Investigation of Rheumatic AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies - INVICTUS

Sep 15, 2022
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Bayer
Date Presented:
08/28/2022
Date Published:
08/28/2022
Date Updated:
09/15/2022
Original Posted Date:
08/28/2022
References

Contribution To Literature:

The INVICTUS trial failed to show that rivaroxaban prevented adverse cardiovascular events among patients with rheumatic heart disease and atrial fibrillation.

Description:

The goal of the trial was to evaluate rivaroxaban compared with a vitamin K antagonist among patients with rheumatic heart disease and atrial fibrillation.

Study Design

  • Randomization
  • Parallel
  • Open-label

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%

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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
  • Pregnancy

Other salient features/characteristics:

  • CHA2DS2-VASc score ≥2: 56%

Principal Findings:

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.

Secondary outcomes:

  • 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)

Interpretation:

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.

References:

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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