Venous thromboembolism (VTE) has a high prevalence in patients with multiple comorbidities undergoing complex surgical procedures. Sometimes, extended prophylaxis for VTE with KLMWH or direct oral anticoagulants (DOACs) is necessary. Currently, there is no consensus in the literature regarding the use of DOACs for extended VTE prophylaxis in patients undergoing lower limb revascularization (LLR). Objective: To evaluate the use of DOACs (already approved to reduce MACE and MALE) in VTE prophylaxis in patients undergoing LLR.
Be adults of any age and gender.
Have critical limb ischemia with a proposed revascularization treatment (either via ATP or bypass surgery) at the Vascular Surgery Service of HC/EBSERH - UFPE.
Sign the informed consent form (ICF) (Appendix 2).
Experience a symptomatic VTE event during hospitalization, as they will require full anticoagulation rather than prophylactic anticoagulation.
Have any contraindications to Rivaroxaban.
Do not return for the 30-day postoperative follow-up visit.
Parallel
rivaroxaban 2.5 mg bid + aspirin 100 mg
Drugrivaroxaban 2.5 mg bid + aspirin
clopidogrel 75 mg od for 3 months followed by aspirin 100 mg od for endovascular procedures or aspirin for open procedures
Drugcomparator
primary efficacy outcome
Incidence of symptomatic + asymptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) 30 days post-hospital discharge.
primary safety outcome
Combination of clinically relevant non-major bleeding + major bleeding defined by the ISTH criteria
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