What is the impact of drug-eluting balloons in Europe?

Nicolas Diehm

By Nicolas Diehm

Endovascular therapy has matured to be the primary revascularisation strategy for about 90% of patients with peripheral arterial disease (EVEM panel data Q2/2012).

Ever since the first percutaneous transluminal angioplasty carried out in Switzerland in 1977, restenosis remains a major drawback of endovascular therapy. Numerous attempts to improve patency after balloon angioplasty including drug treatment approaches, endovascular brachytherapy, bare metal nitinol stents and paclitaxel-coated nitniol stents have been investigated.

To date, despite technical refinements in nitinol stent technology, restenosis occurs in approximately every third patient undergoing femoropopliteal stenting with bare metal nitinol stents. The Zilver PTX randomised study has yielded promising results with the use of a polymer-free paclitaxel-coated stent. However, as for other studies investigating bare metal nitinol stents, no data exist on long-term outcomes. Moreover, the presence of a metal implant remains a cause of concern in a biomechanically challenging environment such as the femoropopliteal and below-the-knee arteries.

Subsequent to the publication of the THUNDER and FEMPAC trials, drug-eluting balloon technology has attracted many interventionalists in Europe. The concept of drug-eluting balloons seems particularly appealing since it allows for the use of anti-restenosis technology without having to leave a foreign body behind in the arterial segment to be treated.

While the class of drug-eluting balloon can meanwhile be considered established for the prevention of restenosis in the femoropopliteal arterial tract, data on the clinical utility in infrapopliteal arteries are scarce. Six randomised trials have shown a reduction of restenosis and need for target lesion revascularisation for the femoropopliteal arteries, three of which have been published in peer-reviewed journals. Moreover, two studies (one randomised and one non-randomised, the latter being published in written) have shown that the use of a drug-eluting balloon reduces restenosis and target lesion revascularisation in patients undergoing endovascular below-the-knee revascularisation.

The widespread clinical adoption of drug-eluting balloons for peripheral arterial revascularisation, however, clearly depends on scientific evidence and local reimbursement policies in different countries. According to current market research reports, drug-eluting balloons are used in about 10% of lower limb procedures in Europe, with a projected increase to 15–20% by the year 2015. It does not take specific behavioural economic models to describe the clear correlation of reimbursement by healthcare providers with sales numbers of various endovascular devices. In Germany, for example, drug-eluting balloons were reimbursed in the year 2011, but not in 2012, which has led to a substantial drop in drug-eluting balloon sales. Based on current negotiations, reimbursement for drug-eluting balloons will be available for 2013, however.

Considering that the price for a drug-eluting balloon makes up only a fraction of the entire budget of a patient undergoing endovascular therapy and the need for re-do interventions as compared to plain balloon angioplasty of the femoropopliteal arteries was shown to be reduced within at least six randomised trials, it is very likely that cost efficacy of drug-eluting balloon is favourable in many healthcare scenarios. However, medical device companies offering drug-eluting balloons should take the hurdles of calculating cost efficacy for individual markets before a widespread distribution of these devices can be recommended for specific countries.

In summary, based on currently available published evidence, drug-eluting balloons are an established strategy for prevention of restenosis in femoropopliteal arteries while randomised data for below-knee arteries are pending. If considered cost-effective in individual countries, drug-eluting balloons may be an interesting anti-restenosis technology for femoropopliteal revascularisation for patients not requiring a stent due to insufficient angioplasty results.


Nicolas Diehm, is a senior consultant and director of Clinical Research, Clinical and Interventional Angiology, Inselspital, University Hospital Bern, Switzerland