One Year Post-discharge Clinical and Economic Outcomes among Patients with ACS Managed with PCI and Treated with Prasugrel versus Clopidogrel (H7T-MC-B022)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B01AC22) prasugrel

  prasugrel

  (B01AC04) clopidogrel

  clopidogrel
• Medical condition to be studied:
  Acute coronary syndrome

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  26079

Study design details

• Main study objective:
  The primary study objective is to compare major adverse cardiovascular events (MACE) up to 1 year post-discharge from an index ACS-PCI hospitalization in patients treated with prasugrel versus clopidogrel. The main hypothesis is that, after adjustment for baseline differences, prasugrel will be associated with a significantly lower risk of MACE than clopidogrel up to one year post-discharge.
• Outcomes:
  Major adverse cardiovascular events (MACE) up to 1 year post discharge from an index ACS-PCI hospitalization. Resource utilization (medical and pharmacy utilization) and other clinical outcomes (MACE components, bleeding rehospitalizations), healthcare charges, and treatment patterns (including adherence and persistence) at one year post discharge from the index hospitalization.
• Data analysis plan:
  Baseline and outcomes data will be analyzed before and after propensity matching. Treatment groups will be matched based on baseline demographic, clinical, procedural, and payer characteristics. Multivariable cox regression will be used to compare adjusted clinical outcomes. Unmatched cohorts will be compared with the appropriate 2-tailed statistic for continuous or categorical variables. Patients will be censored at the end of index treatment exposure time (that is, 7 days after discontinuation or switching of the index medication). Pre- and post-match Kaplan Meier curves will be constructed and log-rank tests used to compare unadjusted rates through 1 year. Per patient per month economic measures and incidence rates will be assessed to account for the variable follow-up period. Economic outcomes and treatment patterns will also be analyzed after matching using descriptive statistics and appropriate regression models (for example, generalized linear model and logistic regression).