Atherectomy and DEBs for Native Disease and In-Stent Restenosis in the SFA and Popliteal: Stents Can Be Avoided Completely

This interview took place at the VeithSymposium, held in New York City from November 14-18, 2012. For more information about the meeting, visit https://www.veithsymposium.com

What is the value of atherectomy when treating lesions in superficial femoral and popliteal arteries?

Stents offer a scaffold for situations where a plain balloon angioplasty result does not end up in a sufficient acute outcome — meaning acute recoil, and possibly dissection. The key question is whether there are other options to prevent the drawbacks of balloon angioplasty. Atherectomy is definitely one option. Removing the plaque before post dilating — for example, with a drug-coated balloon — means there is a very low likelihood that severe dissection will occur, at least flow-limiting dissection. The likelihood is less than 1%, and in my own experience, we have found that atherectomy lets us avoid the problem of acute recoil. Simply using atherectomy avoids stenting in almost all cases.

What we have learned just recently from the DEFINITIVE LE trial (Determination of Effectiveness of SilverHawk/TurboHawk Peripheral Plaque Excision Systems for the Treatment of Infrainguinal Vessels/Lower Extremities) is that atherectomy alone in lesions up to 10 cm works quite well, with primary patency rates of about 80%. However, if the lesion is greater than 10 cm, patency drops to about 60-70% after one year. It is not yet a really promising longer-term outcome, but is almost in line with the use of only bare-metal nitinol stents.

To improve the performance of atherectomy, drug-coated balloons for post dilatation after atherectomy could be used, which should improve the long-term performance of the procedure significantly. Why not simply use drug-eluting balloons only? Even with drug-eluting balloons, about 20% of patients do not respond to treatment, meaning that they develop restenosis. These patients usually have calcified lesions and a heavy plaque burden. If we remove the plaque before applying the drug-eluting balloon, it should result in better drug penetration into the vessel wall layers and a more effective suppression of neointimal hyperproliferation.

What data is available regarding the combination of atherectomy and a drug-eluting balloon?

One small Italian registry trial was recently presented at EuroPCR with results from a series of 30 patients with severely calcified SFA lesions.(1) They performed upfront atherectomy using the TurboHawk system (Covidien), followed by application of a drug-eluting balloon (Medtronic). They reported a primary patency of 90%, which is outstanding and needs to be confirmed definitely. A confirmatory study called the DEFINITIVE AR trial (Atherectomy Followed by a Drug Coated Balloon to Treat Peripheral Arterial Disease) is still ongoing. This is a randomized, controlled trial comparing upfront atherectomy followed by drug-eluting balloon angioplasty versus a drug-eluting balloon as a single approach. DEFINITIVE AR seeks to prove that there is an additional benefit to performing atherectomy prior to the use of a drug-eluting balloon.

 What have been some of the questions that have prevented the use of atherectomy in this setting?

The drawback is that it is expensive. In the United States, the reimbursement situation is positive, because every interventional step is reimbursed. Out of the U.S., it is different. In most countries in Europe, there is reimbursement for one type of procedure — for example, either atherectomy or the use of a drug-eluting balloon, but there is no additional reimbursement if both modalities are used within one procedure. That is the major limitation of this approach. It is simply becoming too expensive to use as a baseline approach to treat femoropopliteal lesions.

 What about the treatment of instent restenosis?

Instent restenosis is hard to treat. Conventional balloon angioplasty does not do a good job, showing a 20-30% primary patency at one year. Other options, like a Cutting Balloon (Boston Scientific) and plain atherectomy have also failed so far to show a satisfying outcome. We do know that if you place a Zilver PTX drug-eluting stent (Cook) inside an instent restenosis, it yields satisfying results, with a patency of about 75% at one year. What we do not yet know is the performance of drug-eluting balloons only, or the use of upfront atherectomy and drug-eluting balloons. There are some signals that the combined use of atherectomy and drug-eluting balloon angioplasty does make sense in the setting of the treatment of instent restenosis. Trials are still ongoing, some of which are investigating the performance of drug-eluting balloons as a standalone approach as compared to conventional balloons. We have just begun a trial called PHOTOPAC (Photoablative Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis in In-stent Femoro-popliteal Obstructions) which investigates the combined approach of laser atherectomy followed by drug-eluting balloon angioplasty versus drug-eluting balloon angioplasty as a single approach. Thus far, one Italian registry was published in JACC2, looking at the performance of drug-eluting balloons as a single approach to treat instent restenosis. The data presented in this paper was outstanding and hard to believe, because they report a primary patency rate of 92% after simple drug-eluting balloon angioplasty of an instent restenosis. This has to be confirmed by independently controlled trials.

 There are alternative options to avoid stenting, regardless of whether it is a bare-metal nitinol stent or a drug-eluting stent. In order to avoid trouble in patients who might potentially need a surgical reconstruction such as bypass surgery, a stentless approach is helpful in areas that are under high mechanical stress, like the distal SFA and the proximal popliteal artery. The key message, in my opinion, is that stenting is definitely not the only way to go. There is a valuable, alternative option in the use of atherectomy, either combined with drug-eluting balloon angioplasty or as a single approach. 

 Dr. Thomas Zeller can be contacted at thomas.zeller@universitaets-herzzentrum.de. 

References

1. Cioppa A. Combined use of directional atherectomy and drug-eluting balloon for the treatment of heavy calcified femoro-popliteal lesions: one-year results from single centre registry. Presented at: EuroPCR; May 2012; Paris, France.
2. Stabile E, Virga V, Salemme L, Cioppa A, Ambrosini V, Sorropago G, et al. Drug-eluting balloon for treatment of superficial femoral artery in-stent restenosis. J Am Coll Cardiol. 2012 Oct 30; 60(18): 1739-1742. doi: 10.1016/j.jacc.2012.07.033.