Peripheral Arterial Disease: Improving Surgical Strategies

Transcript: Deepak L. Bhatt, MD, MPH: I can switch from drugs—we’ll come back to drugs—to Matt, because you’ve got to keep surgeons engaged or often their attention starts to wander. Matt, maybe I can ask you about drug-coated balloons. That’s a really exciting topic, and those members of our audience who aren’t in an angiography suite or an OR [operating room] may not even be aware of these drug-coated balloons. They might have heard of some of the controversy around it, but they may not have heard of the benefits or their role. In a nutshell, can you tell us, what are the actual benefits? Are there any risks? How are they used in your own practice?

Matthew T. Menard, MD: That’s a great question, Deepak. It goes back to one of your earlier questions and the differential between the number of re-interventions in the peripheral artery versus the heart. It seems like the heart specialists have solved in-stent restenosis to some extent with drug elution. There was a lot of hope that there would be a straightforward translation to the legs, but there really hasn’t been. Dividing the anatomy into two different groups, there’s the SFA [superficial femoral artery] and popliteal artery and then the tibial artery stent.

There have been some very promising results with a series of different balloons, and some drug-coated stents as well, that have demonstrated clear efficacy in reducing in-stent restenosis and recurrent stenotic occlusive disease in the SFA. Those studies triggered a real shift in treatment mentality and the algorithm for a lot of different interventionalists and surgeons as well. They became the first line of therapy, with different nuances to the exact algorithm that you might use in terms of prepping the vessel before using the drug-eluting balloon.

They haven’t had the same success in the tibial vessels, and one study even indicated worse effect and perhaps an increased risk of amputation. It remains one of the clear unmet needs and challenges. How do we get that right and find the right drug, the right dose of drug, and the right carrier for the drug?

There was some controversy, as you alluded to, in a meta-analysis published just over a year ago that would suggest mortality risk for drug-eluting balloons above the knee. That’s really curtailed their use pretty broadly. There’s a lot of debate about whether the finding is accurate and a lot of ongoing effort to answer that question. At this moment in time, it’s something that we use. The data that were looked at in that meta-analysis were all for claudicants so we really don’t have much of any data on critical limb ischemia patients, who are the patients at highest risk. The technology does seem to reduce the need for repeat intervention, so often it’s a balance of what you think that risk is versus the benefit. But in the future, I think the answers will get worked out and I predict they’ll continue to be a big part of our armamentarium.

Deepak L. Bhatt, MD, MPH: I share that enthusiasm that over time and with iteration, drug-coated balloons and drug-coated stents will become better for the management of peripheral arteries and even the coronary arteries, for that matter. We’ve had really great advances in terms of coronary stents in first-, second—depending on how you count them—and third-generation drug-eluting stents that I think will ultimately translate into managing peripheral arteries. But what do you think of those advances as they pertain to the coronary arteries and might apply to the peripheral arteries, Mike?

C. Michael Gibson, MS, MD: It’s been amazing to participate in. I think all of us really are stunned by how far we’ve come since the late 1980s and early 1990s in treating the coronary arteries. They are a different animal, as we’ve heard. There is a lot of torsional stress in the limbs and a lot of compressive stress in the limbs. There are very different vascular beds between the coronary and the peripheral arteries, and they require very different answers as well.

I was not as compelled by some of the data that were presented with respect to mortality. I could never see the biologic plausibility of the mortality signal. I found the arguments from some of the oncologists compelling that no data suggest toxicity in their studies. I was less compelled by some of the observational data that were not controlled within the cardiovascular arena. I think the oncologic academics were not compelled by that. But at the end of the day, we need to move on. I do think, hopefully, we’ll find some better solutions for the peripheral disease, particularly the distal peripheral disease.

Deepak L. Bhatt, MD, MPH: I agree with everything you said. I was never personally concerned by those mortality signals. I thought those analyses were largely spurious. On the other hand, I wasn’t blown away by the absolute degrees of risk reduction efficacy either. But I think the point that both you and Matt made is correct. We’ve got to keep searching for better modalities in terms of invasive approaches to treating PAD.

Transcript Edited for Clarity