Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf)

The primary research question is to evaluate the apixaban utilization according to the approved SPAF indication and recommendations by EMA.

In addition a comparison with a cohort of NVAF patients treated with VKA, dabigatran and rivaroxaban for the SPAF indication will also be performed.

Objective 1: To characterize patients using apixaban according to demographics, comorbidity, risk of thromboembolic events (CHADS2 and CHA2DS2-Vasc scores), risk of bleeding events (HAS-BLED score), comedications and compare it with the profile of patients treated with VKA, dabigatran and rivaroxaban.

Objective 2: Describe the level of appropriate usage according to the posology recommended in the apixaban SmPC.

Objective 3: Describe the potential interactions with other drugs prescribed concomintatly according with the SmPC recommendations.

Objective 4: Estimate the level of apixaban adherence by the medication possession ratio (MPR) and discontinuation rates and compare it with VKA, dabigatran and rivaroxaban cohort.

Objective 5: To analyze INR (International Normalized Ratio) values during the last 12 months and to obtain TTR (Time in Therapeutic Range) values in patients previously treated with VKA, and during the whole study period for those in the cohort treated with VKA.

SIDIAP currently collects information from 274 primary health care centers, including more than 5.8 million patients, about 80 % of the Catalonia population, or more than 10 % of the Spanish population covered by the Catalan Institute of Health.

The study population for these cohorts includes all eligible subjects from the source population with a first -recorded prescription of apixaban VKA, dabigatran or rivaroxaban for the SPAF indication, registered in SIDIAP database and diagnosis of NVAF for study period.

• Drug: apixaban
  current or new medication
• Drug: dabigatran
  current or new medication
• Drug: VKA
  current or new medication
• Drug: rivaroxaban
  current or new medication

• Group 1. Apixaban

  Patients who are on treatment with apixaban.

  1a. patients who have initiated with apixaban as treatment naïve (no prior prescription of VKA previous to the 12 months before index date).

  1b. patients who previously have been treated with VKA in the 12 months before index date.

  Intervention: Drug: apixaban
• Group 2. VKA

  Patients who are on treatment with VKA.

  2a. patients who have initiated with VKA as treatment naïve (no prior prescription of VKA previous to the 12 months before index date).

  2b. patients who previously have been treated with VKA in the 12 months before index date.

  Intervention: Drug: VKA
• Group 3. Dabigatran

  Patients who are on treatment with dabigatran.

  3a. patients who have initiated with dabigatran as treatment naïve (no prior prescription of VKA previous to the 12 months before index date).

  3b. patients who previously have been treated with VKA in the 12 months before index date.

  Intervention: Drug: dabigatran
• Group 4. Rivaroxaban

  Patients who are on treatment with rivaroxaban.

  4a. patients who have initiated with rivaroxaban as treatment naïve (no prior prescription of VKA previous to the 12 months before index date).

  4b. patients who previously have been treated with VKA in the 12 months before index date.

  Intervention: Drug: rivaroxaban

Inclusion Criteria:

1. Patients more than 18 years-old.
2. Patients diagnosed with NVAF registered in primary care according to ICD-10.
3. Patients initiating apixaban (naïve or VKA experienced), VKA (naïve or VKA experienced), dabigatran or rivaroxaban for the SPAF indication.
4. Continuous enrolment in the 12 months pre-index.

Exclusion Criteria:

1. Patients with valvular heart disease (ICD 10: I05.0-I05.09, I08.0-I08.9) including patients with mitral prosthetic valves.
2. Lost to follow-up (e.g. transfer to primary care center non-ICS).