(HealthDay News) — The addition of pharmacomechanical thrombolysis does not reduce the risk of post-thrombotic syndrome among patients with acute proximal deep vein thrombosis, according to a study published in the Dec. 7 issue of the New England Journal of Medicine.
Suresh Vedantham, MD, from the Washington University School of Medicine in St. Louis, and colleagues randomized 692 patients with acute proximal deep-vein thrombosis to receive anticoagulation alone (control group) or anticoagulation plus pharmacomechanical thrombolysis.
The researchers found observed no significant between-group difference in the percentage of patients with post-thrombotic syndrome between 6 and 24 months (47% in the pharmacomechanical-thrombosis group and 48% in the control group; risk ratio, 0.96; 95% confidence interval, 0.82 to 1.11; P =.56). More bleeding events within 10 days occurred in the pharmacomechanical thrombolysis group (1.7% vs 0.3% of patients; P =.049); over the 24-month period, there was no significant difference in recurrent venous thromboembolism (12% vs 8%; P =.09). Moderate-to-severe post-thrombotic syndrome occurred in 18% and 24% of patients in the pharmacomechanical thrombolysis and control groups, respectively (risk ratio, 0.73; 95% confidence interval, 0.54 to 0.98; P =.04).
“Among patients with acute proximal deep-vein thrombosis, the addition of pharmacomechanical 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 write.
Several authors disclosed ties to pharmaceutical companies, some of which provided funding for the study; BSN Medical donated compression stockings.
Vedantham S, Goldhaber SZ, Julian JA, et al. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. N Engl J Med. 2017 Dec 7;377(23). doi: 10.1056/NEJMoa1615066