One discussion this week included the ATTRACT trial.
Reference: Vedantham S, et al. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. New England Journal of Medicine. 2017 Dec 7;377(23):2240-2252. doi:10.1056/NEJMoa1615066.
Summary: The ATTRACT trial sought to “determine whether pharmacomechanical thrombolysis prevents the post-thrombotic syndrome in patients with proximal deep-vein thrombosis” (p.2241). A total of 692 patients were enrolled at 56 centers in the US from December 2009 through December 2014. They were between the ages of 16 and 75, and had symptomatic proximal deep-vein thrombosis involving the femoral, common femoral, or iliac vein (p. 2241).
Post-thrombotic syndrome was defined as a Villalta score of 5 or higher or an ulcer in the leg with the index deep-vein thrombosis at any time between the 6-month and 24-month follow-up visits. Severity of post-thrombotic syndrome was evaluated using the Villalta scale and the Venous Clinical Severity Score.
The trial found:
- the addition of pharmacomechanical catheter-directed thrombolysis to anticoagulation did not lower the risk of post-thrombotic syndrome – 47% of patients in pharmacomechanical-thrombolysis group; 48% in anticoagulation alone group.
- There was no difference in quality of life between the groups from baseline to 24-month follow-up.
- Severity scores were lower in the pharmacomechanical-thrombolysis group.
- The addition of pharmacomechanical catheter-directed thrombolysis to anticoagulation resulted in an increased risk of major bleeding – 1.7% of patients vs 0.3% (p.2240).