NHLBI Workshop

Data Needs for Cardiovascular Events, Management, and Outcomes

Privately Funded Cardiovascular Registries - Dr. Eric Peterson*

*Acknowledgment: Receive research support from Schering Plough, BMS, Sanofi, and Millennium Pharmaceuticals

NRMI (National Registry of Myocardial Infarction) Study Overview

• Multicenter acute myocardial infarction (AMI) registry (Genentech sponsor)
• Established in 1990 as FDA post market study
• Data: Demographics, clinical (presenting symptoms, risk factors), in-hospital care (meds, revascularization) and clinical events.
• Hospitals: 1600 peak, now 450-500
• Site feedback: extensive reporting, benchmarks, trends, JCAHO vendor
• Oversight: Company owns database
  
  • National advisory board (oversees publications)

NRMI Strengths /Limitations

• Strengths:
  • Research: >75 scientific papers
  • Epidemiology: Source for US MI care and outcomes in community practice.
  • Quality: Established concept of "door to rx"
    
• Limitations:
  • Sponsors control database
  • Voluntary hospital participation
  • Data audits (limited validation in1990's)
  • In-hospital data only
    

CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines) Study Overview

• Multicenter NSTE ACS registry (STEMI recently added)
• Multi-sponsor: Millennium + Schering Plough, + BMS-Sanofi + Sanofi-Aventis + Merck-Schering Plough
• Established in 2000 as Quality Improvement Initiative
• Hospitals: 400+, mixed like NRMI (3/4th non-academic)
• Data: In-hospital clinical, treatment, outcomes data
• Site feedback: extensive reporting, benchmarks, trends, JCAHO vendor
• Oversight: DCRI owns database:
  
  • National advisory board oversees publications

CRUSADE Site Distribution

• Total sites = 486 (409 active)
• Total Patients = 140,000+

Baseline Characteristics: CRUSADE vs. ACS Clinical Trials*

CRUSADE: Beyond Registry

• Quality Improvement
  • National/regional QI meetings
  • Educational / QI tools/newsletters
  • Quarterly Site Feedback Reports
  • 1 on 1 visit/calls to sites
    
• Collaborations
  • VA: planed use of Crusade for benchmark
  • UHC: Premium hospitals (also NRMI, GWGH)
  • AHA GWTG: EDC cross-walk, joint program efforts
    
• Other programs
  • NIA Grant: Bleeding in Elderly (pending)
  • Longitudinal compliance Study (3000+ pts)
    

CRUSADE Strengths /Limitations

• Strengths:
  • Research: 50+ abstracts/papers
  • Epidemiology: Source for US NST ACS care and outcomes in community practice.
  • Quality: Established association b/t hospital guidelines adherences---outcomes
    
• Limitations:
  • NSTE ACS (STE MI recently added)
  • Voluntary hospital participation
  • Data audits (limited validation, ongoing)
  • In-hospital data only
    

Other Sponsor Databases

• Get With The Guidelines (AHA + sponsor supported)
  • CAD
  • Stroke
  • Heart failure
    
• GRACE (International MI, limited US)
• ADHERE (heart failure)

Opportunities for Partnership

• Most/all programs willing to share data
• Programs generally committed to new knowledge generation/translation
• Efforts afoot to collaborate
  
  • Standardize data elements
  • Share data among?
    

Value as a Model

• Sites are willing to collect high quality data for a good cause with minimal support
  • i.e., value of data feedback itself
• Important insights gained from community based sponsor funded registries
• Limited longitudinal data to date
  
  • Greatest unmet need

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