Efficacy and Safety of Oral Anticoagulants Among Thai Octogenarians With Nonvalvular Atrial Fibrillation

Efficacy and Safety of Oral Anticoagulants Among Thai Octogenarians With Nonvalvular Atrial Fibrillation : A Retrospective Study

A retrospective cohort study of Thai octogenarians with nonvalvular atrial fibrillation (NVAF) initiating apixaban, dabigatran, rivaroxaban or warfarin was conducted in medical school hospital in Thailand. Patients were recruited from January 1, 2013, to December 31, 2018. The efficacy outcome was early recurrence of stroke or transient ischemic attack (TIA) in 90 days after initiation of oral anticoagulants (OACs). The safety outcome were major bleeding and clinically relevant non-major bleeding complications in 180 days. Continuous variables were compared using independent t test and MannWhitney U test, and categorical variables were compared using chi-square test or Fisher's exact test. Furthermore, hazard ratios and P values were calculated by the use of multivariable Cox's regression analysis.

Study Overview

• Status: Completed
• Conditions: Stroke; Atrial Fibrillation
• Intervention / Treatment: Drug: Non vitamin K oral anticoagulants

Detailed Description

This is a retrospective cohort study of Thai octogenarians with NVAF. Patients who were prescribed with apixaban, dabigatran, edoxaban, rivaroxaban or warfarin from January 1, 2013, to December 31, 2018 were recruited. The primary efficacy was recurrent ischemic stroke or TIA in 90 days after initiating OACs. The secondary efficacy were recurrent ischemic stroke or TIA in 180 days after initiating OACs. While any bleeding complications were defied as primary safety outcomes. Continuous variables were compared using independent t test and MannWhitney U test, and categorical variables were compared using chi-square test or Fisher's exact test.

• Study Type: Observational
• Enrollment (Actual): 327

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital, Phramongkutklao Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged over 80 years with non valvular atrial fibrillation who were prescribed oral anticoagulants (OACs) which were apixaban, dabigartran, edoxaban, rivaroxaban and warfarin for stroke secondary prevention.

Description

Inclusion Criteria:

• Age more than 80 years old
• Patients who were diagnosed with I48, I63 or G45 from International Classification of Diseases 10th version (ICD-10). Patients who were diagnosed atrial fibrillation and flutter, cerebral infarction or transient cerebral ischemic attacks (TIA) and related syndromes)
• Patients were prescribed apixaban, dabigatran, edoxaban, rivaroxaban, or warfarin

Exclusion Criteria:

• Patients were prescribed oral anticoagulants for other indications

  1. Prophylaxis thromboembolic events in valvular atrial fibrillation
  2. Treatment of venous thromboembolism
  3. Prophylaxis thromboembolic events in hip or knee replacement

• Patients who had contraindication to oral anticoagulants

  1. Creatinine clearance calculated from Cockcroft-Gault equation 1.1 Creatinine clearance less than 30 mL/min (for patients who receiving Dabigatran) 1.2 Creatinine clearance less than 15 (mL/min (for patients who receiving Apixaban, Edoxaban, Rivaroxaban)
  2. Patients were diagnosed acute hepatitis, chronic active hepatitis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non vitamin K oral anticoagulants (NOACs); Patients who were prescribed with apixaban, dabigatran, edoxaban, or rivaroxaban for stroke secondary prevention.	Drug: Non vitamin K oral anticoagulants; Non vitamin K oral anticoagulants are apixaban, dabigatran, rivaroxaban, and edoxaban
Warfarin; Patients who were prescribed with warfarin for stroke secondary prevention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate recurrence of stroke or TIA in 90 days	Rate recurrence of stroke or TIA in 90 days after initiation of OACs	90 days after initiation of OACs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate recurrence of stroke or TIA in 180 days	Rate recurrence of stroke or TIA in 180 days after initiation of OACs	180 days after initiation of OACs
Rate of major bleeding	Rate of major bleeding in 90 days and 180 days after initiation of OACs	180 days after initiation of OACs
Rate of clinically relevant non-major bleeding	Rate of clinically relevant non-major bleeding in 90 days and 180 days after initiation of OACs	180 days after initiation of OACs
Patients's baseline characteristics associated with recurrence of stroke or TIA as assessed by multivariate cohort analysis	Patients's baseline characteristics associated with recurrence of stroke or TIA in 180 days after initiation of OACs as assessed by multivariate cohort analysis	180 days after initiation of OACs
Patients's baseline characteristics associated with major bleeding and clinically relevant non-major bleeding as assessed by multivariate cohort analysis	Patients's baseline characteristics associated with major bleeding and clinically relevant non-major bleeding in 180 days as assessed by multivariate cohort analysis	180 days after initiation of OACs

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 22, 2019
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: August 3, 2019
• First Posted (ACTUAL): August 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: anticoagulant drugs
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Anticoagulants
• Other Study ID Numbers: NOACs in Thai Octogenarians

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Primary outcome of this study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No