Updates in Vascular Surgery Clinical Trials

Podcast Transcript

Announcer:

Welcome to Love Your Heart, brought to you by Cleveland Clinic's Sydell and Arnold Miller Family Heart, Vascular and Thoracic Institute. This podcast will explore disease prevention, testing, medical and surgical treatments, new innovations and more. Enjoy.

Sean Lyden, MD:

My name is Sean Lyden. I'm the Chairman of Vascular Surgery at Cleveland Clinic, and I'm here with my partner, Dr. Jon Quatromoni. We're going to talk about some of the aortic, peripheral vascular and carotid trials. We're going to talk about the things we do as vascular surgeons, the trials that we're involved in here at Cleveland Clinic, things that we're doing that we can help offer our patients and why we're involved in the trials.

Welcome, Jon. I know we're involved in a lot of aortic trials from the advent of minimally invasive aortic disease. We've been pioneers in pushing that therapy forward, and we're involved in a couple of different trials right now. Why don't you tell us a little bit about the first trial, which is preventing aortic growth, and that's using a novel compound to help, hopefully, maybe make it so people don't need their aneurysm repaired. That is the Nectero trial. Why don't you talk to us a little about that trial and why we're involved in it, Jon?

Jon Quatromoni, MD:

Yeah. Well, this is a very exciting trial. I think this is a new paradigm of trying to treat abdominal aortic aneurysms, and it's the first of its kind. It's being developed for folks where we can try to go in and impregnate medication into the wall of the aneurysm, but try to actually prevent aneurysms from growing. We don't have a technology quite like that yet, and I think that will offer a new tool in our toolbox in the future.

Sean Lyden, MD:

A lot of patients are worried about their aneurysms. There are clear guidelines for when we should repair them in terms of the benefit to the patient, but while we're cautiously watching them, many patients are worried. This provides a new avenue that hopefully will delay the growth of the aneurysm so that maybe they actually don't need it fixed in their lifetime. But once they do need to be fixed, there are a lot of devices that are out. Two of the devices that are out, one is made by a company called GORE. One is made by a company called Endologix. One of the devices we led the national trial here at Cleveland Clinic, and they're trying to compare the two devices, see if they're equal or better. That trial is called the JAGUAR trial. I'm in charge of that nationwide, and it's the first company trying to compare their device versus another device.

Usually, what happens is a company will look at their device, get one-year data, get five-year data, show that it works, but no one's compared one over another. This trial allows us to look at that Ovation Alto device versus whatever device the physician's comfortable with. We've been involved in that trial here in the national leadership, but it's also trying to tell us, is one device better than the other? Because patients ask us. A lot of times, it personally comes down to preference right now because we don't have good data. What are your thoughts about that trial, Jon?

Jon Quatromoni, MD:

I’m excited for this. I think that this study could change the management of abdominal aortic aneurysm moving forward if we're actually able to show that one device is better than another. I like the flexibility of this study because it lets the investigators use an alternative device that they're comfortable with, as well as the Ovation device. I think in terms of the possibility of changing the way that we manage abdominal aortic aneurysms, this is a really exciting trial to be involved with.

Sean Lyden, MD:

Then, once the aneurysm becomes involved in the kidney arteries, sometimes there are devices that are commercially approved we can use, but some patients don't fit that. We have a physician-sponsored trial that I'm the sponsor on and Dr. Frank Caputo is our physician PI, that allows us to create custom off-the-shelf devices and modify them to use in patients. There are also now trials for when patients have thoracoabdominal aneurysms. There's now an FDA-approved device that we are involved in that trial and now we're studying that after release to make sure the results after release continue to mirror what we found in the early trial.

The next big area we treat in vascular disease is carotid disease. Interestingly, there was a big study just came out called CREST-2 that was showing intense medical management and comparing that to surgery and intense medical management and comparing that to stenting.

But the medical arms were equally done if you had carotid surgery or carotid stenting. That was a great study that showed carotid stenting can prove added benefit over medical management alone. Intense medical management with stenting actually prevented more strokes than patients who had just intense medical management alone. We do both trans neck or TCAR carotid stenting, as well as transfemoral and endarterectomy.

The biggest predictor, John, we think from people we can treat with TCAR or transfemoral carotid stenting is calcium. We have two new exciting trials that we're involved with that allow us to help broaden that study, to figure out, can we better treat calcium? Those are studies using a lithoplasty device. It basically uses an ultrasound to bust up the calcium, similar to a kidney stone. We've been using that technology in the peripheral arteries, in the legs and in the groin. We’re getting ready to start those trials. Tell us about your experience with patients you see of how you can or cannot offer them minimally invasive alternatives, and how this trial might help us.

Jon Quatromoni, MD:

Sure. Well, I think here we see some of the most advanced disease anywhere, probably. One of the biggest issues that I'm sure you, as well as I, face is heavy calcification of the carotid artery in that segment. That usually makes me worried about putting a stent in, in terms of it actually being able to open up within that calcification. That's one of the big hindrances right now for carotid stenting. I think this trial has the potential of really expanding that eligibility for that if we're able to address that calcium with a new approach using this special balloon that can actually better fractionate the calcium to make it amenable to stenting. I think that could really be a game changer.

Sean Lyden, MD:

And then we'll transition to peripheral vascular disease, from the abdominal aorta down to the toes. Typically, when it's in the pelvis and the iliac arteries, we treat those patients with stents. The stents we use are generally made out of stainless steel or a self-expanding metal called nitinol, but recently there's been some data suggesting that stents lined with fabric with GORE-TEX perform better. They come at about 10 times the cost. We actually have a trial right now looking at that, comparing it to bare metal stents, that Jon is in charge of here at the clinic. Why don't you talk to us about why and who we can treat in that trial, and what it's trying to tell us?

Jon Quatromoni, MD:

Well, this has been a highly contested topic, both for the iliac arteries as well as other blood vessels that we treat. The question is, do you need fabric on these stents, or do stents without the fabric perform just as well? This has been an ongoing debate in the iliac arteries, looking from various institutional experiences. I think this is one of the first trials that is trying to actually look at this in a highly scientific way to figure out if those stents have fabric on them, will they perform better over the long run? So, I think that these studies will help answer that question.

Sean Lyden, MD:

Then, once you start getting down into the thigh and into the leg, we've learned that when you add drugs, specifically drugs that prevent re-narrowing, those were originally used for cancer. They've been shown, when we put on heart stents, that they reduce the risk of a re-narrowing with a heart stent from 30% now down to like 2 or 3%. We've had first-generation balloons with drugs on them and stents with drugs on them for the thigh, but haven’t had much below the thigh into the calf. We've had first-generation drugs. There have been second-generation drugs that have worked better in the heart. We finally now have trials looking at those second-generation devices, so stents within the calves that are resorbable, that don't stay there forever, and newer generation balloons. We're excited that that will hopefully allow a longer duration of our treatments for our patients when they have blockages in lower extremity arteries.

I think one of the nice things, Jon, is, even though these trials are led through the vascular surgery department, this is an HVTI (Heart, Vascular and Thoracic Institute) trial. There’s a vascular medicine department, there's an interventional cardiology department, and we are co-collaborators. Sometimes we have them as the leaders on that trial, but we have everybody in the Heart, Vascular & Thoracic Institute who can do these therapies involved in these trials. Why don't you talk about some of your thoughts about, right now, the first-generation drugs with paclitaxel and now going to the limus-based drugs, which have been better for the heart, but not necessarily, early on data, better for the lower extremities.

Jon Quatromoni, MD:

Yeah. I think it's an interesting area because we seem to be a little bit behind the cardiac world in this. I think it's a very exciting avenue. As you said before, this is a great demonstration of how we work together as a team, both us, interventional cardiology and vascular medicine. Treating those vessels below the knee is very challenging. Often balloon angioplasty alone, which is what historically we've been falling back on for endovascular approaches, has been limited. I think looking at the data from paclitaxel thus far has been very promising in all the areas of the body that we've been using that thus far. I think there's promise for some of these newer agents that have shown promise in the cardiac world, and now we're transitioning over into the peripheral arterial disease space.

Having that in our toolbox, alongside our traditional approaches with just using a regular balloon, will be very helpful in advancing the options that a lot of these patients have that maybe their other options are limited. I think these trials are very exciting to be able to, again, expand our toolbox for helping these patients.

Sean Lyden, MD:

As vascular surgeons, we don't just treat with the arteries. We also treat with the veins. A lot of times patients will present with blood clots in their veins, many times occluding their veins in their pelvis or their vena cava, which is the main vein that drains from the legs up to the heart. In those, typically, we use stents designed for arterial circulation. Over the last five years, we've seen stents that are now purposely built, designed for the venous circulation, that are larger, have more outward force because they have to resist compression, because they're deep inside the body.

There's a trial going on now that we're participating in that looks at using a stent for the inferior vena cava, as well as the iliac arteries. Jon is in charge of that for us here, and that brings hopefully better novel treatments. The first devices were just designed for the iliac veins, and this trial that's led by the company GORE has a covered stent that has some fabric on it to hopefully prevent that re-narrowing. Jon, why don't you talk to us a little bit about that?

Jon Quatromoni, MD:

This stent is, again, specifically designed for the inferior vena cava in the iliac vein. It's designed to resist compression. It also combines that strength with a very high degree of flexibility. Being designed for that space, I'm hoping this is going to be a game-changer in terms of helping those patients who have those compression syndromes to be able to resist re-narrowing of that iliac vein.

Sean Lyden, MD:

I think the important point is that you can never be good enough. One of the things we try to do at Cleveland Clinic is keep involved with cutting-edge research. Research that allows us to improve the way we treat patients, to continue to push to more minimally-invasive options. If you can achieve the same outcome through a percutaneous approach, as opposed to a large surgical approach, we're doing that. We've been both leaders in many of these trials as well as participants in running them here at Cleveland Clinic. We feel that's vital to offer to our patients throughout the whole Heart, Vascular & Thoracic Institute so we can continue to have the best outcomes for our patients.

Jon Quatromoni, MD:

I agree. I think that's a very important part of what we do here at Cleveland Clinic. I think that's why all of us that are here, we enjoy that aspect and it's one of the things that keeps us going.

Sean Lyden, MD:

We see patients from all across the United States, all across the world. We're happy to see anybody. As we close this session, I want to thank John for coming to let us talk a little about some of the trials we're doing and why we do them.

We really want to continue to be experts in care for a vascular disease, whether it's arterial or venous. We really want to thank everybody for listening to Love Your Heart.

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