Clinical outcomes during the overall trial period
| Clinical outcomes . | 6 wk of LMWH (n = 14) . | 3 wk of LMWH followed by 3 wk of ASA (n = 13) . | P value . | |
|---|---|---|---|---|
| Adherence to treatment | ||||
| 1-3 wk (%), mean (SD) | 96.5 (8.4) | 93.9 (8.2) | .027 | |
| 3-6 wk (%), mean (SD) | 96.3 (10.0) | 94.0 (8.7) | .059 | |
| Bleeding assessment at 3 wk, n (%) | ||||
| Major bleeding | 0 (0) | 0 (0) | ||
| Clinically relevant nonmajor bleeding | 0 (0) | 1 (8.0) | ||
| Minor bleeding | 3 (21.4) | 4 (30.8) | .678 | |
| Heparin-induced thrombocytopenia | 0 (0) | 0 (0) | ||
| Bleeding assessment at 6 wk (covering wk 3-6), n (%) | ||||
| Major bleeding | 0 (0) | 0 (0) | ||
| Clinically relevant nonmajor bleeding | 0 (0) | 0 (0) | ||
| Minor bleeding | 4 (28.6) | 0 (0) | .098 | |
| Heparin-induced thrombocytopenia | 0 (0) | 0 (0) | ||
| Type 1 allergic reaction to heparin | 0 (0) | 0 (0) | ||
| Type 4 allergic skin reaction | 0 (0) | 0 (0) | ||
| (n = 14) | (n = 12) | |||
| Quality-of-life assessment (PACT-Q2) | ||||
| Mean 3 wk score (SD) | 27.1 (8.2) | 29.3 (11.1) | .479 | |
| Mean reversed score (%) | 12.1 | 2.9 | ||
| Mean 6 wk score (SD) | 27.5 (6.7) | 16.2 (2.9) | <.001 | |
| Mean reversed score (%) | 10.4 | 57.5 | ||
| % change in mean reversed score between 3 and 6 wk | 14.1 | 95.0 | < .001 | |
| Clinical outcomes . | 6 wk of LMWH (n = 14) . | 3 wk of LMWH followed by 3 wk of ASA (n = 13) . | P value . | |
|---|---|---|---|---|
| Adherence to treatment | ||||
| 1-3 wk (%), mean (SD) | 96.5 (8.4) | 93.9 (8.2) | .027 | |
| 3-6 wk (%), mean (SD) | 96.3 (10.0) | 94.0 (8.7) | .059 | |
| Bleeding assessment at 3 wk, n (%) | ||||
| Major bleeding | 0 (0) | 0 (0) | ||
| Clinically relevant nonmajor bleeding | 0 (0) | 1 (8.0) | ||
| Minor bleeding | 3 (21.4) | 4 (30.8) | .678 | |
| Heparin-induced thrombocytopenia | 0 (0) | 0 (0) | ||
| Bleeding assessment at 6 wk (covering wk 3-6), n (%) | ||||
| Major bleeding | 0 (0) | 0 (0) | ||
| Clinically relevant nonmajor bleeding | 0 (0) | 0 (0) | ||
| Minor bleeding | 4 (28.6) | 0 (0) | .098 | |
| Heparin-induced thrombocytopenia | 0 (0) | 0 (0) | ||
| Type 1 allergic reaction to heparin | 0 (0) | 0 (0) | ||
| Type 4 allergic skin reaction | 0 (0) | 0 (0) | ||
| (n = 14) | (n = 12) | |||
| Quality-of-life assessment (PACT-Q2) | ||||
| Mean 3 wk score (SD) | 27.1 (8.2) | 29.3 (11.1) | .479 | |
| Mean reversed score (%) | 12.1 | 2.9 | ||
| Mean 6 wk score (SD) | 27.5 (6.7) | 16.2 (2.9) | <.001 | |
| Mean reversed score (%) | 10.4 | 57.5 | ||
| % change in mean reversed score between 3 and 6 wk | 14.1 | 95.0 | < .001 | |
SD, standard deviation.