Table 2.
Event rates, IRRs and HRs (time to first event) in compared PSM-AF patient cohorts; PSM NOAC versus VKA
| Observed outcome (events per 100 patient years)a
|
Observed outcome (time-to-first event)b
|
|||
|---|---|---|---|---|
| PSM cohort 1 (NOAC) N=37,439 patients | PSM cohort 2 (VKA) N=37,439 patients | IRR (95% CI; p-value) cohort 1 versus 2 | PSM-HR (95% CI; p-value) cohort 1 versus 2 | |
| a: Death | 11.28 | 9.23 | 1.22 (1.17–1.28; p<0.001) | 1.22 (1.17–1.28; p<0.001) |
| b: IS | 2.18 | 1.15 | 1.90 (1.69–2.15; p<0.001) | 1.92 (1.69–2.19; p<0.001) |
| c: Non-specified stroke | 0.11 | 0.05 | 2.04 (1.16–3.70; p<0.010) | 1.93 (1.13–3.32; p<0.050) |
| d: TIA | 0.99 | 0.65 | 1.52 (1.29–1.79; p<0.001) | 1.44 (1.21–1.70; p<0.001) |
| e: MI | 1.33 | 1.06 | 1.26 (1.10–1.45; p<0.001) | 1.31 (1.13–1.52; p<0.001) |
| f: AE | 0.39 | 0.22 | 1.75 (1.32–2.32; p<0.001) | 1.81 (1.36–2.34; p<0.001) |
| g: Hemorrhagic stroke | 0.47 | 0.50 | 0.94 (0.76–1.17; p=0.573) | 0.95 (0.76–1.21; p=0.695) |
| h: Severe bleeding | 2.47 | 1.29 | 1.92 (1.71–2.15; p<0.001) | 1.95 (1.74–2.20; p<0.001) |
| CO1 (a–f) | 16.28 | 12.36 | 1.32 (1.27–1.37; p<0.001) | 1.31 (1.26–1.36; p<0.001) |
| CO2 (g and h) | 2.94 | 1.78 | 1.65 (1.49–1.82; p<0.001) | 1.70 (1.53–1.88; p<0.001) |
| CO3 (a–h) | 19.22 | 14.15 | 1.36 (1.31–1.41; p<0.001) | 1.35 (1.30–1.41; p<0.001) |
| Sum observed patient years | 35,746.97 | 37,486.99 | – | – |
Notes:
The table lists results of the event rate analyses based on PSM cohorts. Results are reported as IRRs for events per 100 observed patient years;
The table lists the results of Cox regression analyses based on PSM cohorts. Results are reported as HRs for time-to-first event. “–” indicates not calculated. a. All-cause death; b. Ischemic stroke (I63.x); c. Non-specified stroke (I64.x); d. Transient ischemic attack (G45.x); e. Myocardial infarction (I21.x/I22.x); f. Arterial embolism (H34.x/I26.x/K55.0); g. Hemorrhagic stroke (I60.x/I61.x/I62.x); h. Severe bleeding (ICD-10 codes: K92.2, K62.5, K55.22, R04.x, K25.0, K25.2, K25.4, K25.6, K26.0, K26.2, K26.4, K26.6, K27.0, K27.2, K27.4, K27.6, K28.0, K28.2, K28.4 or K28.6).
Abbreviations: AE, arterial embolism; AF, atrial fibrillation; CO1, effectiveness composite outcome 1; CO2, safety composite outcome 2; CO3, general composite outcome 3; HR, hazard ratio; IRR, incidence rate ratio; IS, ischemic stroke; MI, myocardial infarction; NOAC, non-vitamin K antagonist oral anticoagulants; PSM, propensity score-matched; TIA, transient ischemic attack; VKA, vitamin-K-antagonist.