FOREST TRIAL - A randomized controlled trial comparing drug-eluting balloons and drug-eluting stents in the treatment of femoropopliteal arterial occlusive disease

Background: The optimal endovascular treatment for femoropopliteal arterial occlusive disease has yet to be assessed. Patency rates are disappointing after conventional angioplasty. Stenting techniques have improved outcomes, in particular in long and complex lesion. The presence of a stent however, also has limitations despite the improved outcomes. Intra-arterial stenting may lead to stent thrombosis and flow pattern disruption, which may result in stent fracture or in-stent restenosis and may advocate techniques where nothing is left behind.
In the past decade drug-eluting balloons (DEB) and drug-eluting stents (DES) were introduced. Both DEB and DES have proven to posses anti restenotic features in comparison to conventional techniques.


The objective of this study is to perform a non-inferiority analysis of drug-eluting balloons with provisional stenting and primary stenting with drug-eluting stents in the treatment of femoropopliteal arterial occlusive disease. If DEB with provisional stenting turns out to be non-inferior to primary stenting with DES, than DEB may be a favourable technique, since the postoperative long-term limitations of stents will be restricted.
Methods/Design This is a prospective, randomized, controlled, single-blind, multi-center trail. The study population consists of human volunteers aged over 18, with chronic, symptomatic peripheral arterial occlusive disease (Rutherford classification 2 to 5) due to de novo stenotic or occlusive lesions of the superficial femoral artery or popliteal artery (only P1).
Subjects will either be treated with DEB and provisional stenting with a bare-metal stent, or will be primary stented with a DES. A total of 254 patients will be included (ratio 1:1).
The primary endpoint will be 2-year freedom from binary restenosis, defined as a lumen diameter reduction of <50% assessed by duplex ultrasound (peak velocity ratio <2.5). Secondary outcomes will be technical success, target lesion revascularisation, target vessel revascularisation, changes in ankle-brachial index, changes is Rutherford classification, amputation rate and mortality rate.

Endovascular treatment of femoropopliteal arterial occlusive disease with drug-eluting balloons with provisional stenting leads to the same angiographic and clinical outcomes as primary stenting with a drug-eluting stent

2 year

Subjects will either be treated with a DEB and provisional stenting with a BMS, or will be primary stented with a DES.