10 lessons learned from crusade: a national quality improvement initiative

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Clinical Trial Results . org Characteristics, Management, and Outcomes of 5,557 Patients Age ≥90 Years With Acute Coronary Syndromes: Results From the CRUSADE Initiative Adam H. Skolnick, MD, Karen P. Alexander, MD, Anita Adam H. Skolnick, MD, Karen P. Alexander, MD, Anita Y. Chen, MS, Matthew T. Roe, MD, MSH, Charles V. Y. Chen, MS, Matthew T. Roe, MD, MSH, Charles V. Pollack, Jr, MD, MA, E. Magnus Ohman, MD, John S. Pollack, Jr, MD, MA, E. Magnus Ohman, MD, John S. Rumsfeld, MD, PhD, W. Brian Gibler, MD, Eric D. Rumsfeld, MD, PhD, W. Brian Gibler, MD, Eric D. Peterson, MD, MPH, David J. Cohen, MD, MSc Peterson, MD, MPH, David J. Cohen, MD, MSc J Am Coll Cardiol 2007; 49:1790-7 J Am Coll Cardiol 2007; 49:1790-7 The CRUSADE National Quality Improvement The CRUSADE National Quality Improvement Initiative Initiative

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Page 1: 10 Lessons Learned from CRUSADE: A National Quality Improvement Initiative

Clinical Trial Results . orgClinical Trial Results . org

Characteristics, Management, and Outcomes of 5,557 Patients Age ≥90 Years With Acute Coronary

Syndromes: Results From the CRUSADE Initiative

Characteristics, Management, and Outcomes of 5,557 Patients Age ≥90 Years With Acute Coronary

Syndromes: Results From the CRUSADE Initiative

Adam H. Skolnick, MD, Karen P. Alexander, MD, Anita Y. Chen, Adam H. Skolnick, MD, Karen P. Alexander, MD, Anita Y. Chen, MS, Matthew T. Roe, MD, MSH, Charles V. Pollack, Jr, MD, MA, E. MS, Matthew T. Roe, MD, MSH, Charles V. Pollack, Jr, MD, MA, E.

Magnus Ohman, MD, John S. Rumsfeld, MD, PhD, W. Brian Magnus Ohman, MD, John S. Rumsfeld, MD, PhD, W. Brian Gibler, MD, Eric D. Peterson, MD, MPH, David J. Cohen, MD, MScGibler, MD, Eric D. Peterson, MD, MPH, David J. Cohen, MD, MSc

J Am Coll Cardiol 2007; 49:1790-7J Am Coll Cardiol 2007; 49:1790-7

The CRUSADE National Quality Improvement InitiativeThe CRUSADE National Quality Improvement Initiative The CRUSADE National Quality Improvement InitiativeThe CRUSADE National Quality Improvement Initiative

Page 2: 10 Lessons Learned from CRUSADE: A National Quality Improvement Initiative

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CRUSADE: BackgroundCRUSADE: Background

• Patients aged 90 and older (the “oldest old”) are Patients aged 90 and older (the “oldest old”) are often excluded from clinical trials and included in often excluded from clinical trials and included in low numbers in clinical registrieslow numbers in clinical registries

• In particular, little is known about contemporary In particular, little is known about contemporary treatment and outcomes of acute coronary treatment and outcomes of acute coronary syndromes in such patientssyndromes in such patients

• Patients aged 90 and older (the “oldest old”) are Patients aged 90 and older (the “oldest old”) are often excluded from clinical trials and included in often excluded from clinical trials and included in low numbers in clinical registrieslow numbers in clinical registries

• In particular, little is known about contemporary In particular, little is known about contemporary treatment and outcomes of acute coronary treatment and outcomes of acute coronary syndromes in such patientssyndromes in such patients

Skolnick et al., JACC Vol.49, No.17, 2007Skolnick et al., JACC Vol.49, No.17, 2007

Page 3: 10 Lessons Learned from CRUSADE: A National Quality Improvement Initiative

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CRUSADE: ObjectivesCRUSADE: Objectives

• Describe key differences in baseline characteristics Describe key differences in baseline characteristics and ACS presentation among patients age 90 and and ACS presentation among patients age 90 and older compared with a relatively younger cohortolder compared with a relatively younger cohort

• Determine current treatment patterns in the oldest oldDetermine current treatment patterns in the oldest old

• Determine presenting characteristics associated with Determine presenting characteristics associated with in-hospital mortality among the oldest old with ACSin-hospital mortality among the oldest old with ACS

• Describe key differences in baseline characteristics Describe key differences in baseline characteristics and ACS presentation among patients age 90 and and ACS presentation among patients age 90 and older compared with a relatively younger cohortolder compared with a relatively younger cohort

• Determine current treatment patterns in the oldest oldDetermine current treatment patterns in the oldest old

• Determine presenting characteristics associated with Determine presenting characteristics associated with in-hospital mortality among the oldest old with ACSin-hospital mortality among the oldest old with ACS

Skolnick et al., JACC Vol.49, No.17, 2007Skolnick et al., JACC Vol.49, No.17, 2007

Page 4: 10 Lessons Learned from CRUSADE: A National Quality Improvement Initiative

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CRUSADE: Study DesignCRUSADE: Study Design

Primary Endpoint: Compare baseline characteristics, treatment Primary Endpoint: Compare baseline characteristics, treatment patterns, and in-hospital outcomes of both cohortspatterns, and in-hospital outcomes of both cohorts

Primary Endpoint: Compare baseline characteristics, treatment Primary Endpoint: Compare baseline characteristics, treatment patterns, and in-hospital outcomes of both cohortspatterns, and in-hospital outcomes of both cohorts

Cohort A Cohort A Pts Pts >>90 yrs90 yrs

n=5,557n=5,557

Cohort A Cohort A Pts Pts >>90 yrs90 yrs

n=5,557n=5,557

Cohort B Cohort B Pts 75 to 89 yrsPts 75 to 89 yrs

n=46,270n=46,270

Cohort B Cohort B Pts 75 to 89 yrsPts 75 to 89 yrs

n=46,270n=46,270

51,827 patients 51,827 patients >>75 years with NSTE-ACS from CRUSADE Registry 75 years with NSTE-ACS from CRUSADE Registry arriving at a participating facility either via the emergency department or by transfer within 24 h of onset of arriving at a participating facility either via the emergency department or by transfer within 24 h of onset of

symptoms. In addition, initial evaluation must reveal 1 or more high-risk features including ST-segment symptoms. In addition, initial evaluation must reveal 1 or more high-risk features including ST-segment depression, transient ST-segment elevation, or elevated levels of biomarkersdepression, transient ST-segment elevation, or elevated levels of biomarkers

51,827 patients 51,827 patients >>75 years with NSTE-ACS from CRUSADE Registry 75 years with NSTE-ACS from CRUSADE Registry arriving at a participating facility either via the emergency department or by transfer within 24 h of onset of arriving at a participating facility either via the emergency department or by transfer within 24 h of onset of

symptoms. In addition, initial evaluation must reveal 1 or more high-risk features including ST-segment symptoms. In addition, initial evaluation must reveal 1 or more high-risk features including ST-segment depression, transient ST-segment elevation, or elevated levels of biomarkersdepression, transient ST-segment elevation, or elevated levels of biomarkers

Skolnick et al., JACC Vol.49, No.17, 2007Skolnick et al., JACC Vol.49, No.17, 2007

Page 5: 10 Lessons Learned from CRUSADE: A National Quality Improvement Initiative

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CRUSADE: Baseline CharacteristicsCRUSADE: Baseline Characteristics

CharacteristicCharacteristic 75-89 y.o.75-89 y.o.(N= 46,270)(N= 46,270)

Age Age ≥ 90≥ 90(N=5,557)(N=5,557)

p-valuep-value

Age (yrs)Age (yrs) 81.0 81.0 ± 4.0± 4.0 92.6 92.6 ± 2.6± 2.6 <0.001<0.001

Caucasian (%)Caucasian (%) 85.785.7 86.186.1 NSNS

Female (%)Female (%) 50.150.1 67.467.4 <0.001<0.001

Diabetes Mellitus (%)Diabetes Mellitus (%) 34.234.2 20.420.4 <0.001<0.001

Hypertension (%)Hypertension (%) 76.176.1 73.773.7 <0.001<0.001

Peripheral Vascular Disease (%)Peripheral Vascular Disease (%) 15.615.6 10.710.7 <0.001<0.001

Obesity (BMI>30) (%)Obesity (BMI>30) (%) 18.918.9 7.67.6 <0.001<0.001

Recent/current smoker (%)Recent/current smoker (%) 8.88.8 2.52.5 <0.001<0.001

Family History of CAD (%)Family History of CAD (%) 25.025.0 14.814.8 <0.001<0.001

Prior Aspirin use (%)Prior Aspirin use (%) 49.249.2 46.746.7 0.0010.001

Previous PCI (%)Previous PCI (%) 20.120.1 8.78.7 <0.001<0.001

History of CHF (%)History of CHF (%) 26.926.9 39.339.3 <0.001<0.001

Creatinine Clearance (ml/min)Creatinine Clearance (ml/min) 36.036.0 23.923.9 <0.001<0.001

Skolnick et al., JACC Vol.49, No.17, 2007Skolnick et al., JACC Vol.49, No.17, 2007

Page 6: 10 Lessons Learned from CRUSADE: A National Quality Improvement Initiative

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CRUSADE: Findings at AdmissionCRUSADE: Findings at Admission

FindingFinding 75-89 yrs75-89 yrs(N= 46,270)(N= 46,270)

Age Age ≥ 90≥ 90(N=5,557)(N=5,557)

p-valuep-value

ST-segment depressions (%)ST-segment depressions (%) 36.936.9 3535 <0.001<0.001

CK-MB positive (%)CK-MB positive (%) 71.171.1 74.174.1 <0.001<0.001

Troponin positive (%)Troponin positive (%) 81.881.8 86.886.8 <0.001<0.001

SBP <90 mm Hg (%)SBP <90 mm Hg (%) 4.14.1 4.94.9 0.0040.004

HR >100 bpm (%)HR >100 bpm (%) 25.525.5 28.928.9 <0.001<0.001

Signs of CHF (%)Signs of CHF (%) 33.733.7 45.445.4 <0.001<0.001

Skolnick et al., JACC Vol.49, No.17, 2007Skolnick et al., JACC Vol.49, No.17, 2007

Page 7: 10 Lessons Learned from CRUSADE: A National Quality Improvement Initiative

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CRUSADE: In-Hospital TherapiesCRUSADE: In-Hospital Therapies

TherapyTherapy 75-89 y.o.75-89 y.o.(N= 46,270)(N= 46,270)

Age Age ≥ 90≥ 90(N=5,557)(N=5,557)

p-valuep-value

Aspirin (%)Aspirin (%) 91.791.7 90.690.6 0.0110.011

Beta-blocker (%)Beta-blocker (%) 82.282.2 80.780.7 0.0170.017

Heparin, any route (%)Heparin, any route (%) 82.482.4 75.175.1 <0.001<0.001

Clopidogrel (%)Clopidogrel (%) 40.140.1 35.535.5 <0.001<0.001

Statin (%)Statin (%) 45.745.7 30.430.4 <0.001<0.001

ACE-I (%)ACE-I (%) 47.147.1 45.345.3 0.0250.025

Gp IIb/IIIa inhibitor (%)Gp IIb/IIIa inhibitor (%) 29.229.2 12.012.0 <0.001<0.001

Coronary Revasc, any (%)Coronary Revasc, any (%) 40.140.1 12.612.6 <0.001<0.001

PCI w/in 1PCI w/in 1stst 48 hours (%) 48 hours (%) 20.220.2 6.56.5 <0.001<0.001

CABG (%)CABG (%) 9.49.4 1.11.1 <0.001<0.001

Skolnick et al., JACC Vol.49, No.17, 2007Skolnick et al., JACC Vol.49, No.17, 2007

Page 8: 10 Lessons Learned from CRUSADE: A National Quality Improvement Initiative

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CRUSADE: In-hospital Adverse OutcomesCRUSADE: In-hospital Adverse Outcomes

OutcomeOutcome 75-89 y.o.75-89 y.o.(N=46,270)(N=46,270)

Age Age ≥ 90≥ 90(N=5,557)(N=5,557)

p-valuep-value

Death (%)Death (%) 7.87.8 12.012.0 <0.001<0.001

MI (%)MI (%) 3.53.5 3.03.0 NSNS

Stroke (%)Stroke (%) 1.21.2 0.90.9 0.0320.032

Cardiogenic Shock (%)Cardiogenic Shock (%) 3.53.5 3.13.1 NSNS

CHF (%)CHF (%) 12.912.9 16.416.4 <0.001<0.001

RBC Transfusion RBC Transfusion ŧŧ 14.114.1 12.812.8 --Major Bleeding Event** Major Bleeding Event** ŧŧ (%) (%) 13.113.1 9.99.9 <0.001<0.001Any Adverse Outcome Any Adverse Outcome ŁŁ(%)(%) 21.321.3 26.826.8 --

Skolnick et al., JACC Vol.49, No.17, 2007Skolnick et al., JACC Vol.49, No.17, 2007

** Major Bleeding: (1) Hct decline >11% (2) Intracranial Hemorrhage (3) Retroperitoneal hemorrhage (4) Baseline Hct >27% w/ transfusion (5) Witnessed bleeding event w/ baseline Hct <28 w/ transfusion

ŧ Excluded patients who underwent bypass surgery

Ł Any adverse outcome: post-admission MI, cardiogenic shock, heart failure, stroke, or death

Page 9: 10 Lessons Learned from CRUSADE: A National Quality Improvement Initiative

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14.7%

8.3%6.7% 6.2%

18.9%

11.0%10.2%

11.1%

0%

5%

10%

15%

20%

25%

30%

0-25% 26-50% 51-75% 76-100%

Age 75-89 Age ≥ 90

14.7%

8.3%6.7% 6.2%

18.9%

11.0%10.2%

11.1%

0%

5%

10%

15%

20%

25%

30%

0-25% 26-50% 51-75% 76-100%

Age 75-89 Age ≥ 90

CRUSADE: In-hospital Mortality Across Each Age Group With Increasing Adherence to Recommended Therapies

CRUSADE: In-hospital Mortality Across Each Age Group With Increasing Adherence to Recommended Therapies

In-H

ospi

tal M

orta

lity

(%

)In

-Hos

pita

l Mor

talit

y (

%)

Guidelines recommended therapies included acute (<24h) aspirin, acute B-blockers, acute Guidelines recommended therapies included acute (<24h) aspirin, acute B-blockers, acute heparin and cardiac catheterization within 48h, and receipt of glycoprotein IIb/IIIa inhibitors for heparin and cardiac catheterization within 48h, and receipt of glycoprotein IIb/IIIa inhibitors for patients undergoing early catheterization.patients undergoing early catheterization.

Skolnick et al., JACC Vol.49, No.17, 2007Skolnick et al., JACC Vol.49, No.17, 2007

Percent Adherence ScorePercent Adherence Score

P-value for trend <0.001

P-value for age-treatment interaction = NS

Page 10: 10 Lessons Learned from CRUSADE: A National Quality Improvement Initiative

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9.0%8.3%

11.2% 10.8%11.4%

15.4%

0.0%

3.5%

10.9% 11.3%

13.6%

17.3%

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

20%

None One Two Three Four Five

Age 75-89 Age ≥ 90

9.0%8.3%

11.2% 10.8%11.4%

15.4%

0.0%

3.5%

10.9% 11.3%

13.6%

17.3%

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

20%

None One Two Three Four Five

Age 75-89 Age ≥ 90

CRUSADE: Number of Therapies Provided and the Incidence of In-Hospital Bleeding

CRUSADE: Number of Therapies Provided and the Incidence of In-Hospital Bleeding

Maj

or B

leed

ing

(%

)M

ajor

Ble

edin

g (

%)

*Therapies: (1) Aspirin (2) Beta-blocker (3) Heparin (4) Cath w/in 48 hrs w/ *Therapies: (1) Aspirin (2) Beta-blocker (3) Heparin (4) Cath w/in 48 hrs w/ IIb/IIIa (5) Cath w/in 48 hrs. IIb/IIIa (5) Cath w/in 48 hrs. (CABG Pts and contraindications excluded)(CABG Pts and contraindications excluded)

Skolnick et al., JACC Vol.49, No.17, 2007Skolnick et al., JACC Vol.49, No.17, 2007

Number of Therapies Received *Number of Therapies Received *

P-value for trend <0.001

P-value for age-treatment interaction = NS

Page 11: 10 Lessons Learned from CRUSADE: A National Quality Improvement Initiative

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CRUSADE: Multivariate Analysis: Independent Predictors of In-hospital Mortality Among Patients Aged ≥90

CRUSADE: Multivariate Analysis: Independent Predictors of In-hospital Mortality Among Patients Aged ≥90

FindingFinding Adjusted O.R. Adjusted O.R. (95% C.I.)(95% C.I.)

p-valuep-value

Systolic BP (by 10 mm Hg)Systolic BP (by 10 mm Hg) 1.19 (1.16-1.23)1.19 (1.16-1.23) <0.001<0.001

Signs of CHFSigns of CHF 1.76 (1.45-2.15)1.76 (1.45-2.15) <0.001<0.001

Renal InsufficiencyRenal Insufficiency 1.48 (1.23-1.78)1.48 (1.23-1.78) <0.001<0.001

Troponin RatioTroponin Ratio 1.01 (1.00-1.02)1.01 (1.00-1.02) <0.001<0.001

Diabetes MellitusDiabetes Mellitus 1.38 (1.14-1.67)1.38 (1.14-1.67) <0.001<0.001

BMI >25 vs. normalBMI >25 vs. normal 1.30 (1.08-1.57)1.30 (1.08-1.57) 0.0260.026

Prior PCI Prior PCI 0.63 (0.45-0.90)0.63 (0.45-0.90) 0.0010.001

DyslipidemiaDyslipidemia 0.78 (0.65-0.95)0.78 (0.65-0.95) 0.0140.014

Skolnick et al., JACC Vol.49, No.17, 2007Skolnick et al., JACC Vol.49, No.17, 2007

Page 12: 10 Lessons Learned from CRUSADE: A National Quality Improvement Initiative

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CRUSADE: LimitationsCRUSADE: Limitations

• Further studies are necessary to validate this risk model and to better understand long-term outcomes in this challenging population

• Further studies are necessary to validate this risk model and to better understand long-term outcomes in this challenging population

Skolnick et al., JACC Vol.49, No.17, 2007Skolnick et al., JACC Vol.49, No.17, 2007

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CRUSADE: SummaryCRUSADE: Summary

• Among the oldest old with ACS, traditional risk Among the oldest old with ACS, traditional risk factors for CAD were less common compared factors for CAD were less common compared with the patients aged 75-89, while CHF and with the patients aged 75-89, while CHF and renal dysfunction were more common.renal dysfunction were more common.

• After excluding those with contraindications, After excluding those with contraindications, use of evidence-based medications, early use of evidence-based medications, early catheterization and revascularization were less catheterization and revascularization were less common among the oldest oldcommon among the oldest old

Skolnick et al., JACC Vol.49, No.17, 2007Skolnick et al., JACC Vol.49, No.17, 2007

Page 14: 10 Lessons Learned from CRUSADE: A National Quality Improvement Initiative

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CRUSADE: SummaryCRUSADE: Summary

• Despite an association with major bleeding, Despite an association with major bleeding, increasing use of evidence-based therapies was increasing use of evidence-based therapies was associated with lower in-hospital mortality even associated with lower in-hospital mortality even among the oldest old with ACSamong the oldest old with ACS

• Among the oldest old with ACS, diabetes and Among the oldest old with ACS, diabetes and renal insufficiency were independently renal insufficiency were independently associated with increased in-hospital mortality, associated with increased in-hospital mortality, while elevated systolic BP, prior PCI and while elevated systolic BP, prior PCI and dyslipidemia were associated with decreased in-dyslipidemia were associated with decreased in-hospital mortalityhospital mortality

Skolnick et al., JACC Vol.49, No.17, 2007Skolnick et al., JACC Vol.49, No.17, 2007

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CRUSADE: SummaryCRUSADE: Summary

• ACS in the oldest old is associated with substantial morbidity and mortality compared with a younger elderly population

• Since adherence to ACC/AHA recommended therapies appears to be associated with improved outcomes in this group, advanced age alone should not deter efforts to optimize care for such patients

• ACS in the oldest old is associated with substantial morbidity and mortality compared with a younger elderly population

• Since adherence to ACC/AHA recommended therapies appears to be associated with improved outcomes in this group, advanced age alone should not deter efforts to optimize care for such patients

Skolnick et al., JACC Vol.49, No.17, 2007Skolnick et al., JACC Vol.49, No.17, 2007