Patients achieved optimal serum apixaban levels when discontinuing use 60 hours or more prior to invasive or major surgery, according to clinical trial results published in Vascular Medicine.
Apixaban Discontinuation for Invasive Or major Surgical procedures (ADIOS) (ClinicalTrials.gov Identifier: NCT02935751) was a single site, prospective, observational study conducted at Thomas Jefferson University between 2016 and 2018. Patients (N=130) receiving apixaban for nonvalvular atrial fibrillation or venous thromboembolism (VTE) and who required an elective major or invasive surgery were advised to discontinue using apixaban prior to surgery. Physicians decided on when to advise patients to discontinue use on the basis of plasma apixaban concentrations and anti-Xa activity. Bleeding and major adverse cardiac events were assessed through day 30.
Patients had a mean age of 68.6±11.6 years; 52% were women; median body mass index (BMI) was 30 (range, 21-52); 80.6% were White; 59% used apixaban due to stroke, transient ischemic attack, or systemic embolism risk; 25% due to recurrent venous thromboembolism risk; and 9% for multiple indications.
Prior to surgery, 93.7% had apixaban concentrations less than or equal to 30 ng/mL. The median time since last dose of apixaban was 75.5 hours for the lower than or equal to 30 ng/mL cohort and 59.3 hours for the greater than 30 ng/mL cohort. All patients not achieving the less than or equal to 30 ng/mL concentration were on a 5 mg twice daily maintenance regimen.
A total of 18 events occurred during follow-up, including any major adverse cardiac event (n=5), arrhythmia (n=3), infection (n=3), stroke (n=1), nonmajor bleed (n=1), thromboembolic event (n=1), and other (n=9). These events occurred during the first week (n=7) or weeks 2-4 (n=9).
This study was limited by the provider-directed discontinuation protocol and the resultant wide range of discontinuation windows.
“A large proportion of patients (93.7%; 95% CI, 88–97%) achieved plasma apixaban concentrations of [greater than or equal to] 30 ng/mL following at least 48 hours of discontinuation,” the study authors noted. “A greater proportion (> 90%) of patients achieved below 30 ng/mL when apixaban was discontinued for [greater than] 60 hours. The clinical evidence here supports current pharmacokinetic discontinuation strategies based on patient factors and apixaban half-life.”
Disclosure: An author declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Merli GJ, Kraft WK, Eraso LH, et al. Apixaban discontinuation for invasive or major surgical procedures (ADIOS): a prospective cohort study. Vasc Med. 2021;1358863X211047270. doi:10.1177/1358863X211047270