Kelly Rice, Abigail Hoff, Molly Droege, Timothy Rice, Christopher A Droege, Paige Bradshaw, Lindsey Federle, Savannah Ruess, Carolyn D Philpott
{"title":"Apixaban Lead-In Versus Lead-In Omission in Hospitalized Adults with Acute Venous Thromboembolism: A Retrospective Safety Analysis.","authors":"Kelly Rice, Abigail Hoff, Molly Droege, Timothy Rice, Christopher A Droege, Paige Bradshaw, Lindsey Federle, Savannah Ruess, Carolyn D Philpott","doi":"10.1177/00185787261476068","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Apixaban for acute venous thromboembolism (VTE) is dosed with an intensified 7-day lead-in to decrease recurrence. The optimal initiation dosing in hospitalized patients remains unknown. This study compares the safety and efficacy of apixaban maintenance versus lead-in dose initiation in hospitalized patients with acute VTE.</p><p><strong>Methods: </strong>This IRB-approved, retrospective, single center, cohort study was conducted at a quaternary referral, academic medical center. Adult patients diagnosed with acute VTE who received ≥1 apixaban dose during hospitalization were eligible for inclusion. Patients initiated on apixaban ≥7 days from VTE or anticoagulated within 3 months prior to admission were excluded. Patients were grouped into 2 cohorts: (1) maintenance dose (MD) - no apixaban 10 mg dose and (2) lead-in dose (LD) - received ≥1 apixaban 10 mg dose. Outcomes were assessed for 3 months following apixaban initiation. The primary outcome compared a composite endpoint of major and non-major clinically relevant bleeding (NMCRB) between groups. The secondary outcome compared a composite endpoint of recurrent VTE and all-cause mortality (VTE-M) between groups.</p><p><strong>Results: </strong>A total of 200 (28 MD, 172 LD) patients were included. Patients were 61 (48-72) years old and admitted 5 (2-12) days. Baseline characteristics were similar between groups. Parenteral anticoagulation was administered in 90% (25 [89%] MD, 156 [91%] LD) of patients prior to apixaban initiation. Time on parenteral anticoagulation was longer in MD (61 [37-88] hours] compared to LD (40 [18-65] hours) patients (<i>P</i> = .02). Composite major and NMCRB occurred in 6 (21.4%) MD and 21 (12.2%) LD patients (<i>P</i> = .19). Composite VTE-M occurred in 2 (7.1%) MD and 16 (9.3%) LD patients (<i>P</i> = .71).</p><p><strong>Conclusion: </strong>This study found no difference in bleeding or VTE-M in hospitalized patients with acute VTE receiving apixaban MD versus LD. The high incidence of bleeding suggests caution is needed with apixaban initiation in this population.</p>","PeriodicalId":13002,"journal":{"name":"Hospital Pharmacy","volume":" ","pages":"00185787261476068"},"PeriodicalIF":0.9000,"publicationDate":"2026-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13481519/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Hospital Pharmacy","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/00185787261476068","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Apixaban for acute venous thromboembolism (VTE) is dosed with an intensified 7-day lead-in to decrease recurrence. The optimal initiation dosing in hospitalized patients remains unknown. This study compares the safety and efficacy of apixaban maintenance versus lead-in dose initiation in hospitalized patients with acute VTE.
Methods: This IRB-approved, retrospective, single center, cohort study was conducted at a quaternary referral, academic medical center. Adult patients diagnosed with acute VTE who received ≥1 apixaban dose during hospitalization were eligible for inclusion. Patients initiated on apixaban ≥7 days from VTE or anticoagulated within 3 months prior to admission were excluded. Patients were grouped into 2 cohorts: (1) maintenance dose (MD) - no apixaban 10 mg dose and (2) lead-in dose (LD) - received ≥1 apixaban 10 mg dose. Outcomes were assessed for 3 months following apixaban initiation. The primary outcome compared a composite endpoint of major and non-major clinically relevant bleeding (NMCRB) between groups. The secondary outcome compared a composite endpoint of recurrent VTE and all-cause mortality (VTE-M) between groups.
Results: A total of 200 (28 MD, 172 LD) patients were included. Patients were 61 (48-72) years old and admitted 5 (2-12) days. Baseline characteristics were similar between groups. Parenteral anticoagulation was administered in 90% (25 [89%] MD, 156 [91%] LD) of patients prior to apixaban initiation. Time on parenteral anticoagulation was longer in MD (61 [37-88] hours] compared to LD (40 [18-65] hours) patients (P = .02). Composite major and NMCRB occurred in 6 (21.4%) MD and 21 (12.2%) LD patients (P = .19). Composite VTE-M occurred in 2 (7.1%) MD and 16 (9.3%) LD patients (P = .71).
Conclusion: This study found no difference in bleeding or VTE-M in hospitalized patients with acute VTE receiving apixaban MD versus LD. The high incidence of bleeding suggests caution is needed with apixaban initiation in this population.
期刊介绍：
Hospital Pharmacy is a monthly peer-reviewed journal that is read by pharmacists and other providers practicing in the inpatient and outpatient setting within hospitals, long-term care facilities, home care, and other health-system settings The Hospital Pharmacy Assistant Editor, Michael R. Cohen, RPh, MS, DSc, FASHP, is author of a Medication Error Report Analysis and founder of The Institute for Safe Medication Practices (ISMP), a nonprofit organization that provides education about adverse drug events and their prevention.
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