Table 2.
30-day efficacy and safety outcomes
| Therapeutic anticoagulation group (n=310) | Prophylactic anticoagulation group (n=304) | Effect (95% CI) | p value | |||
|---|---|---|---|---|---|---|
| Efficacy outcomes | ||||||
| Composite thrombotic outcome* | 23 (7%) | 30 (10%) | RR 0·75 (0·45–1·26) | 0·32 | ||
| Venous thromboembolism† | 11 (4%) | 18 (6%) | RR 0·60 (0·29–1·25) | 0·19 | ||
| Deep vein thrombosis | 5 (2%) | 5 (2%) | RR 0·98 (0·29–3·35) | 1·00 | ||
| Pulmonary embolism | 7 (2%) | 13 (4%) | RR 0·53 (0·21–1·31) | 0·18 | ||
| Myocardial infarction | 13 (4%) | 14 (5%) | RR 0·91 (0·44–1·91) | 0·85 | ||
| Stroke | 1 (<1%) | 0 | .. | .. | ||
| Major adverse limb event | 0 | 1 (<1%) | .. | .. | ||
| Composite thrombotic outcome* and all-cause death | 46 (15%) | 44 (14%) | RR 1·03 (0·70–1·50) | 0·91 | ||
| Death | 35 (11%) | 23 (8%) | RR 1·49 (0·90–2·46) | 0·13 | ||
| Cardiovascular | 6 (2%) | 0 | .. | .. | ||
| Non-cardiovascular | 29 (9%) | 22 (7%) | .. | .. | ||
| Unknown | 0 | 1 (<1%) | .. | .. | ||
| Rehospitalisation | 2 (1%) | 5 (2%) | RR 0·39 (0·08–2·01) | 0·28 | ||
| World Health Association 8-point ordinal scale at end of 30 days | .. | .. | Proportional OR 1·35 (0·85–2·16) | 0·21 | ||
| Out of hospital with no oxygen therapy | 263 (85%) | 268 (88%) | .. | .. | ||
| Out of hospital with oxygen therapy | 0 | 0 | .. | .. | ||
| Hospitalised with no oxygen therapy | 3 (1%) | 5 (2%) | .. | .. | ||
| Hospitalised with oxygen by mask or nasal catheter | 8 (3%) | 2 (1%) | .. | .. | ||
| Hospitalised with non-invasive ventilation or high-flow oxygen | 0 | 0 | .. | .. | ||
| Hospitalised with invasive mechanical ventilation without additional support | 1 (<1%) | 4 (1%) | .. | .. | ||
| Hospitalised with invasive mechanical ventilation with additional organ support | 0 | 2 (1%) | .. | .. | ||
| Death | 35 (11%) | 23 (8%) | .. | .. | ||
| Safety outcomes | ||||||
| Major bleeding or clinically relevant non-major bleeding (ISTH definitions) | 26 (8%) | 7 (2%) | RR 3·64 (1·61–8·27) | 0·0010 | ||
| Major bleeding | 10 (3%) | 4 (1%) | RR 2·45 (0·78–7·73) | 0·18 | ||
| Clinically relevant non-major bleeding | 16 (5%) | 3 (1%) | RR 5·23 (1·54–17·77) | 0·0039 | ||
| Any bleeding | 36 (12%) | 9 (3%) | RR 3·92 (1·92–8·00) | <0·0001 | ||
| Combined efficacy and safety outcome | ||||||
| Net benefit‡ | 56 (18%) | 47 (15%) | RR 1·17 (0·82–1·66) | 0·45 | ||
Data are n (%) or point estimate (95% CI). RR=relative risk. OR=odds ratio. ISTH=International Society on Thrombosis and Haemostasis.
*
Defined as any venous thromboembolism, myocardial infarction, stroke, systemic embolism, and major adverse limb events.
†
One patient had one episode of deep vein thrombosis, followed 6 days later by a pulmonary embolism.
‡
Composite outcome including any composite thrombotic outcome, all-cause death, and ISTH definitions of major or clinically relevant bleeding.