2. Duration of Therapy

There is no basis for limiting DOAC therapy when prescribed to prevent thromboembolic events associated with cardiovascular or cerebrovascular disease in those with a high risk of recurrence and low risk of bleeding (e.g., unprovoked proximal DVT, recurrent DVT). However, DOAC treatment duration varies, based on medication utilized, indication for use, underlying disease states, and patient factors⁹. The 2021 “Antithrombotic Therapy for VTE Disease: Second Update of the CHEST Guidelines and Expert Review Panel Report” indicates that extended-phase anticoagulation with DOACs does not have a defined stop date, and patients have been monitored for up to four years while on extended-phase anticoagulation. DOAC treatment durations are summarized in Table 7 through Table 10. 

Table 7. DOAC Recommended Treatment Duration (Adults): Direct Thrombin Inhibitors^1,2,3,9

Drug Name	Indication	Maximum Treatment Duration
dabigatran (Pradaxa)	Reduction of risk of stroke and systemic embolism in non-valvular AF	indefinite
	DVT and PE treatment	3-12 months
	DVT and PE prevention	indefinite
	Prophylaxis of DVT and PE following hip replacement surgery	28-35 days

Legend

• AF = atrial fibrillation
• DVT = deep venous thrombosis
• PE = pulmonary embolism

Table 8. DOAC Recommended Treatment Duration (Adults): Factor Xa Inhibitors^1,4-6,9

Drug Name	Indication	Maximum Treatment Duration
apixaban (Eliquis)	Reduction of risk of stroke and systemic embolism in patients with non-valvular AF	indefinite
	Prophylaxis of DVT following hip or knee replacement surgery	35 days (hip); 12 days (knee)
	Treatment of DVT and PE	3-12 months
	Reduction in risk of recurrence of DVT and PE	indefinite after at least 6 months of treatment
edoxaban (Savaysa)	Reduction of risk of stroke and systemic embolism in patients with non-valvular AF	indefinite
	Treatment of DVT and PE	maximum of 12 months after 5-10 days of initial therapy with a parenteral anticoagulant
rivaroxaban (Xarelto)	Reduction in the risk of stroke in non-valvular AF	indefinite
	Treatment of DVT and PE	3-12 months
	Reduction in risk of recurrence of DVT and PE	up to 12 months after an initial 6 months of treatment
	Prophylaxis of DVT following hip or knee replacement surgery	35 days (hip); 12 days (knee)
	VTE prophylaxis in hospitalized adults with acute illness and limited mobility and other risk factors for VTE	31 to 39 days
	Reduction of major cardiovascular event risk in patients with chronic coronary heart disease, peripheral artery disease	indefinite

Legend

• AF = atrial fibrillation
• DVT = deep venous thrombosis
• PE = pulmonary embolism

The DIVERSITY trial was conducted in pediatric populations to determine the safety and efficacy of dabigatran compared to the standard of care for the treatment of VTE. The median duration of dabigatran for VTE was 84.5 days¹⁰. An additional trial evaluated the safety and effectiveness of dabigatran in patients requiring secondary VTE prophylaxis who completed the DIVERSITY trial. Pediatric patients were treated with dabigatran for up to 12 months after the initial treatment for VTE¹¹.

Table 9. DOAC Recommended Treatment Duration (Pediatrics): Direct Thrombin Inhibitors^1,2,3

Drug Name	Indication	Maximum Treatment Duration
dabigatran (Pradaxa)	VTE treatment	3-12 months
	Reduction in risk of recurrence of DVT and PE	up to 12 months after initial treatment for VTE

The EINSTEIN Junior trial studied the safety and efficacy of rivaroxaban compared to standard of care in pediatric patients with VTE. When appropriate, treatment for VTE and VTE risk reduction was extended to up to 12 months in duration¹³. The UNIVERSE trial assessed the safety and efficacy of rivaroxaban for thromboprophylaxis in pediatric patients with congenital heart disease who have undergone the Fontan procedure. Participants took rivaroxaban for up to 12 months in the study¹⁴. However, thromboembolic risk may persist for several years after the procedure, and further therapy with antiplatelet or anticoagulant drugs may be appropriate¹⁴.

Table 10. DOAC Recommended Treatment Duration (Pediatrics): Factor Xa Inhibitors^1,6,12-14

Drug Name	Indication	Maximum Treatment Duration
rivaroxaban (Xarelto®)	VTE treatment	3-12 months
	Reduction in risk of recurrence of VTE	up to 12 months
	Thromboprophylaxis in patients at least 2 years of age with congenital heart disease who have undergone Fontan procedure	up to 12 months!

Legend

• ! Specific patient factors may require a longer duration of antiplatelet or anticoagulant therapy