A study of catheter-guided thrombolysis in patients with deep-vein thrombosis found no reduction in risk for post-thrombotic syndrome but a higher risk of major bleeding.
The study, published in the New England Journal of Medicine, examined 692 patients with acute proximal deep-vein thrombosis, randomized to receive either anticoagulation drugs alone or anticoagulation plus pharmaco-mechanical thrombolysis. The experimental arm was treated with the intra-thrombus delivery of recombinant tissue plasminogen activator and thrombus aspiration or maceration, with or without stenting. The primary outcome was development of PTS between 6 and 24 months.
The researchers found no significant difference between the groups in terms of PTS, which was found in 47% of the experimental cohort and in 48% of the control group. But there were more major bleeding events in the interventional arm within 10 days (1.7% vs. 0.3%).
However, there were no significant differences in recurrent venous thromboembolism over two yaers, with 12% occurring in the pharmaco-mechanical-thrombolysis group and 8% in the control group. Moderate-to-severe PTS occurred in 18% of patients in the treatment arm versus 24% in the control group.
Severity scores for PTS were lower in the interventional group than in the control group at 6, 12, 18, and 24 months, but “the improvement in quality of life from baseline to 24 months did not differ significantly between the treatment groups,” the study found.
“Among patients with acute proximal deep-vein thrombosis, the addition of pharmaco-mechanical catheter-directed thrombolysis to anticoagulation did not result in a lower risk of the post-thrombotic syndrome but did result in a higher risk of major bleeding,” the authors wrote.