Study | Pioneer-AF-PCI | Re-dual PCI | ||||
Subgroup | Rivaroxaban 15 mg+DAPT | Standard triple therapy | Rivaroxaban 2.5 mg+DAPT | Dabigatran 150 mg+P2Y12 | Standard triple therapy | Dabigatran 110 mg+P2Y12 |
N total bleeding (%) | 16.8 | 26.7 | 18 | 33.3 | 42.9/41.4* | 27.1 |
N MACE (%) | 6.5 | 5.6 | 6 | 11.8 | 13.4/12.8* | 15.2 |
Total bleeding HR (DOAC regimen vs VKAs regimen)† | 0.59 (CI 0.47 to 0.76) | 0.63 (CI 0.50 to 0.80) | 0.72 (CI 0.61 to 0.84) | 0.54 (CI 0.46 to 0.63) | ||
P value | <0.001 | <0.001 | <0.001 | <0.001 | ||
MACE HR (DOAC regimen vs VKAs regimen)† | 1.08 (CI 0.69 to 1.68) | 0.93 (CI 0.59 to 1.48) | 0.89 (CI 0.67 to 1.14) | 1.13 (CI 0.90 to 1.43) | ||
P value | 0.75 | 0.76 | 0.44 | 0.30 |
Cumulative incidence of one primary safety and one secondary efficacy endpoint calculated in the two trials. HRS are intended with 95% CI.
*The two values refer to the number of patients used for HR in dabigatran 150/dabigatran 110 mg arms.
†HRs are calculated from comparison of single subgroups couples (ie, rivaroxaban 15 mg+DAPT vs standard triple therapy).
AF, atrial fibrillation; DAPT, double antiplatelet therapy; DOAC, advent of direct oral anticoagulants; MACE, major cardiovascular events; PCI, percutaneous coronary interventions; VKAs, vitamin K antagonists.