Measurement of the effectiveness of statins in vascular morbidity and mortality reduction in the population without history of vascular disease but with intermediate risk and ankle-brachial Index < 0.9 in primary care setting (MARIA study)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Acute myocardial infarction

  Ischaemic stroke

  Coronary revascularisation

Population studied

• Short description of the study population:
  Population from 35 to 74 years without known vascular disease and with intermediate cardiovascular risk and ankle-brachial index < 0.9.
• Age groups:
  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  6000

Study design details

• Main study objective:
  Objective: To evaluate the effectiveness of statin therapy to reduce the incidence of vascular disease in patients with unknown history of vascular disease with intermediate cardiovascular risk (5-15% at 10 years) and abnormal ankle-brachial index (<0.9).
• Outcomes:
  Acute myocardial infarction, stroke, coronary revascularization, cardiovascular and global mortality, statin adverse effects
• Data analysis plan:
  Design: Population matched cohort on the basis of propensity score. Data were obtained from the Information System for the Development of Primary Care Research whose primary source of data is the the electronic health records (e-CAP) of the Institut Català de la Salut. Subjects: Population from 35 to 74 years without known vascular disease and with intermediate cardiovascular risk and ankle-brachial index <0.9 (3684 subjects in exposed cohort and 7368 in unexposed cohort). The recruitment period will be guarantee at least 3 years of follow-up. Statistical analysis: Time varying Cox regression models will be performed to estimate the incidence of outcomes of interest adjusted for the variable start of treatment and dose (time-dependent variables) and other variables associated with the occurrence of vascular events. We will also calculate estimates of risk reduction and the number needed to treat.