Table 1.
| Characteristic | Rivaroxaban (n = 287) | Placebo (n = 282) |
|---|---|---|
| Age (y), mean (SD) | 65.8 (11.3) | 64.5 (11.1) |
| Male sex, n (%) | 163 (56.8) | 141 (50.0) |
| Comorbidities, n (%) | ||
| Systemic arterial hypertension | 89 (31.0) | 87 (30.9) |
| Diabetes | 33 (11.5) | 27 (9.6) |
| Ischemic heart disease and/or chronic heart failure | 11 (3.8) | 12 (4.3) |
| COPD | 10 (3.5) | 6 (2.1) |
| Previous cancer | 6 (2.1) | 5 (1.8) |
| Liver disease# | 3 (1.0) | 5 (1.8) |
| Laboratory examination at randomization, mean (SD) | ||
| Hemoglobin (mg/dl), mean (SD) | 11.9 (1.6) | 11.5 (1.6) |
| Creatinine (mg/dl), mean (SD) | 0.83 (0.23) | 0.81 (0.21) |
| Neoadjuvant chemotherapy, n (%) | 50 (17.4) | 44 (15.6) |
| Neoadjuvant radiotherapy,‡ n (%) | 48 (16.7) | 46 (16.3) |
| Staging T, n (%) | ||
| T1 | 59 (20.5) | 51 (18.1) |
| T2 | 66 (23.0) | 63 (22.3) |
| T3 | 119 (41.5) | 124 (44.0) |
| T4 | 18 (6.3) | 13 (4.6) |
| TX | 25 (8.7) | 31 (11.0) |
| Staging N, n (%) | ||
| N0 | 201 (70.0) | 203 (72.0) |
| N1 | 62 (21.6) | 47 (16.7) |
| N2 | 24 (8.4) | 25 (8.8) |
| NX | — | 7 (2.5) |
| Staging M, n (%) | ||
| M0 | 284 (98.9) | 274 (97.1) |
| M1 | 3 (1.0) | 8 (2.8) |
| Type of surgery, n (%) | ||
| Right hemicolectomy | 89 (31.0) | 85 (30.1) |
| Left hemicolectomy | 81 (28.2) | 64 (22.7) |
| Rectal anterior resection | 81 (28.2) | 86 (30.5) |
| Rectal anterior resection plus Miles | 8 (2.8) | 10 (3.5) |
| Other | 28 (9.7) | 37 (13.1) |
| Duration of surgery (h), mean (SD) | 3.1 (1.3) | 3.1 (1.3) |
| Initial prophylaxis,§ n (%) | ||
| Enoxaparin | 188 (65.5) | 189 (67.0) |
| Nadroparin | 77 (26.8) | 76 (26.9) |
| Other | 22 (7.7) | 17 (6.0) |
| Mechanical prophylaxis‖,¶ | 136 (47.4) | 132 (46.8) |
| Adjuvant therapy, n (%) | 52 (18.1) | 52 (18.4) |
COPD, chronic obstructive pulmonary disease; SD, standard deviation.
The table reports on patients included in the modified intention-to-treat analysis.
Plus–minus values are means ± SD. None of the numerical differences between the 2 groups was statistically significant at an α level of 0.05.
47 rivaroxaban patients and 42 placebo patients received combined neoadjuvant chemo and radiotherapy.
Prophylaxis was started on the evening of surgery in the majority of the patients.
Graduated compression stockings or intermittent pneumatic compression.
One rivaroxaban patient received both graduated compression stockings and intermittent pneumatic compression; 2 placebo patients received both graduated compression stockings and intermittent pneumatic compression.
Liver disease was known hepatitis infection in 5 patients, alcoholic disease in 1, primary biliary cirrhosis in 1, and other diseases in 1.