The safety and efficacy of pharmaco-mechanical thrombolysis in lower-extremity deep venous thrombosis.

Objective: The aim of this study was to investigate the impact of accelerated pharmaco-mechanical thrombolysis (PMT) with low-dose second-generation urokinase for the management of cases with lower-extremity deep venous thrombosis (DVT), and to compare its efficacy in subjects with acute and subacute DVT.

Methods: Thirty-five patients with acute (< 15 days) or subacute (15-30 days) DVT who underwent PMT in a tertiary centre were enrolled in this single-arm, prospective study. Following the placement of a temporary vena cava filter, urokinase (200 000 IU) was administered into the occlusion through a multi-hole catheter for 15 to 20 minutes. Control venography was performed to assess venous flow and the rate of acute recanalisation. Percutaneous balloon dilatation and stent placement were carried out in case of a residual iliac vein stenosis of > 50%. Any residual thrombi were suctioned with an aspiration catheter. The primary outcome measures of this study were the percentages of vessel patency and PTS in the third month after PMT.

Results: Complete recanalisation was noted in 23 (66%) patients, while two (6%) had poor recanalisation. The rate of minor complications was 14%. None of the subjects experienced major complications, such as intracranial haemorrhage or pulmonary embolism. No mortality was recorded during the three months of follow up. Control duplex ultrasonography in the third month revealed that the target vein was patent in all subjects. None of the subjects experienced PTS during follow up. In addition, the percentage of acute complete recanalisation was significantly higher in subjects with acute DVT compared to those with subacute DVT (95 vs 27%, p < 0.001).

Conclusion: PMT with an accelerated regimen of low-dose urokinase provided excellent efficacy in the resolution of thrombus and prevented the development of PTS in the midterm when used for the management of lower-extremity DVT.