What is the recommended Direct Oral Anticoagulant (DOAC) regimen for patients post Transcatheter Aortic Valve Replacement (TAVR)?

Recommended DOAC Regimen Post-TAVR

For patients post-TAVR, DOACs are not recommended as first-line therapy, and the standard regimen should be aspirin 75-100 mg daily lifelong with clopidogrel 75 mg daily for 3-6 months. 1

Antithrombotic Therapy After TAVR

Standard Regimen (No Indication for Anticoagulation)

• Aspirin 75-100 mg daily lifelong 1
• Clopidogrel 75 mg daily for 3-6 months post-TAVR 1
• This dual antiplatelet therapy (DAPT) regimen was used in the original TAVR clinical trials to minimize thromboembolism risk 1

For Patients With Indication for Anticoagulation (e.g., Atrial Fibrillation)

• Vitamin K antagonist (VKA) such as warfarin with target INR 2.0-2.5 is preferred for the first 3 months post-TAVR 1
• After 3 months, patients with long-term indications for anticoagulation may transition to a DOAC 1
• Antiplatelet therapy can be discontinued after anticoagulation is initiated unless there are specific indications for continued antiplatelet therapy 1

Important Considerations for DOACs Post-TAVR

Safety Concerns

• The FDA label for rivaroxaban (Xarelto) specifically states: "On the basis of the GALILEO study, use of XARELTO is not recommended in patients who have had transcatheter aortic valve replacement (TAVR)" 2
• Rivaroxaban was associated with higher rates of death and bleeding compared to antiplatelet therapy in TAVR patients 2
• Recent evidence from a Cochrane network meta-analysis suggests that rivaroxaban and apixaban may increase all-cause mortality compared to antiplatelet therapy in patients without an indication for anticoagulation 3

Emerging Evidence

• The ATLANTIS trial investigated apixaban versus standard of care after TAVR, but did not demonstrate superiority of apixaban over standard care 4, 5
• While apixaban reduced subclinical valve thrombosis compared to antiplatelet therapy, it was associated with more non-cardiovascular deaths 5
• Limited data from small case series suggest DOACs may be safe in patients who have specific indications for anticoagulation after TAVR 6

Special Scenarios

Patients with Mechanical Valves

• DOACs should NOT be used in patients with mechanical valve prostheses 1
• The RE-ALIGN trial was stopped prematurely due to excessive thrombotic complications with dabigatran compared to warfarin 1

Patients with Bioprosthetic Valves

• For bioprosthetic valves (including TAVR), warfarin with INR target of 2.5 (range 2.0-3.0) may be reasonable for the first 3 months 1
• After 3 months, if there is no other indication for anticoagulation, warfarin can be discontinued 1

Algorithm for DOAC Use Post-TAVR

1. Assess if patient has indication for long-term anticoagulation:

   • If NO: Use standard DAPT (aspirin lifelong + clopidogrel for 3-6 months) 1
   • If YES: Proceed to step 2

2. For first 3 months post-TAVR with anticoagulation indication:

   • Preferred: Warfarin (target INR 2.0-2.5) 1
   • Consider adding low-dose aspirin (≤100 mg) only in patients at high thrombotic risk 1
   • Avoid triple therapy when possible due to bleeding risk 1

3. After 3 months post-TAVR with continued anticoagulation indication:

   • May transition to DOAC monotherapy if no evidence of valve thrombosis 1
   • Apixaban may be preferred based on limited evidence 6, 5
   • Avoid rivaroxaban due to FDA warning against use in TAVR patients 2

Monitoring and Follow-up

• Echocardiography at 30 days post-TAVR and then annually 1
• ECG at 30 days and annually 1
• Consider 4D-CT if valve thrombosis is suspected 5
• Monitor for bleeding complications, especially with combination antithrombotic therapy 1

Pitfalls and Caveats

• DOACs have not been adequately studied in TAVR patients and are not FDA-approved for this indication 2
• Combining anticoagulants with antiplatelet therapy significantly increases bleeding risk 1
• Patients with triple positive antiphospholipid syndrome should not receive DOACs 2
• The risk-benefit ratio of DOACs versus standard therapy continues to evolve as more data becomes available 3, 7