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................................................................................................ In the absence of bleeding, the use of PCC and/or FFP therapy is not recommended and the decision to start vitamin K should be individualized. In asymptomatic patients with INR >10, the VKA must be stopped and oral vitamin K (2.55 mg) prescribed, while the INR must be monitored on a daily base for 2 weeks. Multiple RCTs in patients with INR between 4.5 and 10 suggest no difference in bleeding events with vitamin K vs. placebo.483,485 Therefore, in such patients, warfarin should be stopped temporarily, and a small dose of oral vitamin K (12 mg) can be considered on an individual basis balancing between the risks. Finally, asymptomatic patients with INR <4.5 require careful down-titration and/or skipping one or more doses. In all patients with MHVs, VKAs must be resumed once the INR achieves the therapeutic range or is slightly elevated.

11.3.1.4 Combination of oral anticoagulation (OAC) with antiplatelet drugs The addition of low-dose (75100 mg) acetylsalicylic acid (ASA) to VKA may reduce the incidence of thromboembolism at the cost of bleeding.477 Therefore, addition of antiplatelets to VKAs should be reserved for patients at very high risk of thromboembolism where advantages clearly outweigh the risks.486,487 In patients with thromboembolism despite adequate INR, low dose (75100 mg) ASA should be added to VKAs. Management of oral antithrombotic therapy in patients with CAD is summarized in Supplementary Figure 2.

11.3.1.5 Interruption of anticoagulant therapy for planned invasive procedures In patients with MHVs, preoperative bridging with UFH or LMWH before surgery imposes a risk of perioperative bleeding while interrupting anticoagulation results in an increased risk of thromboembolism.488 Therefore, anticoagulation in patients with MHVs undergoing elective NCS requires careful management by multidisciplinary consensus.478,489 For minor surgical procedures (e.g. dental, cataract, skin incision) in which blood loss is usually small and easily controlled, it is recommended that OAC is not interrupted. Major surgeries require temporary interruption and therapeutic bridging with either UFH or LMWH, aiming for an INR <1.5 (Supplementary Figure 3). Fondaparinux should not be routinely used for bridging, but may have a role in patients with history of heparin-induced thrombocytopenia.490

11.3.2 Bioprostheses 11.3.2.1 Patients with no baseline indication to oral anticoagulation (OAC) Surgical bioprostheses: The optimal antithrombotic strategy early after surgical implantation of an aortic BHV remains controversial due to lack of high-quality evidence. Multiple observational studies support the use of VKAs to reduce the risk of thromboembolism.491493 A small randomized trial found that VKA for 3 months significantly increased major bleeding compared with ASA, without reducing the rate of deaths or thromboembolic events, but the statistical power was low for demonstrating a thrombotic benefit.494 VKA for 3 months should be considered in all patients with a mitral or tricuspid BHV and ASA or VKA should be considered for 3 months after surgical implantation of an aortic bioprosthesis. Transcatheter bioprostheses: A meta-analysis of three small RCTs showed a significant increase in major or life-threatening bleeding with dual antiplatelet therapy (DAPT) over ASA at 30 days, with no difference in ischaemic outcomes.495 Consistently, the more recent POPular TAVI trial (cohort A) found reduced bleeding and the composite of bleeding or thromboembolic events with ASA compared with DAPT.496 A randomized trial was halted prematurely due to safety concerns with a rivaroxaban-based regimen as compared with DAPT, including a higher risk of death or thromboembolic complications and a higher risk of bleeding.497 There is a lack of data on the management of antithrombotic therapy after implantation of transcatheter mitral BHVs (e.g. valve-in-valve or valve-in-ring) for which 3 months of VKA is commonly prescribed.498

11.3.2.2 Patients with baseline indication to oral anticoagulation (OAC) Surgical bioprostheses: OAC is recommended lifelong for patients with surgical BHVs who have other indications for anticoagulation. The evidence supporting the use of NOACs in preference to VKA has increased since the publication of the 2017 VHD Guidelines. In the RIVER trial, including patients with AF and a BHV in the mitral position, the NOAC rivaroxaban was non-inferior to warfarin with respect to a net benefit endpoint at 12 months.499 The benefit of NOAC was consistent among subgroups. However, only 20% of patients were enrolled in the trial before the third postoperative month, which raises a note of caution and calls for additional data in this particular subgroup. In the small ENAVLE trial (N = 220), including patients with and without AF, edoxaban was non-inferior to warfarin for preventing thromboembolism and the occurrence of major bleeding in the first 3 months after aortic or mitral surgical bioprosthetic valve implantation or repair, which warrants confirmation in larger investigations.500

Recommendations for management of antithrombotic therapy after prosthetic valve implantation or valve repair in the perioperative and postoperative periods

Recommendations Classa Levelb

Management of antithrombotic therapy in the perioperative period It is recommended that VKAs are timely discontinued prior to elective surgery to aim for an INR <1.5.c I C Bridging of OAC, when interruption is needed, is recommended in patients with any of the following indications: • Mechanical prosthetic heart valve. • AF with significant mitral stenosis. • AF with a CHA2DS2-VASc score >_3 for

women or 2 for men.d

• Acute thrombotic event within the previous 4 weeks. • High acute thromboembolic risk.e I C

Therapeutic doses of either UFH or subcutaneous LMWH are recommended for bridging.476,504 I B In patients with MHVs, it is recommended to (re)initiate the VKA on the first postoperative day. I C

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