Efficacy and Safety of Rivaroxaban in the Early Postoperative Period for Patients With Bioprosthetic Valves

Efficacy and Safety of Rivaroxaban in the Early Postoperative Period for Patients With Bioprosthetic Valves: A Prospective, Randomized, Controlled Non-Inferiority Trial

this study aims to comprehensively evaluate the efficacy and safety profiles of rivaroxaban and warfarin during the initial postoperative period following surgical bioprosthetic valve in patients.

Inclusion Criteria:

• Aged between 18 and 80 years
• Patients who underwent successful surgical bioprosthetic valve replacement or repair to either the mitral, aortic position or both
• Signed informed consent

Exclusion Criteria:

• Aged below 18 or over 80 years

• Mechanical heart valves (MHV)

• Bioprosthetic valve transcatheter valve replacement (TAVR)

• Hemorrhage risk-related criteria

  1. Active internal bleeding
  2. Major surgical procedure or trauma within 30 days before the randomization visit
  3. History of intracranial, intraocular, spinal, gastrointestinal, or atraumatic intra-articular bleeding
  4. Chronic hemorrhagic disorder
  5. Planned invasive procedure with potential for uncontrolled bleeding, including major surgery

• Concomitant conditions and therapies

  1. Clinically overt stroke within the past 3 months
  2. Major surgery within 1 month
  3. Acute coronary syndrome within 1 month
  4. Active infective endocarditis
  5. Severe hepatic impairment、hepatic disease associated with coagulopathy or Moderate and severe hepatic impairment (Child-Pugh Class B or C)
  6. Uncontrolled severe hypertension
  7. Active malignancy

• Medication-related

  1. Hypersensitivity or contraindications to Rivaroxaban, VKA, heparin.
  2. Concomitant treatment with strong inhibitors of both CYP3A4 and P-gp (e.g., azole antifungals, such as ketoconazole and itraconazole, or HIV protease inhibitors, such as ritonavir)
  3. Concomitant treatment with strong inducers of CYP3A4 (e.g., carbamazepine, phenytoin, rifampin, etc.)

• HAS-BLED score>3

• Others

  1. Abnormal local laboratory results, such as Platelet count < 50 x109/L、Hemoglobin < 8 g/dL (5 mmol/L)
  2. Female subjects of childbearing potential without using adequate contraception、
  3. Female pregnant or breast-feeding
  4. Participation is not likely to comply with the study procedures or will complete follow-up
  5. Participation in another clinical trial that potentially interferes with the current study
  6. Life expectancy less than 6 months beyond the targeted last visit