December 13, 2019
Randomized Controlled Trial Compares Nitinol Stents Versus Bypass in Long Femoropopliteal Lesions
December 13, 2019—Investigators from Paracelsus Medical University in Salzburg, Austria, conducted a study that sought to compare patency rates and clinical outcomes of endovascular therapy using nitinol stents and primary vein bypass in long femoropopliteal lesions. Florian K. Enzmann, MD, et al published the findings online ahead of print in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.
According to the investigators, the background of the study is that an endovascular-first strategy for long femoropopliteal lesions is widely recommended; however, there is not sufficient data comparing standard endovascular therapy with bypass surgery.
This single-center randomized controlled trial was performed with the primary endpoints of technical success, primary patency, and secondary patency. Secondary endpoints were limb salvage, survival, complications, and clinical improvement.
As summarized in JACC: Cardiovascular Interventions, the investigators treated 110 limbs (55 per group) in 103 patients. 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 the endovascular and surgical groups. Technical success was achieved in 87% of patients in the stent group.
During a 2-year follow-up, the investigators found 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%, respectively, versus rates in the bypass group of 56% and 73% in the bypass group. Clinical improvement was significantly better in the bypass group.
The investigators concluded in JACC: Cardiovascular Interventions that although technical success and clinical improvement in the bypass group were significantly better, the promising results of the stent group suggest that an endovascular-first strategy for femoropopliteal lesions up to 30 cm may be reasonable; midterm and long-term results need to be awaited.