Update on the IGuideU Trial: An Interview With Paul Gagne, MD

VASCULAR DISEASE MANAGEMENT 2023;20(2):E36-E37

At the 2022 VEITH Symposium in New York City, Paul Gagne, MD, FACS, RVT, from Vascular Care Connecticut in Darien, Connecticut, presented an update on the Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers (IGuideU) trial, a global, prospective, multicenter, randomized controlled trial to determine if the use of intravascular ultrasound (IVUS) as an adjunctive imaging modality and as an interventional treatment guide will result in a more accurate diagnosis of deep vein occlusion, guide optimal therapy, and provide better clinical outcomes with reduced cost of care for patients presenting with persistent venous leg ulcers. Vascular Disease Management spoke with Dr. Gagne to discuss the trial.

Dr. Gagne, tell us about the presentation on the IGuideU trial that you gave at the 2022 VEITH Symposium.

The IGuideU trial is the first randomized controlled trial looking at the role of IVUS-guided stenting for iliac or common femoral vein stenosis in an effort to heal venous leg ulcers. The current standard of care would be compression, wound care, and then treating superficial vein disease that's relevant to the venous leg ulcer. We know that that only gets you so far. We believe that at least 30% to 40% of patients who have chronic venous leg ulcers may have significant iliac and common femoral vein outflow tract obstruction, and we have multiple lines of evidence that suggest that. Several years ago, Bill Marston published, in the Journal of Vascular Surgery, his evaluation of the venous system in patients who'd had active or healed venous ulcers. And he found a significant proportion of those patients on axial imaging had significant iliac vein compression greater than 80%, in about a quarter of the patients, and probably 30% of the patients had greater than 50% stenosis.

We saw that in patients who had leg ulcers, which was half the cohort, those who had a lesion identified and went ahead and had it stented under IVUS guidance had a significant decrease in the size of their ulcers over 6 months, compared with the cohort that had no lesion identified and didn't see much of a difference between baseline and 6-month follow-up. We know from the original seminal work by Neglin and Raju on nonthrombotic iliac vein lesions, compression lesions, that patients who have venous leg ulcers when they had a lesion that was treated with IVUS-guided stenting had a healing rate of 75%. So there are a lot of prospective and cohort studies that suggest that if there's a lesion and you treat it, you can actually help venous leg ulcers heal, and it may be that if you can treat the underlying pathophysiology more fully than we are doing now as standard of care, we may be able to keep these ulcers from recurring.

The problem is that we haven't proven this in a randomized controlled trial, so you see around the country and around the world that there are a lot of different specialties that see patients with venous leg ulcers. There are a plethora of wound centers, and it's not part of their algorithm of treatment to refer patients for evaluation for iliac and common femoral vein outflow tract obstruction. So as a result, a lot of patients are in the wound centers, about a half a million a year in the United States, and they may get better, they may not; they may get better and then recur. So the question is, can we change the algorithm for the standard of care and get more patients to have a positive impact by what we can offer them?

IGuideU is a randomized controlled trial where patients who have already had their superficial vein disease treated, relevant to where the ulcer is on the leg and have had 3 months of compression therapy, can be randomized. They'll be randomized to continued compression therapy and wound care vs compression therapy wound care, and the addition of venography and IVUS evaluation for iliac and common femoral vein outflow tract obstruction. If identified, stenting is appropriate. The goal would be to see if we can heal ulcers at 3 months, which is the primary endpoint. Can we decrease the recurrence rate over 2 years? That's the secondary endpoint. We also are looking at quality of life data, as well as health economics data. Can we make the care of these patients less expensive than it currently is by healing their ulcers quicker and decreasing recurrences?

We started the study during the pandemic, so that was a challenge. We are looking for sites who are interested in participating to help expand patient enrollment, and it's an exciting opportunity. It's not often that we have randomized controlled trials to change paradigms of care in the world of deep venous disease. And this is a great opportunity for anybody interested in the space to make a very important and positive contribution, hopefully to the benefit of our current and future patients. I thank Phillips for sponsoring this because that's an important part of trying to get a trial of this magnitude off the ground. n

For more information on the IGuideU trial, contact Dr. Gagne at paul.gagne@optonline.net