Table 3. Efficacy and Safety of Rivaroxaban and Aspirin in Combination vs Aspirin Alone Among Patients With Symptomatic Lower Extremity Peripheral Artery Diseasea.
| Outcome | Rivaroxaban plus aspirin (n = 1409) | Aspirin alone (n = 1359) | Rivaroxaban plus aspirin vs aspirin alone | |||||
|---|---|---|---|---|---|---|---|---|
| First events, No. (%) | Annual rate, % per y | 30-mo Kaplan-Meier incidence risk, % | First events, No. (%) | Annual rate, % per y | 30 mo Kaplan-Meier incidence risk, % | Hazard ratio (95% CI)b | Shrinkage estimates hazard ratio (95% credible interval)c | |
| MACEd | 73 (5.2) | 2.9 | 6.9 | 98 (7.2) | 4.1 | 10.8 | 0.71 (0.53-0.97) | 0.74 (0.58-0.92) |
| Cardiovascular death, myocardial infarction, ischemic stroke, acute limb ischemia, or major amputation | 88 (6.2) | 3.6 | 8.1 | 120 (8.8) | 5.1 | 13.0 | 0.70 (0.53-0.93) | 0.72 (0.58-0.89) |
| MALE, including major amputation | 26 (1.8) | 1.0 | 2.5 | 46 (3.4) | 1.9 | 4.7 | 0.55 (0.34-0.88) | 0.55 (0.35-0.85) |
| MACE or MALE, including major amputation | 98 (7.0) | 4.0 | 9.2 | 136 (10.0) | 5.8 | 14.6 | 0.69 (0.53-0.89) | 0.71 (0.57-0.87) |
| Major bleeding | 46 (3.3) | 1.9 | 4.5 | 26 (1.9) | 1.1 | 2.8 | 1.71 (1.06-2.77) | 1.69 (1.18-2.40) |
| Fatal or critical organ bleeding | 15 (1.1) | 0.6 | 1.2 | 7 (0.5) | 0.3 | 0.8 | 2.06 (0.84-5.05) | 1.56 (0.78-3.39) |
| Net clinical benefite | 107 (7.6) | 4.4 | 9.6 | 137 (10.1) | 6.0 | 14.4 | 0.75 (0.58-0.96) | 0.78 (0.63-0.95) |
Abbreviations: MACE, major adverse cardiac events; MALE, major adverse limb event.
a
Percentage is the proportion of patients with an outcome. Percentage per year is the rate per 100 patient-years of follow-up.
b
Hazard ratios (95% CI) are from the stratified Cox proportional hazards models.
c
Shrinkage estimates were obtained via bayesian hierarchical modeling.
d
MACE was defined as a myocardial infarction, stroke, or cardiovascular death.
e
Net clinical benefit was defined as MACE, MALE (including major amputation), or fatal or critical organ bleeding.