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February 2, 2021 Circulation. 2021;143:e72–e227. DOI: 10.1161/CIR.0000000000000923 e84

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

bioprosthetic valves >3 months after implantation or, 2) with native VHD excluding rheumatic MS (Figure 1).

Recommendation-Specific Supportive Text

1.	 The 4 large RCTs8–14 comparing NOACs with warfarin included small numbers of patients with VHD, prior valve repair, and bioprosthetic valves (excluding moderate to severe rheumatic MS and mechanical heart valves). In addition to the subsequent meta-analyses,1,15–17 examinations of insurance claims data and large registries18 have consistently confirmed no signal for a differential effect between NOAC and VKA therapy.19,20 More consistently observed is a net clinical benefit, with fewer events in patients using NOACs than in patients on VKA therapy. Validation of the CHA2DS2-VASc risk schema in patients with VHD (excluding moderate to severe rheumatic MS and mechanical heart valves) has been performed in large registries,2 confirming the applicability of this score. Bioprosthetic valves do not appear to be independent predictors of thromboembolic events in patients with AF.19 2.	 The coexistence of AF and rheumatic MS is common and confers a substantial risk of thromboembolic events. These patients have been specifically excluded from NOAC trials, yet a single registry study and a US claims database analysis do suggest that NOACs may be potentially preferable.21,22 These findings need further validation, and currently the use of NOACs cannot be supported over VKA (target international normalized ratio [INR] of 2.5). 3.	 Postoperative AF after VHD intervention is associated with increased stroke and mortality rates3,4 irrespective of the CHA2DS2-VASc score. Anticoagulation in this setting may reduce these endpoints. There are conflicting data about the safety and efficacy of NOAC therapy in patients early after implantation of a bioprosthesis.5,6,23 Until more data are available, the writing committee favors using VKA for patients with AF in the first 3 months after surgical or transcatheter bioprosthetic valve implantation to prevent thromboembolic events. The optimal duration of anticoagulation is not well defined. Repeat evaluation is encouraged in all patients to detect arrhythmia recurrence in the context of their CHA2DS2-VASc scores. 4.	 The phase II study comparing dabigatran to warfarin (RE-ALIGN [Randomized, Phase II Study to Evaluate the Safety and Pharmacokinetics of Oral Dabigatran Etexilate in Patients after Heart Valve Replacement]) was halted prematurely because of excess stroke and

Figure 1. Anticoagulation for AF in Patients With VHD. Colors correspond to Table 2. AF indicates atrial fibrillation; MS, mitral stenosis; NOAC, non–vitamin K oral anticoagulant; VHD, valvular heart disease; and VKA, vitamin K antagonist.

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