Explore the Efficacy and Safety of Once-Daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Non-Valvular Atrial Fibrillation Scheduled for Cardioversion - X-VeRT

Sep 02, 2014
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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:
01/01/2014
Date Published:
01/01/2014
Date Updated:
09/02/2014
Original Posted Date:
09/02/2014
References

Description:

Vitamin K antagonists are the standard of care before and after DC cardioversion for atrial fibrillation; however, this poses logistical issues for some patients. The goal of the trial was to evaluate treatment with the novel oral anticoagulant, rivaroxaban, compared with vitamin K antagonists among participants undergoing cardioversion for atrial fibrillation.

Hypothesis:

Rivaroxaban will allow for safe cardioversion.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Participants with nonvalvular atrial fibrillation >48 hours (or unknown duration) scheduled for cardioversion

    Number of enrollees: 1,504
    Mean patient age: 65 years
    Percentage female: 27%

Exclusions:

  • Prior acute thromboembolic event
  • MI or stroke ≤14 days (severe disabling stroke ≤3 months)
  • TIA ≤3 days
  • Cardiac thrombus, myxoma, or valvular heart disease
  • Active bleeding or high-risk for bleeding
  • Creatinine clearance <30 ml/min
  • Long-term aspirin therapy
  • Dual antiplatelet therapy

Primary Endpoints:

  • Efficacy: Composite of cardiovascular death, stroke/TIA, non-CNS systemic embolism, or MI
  • Safety: Major bleeding

Drug/Procedures Used:

Participants with nonvalvular atrial fibrillation scheduled for DC cardioversion were randomized to rivaroxaban 20 mg daily (n = 1,002) versus vitamin K antagonist with target international normalized ratio (INR), 2-3 (n = 502).

Participants in whom adequate anticoagulation could be achieved or transesophageal echocardiography performed were administered study medications for 1-5 days (early cardioversion), followed by DC cardioversion, and then resumed on study medication for 42 days.

The remaining participants received study medications for ≥21 days (delayed cardioversion), followed by DC cardioversion, and then resumed on study medication for 42 days.

Principal Findings:

Overall, 1,504 patients were randomized. The mean age was 65 years, 27% were women, mean CHADS2 score was 1.4, 7.7% had previous stroke/transient ischemic attack (TIA) or systemic embolism, and 20% had diabetes.

In the delayed cardioversion group, the median time to cardioversion was 22 days in the rivaroxaban group vs. 30 days in the vitamin K antagonist group (p < 0.001).

The primary efficacy outcome occurred in 0.51% of the rivaroxaban group vs. 1.02% of the vitamin K antagonist group (95% confidence interval [CI] 0.15-1.73, p = not significant [NS]). In the rivaroxaban group, four events occurred after early cardioversion, while one event occurred after late cardioversion. In the vitamin K antagonist group, three events occurred after early cardioversion, while two events occurred after late cardioversion.

- Hemorrhagic stroke: 2 vs. 0, respectively
- Ischemic stroke: 0 vs. 2, respectively
- Non–central nervous system (CNS) systemic embolism: 0 vs. 1, respectively
- Myocardial infarction (MI): 1 vs. 1, respectively
- Cardiovascular death: 4 vs. 2, respectively

The primary safety outcome occurred in 0.61% of the rivaroxaban group versus 0.80% of the vitamin K antagonist group (95% CI 0.21-2.67, p = NS).

Interpretation:

Among patients with nonvalvular atrial fibrillation, the use of rivaroxaban pericardioversion is feasible. This medication was associated with a similar incidence of the primary efficacy outcome and major bleeding compared with a vitamin K antagonist. Rivaroxaban also shortened the time to cardioversion when a delayed strategy was employed.

References:

Cappato R, Ezekowitz MD, Klein AL, et al., on behalf of the X-VeRT Investigators. Rivaroxaban vs. Vitamin K Antagonists for Cardioversion in Atrial Fibrillation. Eur Heart J 2014;Sep 2:[Epub ahead of print].

Presented by Dr. Riccardo Cappato at the European Society of Cardiology Congress, Barcelona, Spain, September 2, 2014.

Clinical Topics: Arrhythmias and Clinical EP, Cardiovascular Care Team, Noninvasive Imaging, EP Basic Science, Echocardiography/Ultrasound

Keywords: Vitamin K, Myocardial Infarction, Stroke, Ischemic Attack, Transient, Morpholines, Thiophenes, Electric Countershock, Standard of Care, International Normalized Ratio, Embolism, Confidence Intervals, Echocardiography, Transesophageal, Diabetes Mellitus, ESC Congress


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