Summary of RCTs evaluating CDT in DVT
| Study . | N . | Study population . | Treatment . | Comparison . | Efficacy . | Safety . |
|---|---|---|---|---|---|---|
| CaVENT38 | 209 | Iliofemoral DVT within 21 d | CDT: tPA at 20 mg + therapeutic anticoagulation (n = 90) | Anticoagulation alone (n = 99) | PTS at 24 mo: | Major bleeding: |
| CDT, 37 (41.1%) vs control, 55 (55.6%; P = .047) | CDT, 3 (3.3%) vs control, 0 (0%) | |||||
| PTS at 5 y: | No intracranial hemorrhage | |||||
| CDT, 37 (42.5%) vs control, 63 (70.8%; P < .001) | ||||||
| ATTRACT39 | 692 | Iliac, femoral, common femoral DVT within 14 d | PMCDT: tPA at <35 mg + therapeutic anticoagulation (n = 336) | Anticoagulation alone (n = 355) | PTS at 24 mo: | Major bleeding in 10 d: |
| PMCDT, 157 (47%) vs control, 171 (48%) | PMCDT, 1.7% vs control, 0.3% | |||||
| RR, 0.96 (95% CI, 0.82-1.11; P = .56) | RR, 6.18 (95% CI, 0.78-49.2; P = .049) | |||||
| Moderate to severe PTS at 24 mo: | No intracranial hemorrhage | |||||
| PMCDT, 60 (18%) vs control, 84 (24%) | ||||||
| RR, 0.73 (95% CI, 0.54-0.98; P = .04) | ||||||
| CAVA40 | 184 | Iliofemoral DVT within 14 d | USAT: urokinase via EKOS catheter + therapeutic anticoagulation (n = 77) | Anticoagulation alone (n = 75) | PTS at 12 mo: | Major bleeding in 10 d: |
| USAT, 22 (29%) vs control, 26 (35%) | USAT, 4 (5%) vs control, 0 (0%) | |||||
| OR, 0.75 (95% CI, 0.38-1.50) | OR, 9.25 (95% CI, 0.49-174.7) | |||||
| No intracranial hemorrhage |
| Study . | N . | Study population . | Treatment . | Comparison . | Efficacy . | Safety . |
|---|---|---|---|---|---|---|
| CaVENT38 | 209 | Iliofemoral DVT within 21 d | CDT: tPA at 20 mg + therapeutic anticoagulation (n = 90) | Anticoagulation alone (n = 99) | PTS at 24 mo: | Major bleeding: |
| CDT, 37 (41.1%) vs control, 55 (55.6%; P = .047) | CDT, 3 (3.3%) vs control, 0 (0%) | |||||
| PTS at 5 y: | No intracranial hemorrhage | |||||
| CDT, 37 (42.5%) vs control, 63 (70.8%; P < .001) | ||||||
| ATTRACT39 | 692 | Iliac, femoral, common femoral DVT within 14 d | PMCDT: tPA at <35 mg + therapeutic anticoagulation (n = 336) | Anticoagulation alone (n = 355) | PTS at 24 mo: | Major bleeding in 10 d: |
| PMCDT, 157 (47%) vs control, 171 (48%) | PMCDT, 1.7% vs control, 0.3% | |||||
| RR, 0.96 (95% CI, 0.82-1.11; P = .56) | RR, 6.18 (95% CI, 0.78-49.2; P = .049) | |||||
| Moderate to severe PTS at 24 mo: | No intracranial hemorrhage | |||||
| PMCDT, 60 (18%) vs control, 84 (24%) | ||||||
| RR, 0.73 (95% CI, 0.54-0.98; P = .04) | ||||||
| CAVA40 | 184 | Iliofemoral DVT within 14 d | USAT: urokinase via EKOS catheter + therapeutic anticoagulation (n = 77) | Anticoagulation alone (n = 75) | PTS at 12 mo: | Major bleeding in 10 d: |
| USAT, 22 (29%) vs control, 26 (35%) | USAT, 4 (5%) vs control, 0 (0%) | |||||
| OR, 0.75 (95% CI, 0.38-1.50) | OR, 9.25 (95% CI, 0.49-174.7) | |||||
| No intracranial hemorrhage |
EKOS, EndoWave Infusion Catheter System; PMCDT, pharmacomechanical CDT; RR, relative risk; USAT, ultrasound-assisted CDT.