Table 2.
Primary and secondary endpoints by treatment group
| Stop-ECS group (n=256) | Continue-ECS group (n=262) | Adjusted hazard ratio (95% CI)/P value | |
|---|---|---|---|
| Primary endpoint | |||
| PTS incidence, % (95% CI) | 19.9 (16 to 24) | 13.0 (9.9 to 17) | 1.6 (1.02 to 2.5)* |
| Absolute No (%) of mild PTS (Villalta scale 5-9) | 43 (84) | 31 (91) | – |
| Absolute No (%) of moderate PTS (Villalta scale 10-14) | 8 (16) | 2 (6) | – |
| Absolute No (%) of severe PTS (Villalta scale >14) | 0 | 1 (3) | – |
| Secondary endpoints | |||
| Incidence of overall mortality, % (95% CI) | 0.78 (0.003 to 3.0) | 0 (0 to 1.7) | 0.97 (NC)† |
| Incidence of ipsilateral recurrent DVT, % (95% CI) | 3.1 (1.5 to 6.2) | 2.3 (0.94 to 5.0) | 1.5 (0.54 to 4.2)‡ |
| Quality of life: | |||
| Median (IQR) VEINES-QOL at end of follow-up | 96 (92-98) | 96 (90-99) | P=0.99§ |
| Median (IQR) VEINES-SYM at end of follow-up | 95 (88-100) | 95 (88-100) | P=0.99§ |
| Mean (95% CI) intra-individual change in VEINES-QOL | −0.15 (−1.5 to 1.2) | 0.93 (−0.29 to 2.1) | P=0.21¶ |
| Mean (95% CI) intra-individual change in VEINES-Sym | −1.1 (−1.7 to 0.44) | 0.58 (−0.90 to 2.1) | P=0.12¶ |
DVT=deep venous thrombosis; IQR=interquartile range; PTS=post-thrombotic syndrome.
*Adjusted for age, sex, body mass index, unprovoked or secondary DVT, extent of index DVT, baseline Villalta score, and use of oral anticoagulants during study period.
†Not computable owing to 0 cases in continue-ECS group.
‡Adjusted for age, sex, unprovoked or secondary DVT, and use of oral anticoagulants during study period,
§Mann-Whitney U test.
¶Independent samples t test.