Table 3.
Safety Outcomes: Long‐Term Follow‐Up
|
Additional Thrombolysis (n=62) |
Standard Treatment (n=58) |
Difference Between Treatment Groups, (95% CI) | OR (95% CI) | |
|---|---|---|---|---|
| Primary outcome | ||||
| Major bleeding20 | 0 | 0 | 0.0% | … |
| Secondary outcomes | ||||
| Pulmonary embolism | 3 (4.8) | 2 (3.4) | 1.4% (−5.7% to 6.8%) | 1.42 (0.23–8.84) |
| Recurrent (nonstent) DVT | 3 (4.8) | 6 (10.3) | −5.5% (−12.8% to 5.0%) | 0.44 (0.11–1.85) |
| In‐stent‐thrombosis | 2 (3.2) | 1 (1.7)* | 1.5% (−3.9% to 4.7%) | 1.90 (0.17–21.5) |
| Death | 0 | 0 | 0.0% | … |
Data are number (percentage). None of the comparisons in this table showed a statistically significant difference between groups. Reported results concern the occurrence of safety outcomes during long‐term follow‐up (>12 months after study inclusion).
*
One patient underwent venous stent placement after completing the 1‐year study follow‐up. Indication for treatment was the presence of May‐Thurner Syndrome. DVT indicates deep vein thrombosis; and OR, odds ratio.