1. What Have We Learned from the CRUSADE Registry
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

2. 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

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

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

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

6. Lesson 1: Complexity of NSTEMI Pts STEMI vs. NSTEMI Characteristics
Variable CRUSADE STEMI CRUSADE NSTEMI (n = 8,011) (n = 180,842)
Mean age ± SD (yrs) ± ± 14
Female sex (%)
Diabetes mellitus (%)
Prior MI (%)
Prior CHF (%)
Prior PCI (%)
Prior CABG (%)
Update to end of 4th quarter CRUSADE data.
CRUSADE through June 30, 2007

7. Lesson 1 ACS Clinical Trials vs Real World Patients
Variable PURSUIT CURE SYNERGY CRUSADE (n = 9461) (n = 12,562) (n = 9975) (n = 180,842)
Mean age ± SD (yrs) 63 ± ± ± ± 14
Female sex (%)
Diabetes mellitus (%)
Prior MI (%)
Prior CHF (%)
Prior PCI (%) 13 18* 20 21
Prior CABG (%) 12 18* 17 19
Update to end of 4th quarter CRUSADE data.
NEJM 1998;339:436-43
NEJM 2001;345:
JAMA 2004:292:45-54
CRUSADE cumulative through June 30, 2006

8. CRUSADE NSTE MI vs. ACS Clinical Trials: Early Mortality Rates
In-hospital mortality rate
4.9%
7-day mortality rate
1.9%
1.8%
1.5%
PURSUIT1 (n = 9,461)
PRISM-PLUS2 (n = 1,915)
SYNERGY3
(n = 9,975)
CRUSADE (n = 180,842)
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

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

10. Lesson 2 Variations Among Hospitals 430 CRUSADE hospitals
Acute
Discharge
Peterson et al, JAMA 2006;295:

11. Lesson 3: Hospital Link Between Overall Guidelines Adherence and Mortality
Every 10%  in guidelines adherence 
10%  in mortality (OR=0.90, 95% CI: )
350 sites; 64, 775 patients
Peterson et al, JAMA 2006;295:

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

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

14. 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

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

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

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

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

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

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

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

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

23. Lesson 9: Adjusted Risk By Transfusion Status*
Death
Death or Re-MI
Finally, inorder to assess the independent prognostic value of peak C-MB we included it in a multivariable model with other predictors of 30-day mortality. We found a strong, linear positive association between peak CK-MB and mortality. After adjustment, the increased risk of 30-day death associated with CK-MB elevations 1 to 2 times the upper limit of normal was no longer statistically significant. 1
2.0
* Non-CABG patients only
Yang X, JACC 2005;46: 17

24. Adjusted* Odds of Major Bleeding
Lesson 9: Likelihood of Major Bleeding with Excess Anti-thrombotic Dose
Excess v. Recommended
1.40 (1.12, 1.75)
1.09 (0.99, 1.26)
1.38 (1.12, 1.70)
2.02 (1.51, 2.69)
1.42 (1.16, 1.73)
UF Heparin
LMWH
GP IIb/IIIa inhibitor
One Excessive Agent
Both Excessive 1 2
Adjusted* Odds of Major Bleeding
Adjusted for age, sex, SBP, CHF, renal insufficiency
Alexander KA, JAMA 2005

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

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

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

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

29. Quality Improvement Initiatives
Institutional Feedback Reports
Ready data availability for rapid cycle measurement
TAKE ACTION™ Campaign
D2B: An Alliance for Quality
Monthly Webcasts
National/Regional Group Meetings
Regional Group Meetings
NCDR™ participants in many cases have organized themselves into regional training and networking groups. ACTION Registry™ staff will support these groups and also seek and organize additional groups as needed. Educational meetings and/or teleconferences may include presentations regarding recent findings from ACTION Registry ™ analyses, strategies for ensuring successful collaboration between various specialties and departments within the institution in support of the quality improvement process, and other topics of interest. They may also include questions and answers, or case studies. Members of the ACTION Registry™ Steering Committee and staff will conduct these sessions.
Institutional Feedback Reports
ACTION Registry™ participants receive access to comprehensive, timely information about measuring quality of care for their ACS patients in the form of quarterly and annual comparative benchmark reports. These reports comprise data on evidence-based elements corresponding to the ACTION Registry™ data elements and definitions. These reports are institution-specific and provide participants the opportunity to compare their institution’s practice patterns to ACTION Registry™ averages and volume-based peer comparison groups. Participants use this information for improving patient care, supporting local quality-improvement programs, and communicating with regulatory and contracting organizations.
D2B: An Alliance for Quality
The D2B Alliance is a network of hospitals, physician champions, and strategic partners who have come together as a nationwide community of committed organizations and individuals to address the challenge of lowering door to balloon (D2B) times. This program is designed to provide hospitals with the key evidence-based strategies and supporting tools that they need to begin reducing their door to balloon times. A web-based networking component will create a learning community hospitals can use to share their findings and experiences with others.
The ACTION Registry™ encourages its participants to join this nationwide effort and supports them by providing detailed feedback reports and graphical depictions of critical measures related to reducing door to balloon/needle time.
TAKE ACTION™
The TAKE ACTION™ campaign will be a three-year, multi-phased project during which NCDR™ will design, develop, and implement the nationwide TAKE ACTION™ campaign—focused on improving the quality of care.  During the first phase of the project the campaign develop tools for physicians and clinicians to improve implementation of the ACC/AHA Guideline recommendations—including conducting educational workshops, developing standardized order sets, pocket cards and other tools.  Included in the initial phase will be participation in the D2B campaign, which aims to reduce door to balloon times for primary PCI.  Additional outreach programs will look at extending the reach of guideline-recommended care to the outpatient setting and improving the continuity of care post initial hospitalization.  Finally, in later phase, the campaign will broaden to include the patient/consumer populations and focus on "What can patients do to TAKE ACTION."  It is envisioned that these phases will be overlapping over the course of the project.

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

31. Question
&
Answer