Endovascular Drug Eluting Balloons vs. Stents: Is Provisional Stenting Back?

12th Biennial Meeting of the International Andreas Gruentzig Society:  Rio de Janeiro - February 2-6, 2014

From SESSION 3 — Endovascular

    Moderator:  Tyrone Collins
    Panelists:  Robert Bersin , Dieter Liermann, Klaus Mathias, Sigrid Nikol, Souheil Saddekni, Jiri Vitek, Jim Zidar

Framing the question at hand, what is the state of the current knowledge?

Endovascular treatment of superficial femoral artery stenoses is widespread in medical practice.  The patient population is diverse with a variety of comorbidities and lesion characteristics.  Treatment is complicated by the unique features of the SFA that include its length, capacity for atheromatous disease volume and forces the vessel endures.  Although the approach to SFA disease has been multidisciplinary, there are few randomized trials to study best treatment strategy in all patients.  Much of the existing data has been accumulated from registries.  Preliminary data with drug-eluting balloons is revealing favorable results which may shift how these patients are initially treated with non-surgical methods.

What are the Gaps in the current knowledge?

When contemplating shifting to drug-eluting balloons it is important to again emphasize the diversity of SFA lesions encountered in clinical practice. Despite all of the therapies to date, there is an ongoing reality of restenosis in stented segments and sometimes reocclusion. We do not know if a pharmacologic solution alone will negate this problem or if it needs to be coupled with a mechanical solution. We do not know which patients would benefit from this combination therapy. What should we do for patients with long (greater than 200 cm) lesions, instent restenosis and lesions in the “no-stent” zones?  Finally, we do not know if paclitaxel is the best drug for this therapy.

Our Summary and Recommendations:  
At the present time there are insufficient data to recommend a solitary treatment strategy in claudicants with SFA disease. We recommend future clinical trials in a randomized fashion to compare drug-eluting stents versus drug-eluting balloons and also drug-eluting stents versus bioreabsorbable stents. Additionally, the variety of different tools available to treat this disease should be compared in a randomized manner.  Perhaps a sequential approach utilizing drug-eluting balloons as the mainstay of therapy and stenting with drug-eluting stents on a provisional basis may evolve as the optimal treatment protocol.