Self-expanding stent beneficial in venous outflow obstruction
Among patients with venous outflow obstruction, a self-expanding venous stent system was safe and effective, researchers reported at the virtual Charing Cross Symposium.
In the single-arm ABRE study of the venous stent system (Abre, Medtronic) among 200 patients with symptomatic iliofemoral venous outflow obstruction, the primary safety and efficacy endpoints were met, Stephen A. Black, MD, FRCS (Ed), FEBVS, consultant vascular surgeon at Guy’s and St. Thomas Hospital, London, said during a presentation.
The primary safety endpoint of 30-day major adverse events, defined as all-cause death, clinically significant pulmonary embolism, major procedural bleeding complication, stent thrombosis or stent migration, occurred in 2% of patients, beating the performance goal of 12.5% (P < .0001), Black said during the presentation.
The primary efficacy endpoint of 12-month primary patency, defined as freedom from occlusion and at least 50% restenosis of the stented segment of the target lesion and freedom from clinically driven target lesion revascularization, occurred in 88% of patients, beating the performance goal of 75% (P < .0001), he said.
“Deep venous lesions are uniquely challenging and require a stent that is strong, flexible and durable while also being able to maintain blood flow,” Black said in a press release. “It is encouraging that the study was able to meet its primary endpoints and demonstrated strong results with secondary endpoints. This is especially remarkable in this challenging study population with stents extending below the inguinal ligament in nearly half of enrolled subjects.”
Among those who had a major adverse event at 30 days, 0.5% had clinically significant PE and 1.5% had stent thrombosis, he said.
The 12-month rate of freedom from clinically driven TLR was 92.4%, and primary patency was achieved in 79.8% of those with post-thrombotic syndrome, 98.6% of those with nonthrombotic iliac vein lesions and 82.4% of those with acute deep vein thrombosis, he said.
The rate of device success was 100% and the rate of procedural success was 99%, according to the researchers.
At 12 months, 1% of patients died, 0.5% had clinically significant PE, 0.5% had a postprocedural major bleeding complication, 4.1% had stent thrombosis and no patients had stent migration or stent fracture, Black said.
VEINES-QOL, EQ-5D Index QOL, Villalta and Venous Clinical Severity scores all improved at 6 and 12 months (P < .001 for all), he said.
The stent system is not yet approved for commercial use in the United States.
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Black SA, et al. Deep Venous Disease Consensus. Presented at: Charing Cross Symposium; May 25-June 26, 2020 (virtual meeting).