PAD in Focus

Progress Made in Endovascular Treatment of Long Lesions

There are no definitive answers on how to treat extremely long and complex femoropopliteal lesions, but evidence suggests we are currently making progress in a way not seen in the past 10 years.

If we are to use endovascular therapy to treat femoropopliteal lesions 20 cm and longer, we need to build an evidence base comparable to that seen for femoropopliteal bypass. The primary patency at 1 year for bypass grafts in randomized controlled trials ranges from 77% to 88%, and at 5 years it ranges from 39% to 76%.

Peter A. Schneider

My sense is drug delivery will play a big role in our next steps forward. We know that drug-coated balloons show more benefit than percutaneous transluminal angioplasty (PTA) for as long as 3 years. We also know the Zilver PTX drug-eluting stent (Cook Medical) shows benefit vs. bare-metal stents at 5 years.

Evidence in Longer Lesions

Three different studies have been published more recently that evaluated TransAtlantic Inter-Society Consensus II (TASC) type C and D lesions. The studies primarily analyzed use of DCBs, and one study included DCB and DES. In one study, mean lesion length was 24 cm and 1-year patency was 79.2%. In another, lesions averaged 25 cm and 1-year primary patency was 83%. In the third study, mean lesion length was 19 cm, and the primary patency of DCB was 76%, whereas it was nearly 70% for DES.

Unpublished data from the IN.PACT Global registry show that in 157 patients with long lesions (mean length, 26.4 cm), 1-year patency was 91%, and in 126 patients with occlusions (mean length, 22.9 cm), the 1-year patency was 84%. Keep in mind that with DCBs, as the lesion lengthens, more stents will be needed because a significant number of luminal defects will be left.

In the ZILVERPASS trial, 1-year patency with Zilver PTX was numerically higher than with polytetrafluoroethylene bypass grafts (78.1% vs. 68.7%; P = .55) in patients with a mean lesion length of 25 cm. In two other studies, 1-year patency for Zilver PTX was 52.5% and 77.6% in patients with long lesions.

All of the points above indicate that drug delivery matters. Overall, we are seeing a signal of better patency with delivery of drugs, whether delivered by balloon or stent.

Figure 1. Algorithm for long-lesion treatment strategies. CFA: common femoral artery. SFA: superficial femoral artery.
Source: Courtesy of Peter A. Schneider, MD

Potential Treatment Strategies

It is important to highlight treatment strategies for long lesions.

Figure 1 represents a potential algorithm for long-lesion treatment strategies based on what we know currently. If there are extenuating circumstances with TASC D lesions such as severe common femoral disease associated with a long superficial femoral lesion, or multiple endovascular failures, a hybrid procedure or a bypass is likely necessary. But if a patient has long-segment superficial femoral artery disease alone, vessel preparation is going to play a role. If there is a good result from aggressive vessel preparation, treatment with a DCB plus focal dissection repair if needed might be best. If there is a bad result from aggressive vessel preparation, a DES or a woven nitinol stent may be required. If the lesion is heavily calcified, we don’t know the best strategy. No one has published anything on patients with TASC D lesions both above and below the knee.

DCB and DES provide patency rates that are starting to approach what we used to get with bypass in the long femoropopliteal lesions. Data are starting to develop for endovascular treatment of long lesions, and we and our patients will very much benefit from it.

Disclosure: Schneider reports he has consulted for Cagent, Cook Medical and Intact Vascular; holds common stock in Cagent and Intact Vascular; and has received research support from Boston Scientific, C.R. Bard and W.L. Gore and Associates.

There are no definitive answers on how to treat extremely long and complex femoropopliteal lesions, but evidence suggests we are currently making progress in a way not seen in the past 10 years.

If we are to use endovascular therapy to treat femoropopliteal lesions 20 cm and longer, we need to build an evidence base comparable to that seen for femoropopliteal bypass. The primary patency at 1 year for bypass grafts in randomized controlled trials ranges from 77% to 88%, and at 5 years it ranges from 39% to 76%.

Peter A. Schneider

My sense is drug delivery will play a big role in our next steps forward. We know that drug-coated balloons show more benefit than percutaneous transluminal angioplasty (PTA) for as long as 3 years. We also know the Zilver PTX drug-eluting stent (Cook Medical) shows benefit vs. bare-metal stents at 5 years.

Evidence in Longer Lesions

Three different studies have been published more recently that evaluated TransAtlantic Inter-Society Consensus II (TASC) type C and D lesions. The studies primarily analyzed use of DCBs, and one study included DCB and DES. In one study, mean lesion length was 24 cm and 1-year patency was 79.2%. In another, lesions averaged 25 cm and 1-year primary patency was 83%. In the third study, mean lesion length was 19 cm, and the primary patency of DCB was 76%, whereas it was nearly 70% for DES.

Unpublished data from the IN.PACT Global registry show that in 157 patients with long lesions (mean length, 26.4 cm), 1-year patency was 91%, and in 126 patients with occlusions (mean length, 22.9 cm), the 1-year patency was 84%. Keep in mind that with DCBs, as the lesion lengthens, more stents will be needed because a significant number of luminal defects will be left.

In the ZILVERPASS trial, 1-year patency with Zilver PTX was numerically higher than with polytetrafluoroethylene bypass grafts (78.1% vs. 68.7%; P = .55) in patients with a mean lesion length of 25 cm. In two other studies, 1-year patency for Zilver PTX was 52.5% and 77.6% in patients with long lesions.

All of the points above indicate that drug delivery matters. Overall, we are seeing a signal of better patency with delivery of drugs, whether delivered by balloon or stent.

Figure 1. Algorithm for long-lesion treatment strategies. CFA: common femoral artery. SFA: superficial femoral artery.
Source: Courtesy of Peter A. Schneider, MD
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Potential Treatment Strategies

It is important to highlight treatment strategies for long lesions.

Figure 1 represents a potential algorithm for long-lesion treatment strategies based on what we know currently. If there are extenuating circumstances with TASC D lesions such as severe common femoral disease associated with a long superficial femoral lesion, or multiple endovascular failures, a hybrid procedure or a bypass is likely necessary. But if a patient has long-segment superficial femoral artery disease alone, vessel preparation is going to play a role. If there is a good result from aggressive vessel preparation, treatment with a DCB plus focal dissection repair if needed might be best. If there is a bad result from aggressive vessel preparation, a DES or a woven nitinol stent may be required. If the lesion is heavily calcified, we don’t know the best strategy. No one has published anything on patients with TASC D lesions both above and below the knee.

DCB and DES provide patency rates that are starting to approach what we used to get with bypass in the long femoropopliteal lesions. Data are starting to develop for endovascular treatment of long lesions, and we and our patients will very much benefit from it.

Disclosure: Schneider reports he has consulted for Cagent, Cook Medical and Intact Vascular; holds common stock in Cagent and Intact Vascular; and has received research support from Boston Scientific, C.R. Bard and W.L. Gore and Associates.