Recent outcomes from the ongoing, real-world CLOUT registry demonstrate that the ClotTriever System safely and effectively removes acute, subacute and chronic thrombus, according to data detailed in “Safety and effectiveness of the ClotTriever system for treating deep vein thrombosis of all chronicities: CLOUT registry six-month outcomes.”
“This work is a subanalysis of data from the CLOUT registry, a multicenter and all-comer study of patients with lower extremity deep vein thrombosis (DVT) who were treated using the ClotTriever System (Inari Medical, Irvine, Calif.),” said Angelo Marino, DO, lead author of the abstract. “A recent publication of interim CLOUT data (Dexter et al., 2022) suggests that ClotTriever is safe and effective for removing DVT. Here, we aim to elucidate the impact of thrombus chronicity on the outcomes in CLOUT. We evaluated case characteristics, ultrasound findings and clinical outcomes through 6 months for patients with either acute, subacute or chronic DVT.”
According to Dr. Marino, he was inspired by the opportunity to better serve his DVT patients, who he says often receive insufficient treatment. “Current therapies for DVT frequently fail to fully remove a patient’s thrombus burden. For example, fibrinolysis removes only acute DVT that is present for approximately 2 weeks or less and is not a viable option for patients contraindicated to fibrinolytics. Patients with subacute or chronic DVT are likely to have significant residual venous obstruction (RVO) after receiving fibrinolytic-based treatments.” Dr. Marino says that greater RVO puts these patients at a higher risk of then developing a debilitating condition called post-thrombotic syndrome (PTS), which is associated with chronic pain, skin changes and even venous ulceration.
“Previous work has indicated that the ClotTriever System can treat not only acute DVT but also subacute and chronic forms of the disease,” said Dr. Marino. “ClotTriever does not utilize fibrinolytics; instead, it offers a completely mechanical thrombectomy approach to removing DVT. The other CLOUT investigators and I were eager to corroborate previous findings that the ClotTriever System can extirpate thrombus regardless of chronicity.”
The analysis of the CLOUT registry outcomes indicate that the ClotTriver System is both safe and effective for extirpating DVT, said Dr. Marino. “Patients in all three chronicity subgroups exhibited low rates of PTS at 6 months, particularly moderate to severe PTS.” According to Dr. Marino, there are several implications of these findings: fibrinolysis cannot remove subacute and chronic DVT, only patients with acute symptoms have been the target for interventions in the past. “The ability of ClotTriever to address thrombus spanning the chronicity spectrum makes it the first effective treatment option for all DVT patients,” said Dr. Marino.
In addition, Dr. Marino pointed out that since the ClotTriever System’s mechanism of action does not include the use of fibrinolytics, patients can be treated without the need of fibrinolytics and the associated risk of major bleeding events. “This obviates the risk–benefit decision interventionalists are often faced with when deciding to treat an otherwise healthy DVT patient,” he said.
According to Dr. Marino, CLOUT enrollment to 500 patients has concluded, and follow-up through 2 years is ongoing. “We intend to expand on this current analysis, evaluating characteristics and 2-year outcomes for the full set of registry patients,” said Dr. Marino. “It will be exciting to determine the impact that ClotTriever has on patients’ quality of life over this extended period.”
