What Have We Learned from the CRUSADE Registry

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What Have We Learned from the CRUSADE Registry? Can Rapid Risk Stratification of Unstable

What Have We Learned from the CRUSADE Registry? Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC and AHA Guidelines Eric D. Peterson, MD, FACC Professor of Medicine Associate Vice Chair for Quality Duke University Medical Center Associate Director and Director of CV Research Duke Clinical Research Institute Durham, NC

10 Lessons Learned from CRUSADE: A National Quality Improvement Initiative Eric D. Peterson, MD,

10 Lessons Learned from CRUSADE: A National Quality Improvement Initiative Eric D. Peterson, MD, MPH Professor of Medicine Vice Chairman of Quality, Dept of Medicine Duke University Medical Center Director of CV Research Duke Clinical Research Institute Disclosures: Research support from Schering Plough, BMS, Sanofi-Aventis, Merck-Schering, PDL Pharma

CRUSADE National CQI n Academic collaboration between cardiology and emergency medicine initiated in 2001

CRUSADE National CQI n Academic collaboration between cardiology and emergency medicine initiated in 2001 n Multi-industry sponsor l l l n Millennium-Schering Plough BMS Sanofi-Aventis Merck-Schering PDL Pharma Goal: Improve adherence to ACC/AHA ACS guidelines l NSTE ACS and later STEMI

Goals for CRUSADE: Improve Adherence to ACC/AHA Guidelines for Acute Coronary Syndrome Acute Therapies

Goals for CRUSADE: Improve Adherence to ACC/AHA Guidelines for Acute Coronary Syndrome Acute Therapies n n n Aspirin l Clopidogrel Beta Blocker Reperfusion Rx (STEMI) l Timely PCI, Lytics Discharge Therapies n Aspirin n Clopidogrel n Beta Blocker n ACE Inhibitor n Heparin (NSTEMI) n Statin/Lipid Lowering n GP IIb-IIIa (NSTEMI) l Targeted for Trop + n Smoking Cessation n Cardiac Rehabilitation Circulation, JACC 2002 and 2004 - ACC/AHA Guidelines updates

CRUSADE Highlights – n Data collection: 7/2001 - 12/2006 n > 500 US sites

CRUSADE Highlights – n Data collection: 7/2001 - 12/2006 n > 500 US sites participated in CRUSADE l n 25% academic, 68% with PCI/CABG 201, 032 Data Collection Forms received l l 190, 000 NSTEMI: : 8, 800+ STEMI patients 1000+ MAINTAIN patients (long-term follow-up) n 50+ CRUSADE publications n Referenced within ACC/AHA guidelines n Successful transition to NCDR ACTION ACS

Lesson 1: Complexity of NSTEMI Pts STEMI vs. NSTEMI Characteristics Variable NSTEMI CRUSADE STEMI

Lesson 1: Complexity of NSTEMI Pts STEMI vs. NSTEMI Characteristics Variable NSTEMI CRUSADE STEMI (n = 8, 011) CRUSADE (n = 180, 842) Mean age ± SD (yrs) 62 ± 12 Female sex (%) 31 Diabetes mellitus (%) 22 69 ± 14 40 33 Prior MI (%) 18 Prior CHF (%) 6 18 Prior PCI (%) 17 21 Prior CABG (%) 30 7 CRUSADE through June 30, 2007 19

Lesson 1 ACS Clinical Trials vs Real World Patients Variable PURSUIT (n = 9461)

Lesson 1 ACS Clinical Trials vs Real World Patients Variable PURSUIT (n = 9461) CURE SYNERGY (n = 12, 562) CRUSADE (n = 9975) Mean age ± SD (yrs) 63 ± 11 63 ± 12 67 ± 11 69 ± 14 Female sex (%) 36 39 34 40 Diabetes mellitus (%) 23 23 29 Prior MI (%) 32 25 28 30 Prior CHF (%) 11 8 9 18 Prior PCI (%) 13 18* 20 21 Prior CABG (%) 12 18* 17 19 NEJM 1998; 339: 436 -43 NEJM 2001; 345: 494 -502 JAMA 2004: 292: 45 -54 CRUSADE cumulative through June 30, 2006 33 (n = 180, 842)

CRUSADE NSTE MI vs. ACS Clinical Trials: Early Mortality Rates In-hospital mortality rate 4.

CRUSADE NSTE MI vs. ACS Clinical Trials: Early Mortality Rates In-hospital mortality rate 4. 9% 7 -day mortality rate 1. 8% PURSUIT 1 (n = 9, 461) 1. 9% PRISM-PLUS 2 (n = 1, 915) 1. The PURSUIT Trial Investigators. N Engl J Med 1998 2. The PRISM-PLUS Study Investigators. N Engl J Med 1998 3. The Synergy Study JAMA 2004 CRUSADE cumulative data through 6/30/2006 1. 5% SYNERGY 3 (n = 9, 975) CRUSADE (n = 180, 842)

Lesson 2: Acute Medications NSTEMI vs STEMI Use CRUSADE DATA: July 1, 2005 –

Lesson 2: Acute Medications NSTEMI vs STEMI Use CRUSADE DATA: July 1, 2005 – June 30, 2006 (n=31, 665)

Lesson 2 Variations Among Hospitals 430 CRUSADE hospitals Acute Discharge Peterson et al, JAMA

Lesson 2 Variations Among Hospitals 430 CRUSADE hospitals Acute Discharge Peterson et al, JAMA 2006; 295: 1863 -1912

Lesson 3: Hospital Link Between Overall Guidelines Adherence and Mortality Every 10% in guidelines

Lesson 3: Hospital Link Between Overall Guidelines Adherence and Mortality Every 10% in guidelines adherence 10% in mortality (OR=0. 90, 95% CI: 0. 84 -0. 97) Peterson et al, JAMA 2006; 295: 1863 -1912

Lesson 4 Timely Care: Reperfusion among STEMI Patients Median Times • Thrombolytics – 33

Lesson 4 Timely Care: Reperfusion among STEMI Patients Median Times • Thrombolytics – 33 min • Primary PCI – 98 min Q 2 2006 CRUSADE STEMI data

Lesson 5: Invasive Cardiac Procedures (Excluding Patients with Contraindications to Cath) CRUSADE DATA: July

Lesson 5: Invasive Cardiac Procedures (Excluding Patients with Contraindications to Cath) CRUSADE DATA: July 1, 2005 – June 30, 2006 (n=31, 665)

Lesson 6: Interventional Care Trends in Early Cath Use by Risk Status 75. 5

Lesson 6: Interventional Care Trends in Early Cath Use by Risk Status 75. 5 64. 1 63. 2 53. 5 32. 2 26. 6 Tricoci et al, AHA 2005 Abstract

Trends in Type of Revascularization Strategy for 3 -Vessel CAD in CRUSADE Gogo P,

Trends in Type of Revascularization Strategy for 3 -Vessel CAD in CRUSADE Gogo P, ACC Scientific Sessions, 2006

Recent Decline in DES Use: CRUSADE July 2006 - March 2007

Recent Decline in DES Use: CRUSADE July 2006 - March 2007

% Use Lesson 7: Discharge Care Gaps *LVEF < 40%, CHF, DM, HTN #

% Use Lesson 7: Discharge Care Gaps *LVEF < 40%, CHF, DM, HTN # Known hyperlipidemia, TC, LDL CRUSADE DATA: July 1, 2005 – June 30, 2006 (n=31, 665)

Proportion of Patients Receiving 100% of All Guidelines-Recommended Therapies* Mehta et al, AHA 2005

Proportion of Patients Receiving 100% of All Guidelines-Recommended Therapies* Mehta et al, AHA 2005 *In patients without contraindications

Challenges To Healthcare Delivery Medical Errors n Errors of omission l n Failure to

Challenges To Healthcare Delivery Medical Errors n Errors of omission l n Failure to use therapies proven to be beneficial Errors of commission l Inappropriate or incorrect use of treatment strategies, dose, procedures

Lesson 8 Safe Care Percentage of Hospitals (%) Hospital Variation in RBC Transfusion Rates

Lesson 8 Safe Care Percentage of Hospitals (%) Hospital Variation in RBC Transfusion Rates Percentage of Patients Receiving Blood Transfusions (%) Yang X, J Am Coll Cardiol 2005; 46: 1490 -5.

Safety Concerns in ACS Care: Need for Blood Transfusions Yang X, JACC 2005; 46:

Safety Concerns in ACS Care: Need for Blood Transfusions Yang X, JACC 2005; 46: 1490 -5.

Excessive Antithrombotic Dosing by Age Alexander KA, et al. JAMA 2005; 294: 3108 -3116

Excessive Antithrombotic Dosing by Age Alexander KA, et al. JAMA 2005; 294: 3108 -3116

Lesson 9: Adjusted Risk By Transfusion Status* Death or Re-MI 1 * Non-CABG patients

Lesson 9: Adjusted Risk By Transfusion Status* Death or Re-MI 1 * Non-CABG patients only 2. 0 Yang X, JACC 2005; 46: 1490 -5.

Lesson 9: Likelihood of Major Bleeding with Excess Anti-thrombotic Dose Excess v. Recommended 1.

Lesson 9: Likelihood of Major Bleeding with Excess Anti-thrombotic Dose Excess v. Recommended 1. 09 (0. 99, 1. 26) UF Heparin 1. 40 (1. 12, 1. 75) LMWH GP IIb/IIIa inhibitor 1. 38 (1. 12, 1. 70) One Excessive Agent 1. 42 (1. 16, 1. 73) Both Excessive 0 2. 02 (1. 51, 2. 69) 1 2 Adjusted* Odds of Major Bleeding Adjusted for age, sex, SBP, CHF, renal insufficiency Alexander KA, JAMA 2005

Lesson 10: Improving Care: Concept Clinical Trials Guidelines Outcomes CRUSADE CQI Performance Indicators Intervention

Lesson 10: Improving Care: Concept Clinical Trials Guidelines Outcomes CRUSADE CQI Performance Indicators Intervention Action Measurement Adapted from Califf RM, Peterson ED et al. JACC 2002; 40: 1895 -901

Lesson 10 Efforts to Improve Care Delivery: CRUSADE QI Interventions n Ongoing quarterly site

Lesson 10 Efforts to Improve Care Delivery: CRUSADE QI Interventions n Ongoing quarterly site feedback l Benchmarking care versus peers n National, regional, and local meetings l Share treatment results and successful quality improvement strategies n Clearinghouse for successful site QI solutions n QI Materials: Algorithms, order sets, etc n Publications: Updates, Focus on QI n “Care Consults” by CRUSADE leadership l Site results teleconferences

Rate of Excess Dosing Composite Adherence Rates Improvements in Guidelines Adherence And Rates of

Rate of Excess Dosing Composite Adherence Rates Improvements in Guidelines Adherence And Rates of Drug Overdosing Over Time Mehta RH, et al AHJ 2007

CRUSADE to NCDR ACTION™ n Need for Growth l n Need for Alignment l

CRUSADE to NCDR ACTION™ n Need for Growth l n Need for Alignment l l n Many US hospitals not in CRUSADE Several similar US registries (AHA GWTG, ACC PCI registry, NRMI) Hospitals wanted single source answer Need for National Policy Change: l Live under the direction of professional societies l Be single source answer for ACS for providers, payers and policy makers

Quality Improvement Initiatives • Institutional Feedback Reports • Ready data availability for rapid cycle

Quality Improvement Initiatives • Institutional Feedback Reports • Ready data availability for rapid cycle measurement • • TAKE ACTION™ Campaign D 2 B: An Alliance for Quality Monthly Webcasts National/Regional Group Meetings

Taking These Lessons to ACTION! q Broaden Quality Mission q No hospital or patient

Taking These Lessons to ACTION! q Broaden Quality Mission q No hospital or patient left behind q Personalized site feedback q National QI new initiatives q Bridging the transitions in care q Continue research mission q Support science and guidelines q Broaden policy mission q Become nation’s leading ACS surveillance system