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Combination Therapies in Peripheral Artery Disease: Which Devices Give the Best Outcomes?
Rajat Mohanka • Updated Aug 12, 2024 • 40 hits
Because arterial disease morphology is highly variable, there are several interventional approaches and devices that are used to treat peripheral artery disease (PAD). So many, in fact, that it can often be unclear which strategy will lead to the optimal outcome for each individual patient. The experienced interventionalist uses a combination of drug-coated balloons (DCB), drug-eluting stents (DES), lithotripsy, and other devices to treat flow-limiting lesions.
Interventional cardiologist Dr. Eric Secemsky from Beth Israel Deaconess Medical Center in Boston shares some of his decision making rules when choosing which device or combination of devices to use in specific PAD treatment scenarios. This article includes excerpts from the BackTable Podcast. You can listen to the full episode below.
The BackTable Brief
• Drug-coated stents are essential for maintaining patency in long calcified and occluded regions in order to maintain proper arterial flow to the lower extremities.
• Interwoven Supera stents offer flexibility and strength and are exclusively used in challenging tortuous locations as well as in the P2 to P3 segments.
• Dr. Secemsky recommends using DCB angioplasty as a standard initial step, regardless of the need for subsequent scaffolding.
• Lithotripsy combined with atherectomy ensures the drug penetrates the vessel wall effectively in calcific PAD.
• The PAD III trial showed that lithotripsy combined with DCB decreased bailout stenting risk and safe vessel prep to allow for proper stent placement in the shape of the artery and to decrease risk of restenosis.
Table of Contents
(1) Drug-Eluting vs Bare Metal: Stenting Algorithms for Femoral-Popliteal Disease
(2) Combining Drug-Coated Balloons & Stents in PAD
(3) The Role of Lithotripsy & Atherectomy in Enhancing Peripheral Arterial Drug Delivery
Drug-Eluting vs Bare Metal: Stenting Algorithms for Femoral-Popliteal Disease
Managing femoropopliteal (fem-pop) disease requires a nuanced approach, particularly when deciding between stenting strategies. Dr. Secemsky highlights the importance of a "no scaffold" strategy for specific lesions, particularly in regions prone to stent fractures, like Hunter’s Canal and the distal SFA popliteal. However, for longer occlusions and calcified, hostile areas, stents are indispensable. Drug-coated scaffolds, such as Zilver PTX and Eluvia, are preferred for these complex cases. Dr. Secemsky also emphasizes the utility of interwoven Supera stents for the P2 to P3 segments due to their durability and flexibility. This tailored algorithm, combining drug-coated and bare-metal stents, helps to ensure effective revascularization while minimizing complications.
[Dr. Sabeen Dhand]
Yeah, totally. Along the lines of stenting, in the past, there would be "leave no metal behind." What's your general sense on your stenting algorithm for say, fem pop disease?
[Dr. Eric Secemsky]
Yeah, absolutely. Again, there's always different ways to break that down, claudicants, and CLI, CLTI. But in the average case, I think that the no scaffold or leave nothing behind approach is really sound in particular for specific lesions. If you have a very focal lesion, if you have a lesion in a very aggressive area that you know stent fracture could be an issue, Hunter's Canal, anything in the distal SFA pop, those areas, they're definitely going to benefit from having no scaffold left behind. That said, that's not the reality for the majority of disease that we encounter. We encounter today long occlusions, aggressive, hostile areas with calcification. We use reentry, whether we intend to or not. We use reentry, and that's where IVUS has taught me so much. There's just some areas we all know where you can try and try again, but you cannot keep that open without a scaffold or it may not be the right strategy for a very long occlusion. That's really where these stents come into play, the scaffolds. That's, for me, where I almost only use drug-coated scaffolds is for when I know that a scaffold-free approach is not going to work.
[Dr. Sabeen Dhand]
Yeah, perfect. Exactly. I was going to ask you, are you using bare stents at all?
[Dr. Eric Secemsky]
I can't.
[Dr. Sabeen Dhand]
Yeah. In fem pop segment, are you even using bare stents minus, obviously, interwoven Supera, but other than that, are you using bare stents?
[Dr. Eric Secemsky]
Yeah, great question. If anything, if I ever have to stent, particularly P2, P3, it's always a Supera. I won't put anything else in there. Honestly, anything from distal SFA to P3, I'm usually using a Supera. Anything that's not involved in that distal zone, I'm almost universally using a drug-coated stent. I've been using Zilver PTX for many years, including back to when I trained at Mass General. I also have an Eluvia drug-eluting stent. I had the opportunity to use and learn for both of these scaffolds, but that's my approach for any long segment fem pop disease that is not ripe for a leave nothing behind strategy. I think my algorithm has been successful.
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Combining Drug-Coated Balloons & Stents in PAD
Dr. Secemsky highlights anecdotal evidence and studies suggesting that the dual DCB and DES approach is not only safe but may enhance long-term outcomes. Leveraging his interventional cardiology experience, Dr. Secemsky emphasizes the efficacy of drug-coated technologies in reducing the need for repeat procedures and hospital visits. This strategy involves initial treatment with a DCB, even when scaffolding is anticipated, followed by focal stenting with a DES or Supera stent as needed. The underlying principle is to maximize drug exposure to optimize patient outcomes while minimizing procedural risks.
[Dr. Sabeen Dhand]
Yeah, I totally agree. I share the same opinion. What about now, you're treating a lesion, you're trying to not leave a scaffold behind, you do a DCB treatment, and then do you think there's an additive effect of having a DES on top of a previously treated DCB?
[Dr. Eric Secemsky]
Great question. Last year, I think it was in the Journal of Invasive Cardiology, we presented a series of patients treated with DCB and DBS, led by Aaron Armstrong and his fellow, Stefano Giannopoulos. It was a single-arm anecdotal study. Again, it's not life-breaking science, but the concept here was, is it safe? Is there a role for it? I think also, more recently, PK, Prakash Krishnan from Mount Sinai, published an experience of DCB and then Supera. My feeling is, and again, I'm going to put my interventional cardiology cap on. My bias and conflict here is, I believe in drug, and it's because of being an interventional cardiologist and living in that space for coronary intervention, is drug is the right way to get the longest benefit for a patient, to really reduce the risk of needing another procedure, coming back to the hospital, taking time off work, being bed-bound, whatever it might be.
I feel that I typically put a drug-coated balloon down in a lot of cases, even if I know I'm probably going to scaffold some of it. I still usually start with a DCB, because I see no downside. Then, from there, I can also focally stent or rely on the whole thing if I need to. I almost always use drug-coated technology in that same algorithm that I presented to you, long fem pop, outside of the distal SFA pop, I'm going to put in drug-coated or drug-letting stent. If it's the pop, I'm going to put in a Supera. I don't have many procedures where there's not some drug touching the patient. I don't think there's any downside for double treating. Again, I think that the drug-coated balloon and the drug stents might have different properties and when that paclitaxel might be most effective. I'm looking for a long-term benefit, and I think that the dual technology could have an impact, but at minimum, it's not going to hurt the patient.
The Role of Lithotripsy & Atherectomy in Enhancing Peripheral Arterial Drug Delivery
Combination therapy consisting of intravascular lithotripsy with plaque modification and atherectomy improves technical success when treating calcific disease. Despite challenges in clinical demonstration, studies like the PAD III trial show that lithotripsy reduces bailout stenting risks, supporting its role in vessel preparation. The underlying principle is that effective drug delivery, particularly in calcified vessels, hinges on adequate vessel preparation, ensuring the drug penetrates the vessel wall rather than remaining on the calcified surface. Dr. Secemsky's approach includes selective use of intravascular lithotripsy and atherectomy to optimize long-term outcomes.
[Dr. Sabeen Dhand]
Sure. What about, do you think-- There's probably data on this too. What about lithotripsy before putting drug-coated technology, does that improve the delivery of the drug to the target?
[Dr. Eric Secemsky]
This is probably one of the hardest questions that remain, and it feeds into the whole idea of plaque modification and atherectomy, really, is what is the value of atherectomy? I'm lumping intravascular lithotripsy with plaque modification and atherectomy. One of the main feelings across the space is that atherectomy and plaque modification help in calcific disease, the transfer of drug into the vessel wall to be effective. This comes back to Fabrizio Fanelli, who had this really classic slide just demonstrating what happens with drug-coated balloons in calcific disease and the inability for a drug to make any penetration to the vessel wall.
The problem, though, is it's been really challenging in a non-animal model to demonstrate this clinically. There's been several attempts, anywhere from the VIVA reality trial, which used directional atherectomy with the DCB, to PAD III, which was a randomized trial of lithotripsy with drug-coated balloon versus drug-coated balloon itself. To your comment about IVL, the PAD III trial really was trying to do two things. One, show the early benefits of intravascular lithotripsy combined with a drug-coated balloon, which is standard of care. Then they looked at this up to two to three years. What they found in that trial was intravascular lithotripsy decreased the risk of bailout stenting. It was really a safe and effective way to prep before drug-coated balloon angioplasty.
The problem was the patency looked good in the long-term, but the DCB arm that didn't get lithotripsy got a lot of stents. It was really hard to understand the patency differences, if there were any, when you're comparing now DCB and stent versus IVL and DCB, and how much the drug impacted those long-term outcomes. The bottom line is, I do feel like if you have a cleft of calcium and you're putting paclitaxel on it, it's just going to be on calcium. Vessel prep's important. I use IVL, I use a little bit of atherectomy. I'm not a heavy atherectomy user, but more importantly, I think getting drug to the vessel wall is critical for long-term outcomes.
Podcast Contributors
Dr. Eric Secemsky
Dr. Eric A. Secemsky, MD, MSc, RPVI, FACC, FSCAI, FSVM is the Director of Vascular Intervention and an Interventional Cardiologist within the CardioVascular Institute at Beth Israel Deaconess Medical Center (BIDMC).
Dr. Sabeen Dhand
Dr. Sabeen Dhand is a practicing interventional radiologist with PIH Health in Los Angeles.
Cite This Podcast
BackTable, LLC (Producer). (2024, January 22). Ep. 407 – The Evolving Role of Drug Eluting Stents in PAD [Audio podcast]. Retrieved from https://www.backtable.com
Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.
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