Author + information
- Received July 1, 2019
- Revision received September 3, 2019
- Accepted September 5, 2019
- Published online December 16, 2019.
- Florian K. Enzmann, MDa,∗ (, )@Fkenzm,
- Patrick Nierlich, MD, PhDa,
- Manuela Aspalter, MDa,
- Wolfgang Hitzl, PhDb,c,d,
- Werner Dabernig, MDa,
- Thomas Hölzenbein, MDa,
- Ara Ugurluoglu, MDa,
- Rainald Seitelberger, MDa and
- Klaus Linni, MDa
- aDepartment of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria
- bResearch Office (Biostatistics), Paracelsus Medical University, Salzburg, Austria
- cDepartment of Ophthalmology and Optometry, Paracelsus Medical University, Salzburg, Austria
- dResearch Program Experimental Ophthalmology and Glaucoma Research, Paracelsus Medical University, Salzburg, Austria
- ↵∗Address for correspondence:
Dr. Florian K. Enzmann, Department of Cardiac, Vascular and Endovascular Surgery, Paracelsus Medical University, Müllner Hauptstrasse 48, A-5020 Salzburg, Austria.
Objectives This study sought to compare patency rates and clinical outcomes of nitinol stents and primary vein bypass in long femoropopliteal lesions.
Background An endovascular-first strategy for long femoropopliteal lesions is widely recommended without sufficient data comparing it with bypass surgery. Nitinol stents are widely used as the standard endovascular therapy.
Methods A single-center randomized controlled trial was performed with the primary endpoints of technical success, primary and secondary patency. Secondary endpoints were limb salvage, survival, complications, and clinical improvement.
Results A total of 110 limbs (55 per group) in 103 patients were treated. Baseline and lesion characteristics were similar, with a mean lesion length of 276 mm. Critical limb threatening ischemia was the indication for treatment in 49% of limbs in both groups. Technical success was achieved in 87% in the stent group. During a 2-year follow-up, patency rates, limb salvage, survival and complications showed no significant differences between both groups. At 24 months, primary and secondary patency rates for the stent group were 60% and 72% versus 56% and 73% in the bypass group, respectively. Clinical improvement was significantly better in the bypass group.
Conclusions There were no significant differences regarding patency rates, limb salvage, survival, or complications after 2 years. Technical success and clinical improvement in the bypass group were significantly better, but the promising results of the stent group suggest that an endovascular-first strategy for femoropopliteal lesions up to 30 cm may be reasonable. Mid- as well as long-term results need to be awaited.
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 1, 2019.
- Revision received September 3, 2019.
- Accepted September 5, 2019.
- 2019 American College of Cardiology Foundation
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