Rivaroxaban vs. Warfarin for Post Cardiac Surgery Atrial Fibrillation

Massachusetts General Hospital100 enrolled

Overview

This prospective, randomized, active-controlled, parallel arm study compares the safety and financial benefits of arterial thromboembolism prophylaxis with Warfarin vs. Rivaroxaban (A novel oral anticoagulant) in patients with new onset atrial fibrillation after sternotomy for cardiac operations.

New onset atrial fibrillation (NOAF) is a common occurrence following cardiac surgery, occurring in 20-30% of patients post-operatively. Historically, Vitamin K antagonist therapy with Warfarin has been the treatment of choice for prophylaxis against stroke and systemic arterial thromboembolism in NOAF. Warfarin inhibits the Vitamin K dependent factors involved in both the intrinsic and extrinsic coagulation cascades, thus decreasing systemic clotting. However, Warfarin therapy comes with many challenges including prolonged titration, tedious monitoring requirements and in some cases, increased bleeding risk. The limitations associated with Warfarin may be mitigated by using new oral anticoagulants (NOACs) like Rivaroxaban which have no routine monitoring requirements. Rivaroxaban is a direct inhibitor of Factor Xa, a central reactant in both the intrinsic and extrinsic coagulation cascades. Studies in non-operative patients with atrial fibrillation have shown that Rivaroxaban is non-inferior to Warfarin for stroke prophylaxis with similar risk profiles. This study aims to compare the efficacy, safety and financial cost of these two drugs when used for the management of new onset atrial fibrillation that occurs after cardiac operations.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

100

Conditions

Atrial Fibrillation Stroke Bleeding

Interventions

RivaroxabanDRUG

Anticoagulant drug that works via direct inhibition of factor Xa. FDA approved for prophylaxis against stroke in non-valvular atrial fibrillation

WarfarinDRUG

Anticoagulation drug that works via inhibition of vitamin K dependent clotting factors. FDA approved for prophylaxis against stroke in atrial fibrillation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or Female ≥ 18 years * At least one of the following procedures: coronary artery bypass grafting, aortic valve repair, mitral valve repair, non-mechanical aortic valve replacement, any combination of these procedures * Two or more episodes of New Onset Atrial Fibrillation (each lasting \> 20 minutes) or persistent atrial fibrillation lasting \> 24 hours (Or for \>18 hours over a 24-hour interval) * If female of child-bearing age, use of adequate contraception Exclusion Criteria: * Pre-existing paroxysmal atrial fibrillation before cardiac surgery * Pre-existing indications for therapeutic anticoagulation (Including but not limited to PE, DVT, mechanical valve) * Moderate-to-severe mitral valve stenosis not surgically corrected * Pre-existing allergy to study medications * Recent (\< 1 year) or ongoing pregnancy (Urine pregnancy test will be obtained for women of child bearing age at the time of enrollment into the study) * Stroke within 1 month prior to surgery or postoperatively prior to initiation of study drugs * Postoperative bleeding episode prior to initiation of study drug * Severe dysfunction of another organ system including GFR \< 30 ml/min, baseline INR \> 1.7, ileus or other gastrointestinal pathology hindering ability to absorb oral medications, and known coagulation pathway deficiencies * Postoperative need for non-aspirin anti-platelet therapy that cannot be discontinued when therapeutic anticoagulation is initiated * Patient taking medications with known major interactions with study drugs with no therapeutic alternatives)

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Postoperative Length of Stay

Length of inpatient stay in days from time of departure from the operating room

Time frame: Up to 6 months following the cardiac operation

Secondary Outcomes

Episode of Major Bleeding (Defined as the occurrence of any of several events listed in the description. No specific scale, questionnaire or instrument will be used)

Major bleeding defined as re-operation or other therapeutic intervention for bleeding (including but not limited to colonoscopy, upper endoscopy and urologic procedures for hematuria), development of any intracranial bleeding, cessation of study drug for bleeding concerns, reversal of study drug for bleeding concerns and/or new transfusion requirement \> 2 units of blood after drug administration

Time frame: Up to 30 days after discharge from the initial postoperative hospitalization

Cerebrovascular accident (CVA)

Rates of cerebrovascular accident including stroke and transient ischemic attack (TIA)

Time frame: Up to 30 days after discharge from the initial postoperative hospitalization

Other systemic embolism

Rates of non-neurological systemic arterial embolism involving any organ system

Time frame: Up to 30 days after discharge from the initial postoperative hospitalization

Deep venous thrombosis (DVT) and/or Pulmonary Embolism (PE)

Occurrence of pathologic venous thrombo-embolism including DVT and PE

Time frame: Up to 30 days after discharge from the initial postoperative hospitalization

Minor Bleeding

Minor bleeding defined as blood transfusions \<= 2 units or drop in hemoglobin greater 3g/dL following administration of study drugs

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.