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February 2, 2021 Circulation. 2021;143:e72–e227. DOI: 10.1161/CIR.0000000000000923 e146

CLINICAL STATEMENTS AND GUIDELINES Otto et al 2020 ACC/AHA Guideline for the Management of Valvular Heart Disease

of low-dose aspirin plus clopidogrel (75 mg daily). The study was terminated prematurely by the Data and Safety Monitoring Board because of safety concerns. The rivaroxaban strategy was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than those seen with the antiplatelet-based strategy.30 13.  Dabigatran was compared with warfarin in the RE-ALIGN (Randomized, Phase II Study to Evaluate the Safety and Pharmacokinetics of Oral Dabigatran Etexilate in Patients after Heart Valve Replacement) trial. It was stopped prematurely for excessive thrombotic and bleeding complications in the dabigatran arm.4,5 14.  The safety and efficacy of conventional-dose oral anti-Xa agents in patients with a mechanical valve prosthesis have not been evaluated.33–36 11.3 Bridging Therapy

Recommendations for Bridging Therapy During Interruption of Oral Anticoagulation in Patients With Prosthetic Heart Valves COR LOE Recommendations

1 C-EO 1.  For patients with mechanical heart valves who are undergoing minor procedures (eg, dental extractions or cataract removal) where bleeding is easily controlled, continuation of VKA anticoagulation with a therapeutic INR is recommended.

1 C-LD 2.  For patients with a bileaflet mechanical AVR and no other risk factors for thromboembolism who are undergoing invasive procedures, temporary interruption of VKA anticoagulation, without bridging agents while the INR is subtherapeutic, is recommended.

2a C-LD 3.  For patients with a mechanical valve prosthesis receiving VKA therapy who require immediate/ emergency noncardiac surgery or an invasive procedure, administration of 4-factor prothrombin complex concentrate (or its activated form) is reasonable.

Figure 13. Management of embolic events and valve thrombosis. Colors correspond to Table 2. 3D indicates 3-dimensional; 4D, 4-dimensional; AVR, aortic valve replacement; CT, computed tomography; INR, international normalized ratio; MVR, mitral valve replacement; Rx, medication; TEE, transesophageal echocardiography; TTE, transthoracic echocardiography; and VKA, vitamin K antagonist.

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