Leaving no metal behind – Is this the future of superficial femoral artery revascularisation?


Stenting has become the revascularisation option of choice for most cases of superficial femoral artery treatment, Thomas Zeller, Heart Center Bad Krozingen, Germany, told delegates at the Leipzig Interventional Course (LINC). However, he said, alternative interventional techniques such as drug-coated balloons and atherectomy have the potential to replace stents in a significant number of femoropopliteal interventions.


“There are well-known drawbacks with stenting. The number of stent fractures with the new generation of stents is going down, but it still can happen. Stent fracture can result in reduced patency and vessel wall damage with pseudoaneurysm formation. The femoropopliteal segment is an area where stents might not be the perfect solution in the long-term,” Zeller said.


“Drug-eluting balloons might be the way to avoid stents in the near future,” he added. Zeller referred to data from the THUNDER trial (Tepe, et al; N Engl J Med 2008;358:689–99), which compared the use of a paclitaxel-eluting balloon (Medrad) and angioplasty. At 24 months, target lesion revascularisation rates were 15% with the drug-eluting balloon and 52% with angioplasty. “This is a durable result up to five years,” he noted. “The trial results also showed that drug-eluting balloons increased the time to first revascularisation after primary treatment as compared to the uncoated balloon.”


Zeller added that all the trials (FEMPAC, LEVANT I and PACIFIER) are in line with THUNDER in the reduction of late lumen loss.


He told delegates that the association of atherectomy and drug-eluting balloons might be a solution to overcome the rare technical limitations of both techniques if applied as single treatment approaches.


“There is no perfect technique and, especially in cases where we have significant calcification, there is risk of restenosis after the use of a drug-eluting balloon. The solution to overcome this drawback of drug-coated balloons might be atherectomy prior to the drug coated balloon application. With atherectomy, we remove the plaque and with that the diffusion barrier towards the vessel wall for later application of a drug-eluting balloon. The question is: could atherectomy be enough as a standalone procedure?


Zeller mentioned studies (by Zeller et al and Krankenberg et al) showing good results with atherectomy alone. “However, there are scenarios where atherectomy as a standalone approach does not work very well, such as in in-stent restenosis lesions and restenotic lesions of native vessels.”


The association of drug-eluting balloons and atherectomy is being studied in the PHOTOPAC trial (laseratherectomy and drug-eluting balloon vs. drug-eluting balloon in in-stent restenosis) and in the DEFINITE AR (directional atherectomy and drug-eluting balloon vs. drug-eluting balloon in native vessels).

Each of these two techniques – drug-eluting balloons and atherectomy – has its individual limitations, Zeller said. “The combination of both modalities will potentially increase the acute treatment success and the durability. Stents might become reserved for particular anatomical situations demanding a scaffold like those involving calcium or dissection,” he concluded.