A braided self-expanding venous stent showed long-term safety and efficacy in patients with iliofemoral vein obstruction, researchers reported.
The researchers analyzed 67 patients (median age, 63 years; 55% men) who had the stent (Wallstent, Boston Scientific) implanted in 77 limbs to treat chronic iliofemoral vein obstruction.
“Our experience found that stenting of chronic iliofemoral venous obstruction resulted in excellent long-term patency rates and significant clinical improvement for many patients,” Paul J. Gagne, MD, vascular surgeon at The Vascular Experts in Darien, Connecticut, said in a press release.
Among the limbs in the cohort, 55% were nonthrombotic, 62% were left-sided and 42% had long lesions. The mean Venous Clinical Severity Score was 9 (range, 3-23).
According to the researchers, stenting correlated with venography and IVUS in 48% of limbs and more closely aligned with IVUS in 45% of limbs. Stents were deployed into the common femoral vein in 22% of cases, and into the inferior vena cava in 8% of cases.
Ninety-seven percent of patients had imaging follow-up at a median of 50 months.
At 72 months, the rate of primary patency was 87%, the rate of assisted primary patency was 95% and the rate of secondary patency was 95%, Gagne and colleagues wrote.
In patients with nonthrombotic lesions, the rate of primary patency was 97% and the rates of assisted primary patency and secondary patency were 100%, according to the researchers.
In the post-thrombotic subgroup, the rate of primary patency was 75% and the rates of assisted primary patency and secondary patency were 88%, Gagne and colleagues wrote.
Eight patients required reintervention (range, 0.5-80 months): There were three early failures and five patients required interventions to maintain patency, according to the researchers.
At a median of 26 months, 68% of patients had an improvement of at least 4 points in Venous Clinical Severity Score, and none had a worse score, the researchers wrote.
The only independent predictor of loss of primary patency was involvement of the common femoral vein (HR = 4.4; 95% CI, 2.9-5.8), they found.
“The analysis of most and least improved limbs found that improved outcomes were observed in patients who presented with more severe venous disease,” Gagne said in the release. “The most improved subset was disproportionally composed of C6 patients with open ulcers, whereas one-third of the C3 patients treated in the overall series were among the least improved.” – by Erik Swain
Disclosure: The study was investigator-initiated and supported in part by Boston Scientific. One author reports being an employee of Syntactx.