What did the FIGARO (Factor Xa Inhibitor Rivaroxaban (rivaroxaban) Assessment in Reduction of Stroke and Other Thromboembolic Events) trial show regarding the efficacy of rivaroxaban in reducing the risk of stroke and systemic embolism in patients with atrial fibrillation?

FIGARO Trial - Clarification Required

The question appears to contain an error: there is no "FIGARO" trial related to rivaroxaban and atrial fibrillation. The trial you are likely referring to is ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation), which was the pivotal trial evaluating rivaroxaban for stroke prevention in atrial fibrillation 1.

ROCKET AF Trial: Key Findings

Study Design

• Double-blind, noninferiority trial that randomized 14,264 patients with nonvalvular atrial fibrillation at moderate to high stroke risk 1
• Compared rivaroxaban 20 mg daily (15 mg for CrCl 30-49 mL/min) versus dose-adjusted warfarin (target INR 2.0-3.0) 1
• Higher-risk population than other DOAC trials: mean CHADS2 score of 3.5, with 55% having prior stroke, TIA, or systemic embolism 1
• Median follow-up: 707 days 1

Primary Efficacy Results

Rivaroxaban was noninferior to warfarin for stroke prevention:

• Per-protocol analysis (as-treated): 1.7%/year (rivaroxaban) vs 2.2%/year (warfarin) for stroke/systemic embolism (HR 0.79; 95% CI 0.66-0.96; P<0.001 for noninferiority) 1
• Intention-to-treat analysis: 2.1%/year vs 2.4%/year (HR 0.88; 95% CI 0.74-1.03; P=0.12 for superiority) 1

Safety Outcomes

Overall bleeding risk was similar between groups:

• Major or nonmajor clinically relevant bleeding: 14.9%/year (rivaroxaban) vs 14.5%/year (warfarin) (HR 1.03; P=0.44) 1

Critical mortality and safety advantages with rivaroxaban:

• Intracranial hemorrhage reduced by 33%: 0.5% vs 0.7% (HR 0.67; P=0.02) 1
• Fatal bleeding reduced by 50%: 0.2% vs 0.5% (HR 0.50; P=0.003) 1
• Gastrointestinal bleeding increased: 3.2% vs 2.2% (P<0.001) 1

Important Subgroup Findings

Primary prevention (no prior stroke/TIA):

• Rivaroxaban showed borderline superiority: HR 0.71 (95% CI 0.54-0.94) for primary endpoint 1
• Event rate: 2.57%/year (rivaroxaban) vs 3.61%/year (warfarin) 1

Secondary prevention (prior stroke/TIA):

• No significant difference in efficacy: 4.8% vs 4.9% (HR 0.98) 1

Warfarin-naïve patients:

• Lower event rates with rivaroxaban: 3.79% vs 4.94% (HR 0.76; 95% CI 0.59-0.98) 1

Heart failure patients (63.7% of trial):

• Consistent efficacy and safety regardless of ejection fraction or NYHA class 2

Clinical Interpretation Caveats

Important limitations to consider:

• Suboptimal warfarin management: mean time in therapeutic range only 55%, raising questions about comparative effectiveness in well-managed warfarin patients 1
• High event rate after drug cessation: relatively high number of outcomes beyond 2-day monitoring period after stopping study drug 1
• Higher baseline risk population than RE-LY or ARISTOTLE trials, limiting direct comparisons 1

FDA Approval and Current Use

Rivaroxaban is FDA-approved to reduce stroke and systemic embolism risk in adults with nonvalvular atrial fibrillation, with the caveat that there are limited data on relative effectiveness versus warfarin when warfarin therapy is well-controlled 3.

Note: The FIGARO trial actually refers to a completely different study—FIGARO-DKD (Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease)—which evaluated finerenone, not rivaroxaban, in patients with chronic kidney disease and type 2 diabetes. This is an entirely separate therapeutic area unrelated to atrial fibrillation or anticoagulation.