Cardiovascular events after exacerbations of chronic obstructive pulmonary disease: Results from the EXAcerbations of COPD and their OutcomeS in CardioVascular diseases study in Italy

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• 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:
  Chronic obstructive pulmonary disease
• Additional medical condition(s):
  Exacerbations of chronic obstructive pulmonary disease, Cardiovascular events

Population studied

• Short description of the study population:
  Patients with COPD and aged 45 years or older were identified within the ReS database from 2015 to 2018. Patients with at least one day of follow-up after the index date were included. Both newly diagnosed (defined as the absence of COPD criteria within the 24-month look-back period) and previously diagnosed patients with COPD were included.
• 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)

Study design details

• Study design:
  Observational retrospective longitudinal cohort study. Patients with COPD and aged 45 years or older were identified; between January 1st 2015 and December 31st 2018 and followed from index date to the first occurrence of a severe CV event/right censoring due to reaching 31/12/2019/loss to follow-up
• Main study objective:
  The aim of this study was to evaluate the association between time periods following an exacerbation of COPD and the occurrence of a severe CV event compared to unexposed time periods (i.e., without an exacerbation), using data from the Italian National Health Service (SSN).
• Setting:
  Italian inhabitants or beneficiaries of the SSN which is a unversal coverage health system. ; Inhospital/local outpatient settings. ; Overall observation period: 2013-2019. ; Patients aged ≥45 were identified as having COPD by at least one of the following criteria: at least one hospitalization with a primary/secondary diagnosis of COPD in the hospital discharge forms (ICD-9CM codes: 491.x, 492.x, 496); disease waiver claims for COPD (057); at least 4 dispensations of drugs for obstructive airway diseases (ATC code: R03) within a same 12-month period. Patients with at least one day of follow-up after the index date were included. ; Patients with Alpha-1-antitrypsin deficiency (ICD-9-CM code 273.4) and patients with asthma during the accrual period were excluded.
• Summary results:
  Of 216,864 COPD patients, >55 % were male, mean age was 74 years, frequent comorbidities were; cardiovascular, metabolic and psychiatric. ; During an average 34-month follow-up, 69,620 (32 %) patients had ≥1 exacerbation and 46,214 (21 %) experienced ≥1 cardiovascular event. During follow-up, 55,470 patients died; 4,661 were in-hospital cardiovascular-related deaths. ; Among 10,269 patients experiencing cardiovascular events within 365 days post-exacerbation, the IR was 15.8 per 100 person-years (95 %CI 15.5–16.1). ; Estimated hazard ratios (HR) for the cardiovascular event risk associated with periods post-exacerbation were highest within 7 days (HR: 34.3, 95 %CI: 33.1–35.6), especially for heart failure (HR 50.6; 95 %CI 48.6–52.7) and remained elevated throughout 365 days (HR 1.1, 95 %CI 1.02–1.13).