Investigation of Rheumatic AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies - INVICTUS
Contribution To Literature:
The INVICTUS trial failed to show that rivaroxaban prevented adverse cardiovascular events among patients with rheumatic heart disease and atrial fibrillation.
The goal of the trial was to evaluate rivaroxaban compared with a vitamin K antagonist among patients with rheumatic heart disease and atrial fibrillation.
Patients with rheumatic heart disease were randomized to rivaroxaban 20 mg daily (15 mg daily if creatinine clearance <50 ml/min) (n = 2,275) versus a vitamin K antagonist (international normalized ratio [INR] range 2.0-3.0) (n = 2,256).
- Total number of enrollees: 4,531
- Duration of follow-up: 3.1 years
- Mean patient age: 50 years
- Percentage female: 72%
- Percentage with diabetes: 6.4%
- At least 18 years of age with rheumatic heart disease
- Atrial fibrillation or atrial flutter
- At least one of the following: CHA2DS2-VASc score >1, mitral valve area <2 cm2, echocardiographic evidence of either left atrial spontaneous echo contrast or left atrial thrombus
- Mechanical heart valve
- Dual antiplatelet therapy
- Treatment with dual strong inhibitors of CYP3A4 and P-glycoprotein
- Estimated glomerular filtration rate <15 ml/min/1.73 m2
Other salient features/characteristics:
- CHA2DS2-VASc score ≥2: 56%
The primary outcome, death from vascular or unknown cause, stroke, systemic embolism, or myocardial infarction, occurred in 8.2% of the rivaroxaban group vs. 6.5% of the vitamin K antagonist group (p < 0.001). Event curves appeared to diverge after 18 months of follow-up.
- Vascular death: 6.3% of the rivaroxaban group vs. 4.8% of the vitamin K antagonist group (p < 0.05)
- Ischemic stroke: 1.1% of the rivaroxaban group vs. 0.7% of the vitamin K antagonist group (p < 0.05)
Among patients with rheumatic heart disease and atrial fibrillation, rivaroxaban did not prevent adverse cardiovascular events compared with a vitamin K antagonist. Rivaroxaban compared with a vitamin K antagonist was also associated with an increased risk of ischemic stroke and vascular death. This trial supports current treatment guidelines to use a vitamin K antagonist for stroke prevention among patients with rheumatic heart disease and atrial fibrillation.
Connolly SJ, Karthikeyan G, Ntsekhe M, et al., on behalf of the INVICTUS Investigators. Rivaroxaban in Rheumatic Heart Disease–Associated Atrial Fibrillation. N Engl J Med 2022;387:978-88.
Editorial: Lip GY. Anticoagulation in Atrial Fibrillation and Rheumatic Heart Disease. N Engl J Med 2022;387:1036-8.
Presented by Dr. Ganesan Karthikeyan at the European Society of Cardiology Congress (ESC 2022), Barcelona, Spain, August 28, 2022.
Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Noninvasive Imaging, Prevention, Valvular Heart Disease, Anticoagulation Management and Atrial Fibrillation, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Echocardiography/Ultrasound
Keywords: Anticoagulants, Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Creatinine, Echocardiography, Embolism, ESC22, ESC Congress, Heart Valve Diseases, Ischemic Stroke, Mitral Valve, Myocardial Infarction, Primary Prevention, Rheumatic Heart Disease, Rivaroxaban, Thrombosis, Vitamin K
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