Venous Stenting and Why We Need It

by Debra L. Beck

Hollywood, FL (January 23, 2020) – Endovenous stenting to relieve chronic venous disease secondary to post-thrombotic or non-thrombotic iliac vein obstruction is becoming increasingly established. International Symposium on Endovascular Therapy (ISET) attendees were treated to a review of the field by vascular surgeon and venous expert Anthony Comerota, MD, from Inova Medical Group in Alexandria, Virginia.

Dr. Comerota started his talk with a case study: a 28-year-old male military officer who experienced a left iliofemoral deep vein thrombosis (DVT) after a 2-day motor coach trip. His leg edema, pain, and venous claudication of 3-years duration was such that he was discharged from the military.

“We stented a focal, relative short post-thrombotic lesion in the common iliac [with a] beautiful results,” reported Dr. Comerota. “He became asymptomatic, walking and running without pain.”

Back in 2000, in the largest reported series of patients undergoing iliac vein stenting with long-term follow-up, authored by Gerry O’Sullivan and colleagues, “showed us very nicely that when you treat endovascularly iliovein compression syndrome you can have excellent results when stenting non-thrombotic lesions (JVIR. 200;11(7):823),” said Dr. Comerota.

This was echoed by Peter Neglén and Seshadri Raju, who in 2007 reported on nearly 1000 patients with non-thrombotic and post-thrombotic nonmalignant obstructions in femoral-ilio-caval segments. They demonstrated excellent outcomes for non-thrombotic obstructions, with a 79% primary patency rate and 100% assisted patent, “not one stent occluded,” said Dr. Comerota

But when looking at the subgroup with thrombotic obstruction, these rates dropped markedly, to 57% for primary patency, 80% for assisted-primary patency, and 86% for secondary patency. “And this does not address thrombotic occlusion,” Dr. Comerota added.

So, you can see that there's a difference between post-thrombotic obstructions and nonthrombotic obstructions,” said Dr. Comerota.

In recent pivotal trials of two venous stents that have now been approved by the FDA—the Vernacular trial of the Venovo venous stent (BD) and the Virtus trial of the Vici venous stent (Boston Scientific)— “one-year primary patency rates are very acceptable at 88% and 84%, [for Venovo and Vici, respectively], freedom from major adverse events at 30 days very respectful at 94% and 99%,” he reported.

Two-year primary patency, as teased by Dr. Comerota and reported later by other presenters, were 84% in Vernacular and 79% in Virtus, with both trials reporting an 89-percent freedom from target vessel revascularization at 2 years.

“Just to underscore that there's a difference, even in these trials, on treating post-thrombotic disease and non-thrombotic iliac vein disease, in the Vernacular trial, the primary patency rates at 24 months for non-thrombotic iliac vein disease was very excellent at 95%, while 24-month primary patency was respectable at 75% in the post-thrombotic patients.”

Importantly, Rossi et al (J Vasc Surg Venous Lymphat Disord. 2018;6:183-191) have reported that, in symptomatic patients with chronic venous disease, endovascular treatment of iliac vein obstruction with stenting is associated with better relief of symptoms and greater improvements in quality of life, as compared with medical treatment.

Stressing the “why” we treat, Dr. Comerota said that the substantial improvements seen after stenting in vitality, social functioning, and mental health “underscore the morbidity and the impact of chronic iliofemoral venous obstruction on the physical capacity and mental capacity of these patients.”