The interim results are the largest prospective, multi-center two-year dataset in deep vein thrombosis (DVT) since the ATTRACT trial and confirm the excellent safety, effectiveness, and long-term outcomes of the ClotTriever system in real-world DVT patients. Patients had low incidence of independently adjudicated safety events related to rethrombosis, with only 5.0% and 8.4% at 30-days and 6 months, respectively. In the interim analysis, 228 patients completed their two-year follow-up visit. Patients had significant and sustained improvement in post-thrombotic syndrome (PTS) over the follow-up period, with only 7.3% moderate-severe PTS at two years. The PTS rates reported in CLOUT are significantly lower than those from historical DVT studies such as ATTRACT and CAVA, which reported moderate-severe PTS rates ranging from 18-24%.
“With third-party adjudication of all safety events in this robust, large dataset, ClotTriever has a strong safety profile. And the longer-term results are suggestive of sustained benefit through a critical window when longer-term sequalae typically manifest in DVT patients,” said
“This data continues to reinforce the strong safety and effectiveness profile of the ClotTriever system, which is not only the most utilized, but also the most studied thrombectomy device in DVT,” said Dr.
PTS Rates in Context:
ClotTriever CLOUT Registry Interim results (n=228) | ATTRACT Anticoagulation Arm (n=236) | ATTRACT Intervention Arm (n=258) | CAVA Anticoagulation Arm (n=58) | CAVA Intervention Arm (n=62) | |
2-Year PTS | 19.9% | 36.0% | 30.6% | 44.8%* | 30.6%* |
2-Year Moderate-Severe PTS | 7.3% | 24.0% | 18.2% | 24.1%* | 22.6%* |
*Median follow-up 39.0 months
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References:
ATTRACT: Vedantham, et al. N Eng J Med. 2017. CAVA: Notten, et al.
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