Table 2.
Severe complications by indication and other relevant variables
| Any major eventa | Thromboembolic | Major hemorrhagic | Intracranial bleeding | Transient ischemic attack | Mortality | |
|---|---|---|---|---|---|---|
| n; numbers per 100 patient-years (95% CI) | ||||||
| Overall (n = 927) | 106; 1.87 (1.54–2.27) | 50; 0.86 (0.64–1.13) | 59; 1.01 (0.77–1.31) | 13; 0.2 (0.12–0.38) | 17; 0.29 (0.17–0.46) | 88; 1.46 (1.17–1.80) |
| Indication | ||||||
| Atrial fibrillation (n = 120) | 14; 2.00 (1.10–3.37) | 3; 0.42 (0.09–1.22) | 11; 1.57 (0.78–2.81) | 6; 0.85 (0.31–1.86) | 0 | 17; 2.34 (1.36–3.75) |
| MHV (n = 465) | 71; 2.39 (1.87–3.01) | 33; 1.06 (0.73–1.50) | 41; 1.32 (0.95–1.79) | 5; 0.16 (0.05–0.38) | 14; 0.44 (0.24–0.74) | 58; 1.79 (1.36–2.32) |
| VTE (n = 213) | 11; 0.89 (0.45–1.60) | 8; 0.64 (0.28–1.26) | 3; 0.24 (0.05–0.69) | 0 | 2; 0.16 (0.02–0.56) | 5; 0.38 (0.13–0.91) |
| Other indication (n = 129) | 10; 1.34 (0.64–2.47) | 6; 0.78 (0.29–1.71) | 4; 0.53 (0.14–1.36) | 2; 0.26 (0.03–0.96) | 1; 0.13 (0–0.73) | 8; 1.04 (0.45–2.05) |
| Male (n = 496) | 53; 1.80 (1.35–2.36) | 19; 0.62 (0.38–0.97) | 35; 1.17 (0.81–1.62) | 8; 0.27 (0.11–0.52) | 9; 0.29 (0.13–0.55) | 51; 1.64 (1.22–2.16) |
| Female (n = 431) | 53; 1.95 (1.47–2.56) | 31; 1.11 (0.75–1.58) | 24; 0.85 (0.55–1.27) | 5; 0.18 (0.06–0.41) | 8; 0.28 (0.12–0.55) | 37; 1.27 (0.89–1.75) |
| TTR < 55% (n = 199)b | 40; 3.66 (2.61–4.98) | 24; 2.09 (1.34–3.11) | 18; 1.54 (0.91–2.43) | 2; 0.17 (0.02–0.62) | 8; 0.67 (0.29–1.32) | 22; 1.78 (1.12–2.70) |
| TTR 55–64% (n = 216) | 22; 1.55 (0.97–2.35) | 10; 0.68 (0.33–1.25) | 12; 0.82 (0.43–1.44) | 1; 0.07 (0–0.38) | 4; 0.27 (0.07–0.69) | 23; 1.53 (0.47–2.24) |
| TTR 65–75% (n = 277) | 22; 1.16 (0.73–1.76) | 10; 0.52 (0.25–0.95) | 12; 0.62 (0.32–1.09) | 2; 0.10 (0.01–0.38) | 2; 0.10 (0.01–0.37) | 17; 0.86 (0.50–1.38) |
| TTR > 75 (n = 169) | 8; 0.77 (0.33–1.51) | 2; 0.19 (0.02–0.68) | 6; 0.57 (0.21–1.24) | 4; 0.38 (0.1–0.97) | 0 | 7; 0.65 (0.26–1.34) |
| With previous severe complication (n = 163) | 35; 3.70 (2.56–5.12) | 17; 1.71 (0.99–2.73) | 19; 1.86 (1.12–2.90) | 3; 0.29 (0.06–0.86) | 9; 0.88 (0.40–1.67) | 17; 1.59 (0.93–2.55) |
| Without previous complications (n = 764) | 71; 1.51 (1.18–1.91) | 33; 0.68 (0.47–0.96) | 40; 0.83 (0.60–1.13) | 10; 0.21 (0.10–0.38) | 8; 0.16 (0.07–0.32) | 71; 1.43 (1.12–1.81) |
| > 3 comorbidities (n = 202) | 46; 3.36 (2.46–4.48) | 19; 1.31 (0.79–2.04) | 29; 2.01 (1.35–2.84) | 5; 0.35 (0.11–0.81) | 5; 0.33 (0.11–0.78) | 51; 3.34 (2.44–4.40) |
| ≤ 3 comorbidities (n = 725) | 60; 1.40 (1.07–1.81) | 31; 0.71 (0.48–1.00) | 30; 0.68 (0.46–0.98) | 8; 0.18 (0.08–0.36) | 12; 0.27 (0.14–0.47) | 37; 0.82 (0.58–1.14) |
| Age < 40 (n = 134) | 11; 1.25 (0.63–2.24) | 6; 0.66 (0.24–1.43) | 6; 0.67 (0.25–1.46) | 0 | 0 | 0 |
| Age 40–59.9 (n = 388) | 34; 1.34 (0.93–1.88) | 15; 0.58 (0.32–0.96) | 20; 0.77 (0.47–1.20) | 3; 0.12 (0.02–0.34) | 6; 0.23 (0.08–0.50) | 31; 1.18 (0.80–1.67) |
| Age 60–75 (n = 359) | 50; 2.46 (1.83–3.25) | 27; 1.29 (0.85–1.87) | 24; 1.12 (0.72–1.67) | 3; 0.14 (0.03–0.41) | 9; 0.42 (0.19–0.79) | 43; 1.95 (1.41–2.63) |
| Age > 75 (n = 46) | 11; 5.27 (2.63–9.42) | 2; 0.84 (0.10–3.02) | 9; 4.27 (1.95–8.1) | 7; 3.32 (1.33–6.84) | 2; 0.84 (0.10–3.04) | 14; 5.82 (3.18–9.75) |
| Patients managed by a third person (n = 66) | 15; 3.44 (1.93–5.67) | 6; 1.30 (0.48–2.82) | 9; 1.89 (0.86–3.59) | 6; 1.26 (0.46–2.74) | 2; 0.40 (0.05–1.46) | 19; 3.77 (2.27–5.84) |
| Patients under strict PSM (n = 861) | 91; 1.75 (1.41–2.14) | 44; 0.82 (0.60–1.10) | 50; 0.93 (0.64–1.23) | 7; 0.13 (0.05–0.27) | 15; 0.27 (0.15–0.45) | 69; 1.25 (0.97–1.58) |
We have grouped as “other”: cardiopathies, valvulopathies and other indications, because of small number of patients in each category
CI confidence interval
a Any major event includes thromboembolic and/or haemorrhagic. b TTR was calculated only in 861 patients