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Endovascular Thrombus Removal for Iliofemoral DVT
Study Questions:
What is the utility of pharmaco-mechanical catheter-directed thrombolysis (PCDT) in patients with iliofemoral deep vein thrombosis (DVT)?
Methods:
The ATTRACT trial randomized patients with femoral or a more proximal vein acute DVT (symptom onset for ≤14 days) to adjunctive PCDT or anticoagulation alone. This study is a subgroup analysis of 391 patients in the ATTRACT trial with acute iliofemoral DVT. Patient outcomes were assessed over a 24-month follow-up by blinded clinicians. Post-thrombotic syndrome (PTS), defined as a Villalta score of >5 or a venous ulcer in the leg with the index DVT that occurred at any one or more assessments between the 6-month and 24-month follow-up visits, was the study’s primary efficacy outcome. In addition, the presence of moderate or severe PTS (Villalta score ≥10, or an ulcer), or severe PTS (Villalta score ≥15, or an ulcer) were assessed as secondary outcomes. Generic health-related quality of life (QOL) was assessed with the Short-Form (SF)-36 Health Status Survey, and venous disease-specific QOL was assessed with the Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) measure. Safety outcomes included bleeding, recurrent venous thromboembolism, and death, which were recorded throughout follow-up and summarized through 10 days and 24 months.
Results:
Of the 692 patients in the ATTRACT trial, 391 (57%) had iliofemoral DVT, of whom 196 were randomized to PCDT and 195 were randomized to No-PCDT. Median age was 52 years, 53% were male, the index DVT was in the left leg in 64%, and symptoms were present for a median of 6 days. In the intention-to-treat analysis, incident PTS was similar during 24 months of follow-up. However, moderate or severe PTS developed in 36 (18%) patients assigned to PCDT and in 55 (28%) patients assigned to No-PCDT (risk ratio [RR], 0.65; 95% confidence interval [CI], 0.45-0.94; p = 0.021). Severe PTS developed in 17 (8.7%) patients assigned to PCDT and in 30 (15%) patients assigned to anticoagulation alone (RR, 0.57; 95% CI, 0.32-1.01; p = 0.048). These findings were similar in per-protocol analyses. 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). Safety outcomes were similar in both groups.
Conclusions:
In patients with iliofemoral DVT, PCDT did not reduce overall incidence of any PTS over anticoagulation alone. However, moderate or severe PTS was significantly less common with PCDT use in this patient population.
Perspective:
While we await real-world data on safety of PCDT in patients with acute iliofemoral DVT, these findings support early use of PCDT in patients with acute iliofemoral DVT and low overall bleeding risk.
Clinical Topics: Anticoagulation Management, Cardiac Surgery, Prevention, Pulmonary Hypertension and Venous Thromboembolism, Vascular Medicine, Anticoagulation Management and Venothromboembolism, Aortic Surgery, Cardiac Surgery and Arrhythmias
Keywords: Anticoagulants, Endovascular Procedures, Intention to Treat Analysis, Mechanical Thrombolysis, Postphlebitic Syndrome, Postthrombotic Syndrome, Quality of Life, Secondary Prevention, Ulcer, Varicose Ulcer, Vascular Diseases, Venous Thromboembolism, Venous Thrombosis
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