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

Pfizer

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: rivaroxaban; Drug: VKA; Drug: dabigatran; Drug: apixaban

Study type: Observational

Funder types: Industry

Identifiers

NCT03441633

B0661076

SPAF

Details and patient eligibility

About

Apixaban is a direct anticoagulant, which inhibits the factor Xa. Its clinical efficiency in prevention of stroke and systemic embolism in adult patients with NVAF (non/valvular atrial fibrillation) was demonstrated as well as has shown better safety profile compared with warfarin. A Drug Utilization study will evaluate whether this drug has been used in accordance with the approved indication and recommendations described in the summary of product characteristics (SmPC) and estimate possible misuse or overuse apixaban.

Full description

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.

Enrollment: 51,690 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

51,690 participants in 4 patient groups

Group 1. Apixaban

Description:

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.

Treatment:

Drug: apixaban

Group 2. VKA

Description:

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.

Treatment:

Drug: VKA

Group 3. Dabigatran

Description:

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.

Treatment:

Drug: dabigatran

Group 4. Rivaroxaban

Description:

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.

Treatment:

Drug: rivaroxaban