Background
Methods
Study population
Endpoints
Statistical analysis
Results
Comparison of baseline patient characteristics in symptomatic and asymptomatic PE and DVT groups
PE with/without DVT | DVT | |||||||
---|---|---|---|---|---|---|---|---|
Variable | Total | Asymptomatic | Symptomatic |
P-Value | Total | Asymptomatic | Symptomatic |
P-Value |
n = 419 |
n = 197 |
n = 222 |
n = 597 |
n = 203 |
n = 394 | |||
Age (years) | 66 ± 15 | 65 ± 14 | 66 ± 15 | 0.32 | 70 ± 15 | 72 ± 12 | 69 ± 16 | 0.017 |
≥ 75 years | 137 (32.7%) | 58 (29.4%) | 79 (35.6%) | 0.21 | 253 (42.4%) | 88 (43.3%) | 165 (41.9%) | 0.79 |
Female sex | 220 (52.5%) | 94 (47.7%) | 126 (56.8%) | 0.08 | 379 (63.5%) | 151 (74.4%) | 228 (57.9%) | < 0.001 |
Body weight (kg) | 63.0 ± 14.9 | 62.7 ± 13.8 | 63.3 ± 15.9 | 0.69 | 58.3 ± 12.9 | 55.5 ± 11.7 | 59.9 ± 13.5 | < 0.001 |
< 50 kg | 80 (19.1%) | 33 (16.8%) | 47 (21.2%) | 0.26 | 142 (23.8%) | 63 (31.0%) | 79 (20.1%) | 0.003 |
Body mass index (kg/m2) | 24.2 ± 4.4 | 23.8 ± 3.9 | 24.5 ± 4.8 | 0.09 | 23.5 ± 4.0 | 23.1 ± 3.9 | 23.8 ± 4.1 | 0.05 |
Heart rate (beats per minute) | 87.9 ± 19.4 | 81.0 ± 14.8 | 93.9 ± 20.9 | < 0.001 | 78.3 ± 13.5 | 77.3 ± 13.6 | 79.0 ± 13.5 | 0.21 |
Systolic blood pressure (mmHg) | 129.9 ± 23.5 | 129.8 ± 19.8 | 130.0 ± 26.3 | 0.93 | 128.8 ± 18.1 | 126.5 ± 15.7 | 130.1 ± 19.3 | 0.036 |
SpO2 (%) | 95 ± 5 | 97 ± 2 | 94 ± 6 | < 0.001 | 97 ± 2 | 97 ± 2 | 97 ± 2 | 0.26 |
Outpatient | 112 (26.7%) | 62 (31.5%) | 50 (22.5%) | 0.046 | 310 (51.9%) | 57 (28.1%) | 253 (64.2%) | < 0.001 |
CrCL (mL/minute) | 82.1 ± 37.6 | 84.5 ± 33.7 | 79.9 ± 40.6 | 0.21 | 77.2 ± 35.0 | 74.0 ± 29.2 | 79.0 ± 37.8 | 0.045 |
<50 mL/minute | 71 (16.9%) | 29 (14.7%) | 42 (18.9%) | 0.30 | 199 (33.3%) | 69 (34.0%) | 130 (33.0%) | 0.74 |
D-dimer (µg/mL) | 10.0 (5.5–19.0) | 9.3 (5.3–17.5) | 10.7 (5.7–19.9) | 0.13 | 7.6 (3.5–15.1) | 7.9 (3.5–14.2) | 7.6 (3.4–16.2) | 0.84 |
Medical history | ||||||||
Hypertension | 171 (40.8%) | 71 (36.0%) | 98 (44.1%) | 0.11 | 211 (35.3%) | 69 (34.0%) | 142 (36.0%) | 0.65 |
Diabetes mellitus | 54 (12.9%) | 27 (13.7%) | 27 (12.2%) | 0.66 | 64 (10.7%) | 28 (13.8%) | 36 (9.1%) | 0.09 |
Heart failure | 18 (4.3%) | 3 (1.5%) | 15 (6.8%) | 0.008 | 16 (2.7%) | 7 (3.4%) | 9 (2.3%) | 0.43 |
Atrial fibrillation | 16 (3.8%) | 5 (2.5%) | 11 (5.0%) | 0.21 | 10 (1.7%) | 6 (3.0%) | 4 (1.0%) | 0.10 |
Coronary artery disease | 19 (4.5%) | 5 (2.5%) | 14 (6.3%) | 0.10 | 26 (4.4%) | 9 (4.4%) | 17 (4.3%) | 1.00 |
Chronic heart and lung disease | 27 (6.4%) | 7 (3.6%) | 20 (9.0%) | 0.028 | 20 (3.4%) | 9 (4.4%) | 11 (2.8%) | 0.34 |
Previous stroke | 28 (6.7%) | 13 (6.6%) | 15 (6.8%) | 1.00 | 45 (7.5%) | 16 (7.9%) | 29 (7.4%) | 0.87 |
Previous atrial fibrillation | 8 (1.9%) | 2 (1.0%) | 6 (2.7%) | 0.29 | 15 (2.5%) | 7 (3.4%) | 8 (2.0%) | 0.41 |
Risk factor | ||||||||
Active cancer | 88 (21.0%) | 54 (27.4%) | 34 (15.3%) | 0.003 | 105 (17.6%) | 55 (27.1%) | 50 (12.7%) | < 0.001 |
Recent surgery | 78 (18.6%) | 48 (24.4%) | 30 (13.5%) | 0.006 | 182 (30.5%) | 113 (55.7%) | 69 (17.5%) | < 0.001 |
Recent injury | 31 (7.4%) | 14 (7.1%) | 17 (7.7%) | 0.85 | 62 (10.4%) | 33 (16.3%) | 29 (7.4%) | 0.001 |
Inactivity | 130 (31.0%) | 64 (32.5%) | 66 (29.7%) | 0.60 | 237 (39.7%) | 119 (58.6%) | 118 (29.9%) | < 0.001 |
Thrombophilia | 21 (5.0%) | 10 (5.1%) | 11 (5.0%) | 1.00 | 17 (2.8%) | 4 (2.0%) | 13 (3.3%) | 0.44 |
Previous VTE | 28 (6.7%) | 13 (6.6%) | 15 (6.8%) | 1.00 | 55 (9.2%) | 16 (7.9%) | 39 (9.9%) | 0.46 |
Concomitant medications | ||||||||
Antiplatelet agents | 38 (9.1%) | 18 (9.1%) | 20 (9.0%) | 1.00 | 66 (11.1%) | 28 (13.8%) | 38 (9.6%) | 0.13 |
Estrogen preparations | 7 (1.7%) | 3 (1.5%) | 4 (1.8%) | 1.00 | 16 (2.7%) | 1 (0.5%) | 15 (3.8%) | 0.016 |
Anticancer agents | 43 (10.3%) | 20 (10.2%) | 23 (10.4%) | 1.00 | 45 (7.5%) | 21 (10.3%) | 24 (6.1%) | 0.07 |
NSAIDs | 61 (14.6%) | 38 (19.3%) | 23 (10.4%) | 0.012 | 135 (22.6%) | 72 (35.5%) | 63 (16.0%) | < 0.001 |
DVT | 320 (76.4%) | 164 (83.2%) | 156 (70.3%) | 0.002 | ||||
Proximal | 235 (56.1%) | 133 (67.5%) | 102 (45.9%) | < 0.001 | 294 (49.3%) | 53 (26.1%) | 241 (61.2%) | < 0.001 |
Distal | 85 (20.3%) | 31 (15.7%) | 54 (24.3%) | 0.038 | 303 (50.8%) | 150 (73.9%) | 153 (38.8%) | < 0.001 |
Localization of right DVT | 196 (46.8%) | 97 (49.2%) | 99 (44.6%) | 0.38 | 332 (55.6%) | 137 (67.5%) | 195(49.5%) | < 0.001 |
Localization of left DVT | 194 (46.3%) | 97 (49.2%) | 97 (43.7%) | 0.28 | 402 (67.3%) | 124 (61.1%) | 278 (70.6%) | 0.021 |
Localization of both DVT | 70 (16.7%) | 30 (15.2%) | 40 (18.0%) | 0.51 | 137 (22.9%) | 58 (28.6%) | 79 (20.1%) | 0.024 |
Asymptomatic DVT | 205 (48.9%) | 125 (63.5%) | 80 (36.0%) | < 0.001 | ||||
PE | ||||||||
Cardiac arrest or Collapse or Massive | 23 (5.5%) | 0 (0.0%) | 23 (10.4%) | < 0.001 | ||||
Sub-massive or Non-massive | 371 (88.5%) | 175 (88.8%) | 196 (88.3%) | 0.88 | ||||
Non-massive | 248 (59.2%) | 162 (82.2%) | 86 (38.7%) | < 0.001 | ||||
Severer than Sub-massive | 146 (34.8%) | 13 (6.6%) | 133 (59.9%) | < 0.001 | ||||
RV pressure indexes | ||||||||
Mean RV diameter (mm) | 36.1 ± 9.4 | 32.6 ± 6.3 | 38.5 ± 10.4 | < 0.001 | ||||
RV/LV diameter ratio | 0.96 ± 0.36 | 0.81 ± 0.21 | 1.06 ± 0.41 | < 0.001 | ||||
Prior treatment | ||||||||
Anticoagulation therapy | 171 (40.8%) | 59 (29.9%) | 112 (50.5%) | < 0.001 | 93 (15.6%) | 24 (11.8%) | 69 (17.5%) | 0.07 |
Inferior vena cava filter | 40 (9.5%) | 23 (11.7%) | 17 (7.7%) | 0.18 | 47 (7.9%) | 6 (3.0%) | 41 (10.4%) | 0.001 |
Thrombolytic therapy | 33 (7.9%) | 11 (5.6%) | 22 (9.9%) | 0.10 | 14 (2.3%) | 0 (0.0%) | 14 (3.6%) | 0.004 |
Catheterization | 4 (1.0%) | 2 (1.0%) | 2 (0.9%) | 1.00 | 8 (1.3%) | 0 (0.0%) | 8 (2.0%) | 0.06 |
Pulmonary thrombus removal | 1 (0.2%) | 0 (0.0%) | 1 (0.5%) | 1.00 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | - |
PCPS | 3 (0.7%) | 0 (0.0%) | 3 (1.4%) | 0.25 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | - |
Others | 14 (3.3%) | 5 (2.5%) | 9 (4.1%) | 0.43 | 12 (2.0%) | 2 (1.0%) | 10 (2.5%) | 0.36 |
Initial rivaroxaban treatment | ||||||||
DOSE (mg/day) | 0.37 | 0.004 | ||||||
30 mg/day | 341 (81.4%) | 154 (78.2%) | 187 (84.2%) | 326 (54.6%) | 90 (44.3%) | 236 (59.9%) | ||
20 mg/day | 6 (1.4%) | 4 (2.0%) | 2 (0.9%) | 16 (2.7%) | 7 (3.4%) | 9 (2.3%) | ||
15 mg/day | 64 (15.3%) | 34 (17.3%) | 30 (13.5%) | 218 (36.5%) | 92 (45.3%) | 126 (32.0%) | ||
10 mg/day | 8 (1.9%) | 5 (2.5%) | 3 (1.4%) | 37 (6.2%) | 14 (6.9%) | 23 (5.8%) | ||
Treatment duration, days | ||||||||
Median (IQR) | 388 (176–643) | 442 (183–661) | 361 (165–630) | 0.08 | 282 (106–619) | 106 (68–259) | 338 (111–637) | < 0.001 |
Clinical outcomes in asymptomatic and symptomatic PE and DVT groups
PE with/without DVT | DVT | |||||||
---|---|---|---|---|---|---|---|---|
Asymptomatic | Symptomatic | HR (95% CI) |
P-Value | Asymptomatic | Symptomatic | HR (95% CI) |
P-Value | |
n = 197 |
n = 222 |
n = 203 |
n = 394 | |||||
Recurrence or aggravation of symptomatic VTE | 1.8 (0.7–4.0) | 3.1 (1.5–5.5) | 0.60 (0.22–1.62) | 0.31 | 1.7 (0.6–3.8) | 3.1 (1.9–4.8) | 0.56 (0.23–1.40) | 0.21 |
Recurrence or aggravation of symptomatic PE | 0.9 (0.2–2.7) | 2.5 (1.1–4.5) | 0.37 (0.10–1.35) | 0.12 | 0.3 (0.0–1.6) | 1.1 (0.4–2.2) | 0.26 (0.03–2.15) | 0.18 |
Recurrence or aggravation of symptomatic DVT | 1.2 (0.3–3.2) | 0.8 (0.2–2.4) | 1.49 (0.33–6.67) | 0.60 | 1.4 (0.5–3.4) | 2.2 (1.2–3.6) | 0.68 (0.24–1.88) | 0.45 |
Acute coronary syndrome | 0 | 0.3 (0.0–1.5) | - | 0.35 | 0.3 (0.0–1.6) | 0.2 (0.0–0.8) | 1.90 (0.12–30.36) | 0.64 |
Ischemic stroke | 1.2 (0.3–3.1) | 1.1 (0.3–2.8) | 1.11 (0.28–4.45) | 0.88 | 0 | 0 | - | - |
Death from any cause | 5.2 (3.0–8.3) | 4.6 (2.7–7.4) | 1.11 (0.57–2.18) | 0.76 | 6.5 (4.1–9.8) | 5.6 (4.0–7.7) | 1.17 (0.69–1.96) | 0.56 |
Death related to VTE | 0.6 (0.1–2.2) | 0.5 (0.1–2.0) | 1.11 (0.16–7.89) | 0.92 | 0.3 (0.0–1.6) | 0.5 (0.1–1.4) | 0.62 (0.06–5.94) | 0.67 |
Death related to CVD | 0.9 (0.2–2.7) | 0.5 (0.1–2.0) | 1.67 (0.28–9.99) | 0.57 | 0.3 (0.0–1.6) | 1.1 (0.4–2.2) | 0.27 (0.03–2.19) | 0.19 |
Major bleeding | 1.9 (0.5–4.9) | 2.7 (1.1–5.7) | 0.68 (0.20–2.33) | 0.58 | 5.2 (1.9–11.4) | 3.0 (1.5–5.2) | 1.47 (0.54–3.97) | 0.45 |
Minor bleeding | 3.4 (1.4–7.0) | 9.5 (6.0–14.3) | 0.36 (0.15–0.83) | 0.004 | 12.4 (6.8–20.8) | 9.1 (6.3–12.6) | 1.03 (0.55–1.92) | 0.94 |
Fatal bleeding | 0 | 0 | - | - | 0 | 0.5 (0.1–1.3) | - | 0.21 |
Clinically relevant events | 7.8 (5.1–11.6) | 9.5 (6.5–13.3) | 0.83 (0.49–1.39) | 0.48 | 9.9 (6.8–13.9) | 9.4 (7.2–12.1) | 1.05 (0.69–1.61) | 0.82 |
PE with/without DVT | DVT | |||||||
---|---|---|---|---|---|---|---|---|
Variables | Univariate analysis HR (95% CI) |
P-Value | Multivariable analysis HR (95% CI) |
P-Value | Univariate analysis HR (95% CI) |
P-Value | Multivariable analysis HR (95% CI) |
P-Value |
Age ≥ 75 years | 0.76 (0.43–1.35) | 0.35 | 1.55 (1.03–2.32) | 0.036 | 1.22 (0.73–2.03) | 0.44 | ||
Female | 0.61 (0.36–1.03) | 0.06 | 0.81 (0.54–1.22) | 0.32 | ||||
Body weight < 50 kg | 1.50 (0.83–2.70) | 0.18 | 1.92 (1.26–2.94) | 0.003 | 0.59 (0.34–1.03) | 0.06 | ||
CrCL < 50 mL/minute | 0.73 (0.35–1.54) | 0.41 | 2.46 (1.61–3.74) | 0.025 | 2.02 (1.20–3.42) | 0.008 | ||
Diabetes | 1.10 (0.52–2.31) | 0.81 | 0.65 (0.30–1.39) | 0.27 | ||||
Chronic heart and lung disease | 2.11 (0.96–4.65) | 0.06 | 2.00 (0.87–4.57) | 0.10 | ||||
Active cancer | 4.55 (2.72–7.62) | < 0.001 | 5.19 (2.85–9.47) | < 0.001 | 3.84 (2.53–5.82) | < 0.001 | 4.12 (2.65–6.38) | < 0.001 |
Asymptomatic | 1.61 (0.83–3.12) | 0.16 | 1.44 (0.74–2.81) | 0.29 | 0.95 (0.62–1.46) | 0.82 | 1.13 (0.56–1.78) | 0.58 |
Risk factors for clinically relevant events, recurrence or aggreviation of symptomatic VTE or major bleeding among the asymptomatic PE and DVT groups
Asymptomatic PE with/without DVT | Asymptomatic DVT | |||||||
Total | Occurred clinical events | Not occurred clinical events |
P-value | Total | Occurred clinical events | Not occurred clinical events |
P-value | |
Clinically relevant events |
n = 197 |
n = 25 |
n = 172 |
n = 203 |
n = 33 |
n = 170 | ||
Age (years) | 65 ± 14 | 67 ± 14 | 65 ± 15 | 0.47 | 72 ± 12 | 74 ± 11 | 71 ± 12 | 0.28 |
≥ 75 years | 58 (29.4%) | 7 (28.0%) | 51 (29.7%) | 1.00 | 88 (43.3%) | 17 (51.5%) | 71 (41.8%) | 0.34 |
Female | 94 (47.7%) | 11 (44.0%) | 83 (48.3%) | 0.83 | 151 (74.4%) | 24 (72.7%) | 127 (74.7%) | 0.49 |
Body weight (kg) | 62.7 ± 13.8 | 61.3 ± 13.5 | 62.9 ± 13.8 | 0.60 | 55.5 ± 11.6 | 51.0 ± 10.5 | 56.3 ± 11.8 | 0.017 |
< 50 kg | 33 (16.8%) | 7 (28.0%) | 26 (15.1%) | 0.15 | 63 (31.0%) | 15 (45.5%) | 48 (28.2%) | 0.06 |
CrCL (mL/minute) | 84.5 ± 33.8 | 83.7 ± 37.3 | 84.7 ± 33.3 | 0.90 | 72.9 ± 28.4 | 67.8 ± 31.4 | 73.9 ± 27.7 | 0.26 |
< 50 mL/minute | 29 (14.7%) | 4 (16.0%) | 25 (14.5%) | 0.77 | 47 (23.2%) | 13 (39.4%) | 34 (20.0%) | 0.025 |
Diabetes mellitus | 27 (13.7%) | 1 (4.0%) | 26 (15.1%) | 0.21 | 28 (13.8%) | 3 (9.1%) | 25 (14.7%) | 0.58 |
Chronic heart and lung disease | 7 (3.6%) | 3 (12.0%) | 4 (2.3%) | 0.045 | 9 (4.4%) | 3 (9.1%) | 6 (3.5%) | 0.16 |
Active cancer | 54 (27.4%) | 14 (56.0%) | 40 (23.3%) | 0.001 | 55 (27.1%) | 18 (54.5%) | 37 (21.8%) | < 0.001 |
D-dimer (µg/mL) | 9.3 (5.3–17.5) | 9.5 (6.3–16.1) | 9.1 (5.1–17.5) | 0.65 | 6.6 (2.9–11.9) | 7.1 (3.4–11.1) | 6.4 (2.7–12.3) | 0.40 |
Initial rivaroxaban treatment | ||||||||
Treatment duration, days | ||||||||
Median (IQR) | 361 (165–630) | 222 (107–319) | 406 (173–647) | 0.002 | 106 (68–259) | 170 (100–388) | 99 (55–223) | 0.030 |
Recurrence or aggravation of symptomatic VTE |
n = 197 |
n = 6 |
n = 191 |
n = 203 |
n = 6 |
n = 197 | ||
Age (years) | 65 ± 14 | 60 ± 17 | 65 ± 14 | 0.35 | 70 ± 12 | 72 ± 10 | 70 ± 12 | 0.81 |
≥ 75 years | 58 (29.4%) | 1 (16.7%) | 57 (29.8%) | 0.67 | 134 (42.1%) | 3 (37.5%) | 131 (42.3%) | 1.00 |
Female | 94 (47.7%) | 4 (66.7%) | 90 (47.1%) | 0.43 | 220 (69.2%) | 6 (75.0%) | 214 (69.0%) | 1.00 |
Body weight (kg) | 62.7 ± 13.7 | 70.0 ± 14.0 | 62.4 ± 13.7 | 0.18 | 57.3 ± 12.6 | 55.7 ± 13.5 | 57.3 ± 12.6 | 0.72 |
< 50 kg | 33 (16.8%) | 1 (16.7%) | 32 (16.8%) | 1.00 | 90 (28.3%) | 4 (50.0%) | 86 (27.7%) | 0.23 |
CrCL (mL/minute) | 84.5 ± 33.8 | 114.4 ± 44.0 | 83.6 ± 33.1 | 0.027 | 72.9 ± 28.4 | 67.5 ± 33.3 | 73.1 ± 28.3 | 0.64 |
< 50 mL/minute | 29 (14.9%) | 0 (0.0%) | 29 (15.3%) | 0.59 | 69 (22.0%) | 3 (37.5%) | 66 (21.6%) | 0.38 |
Diabetes mellitus | 27 (13.7%) | 0 (0.0%) | 27 (14.1%) | 1.00 | 41 (12.9%) | 1 (12.5%) | 40 (12.9%) | 1.00 |
Chronic heart and lung disease | 7 (3.6%) | 0 (0.0%) | 7 (3.7%) | 1.00 | 17 (5.4%) | 1 (12.5%) | 16 (5.2%) | 0.36 |
Active cancer | 51 (25.9%) | 1 (16.7%) | 50 (26.2%) | 1.00 | 75 (23.6%) | 2 (25.0%) | 73 (23.6%) | 1.00 |
D-dimer (µg/mL) | 9.3 (5.3–17.5) | 8.0 (5.1–9.3) | 9.3 (5.2–17.5) | 0.30 | 7.9 (3.5–14.2) | 10.7 (3.1–16.5) | 7.8 (3.5–14.2) | 0.60 |
Initial rivaroxaban treatment | ||||||||
Treatment duration, days | ||||||||
Median (IQR) | 361 (165–630) | 216 (80–477) | 362 (166–630) | 0.37 | 106 (68–259) | 170 (147–321) | 173 (85–514) | 0.82 |
Major bleeding |
n = 197 |
n = 4 |
n = 193 |
n = 203 |
n = 6 |
n = 197 | ||
Age (years) | 65 ± 14 | 55 ± 19 | 65 ± 14 | 0.16 | 70 ± 12 | 72 ± 10 | 70 ± 12 | 0.72 |
≥ 75 years | 58 (29.4%) | 0 (0.0%) | 58 (30.1%) | 0.32 | 134 (42.1%) | 3 (37.5%) | 131 (42.3%) | 1.00 |
Female | 94 (47.7%) | 3 (75.0%) | 91 (47.2%) | 0.35 | 220 (69.2%) | 5 (62.5%) | 215 (69.4%) | 0.71 |
Body weight (kg) | 62.7 ± 13.8 | 54.9 ± 13.5 | 62.8 ± 13.8 | 0.26 | 57.3 ± 12.6 | 54.3 ± 8.5 | 57.4 ± 12.7 | 0.50 |
< 50 kg | 33 (16.8%) | 2 (50.0%) | 31 (16.1%) | 0.13 | 90 (28.3%) | 1 (12.5%) | 89 (28.7%) | 0.45 |
CrCL (mL/minute) | 84.5 ± 33.8 | 111.9 ± 58.6 | 84.0 ± 33.1 | 0.10 | 72.9 ± 28.4 | 63.1 ± 18.7 | 73.2 ± 28.6 | 0.39 |
< 50 mL/minute | 29 (14.9%) | 0 (0.0%) | 29 (15.2%) | 1.00 | 69 (22.0%) | 2 (25.0%) | 67 (21.9%) | 0.69 |
Diabetes mellitus | 27 (13.7%) | 0 (0.0%) | 27 (14.0%) | 1.00 | 41 (12.9%) | 1 (12.5%) | 40 (12.9%) | 1.00 |
Chronic heart and lung disease | 7 (3.6%) | 1 (25.0%) | 6 (3.1%) | 0.14 | 17 (5.4%) | 0 (0.0%) | 17 (5.5%) | 1.00 |
Active cancer | 54 (27.4%) | 0 (0.0%) | 54 (28.0%) | 0.58 | 75 (23.6%) | 4 (50.0%) | 71 (22.9%) | 0.09 |
D-dimer (µg/mL) | 9.3 (5.3–17.5) | 10.3 (9.5–15.4) | 9.1 (5.2–17.5) | 0.53 | 7.9 (3.5–14.2) | 7.1 (2.7–23.7) | 7.9 (3.6–14.2) | 0.96 |
Initial rivaroxaban treatment | ||||||||
Treatment duration, days | ||||||||
Median (IQR) | 361 (165–630) | 236 (41–371) | 362 (168–631) | 0.18 | 106 (68–259) | 294 (38–595) | 173 (86–514) | 0.92 |
Relationship between active cancer and clinical events in the asymptomatic PE and DVT groups
Asymptomatic PE with/without DVT | Asymptomatic DVT | |||||||
---|---|---|---|---|---|---|---|---|
Total | With active cancer | Without active cancer |
P-value | Total | With active cancer | Without active cancer |
P-value | |
n = 197 |
n = 54 |
n = 143 |
n = 203 |
n = 55 |
n = 148 | |||
Recurrence or aggravation of symptomatic VTE | 6 (3.0%) | 1 (1.9%) | 5 (3.5%) | 1.00 | 6 (3.0%) | 1 (1.8%) | 5 (3.4%) | 1.00 |
Recurrence or aggravation of symptomatic PE | 3 (1.5%) | 1 (1.9%) | 2 (1.4%) | 1.00 | 1 (0.5%) | 0 (0.0%) | 1 (0.7%) | 1.00 |
Recurrence or aggravation of symptomatic DVT | 4 (2.0%) | 0 (0.0%) | 4 (2.8%) | 0.58 | 5 (2.5%) | 1 (1.8%) | 4 (2.7%) | 1.00 |
Acute coronary syndrome | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | - | 1 (0.5%) | 0 (0.0%) | 1 (0.7%) | 1.00 |
Ischemic stroke | 4 (2.0%) | 2 (3.7%) | 2 (1.4%) | 0.30 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | - |
Death from any cause | 17 (8.6%) | 14 (25.9%) | 3 (2.1%) | < 0.001 | 23 (11.3%) | 16 (29.1%) | 7 (4.7%) | < 0.001 |
Death related to VTE | 2 (1.0%) | 1 (1.9%) | 1 (0.7%) | 0.47 | 1 (0.5%) | 0 (0.0%) | 1 (0.7%) | 1.00 |
Death related to CVD | 3 (1.5%) | 1 (1.9%) | 2 (1.4%) | 1.00 | 1 (0.5%) | 0 (0.0%) | 1 (0.7%) | 1.00 |
Major bleeding | 4 (2.0%) | 0 (0.0%) | 4 (2.8%) | 0.58 | 6 (3.0%) | 4 (7.3%) | 2 (1.4%) | 0.047 |
Minor bleeding | 7 (3.6%) | 3 (5.6%) | 4 (2.8%) | 0.40 | 14 (6.9%) | 3 (5.5%) | 11 (7.4%) | 0.76 |
Fatal bleeding | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | - | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | - |
Clinically relevant events | 25 (12.7%) | 14 (25.9%) | 11 (7.7%) | 0.001 | 33 (16.3%) | 18 (32.7%) | 15 (10.1%) | < 0.001 |