Clot-retrieval device safe, effective for treatment of chronic thrombus in DVT at 30 days
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A clot-removal device successfully removed chronic thrombus from patients with deep vein thrombosis and was associated with few adverse events at 30 days, researchers reported.
Robert E. Beasley, MD, FSIR, FSCAI, vascular and interventional radiologist at Palm Vascular Centers in Miami Beach and Coral Gables, Florida, presented 30-day results of the CLOUT Registry of real-world patients with DVT who underwent a clot-removal procedure with the device (ClotTriever, Inari Medical) at the International Symposium on Endovascular Therapy.
In many patients with acute DVT, “there is more chronic thrombus in there than you’d think,” Beasley said during the presentation. “Thrombolytics do not work well on chronic thrombus, and there have been reports that thrombus at 1 week has about 20% collagen, and then at 3 weeks, about 80% collagen.”
The researchers analyzed acute outcomes of 64 patients with DVT and chronic thrombus (mean age, 64 years; 45% men) who underwent a procedure with the device. The primary effectiveness endpoint was technical success, defined as at least 75% removal of venous thrombus as determined by the Marder score. The primary safety endpoint was 30-day major adverse events, defined as all-cause mortality, major bleeding, new symptomatic pulmonary embolism and rethrombosis of a target segment.
Among the cohort, 98.4% needed a single session, the average number of device passes was four, no patients required thrombolytics and 1.9% required an ICU stay, Beasley said during the presentation.
Median Marder score was 8.9 at baseline and 0.9 at 30 days, for a median reduction of 90% (P < .0001), Beasley said, noting 82% of patients achieved technical success and 44% of patients achieved 100% removal of thrombus.
There were no deaths or device-related serious adverse events, Beasley said, adding that 1.6% of patients had major bleeding, 1.6% had new symptomatic PE and 4.7% had rethrombosis of the target segment.
Median Villalta scores improved from 12 at baseline to 4 at 30 days (P < .0001), and 79% of patients improved in post-thrombotic syndrome category, whereas 60% had complete reversal of post-thrombotic syndrome, he said.
At 30 days, Numeric Pain Rating Scale improved from 6 to 1 (P < .0001) and revised Venous Clinical Severity Score improved from 8 to 5 (P < .0001), according to the researchers.
Quality of life as assessed by the EQ-5D score improved from 0.53 at baseline to 0.86 at 30 days, Beasley said.
“The ClotTriever successfully removes chronic thrombus in real-world DVT patients in a single session without the need for thrombolytics or ICU stays,” Beasley said during the presentation. “It is a very safe procedure, with no device-related serious adverse events out to 30 days. We are continuing to enroll, and there will be further follow-up on this particular data set.”
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Beasley R, et al. Late-breaking data and hot topics. Presented at: the International Symposium on Endovascular Therapy; May 9-11, 2021; Miami Beach, Florida (hybrid meeting).
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