Table 3.

IRRs, HRs in PSM cohorts and aHRs for patients assigned to cohort 1 (NOAC) versus cohort 2 (VKA) compared with HRs reported in clinical trials

Events	Own analysis				Known major clinical trials
	PSM-IRRs (95% CI; p-value)	PSM-HRs (95% CI; p-value)	aHRs (95% CI; p-value)	PSM-HRs (95% CI; p-value) for therapy-naive patients	HRs (95% CI; p-value) – RE-LY8	HRs (95% CI; p-value) – ROCKET AF9	HRs (95% CI; p-value) – ARISTOTLE15
Death	1.22**** (1.17–1.28; p<0.001)	1.22**** (1.17–1.28; p<0.001)	1.10**** (1.06–1.15; p<0.001)	1.11** (1.03–1.20; p<0.010)	0.88 (0.77–0.00; NSR)	0.85 (0.70–1.02; NSR)	0.89* (0.80–1.00; p<0.050)
IS	1.90**** (1.69–2.15; p<0.001)	1.92**** (1.69–2.19; p<0.001)	1.52**** (1.37–1.69; p<0.001)	1.175**** (1.42–2.17; p<0.001)	0.76* (0.60–0.98; p<0.050)	0.94 (0.75–1.17; NSR)	0.92 (0.74–1.13; NSR)
Hemorrhagic stroke	0.94 (0.76–1.17; NSR)	0.95 (0.76–1.21; NSR)	0.68**** (0.56-0.82; p<0.001)	0.76 (0.52–1.11; NSR)	0.26**** (0.14–0.49; p<0.001)	0.59* (0.37–0.93; p<0.050)	0.51**** (0.35–0.75; p<0.001)
Severe bleedings	1.92**** (1.71–2.15; p<0.001)	1.95**** (1.74–2.20; p<0.001)	1.57**** (1.43–1.73; p<0.001)	1.58 (1.30–1.92; NSR)	0.93 (0.81–1.07; NSR)	1.03 (0.90–1.18; NSR)	0.71**** (0.61–0.81; p<0.001)

Notes: aHR is based on a multivariable Cox regression analysis; PSM-HR represents hazard ratio based on Cox regression analysis of time-to-first event with regard to PSM cohorts; PSM-IRR represents incidence rate ratio based on comparison of PSM cohorts.

^*p<0.050;

^**p< 0.010;

^****p<0.001.

Abbreviations: AF, atrial fibrillation; aHR, adjusted hazard ratio; HR, hazard ratio; IS, ischemic stroke; NOAC, non-vitamin K antagonist oral anticoagulants; IRR, incidence rate ratio; NSR: non-significant results; PSM, propensity score matching; VKA, vitamin-K-antagonist.