ABSTRACT
David Dexter, MD
Assistant Professor of Surgery
Eastern Virginia Medical School
Norfolk, Virginia, United States
The prospective, multi-center CLOUT registry (NCT03575364) evaluates all-comer patients with lower extremity deep vein thrombosis (DVT) treated with the ClotTriever System. We present here the interim 1-year outcomes.
Methods:
Patients with bilateral DVT, failed prior treatment, and symptom duration >2 weeks were not excluded. The primary effectiveness endpoint was complete or near-complete (≥75%) thrombus removal, assessed by an independent core laboratory. Serious adverse events (SAEs) at 30 days, including device-relatedness, were adjudicated by an independent medical monitor. Duplex ultrasound and clinical outcomes are reported to 1 year.
Results:
: Of the 500 patients (520 treated limbs) enrolled, the median age was 61.9 years, 49.6% (248/500) were male, 24.6% (123/499) had prior history of DVT, and 29.5% (147/499) had a high bleeding risk with thrombolytics. Patients had a median baseline Villalta score of 9. Procedures were completed in a single session in 99.4% (497/500) of patients, with a median of 4 device passes. Adjunctive venoplasty was used in 72.9% (379/520) and stents were placed in 44.2% (230/520) of treated limbs. Median blood loss was 37.5mL. At least 75% thrombus removal was was achieved in 89.0% (324/364) of limbs, including 58.8% (214/364) with complete (100%) thrombus removal. The median post-thrombectomy hospital stay was 1 day. Through 30 days, there was 1 (0.2%) device-related SAE, no major bleeding events, and all-cause mortality was 1.0% (4/421). One-year follow-up for 176 patients was completed (Table 1): 93.5% (130/139) of limbs had flow present and 97.1% (135/139) were compressible; 21.0% (34/162) of patients presented with post-thrombotic syndrome (PTS, Villalta score >4) and 10.5% (17/162) with moderate or severe PTS (Villalta score >9). Significant improvements in pain, revised venous clinical severity score, quality of life, and mid-calf edema were observed at 1 year. This 1-year interim analysis from the real-world CLOUT registry indicates that the ClotTriever System can effectively remove thrombi with significant and sustained long-term clinical improvements, including PTS, pain, and quality of life. Follow-up with the complete dataset to 2 years is ongoing.
Conclusions: