Event rate in a selection of different SVT treatment trials
| Characteristic . | Marchiori et al. . | STENOX . | VESALIO . | STEFLUX . | CALISTO . | SURPRISE . |
|---|---|---|---|---|---|---|
| Reference | 42 | 29 | 31 | 32 | 16 | 27 |
| Number of patients | 60 | 427 | 164 | 664 | 3002 | 472 |
| Treatments | Low-dose UFH (5000 IU) | Low-dose placebo enoxaparin (40 mg) | Low-dose nadroparin (0.3 mL to 2850 a-Xa IU) | A: Parnaparin (8500 IU once daily for 10 d) | Placebo | Rivaroxaban (10 mg po) |
| High-dose UFH (12 500 IU for 1 wk, followed by 10 000 IU) | High-dose enoxaparin (1.5 mg/kg body weight) | High-dose nadroparin (adjusted to body weight) | B: Parnaparin (8500 IU once daily for 10 d, followed by 6400 IU once daily for 20 d) | Fondaparinux (2.5 mg sc) | Fondaparinux (2.5 mg sc) | |
| C: Parnaparin (4250 IU once daily for 30 d) | ||||||
| Risk profile, % | ||||||
| History of VTE | 10-13 | 15 | Unknown | 38 | 7 | 48.5 |
| Cancer | 6-10 | <2 | Excluded | Excluded | Excluded | 9.5 |
| Age >65 y | 45 | ≈55 | Unknown | Unknown | Unknown | 37.3 |
| Male sex | Unknown | ≈40 | <30 | 37 | ≈35 | ≈40 |
| Nonvaricose vein | Unknown | Unknown | 30 | 35 | 12 | 30 |
| ≥2 RFs: ≈70 | ||||||
| Duration of treatment | 4 wk | 2 wk | 4 wk | 10-30 d | 6 wk | 6 wk |
| Rate of DVT/PE during treatment, % | Low-dose UFH: 13.3 | Placebo: 3.6 | Low-dose nadroparin: 0 | A: 4.6 | Fondaparinux: 0.2 | Rivaroxaban: 1.3 |
| High-dose UFH: 0 | Low-dose enoxaparin: 0.9 | High-dose nadroparin: 1.2 | B: 0.4 | Placebo: 1.3 | Fondaparinux: 0.4 | |
| High-dose enoxaparin: 1.0 | C: 1.3 | |||||
| Symptomatic SVT recurrence/ extension during treatment, % | Symptomatic plus asymptomatic events: | Placebo: 24 | Low-dose nadroparin: 1.2 | A: 10.6 | Fondaparinux: 0.6 | Rivaroxaban: 1.7 |
| Low-dose UFH: 23 | Low-dose enoxaparin: 4.5 | High-dose nadroparin: 0 | B: 1.3 | Placebo: 5.0 | Fondaparinux: 1.3 | |
| High-dose UFH: 10 | High-dose enoxaparin: 2.8 | C: 5.8 | ||||
| Duration of follow-up | 6 mo | 90 d (duplex at day 12) | 90 d (4 × duplex surveillance) | 93 d | 77 d | 90 d |
| VTE rate until end of follow-up, % | Low-dose UFH: 20.0 | Placebo: 4.5 | Low-dose nadroparin: 2.5 | A: 5.1 | Fondaparinux: 0.3 | Rivaroxaban: 2.5 |
| High-dose UFH: 3.3 | Low-dose enoxaparin: 5.7 | High-dose nadroparin: 4.8 | B: 1.8 | Placebo: 1.5 | Fondaparinux: 0.9 | |
| High-dose enoxaparin: 3.9 | C: 3.1 | |||||
| Symptomatic SVT recurrence/ extension until end of follow-up, % | Symptomatic plus asymptomatic events | Placebo: 27.7 | Low-dose nadroparin: 1.2 | A: 17.1 | Fondaparinux: 0.9 | Rivaroxaban:4.2 |
| Low-dose UFH: 36.7 | Low-dose enoxaparin: ≈11.0 | High-dose nadroparin: 1.2 | B: 6.7 | Placebo: 5.3 | Fondaparinux: 5.5 | |
| High-dose UFH: 26.7 | High-dose enoxaparin: ≈12.3 | C: 10.8 |
| Characteristic . | Marchiori et al. . | STENOX . | VESALIO . | STEFLUX . | CALISTO . | SURPRISE . |
|---|---|---|---|---|---|---|
| Reference | 42 | 29 | 31 | 32 | 16 | 27 |
| Number of patients | 60 | 427 | 164 | 664 | 3002 | 472 |
| Treatments | Low-dose UFH (5000 IU) | Low-dose placebo enoxaparin (40 mg) | Low-dose nadroparin (0.3 mL to 2850 a-Xa IU) | A: Parnaparin (8500 IU once daily for 10 d) | Placebo | Rivaroxaban (10 mg po) |
| High-dose UFH (12 500 IU for 1 wk, followed by 10 000 IU) | High-dose enoxaparin (1.5 mg/kg body weight) | High-dose nadroparin (adjusted to body weight) | B: Parnaparin (8500 IU once daily for 10 d, followed by 6400 IU once daily for 20 d) | Fondaparinux (2.5 mg sc) | Fondaparinux (2.5 mg sc) | |
| C: Parnaparin (4250 IU once daily for 30 d) | ||||||
| Risk profile, % | ||||||
| History of VTE | 10-13 | 15 | Unknown | 38 | 7 | 48.5 |
| Cancer | 6-10 | <2 | Excluded | Excluded | Excluded | 9.5 |
| Age >65 y | 45 | ≈55 | Unknown | Unknown | Unknown | 37.3 |
| Male sex | Unknown | ≈40 | <30 | 37 | ≈35 | ≈40 |
| Nonvaricose vein | Unknown | Unknown | 30 | 35 | 12 | 30 |
| ≥2 RFs: ≈70 | ||||||
| Duration of treatment | 4 wk | 2 wk | 4 wk | 10-30 d | 6 wk | 6 wk |
| Rate of DVT/PE during treatment, % | Low-dose UFH: 13.3 | Placebo: 3.6 | Low-dose nadroparin: 0 | A: 4.6 | Fondaparinux: 0.2 | Rivaroxaban: 1.3 |
| High-dose UFH: 0 | Low-dose enoxaparin: 0.9 | High-dose nadroparin: 1.2 | B: 0.4 | Placebo: 1.3 | Fondaparinux: 0.4 | |
| High-dose enoxaparin: 1.0 | C: 1.3 | |||||
| Symptomatic SVT recurrence/ extension during treatment, % | Symptomatic plus asymptomatic events: | Placebo: 24 | Low-dose nadroparin: 1.2 | A: 10.6 | Fondaparinux: 0.6 | Rivaroxaban: 1.7 |
| Low-dose UFH: 23 | Low-dose enoxaparin: 4.5 | High-dose nadroparin: 0 | B: 1.3 | Placebo: 5.0 | Fondaparinux: 1.3 | |
| High-dose UFH: 10 | High-dose enoxaparin: 2.8 | C: 5.8 | ||||
| Duration of follow-up | 6 mo | 90 d (duplex at day 12) | 90 d (4 × duplex surveillance) | 93 d | 77 d | 90 d |
| VTE rate until end of follow-up, % | Low-dose UFH: 20.0 | Placebo: 4.5 | Low-dose nadroparin: 2.5 | A: 5.1 | Fondaparinux: 0.3 | Rivaroxaban: 2.5 |
| High-dose UFH: 3.3 | Low-dose enoxaparin: 5.7 | High-dose nadroparin: 4.8 | B: 1.8 | Placebo: 1.5 | Fondaparinux: 0.9 | |
| High-dose enoxaparin: 3.9 | C: 3.1 | |||||
| Symptomatic SVT recurrence/ extension until end of follow-up, % | Symptomatic plus asymptomatic events | Placebo: 27.7 | Low-dose nadroparin: 1.2 | A: 17.1 | Fondaparinux: 0.9 | Rivaroxaban:4.2 |
| Low-dose UFH: 36.7 | Low-dose enoxaparin: ≈11.0 | High-dose nadroparin: 1.2 | B: 6.7 | Placebo: 5.3 | Fondaparinux: 5.5 | |
| High-dose UFH: 26.7 | High-dose enoxaparin: ≈12.3 | C: 10.8 |
For a more complete overview of historic SVT trials, refer to Di Nisio et al.25 a-Xa, inhibition of activated factor Xa; CALISTO, Comparison of Arixtra in Lower Limb Superficial Vein Thrombosis With Placebo; DVT, deep vein thrombosis; PE, pulmonary embolism; po, by mouth; RF, risk factor. STEFLUX, Superficial Thromboembolism Fluxum; STENOX, Superficial Thrombophlebitis Treated by Enoxaparin; SURPRISE, Superficial Phlebitis Treated for 45 Days with Rivaroxaban Versus Fondaparinux; SVT, superficial vein thrombosis; UFH, unfractionated heparin; VTE, venous thromboembolism.