BRIDGE CV Prevention

Clinical Trial Details

Effects of a Multifaceted Intervention to Narrow the Evidence-Based Gap in the Treatment of High Cardiovascular Risk Patients: The BRIDGE CV Prevention Cluster Randomized Trial

This behavioral quality improvement trial in Brazil evaluates whether a multifaceted intervention increases the use of/adherence to evidence-based treatments prescribed for cardiovascular prevention in a high-risk population.

Key Findings

Adherence to evidence-based therapies (antiplatelets, statins and ACE inhibitors) for high CV risk Brazilian patients was improved with use of a multifaceted quality improvement educational intervention vs. routine practice.

Principal Investigator Otto Berwanger on BRIDGE CV Prevention

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Otto Berwanger, MD, PhD,  summarizes the results of BRIDGE CV Prevention, which he presented during Scientific Sessions 2018 in Chicago.

BRIDGE CV Prevention - Commentary

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Eric Peterson, MD, chair of the program committee for Scientific Sessions 2018, comments on the results of the BRIDGE CV Prevention trial.

Purpose: evaluation of a multifaceted educational quality improvement intervention on patient care and clinical outcomes in high-risk cardiovascular patients in Brazil.

Trial Design: 2-arm cluster, randomized trial; randomized to multifaceted quality improvement intervention or to routine practice. 1619 high-risk CV patients in Brazil. 40 clusters.

Primary Endpoints: complete adherence to evidence-based therapies @ 12 months (statins, antiplatelet therapy and ACE inhibitors or angiotensin receptor blockers).

Results: Adherence to evidence-based therapies (antiplatelets, statins and ACE inhibitors) for high CV risk Brazilian patients was improved with the use of a multifaceted quality improvement educational intervention vs routine practice.

BRIDGE CV Prevention Data
Adherence to evidence-based therapies @ 12 months
 InterventionControlPop. Avg.
Adds Ratio
All or None Primary73.5%58.7%OR=2.30;
p=0.01
Statins93.6%81.7%OR=4.04;
p>0.01
Antiplatelet therapy94.0%86.3%OR=3.13;
p>0.01
ACEi or ARB80.3%74.4%P=0.09
Composite MACE  HR=0.76;
p=0.34

Detailed Results

Primary Endpoint: all or none adherence to statins, antiplatelet therapy, and ACEi or ARB at 12 months:
Intervention: 73.5%; Control: 58.7%; population average OR = 2.30; p=0.01

Secondary endpoints:

  1. Composite outcome of major cardiovascular events (cardiovascular mortality, nonfatal myocardial infarction, or nonfatal stroke)
    Intervention vs Control: HR=0.76, p=0.34
     
  2. Adherence to lipid lowering agents (statins)
    Intervention 93.6% vs Control 81.7%: population average OR=4.04; p<0.01
     
  3. Adherence to antiplatelets Intervention 94.0% vs Control 86.3%: population average OR= 3.13; p<0.01
     
  4. Adherence to ACE inhibitors or ARBs
    Intervention 80.3% vs Control 74.4%: population average OR=1.44; p=0.09

Trial Design — non-blinded, cluster, randomized trial; patients from 40 outpatient clinics in Brazil. 12 months follow-up; randomization 1:1 to the multifaceted intervention group or to the routine practice (control) group; The multifaceted intervention includes case management, care algorithms, training of a case manager, reminders, check lists, educational materials, and audit and feedback reports.

Trial Population — 1623 patients > 40 years of age who have with coronary artery disease, stroke or transient ischemic attack, or peripheral artery disease.

Primary Endpoints:— "all or none" adherence to evidence-based therapies at six and twelve months. Evidence-based therapies: aspirin/antiplatelets, statins, and ACE inhibitors, and angiotensin receptor blockers (ARB).

Secondary Endpoints

  1. Using an "all or none" model, adherence to evidence-based therapies at six and twelve months.

    At 12 months:
     
  2. Composite outcome of major cardiovascular events (cardiovascular mortality, nonfatal myocardial infarction, or nonfatal stroke)
  3. LDL < 100mg/dL
  4. LDL < 70mg/dL
  5. Adherence to lipid lowering agents (statins)
  6. Adherence to antiplatelets
  7. Adherence to ACE inhibitors or ARBs
  8. Adherence to beta blockers
  9. Smoke cessation education
  10. Blood Pressure < 140 x 90 mmHg
  11. Blood Pressure < 120 mmHg

Sponsor— Instituto de Pesquisa, Hospital do Coracao

References

Key Words
Quality improvement, cluster analysis, prevention, aspirin, antiplatelets, lipid lowering agents, statins, ACE inhibitors, ARB.

Related Clinical Topics
Atherosclerosis, stroke, transient ischemic attack, quality, coronary artery disease