Li (2018) | Retrospective Cohort (n = 80,279) | Apixaban 2.5, 5 mg vs. warfarin respectively | Apixaban 5 mg 68.6 + 11 Apixaban 2.5 mg 82.5 + 9.5 | Apixaban 5 mg BID associated with lower risk of major bleeding (HR: 0.59, 95% CI: 0.53 - 0.66). Apixaban 2.5 mg BID is also associated with a lower risk of major bleeding (HR: 0.59, 95% CI: 0.49 - 0.71) [14] . |
Siontis (2019) | Retrospective Cohort (n = 25,523) | NVAF and ESKD Apixaban vs. warfarin | 68.22 + 11.89 | Apixaban was associated with significantly less bleeding (HR 0.72, 95% CI 0.59 - 0.87; P < 0.001) [15] |
Janssen Scientific Affairs, LLC (2016) PIONEER AF-PCI | RCT (n = 2,124) | Group 1: Rivaroxaban 15 mg daily plus P2Y12 Group 2: Rivaroxaban 2.5 mg twice daily followed by rivaroxaban 15 mg daily plus low-dose aspirin. Group 3: Warfarin plus DAPT followed by warfarin plus low-dose aspirin. | 70.1 ± 8.97 | Incidence of clinically significant bleeding: 16.8% of group 1 vs. 18.0% of group 2 vs. 26.7% of group 3 (HR 0.59, 95% CI 0.47 to 0.76; P < 0.001 for group 1 vs. 3; HR 0.63, 95% CI 0.5 to 0.8; P < 0.001 for group 2 vs. 3).
Incidence of major bleeding (secondary outcome): 2.1% of group 1 vs. 1.9% of group 2 vs. 3.3% of group 3 (HR 0.66, 95% CI 0.33 to 1.31; P = 0.234 for group 1 vs. 3; HR 0.57, 95% CI 0.28 to 1.16; P = 0.114 for group 2 vs. 3) |
Janssen Scientific Affairs, LLC (2010) NCT00403767 | RCT (n = 14,269) | Rivaroxabanvswarfarin | 71.2 ± 9.42 | Composite event of major/non-major bleeding events of rivaroxaban vs. warfarin were similar: 0.21% vs. 0.20% (HR 1.03; 95% CI 0.96 to 1.11, P = 0.442). |
Boehringer Ingelheim (2009) RE-LY NCT00262600 | RCT (n = 5,883) | Group 1: Dabigatran 110 mg PO BID Group 2: Dabigatran 150 mg PO BID Group 3: Warfarin (INR 2 - 3) | 71.5 ± 8.7 | Major Bleeding: Group 1: 2.99%/YR (HR 0.80; 95% CI 0.70 to 0.93, P = 0.0026) Group 2: 3.55%/YR (HR 0.93; 95% CI 0.81 to 1.07, P = 0.3146) Group 3: 3.81%/YR. |
Bristol-Myers Squibb (2011) ARISTOTLE NCT00412984 | RCT (n = 18,201) | Apixaban (2.5, 5 mg) vs warfarin (INR 2 - 3) | 69.1 ± 9.68 | Rate of major bleeding for apixaban was 2.13%/yr compared to warfarin, 3.09% (HR 0.69; 95% CI 0.80 to 0.99, P < 0.001). |
Bristol-Myers Squibb (2018) NCT02415400 | RCT (n = 4,614) | Apixaban + ASA or placebo vs warfarin + ASA or placebo | 69.9 ± 9.17 | Major or clinically relevant bleeding: Apixaban 24.66%/yr demonstrated superiority vs warfarin 35.79%/yr (HR 0.69; 95% CI 0.58 to 0.82, P < 0.0001).
ASA as adjuvant showed increase bleeding risk: 40.51%/yrvs placebo matching ASA 21.03% (HR 1.88; 95% CI 1.58 to 2.23, P < 0.0001). |