BACKGROUND: The ATTRACT Trial previously reported that pharmacomechanical catheter-directed thrombolysis (PCDT) did not prevent the post-thrombotic syndrome (PTS) in patients with acute proximal deep vein thrombosis (DVT). In the current analysis, we examine the effect of PCDT in ATTRACT patients with iliofemoral DVT.METHODS: Within a large multicenter randomized trial, 391 patients with acute DVT involving the iliac and/or common femoral veins were randomized to PCDT with anticoagulation versus anticoagulation alone (No-PCDT) and were followed for 24 months to compare short-term and long-term outcomes.RESULTS: Between 6 and 24 months, there was no difference in the occurrence of PTS (Villalta scale =5 or ulcer: 49% PCDT versus 51% No-PCDT; risk ratio (RR)=0.95; 95% confidence interval (CI), 0.78-1.15; p=0.59). PCDT led to reduced PTS severity as shown by: lower mean Villalta and Venous Clinical Severity Scores [VCSS] (p<0.01 for comparisons at 6, 12, 18, and 24 months); and fewer patients with moderate-or-severe PTS (Villalta scale =10 or ulcer: 18% versus 28%; RR 0.65; 95% CI 0.45-0.94, p=0.021) or severe PTS (Villalta scale =15 or ulcer: 8.7% versus 15%; RR 0.57; 95% CI 0.32-1.01, p=0.048; and VCSS =8: 6.6% versus 14%; RR 0.46; 95% CI 0.24-0.87, p=0.013). From baseline, PCDT led to greater reduction in leg pain and swelling (p<0.01 for comparisons at 10 and 30 days) and greater improvement in venous disease-specific QOL (VEINES-QOL unit difference 5.6 through 24 months, p=0.029), but no difference in generic QOL (p > 0.2 for comparisons of SF-36 mental and physical component summary scores through 24 months). In patients having PCDT versus No-PCDT, major bleeding within 10 days occurred in 1.5% versus 0.5% (p=0.32), and recurrent VTE over 24 months was observed in 13% versus 9.2% (p=0.21).CONCLUSIONS: In patients with acute iliofemoral DVT, PCDT did not influence the occurrence of PTS or recurrent VTE. However, PCDT significantly reduced early leg symptoms and, over 24 months, reduced PTS severity scores, reduced the proportion of patients who developed moderate-or-severe PTS, and resulted in greater improvement in venous disease-specific QOL.CLINICAL TRIAL REGISTRATION: URL: www.clinicaltrials.gov Unique Identifier: NCT00790335.
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