ResultsResults

Early Medical Therapies

Regular hours% (n)

Off-hours % (n)

PValue

Aspirin within 24h * 91.2 (23,634) 91.3 (27,928) 0.65

Beta blocker within 24h * 84.0 (20,177) 84.7 (23,985) 0.02


* Overall AMI patients


ResultsResultsReperfusion and Timeliness of Reperfusion

Regular hours% (n)

Off-hours % (n)

PValue

Reperfusion therapy *

Any Reperfusion 65.5 (5,970) 66.2 (7,384) 0.21

PCI 60.5 (5,516) 58.9 (6,570) 0.03

Fibrinolytics 9.8 (893) 14.1 (1,574) <0.0001

Timeliness of Reperfusion *

DTN time, Median (25th-75th), min 40 (23-65) 40 (25-65) 0.59

DTB time, Median (25th-75th), min 85 (60-127) 110 (83-157) <0.0001

DTN time ≤ 30 min, % (n) 35.4 (271) 33.5 (485) 0.36

DTB time ≤ 90 min, % (n) 54.2 (1,390) 30.9 (891) <0.0001

DTB: Door-To-Balloon; DTN: Door-To-Needle. * STEMI Patients only



ResultsResultsInvasive Procedures

Regular hours% (n)

Off-hours % (n)

PValue

All AMI patients Cardiac catheterization 52.8 (13,764) 52.8 (15,972) 0.8 PCI 45.2 (11,800) 44.4 (13,441) 0.07 CABG 8.0 (2,083) 7.6 (2,301) 0.1 Any Revascularization 52.2 (13,620) 51.0 (15,433) 0.006STEMI patients Cardiac catheterization 60.3 (5,027) 60.2 (6,046) 0.9 CABG 7.1 (596) 7.8 (788) 0.07 Any Revascularization 70.2 (5,855) 69.9 (7,021) 0.7NSTEMI patients Cardiac catheterization 49.2 (8,737) 49.1 (9,926) 1.0 PCI 36.1 (6,403) 34.7 (7,021) 0.009 CABG 8.4 (1,487) 7.5 (1,513) 0.002 Any Revascularization 43.7 (7,765) 41.6 (8,412) <0.0001



ResultsResultsIn-hospital Mortality in the Overall AMI Cohort

Jneid, H. et al. Circulation May 2008, figure 1.


ResultsResults

In-hospital Mortality in the NSTEMI Cohort

In-hospital Mortality in the STEMI Cohort

Jneid, H. et al. Circulation May 2008, figure 1.


ResultsResults

N

OR (95% CI)Off-hours

vs.Regular hours

P value

Aspirin within 24 h 56,491 1.03 (0.98-1.09) 0.28

Beta blocker within 24 h 52,343 1.05 (1.01-1.10) 0.03

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.


ResultsResults

NOR (95% CI)Off-hours vs.Regular hours

P value

Reperfusion Therapy * Any Reperfusion therapy 19,848 1.03 (0.98-1.09) 0.25 PCI 19,848 0.93 (0.89-0.98) 0.004

Fibrinolytic therapy 19,848 1.40 (1.28-1.54)<

0.0001Timeliness of Reperfusion * Door-to-needle time ≤ 30 min

2,216 0.93 (0.77-1.12) 0.44

Door-to-balloon time ≤ 90 min

5,454 0.34 (0.29-0.39)<

0.0001

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.


ResultsResults

NOR (95% CI)Off-hours vs.

Regular hoursP value

All AMI patients Cardiac catheterization 54,383 0.98 (0.94-1.01) 0.17 PCI 54,383 0.96 (0.92-0.99) 0.02 CABG 54,383 0.92 (0.86-1.00) 0.04 Revascularization 54,383 0.94 (0.90-0.97) 0.0006STEMI patients Cardiac catheterization 18,048 0.97 (0.92-1.02) 0.18 CABG 18,048 1.07 (0.95-1.22) 0.26 Any Revascularization 18,048 0.96 (0.90-1.01) 0.11NSTEMI patients Cardiac catheterization 36,335 0.99 (0.95-1.04) 0.71 PCI 36,335 0.97 (0.93-1.01) 0.18 CABG 36,335 0.87 (0.80-0.93) 0.0002 Any Revascularization 36,335 0.93 (0.89-0.97) 0.002

Adjusted Odds Ratios for InvasiveTherapies in Patients Arriving during Off-hours vs. Regular hours



ResultsResults

2.1%(133)

2.3%(117)

5.2%(647)

4.8%(520)

12.0%(1,371)

12.2%(1,247)

In-hospital Mortality across Age Subgroups with respect to Hospital Arrival Time

Jneid, H. et al. Circulation May 2008, figure 2..


ResultsResultsIn-Hospital Mortality in Men and Women with

Respect to Arrival time

6.0%(1,094)

6.2%(968)

8.7%(1,051)

8.9%(912)

Jneid, H. et al. Circulation May 2008, figure 2..


ConclusionsConclusions• IIn this large cohort study of 62,814 patients with AMI from the n this large cohort study of 62,814 patients with AMI from the

multicenter GWTG-CAD database, we found that arrival during multicenter GWTG-CAD database, we found that arrival during off-hours was associated with slightly lower rates of primary off-hours was associated with slightly lower rates of primary PCI and revascularization during the initial hospitalization, and PCI and revascularization during the initial hospitalization, and significantly longer Dsignificantly longer Door-to-Balloonoor-to-Balloon times. times.

• There were no measurable differences in in-hospital mortality There were no measurable differences in in-hospital mortality in the overall AMI cohort, and in the STEMI and NSTEMI in the overall AMI cohort, and in the STEMI and NSTEMI subpopulations.subpopulations.

• Similar observations were made across most age and sex Similar observations were made across most age and sex subgroups and using an alternative definition for arrival time subgroups and using an alternative definition for arrival time (weekends/holidays vs. weekdays).(weekends/holidays vs. weekdays).



ConclusionsConclusions

Healthcare providers should continue to work to enhance the Healthcare providers should continue to work to enhance the

healthcare system during regular and off-hours and reduce healthcare system during regular and off-hours and reduce

existing disparities in cardiac care through multifaceted existing disparities in cardiac care through multifaceted

initiatives aiming to improve the initiatives aiming to improve the timely delivery of evidence-timely delivery of evidence-

based therapies. based therapies.



AUTHORS: AUTHORS:

Hani Jneid, Gregg C. Fonarow, Christopher P. Cannon, Igor F. Hani Jneid, Gregg C. Fonarow, Christopher P. Cannon, Igor F. Palacios,Palacios, Teoman Kilic, George V. Moukarbel, Andrew O. Maree, Teoman Kilic, George V. Moukarbel, Andrew O. Maree, KenKenneth Aneth A LaBresh, LaBresh, Li Liang, L. Kristin Newby, Gerald Fletcher, Li Liang, L. Kristin Newby, Gerald Fletcher, Laura Wexler, Eric Peterson; for the Laura Wexler, Eric Peterson; for the Get With The Get With The GuidelinesGuidelines Steering Committee and Investig 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


Funding/SupportFunding/Support

This This analysis and analysis and publication is supported by a grant from the publication is supported by a grant from the Council on Clinical Cardiology of the American Heart Council on Clinical Cardiology of the American Heart Association. Association.

The GWTG-CAD program is funded in part by the Merck The GWTG-CAD program is funded in part by the Merck Schering Plough partnership. Data collection and management Schering Plough partnership. Data collection and management was performed by Outcome, Inc (Cambridge, MA). was performed by Outcome, Inc (Cambridge, MA).

The analysis of registry data was preformed at Duke Clinical The analysis of registry data was preformed at Duke Clinical Research Institute (Durham, NC), which also receives funding Research Institute (Durham, NC), which also receives funding from the American Heart Association. from the American Heart Association.



DisclosuresDisclosures

Dr. Hani Jneid has received a database research seed grant from the Council Dr. Hani Jneid has received a database research seed grant from the Council on Clinical Cardiology. on Clinical Cardiology.

Dr. Gregg C. Fonarow serves as chair of the American Heart Association's Dr. Gregg C. Fonarow serves as chair of the American Heart Association's Get With the Guidelines Steering Committee. Get With the Guidelines Steering Committee.

Dr. Christopher Cannon serves as the chair of the American Heart Dr. Christopher Cannon serves as the chair of the American Heart Association's Get With the Guidelines Steering Science Sub-Committee. Association's Get With the Guidelines Steering Science Sub-Committee.

Dr. Eric Peterson is the Associated Director of the Duke Clinical Research Dr. Eric Peterson is the Associated Director of the Duke Clinical Research Institute, which also receives funding from the American Heart Association. Institute, which also receives funding from the American Heart Association.



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

© 2008, American Heart Association. All rights reserved. Impact of Time of Presentation on the Care and Outcomes of Acute Myocardial Infarction Hani Jneid,

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