Table 2.
ATLAS ACS 2 TIMI 51 trial – incidence rates of efficacy and safety outcomes in all patients and in those with elevated cardiac biomarkers and without prior stroke/transient ischaemic attack 27.
| Endpoint | Populationa | Incidence rate, % | ARRe, % | HR (95% CI)f | P-valueg | |
|---|---|---|---|---|---|---|
| Rivaroxaban 2.5 mg bidg | Placebog | |||||
| CV death, MI or stroke | Overall | 6.1 | 7.4 | 1.3 | 0.84 (0.72–0.97) | P = 0.020* |
| Elevated biomarkers (without prior stroke/TIA) | 6.2 | 7.9 | 1.7 | 0.80 (0.68–0.94) | P = 0.007** | |
| CV death | Overall | 1.8 | 2.8 | 1.0 | 0.66 (0.51–0.86) | P = 0.002** |
| Elevated biomarkers (without prior stroke/TIA) | 1.7 | 3.1 | 1.4 | 0.55 (0.41–0.74) | P < 0.001** | |
| Stroke (ischaemic or haemorrhagic) | Overall | 0.9 | 0.8 | 0.1 | 1.13 (0.74–1.73) | P = 0.562 |
| Elevated biomarkers (without prior stroke/TIA) | 0.9 | 0.7 | 0.2 | 1.23 (0.75–2.02) | P = 0.403 | |
| MI | Overall | 4.0 | 4.5 | 0.5 | 0.90 (0.75–1.09) | P = 0.270 |
| Elevated biomarkers (without prior stroke/TIA) | 4.3 | 4.9 | 0.6 | 0.88 (0.72–1.08) | P = 0.215 | |
| TIMI major bleeding not related to CABGc | Overall | 1.3 | 0.4 | 0.9 | 3.46 (2.08–5.77) | P < 0.001 |
| Elevated biomarkers (without prior stroke/TIA) | 1.3 | 0.4 | 0.9 | 3.44 (1.97–6.01) | P < 0.001 | |
| Stent thrombosis (in patients who underwent PCI)d | Overall | 1.3 | 2.0 | 0.7 | 0.64 (0.43–0.95) | P = 0.026 |
| Elevated biomarkers (without prior stroke/TIA) | 1.4 | 2.0 | 0.6 | 0.64 (0.42–0.96) | P = 0.028 | |
bid, twice-daily; CABG, coronary artery bypass graft; CI, confidence interval; CV, cardiovascular; HR, hazard ratio; MI, myocardial infarction; PCI, percutaneous coronary intervention; TIA, transient ischaemic attack.
Statistically superior.
Nominally significant.
For efficacy events, the mITT (excluding three potentially noncompliant study sites) Analysis Set was used; for safety events, the treatment-emergent Safety Analysis Set was used. For stent thrombosis, the component of the mITT population who had undergone PCI (either history of stent or for the index event) was used.
mITT populations: Rivaroxaban 2.5 mg bid: N = 5114 overall, n = 4104 elevated biomarkers; Placebo: N = 5113 overall, n = 4160 elevated biomarkers.
Safety Analysis Set populations: Rivaroxaban 2.5 mg bid: N = 5115 overall, n = 4096 elevated biomarkers; Placebo: N = 5125 overall, n = 4157 elevated biomarkers.
mITT population for PCI patients: Rivaroxaban 2.5 mg bid: N = 3114 overall, n = 2757 elevated biomarkers; Placebo: N = 3096 overall, n = 2759 elevated biomarkers.
ARR = Absolute risk reduction (percentage points) vs. placebo (difference of incidence rates between placebo and rivaroxaban).
HR (95% CI): Hazard ratios (95% confidence interval) as compared to placebo arm are based on the stratified (by standard of care with ASA or ASA + thienopyridine) Cox proportional hazards model.
P-values (two-sided) as compared to placebo arm are based on the stratified (by standard of care with ASA or ASA + thienopyridine) log rank test.