Is rivaroxaban (Xarelto) effective for stroke prevention in patients with rheumatic valvular atrial fibrillation?

Rivaroxaban is Contraindicated in Rheumatic Valvular Atrial Fibrillation

Rivaroxaban should NOT be used in patients with rheumatic valvular atrial fibrillation—vitamin K antagonists (warfarin) remain the standard of care for this population. 1

Critical Evidence from the INVICTUS Trial

The INVICTUS trial (2023) definitively demonstrated that rivaroxaban is inferior to warfarin in patients with rheumatic heart disease-associated atrial fibrillation 1:

• Primary outcome: Rivaroxaban resulted in 76 fewer days of survival compared to warfarin (1599 vs 1675 days; 95% CI -121 to -31; P <0.001) 1
• Mortality: Higher death rates occurred with rivaroxaban (1608 vs 1680 days; difference -72 days; 95% CI -117 to -28) 1
• Stroke prevention: Warfarin led to lower rates of ischemic stroke and lower vascular mortality without significantly increasing major bleeding 1
• Study population: 4,531 patients followed for 3.1 years—this is the largest and most recent high-quality evidence specifically addressing this question 1

Guideline Recommendations

Current guidelines explicitly exclude rheumatic valvular disease from NOAC indications 2, 3:

• The American College of Cardiology states that rivaroxaban is approved only for nonvalvular atrial fibrillation 2
• Rivaroxaban is contraindicated in patients with prosthetic heart valves or hemodynamically significant valvular disease 2, 3
• The ROCKET AF trial, which established rivaroxaban's efficacy, specifically excluded patients with mitral stenosis 4, 5

Why This Distinction Matters

Rheumatic valvular disease creates fundamentally different thromboembolic mechanisms compared to nonvalvular AF 1:

• Rheumatic mitral stenosis causes severe left atrial enlargement and stasis
• The inflammatory and fibrotic changes in rheumatic valves create unique prothrombotic conditions
• These patients were systematically excluded from all major NOAC trials 4, 5

Practical Management Algorithm

For patients with rheumatic valvular AF:

1. Initiate vitamin K antagonist therapy (warfarin, target INR 2.0-3.0) 1
2. Monitor INR regularly and adjust dosing to maintain therapeutic range 1
3. Do NOT substitute with rivaroxaban or other NOACs—this increases mortality and stroke risk 1

Common pitfall to avoid: Do not assume that "valvular heart disease" mentioned in observational studies 6, 5 refers to rheumatic disease. Most studies define "valvular disease" as native valve abnormalities in nonvalvular AF, which is entirely different from rheumatic valvular disease 5.

The Evidence Hierarchy

While a 2014 post-hoc analysis from ROCKET AF examined patients with "significant valvular disease" (native mitral/aortic disease), these were NOT rheumatic patients 5. That analysis showed higher bleeding with rivaroxaban in valve disease patients (HR 1.25,95% CI 1.05-1.49) 5, but more importantly, the INVICTUS trial's 2023 data supersedes all prior evidence by directly studying rheumatic patients and demonstrating clear inferiority of rivaroxaban 1.

The bottom line: Warfarin remains the only evidence-based anticoagulant for stroke prevention in rheumatic valvular atrial fibrillation, and switching to rivaroxaban increases the risk of death and stroke 1.