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*

Variable PURSUIT (n = 9461) CURE (n = 12,562) SYNERGY (n=9975) CRUSADE (n = 119,046)
Mean age +/- SD (Yrs) 63 ± 11 63 ± 12 67 ± 11 68 ± 14
Female sex (%) 36 39 34 40
Diabetes mellitus (%) 23 23 29 33
Prior MI (%) 32 25 28 30
Prior CHF (%) 11 8 9 18
Prior PCI (%) 13 18 20 21
Prior CABG (%) 12 18 17 20
ST depression (%) 50 42 55 37
*NEJM 1998;339:436-43; NEJM 2001;345:494-502; JAMA 2004:292:45-54; CRUSADE cumulative through September 30, 2004

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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