The rates of patency and reinterventions, limb salvage, survival, and complications were similar when nitinol stents or primary vein bypass were used for the treatment of long femoropopliteal lesions, according to a study published in JACC Cardiovascular Interventions.
The study included 103 patients with 110 femoropopliteal lesions who were randomly assigned to receive angioplasty and nitinol stent placement (n=50) or primary femoropopliteal vein bypass grafting (n=53). Clinical examinations, which included duplex ultrasound and ankle-brachial indices were conducted at weeks 2 and 4, and at months 3, 6, 12, and 24. Primary study endpoints were technical success and primary and secondary patency, and secondary endpoints were limb salvage, survival, systemic complications, and clinical improvement.
Technical success was achieved in 87% and 100% of patients who received a stent and bypass, respectively (P =.006). Primary and secondary patency were similar in both groups at all time points. Revision procedures were performed to revascularize 28 and 35 lesions in the stent and bypass groups, respectively. Limb salvage, survival, and complications were comparable in both groups. The mean Rutherford category for change was better in patients who received a bypass vs a stent (P =.002), and 51% of patients who received a bypass reached a Rutherford category 0 compared with 20% of those who received a stent (P <.001).
Study limitations include the inability to conduct subgroup analyses due to small sample sizes. “There were no significant differences regarding patency rates, limb salvage, survival or complications after two 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,” concluded the study authors.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Enzmann FK, Nierlich P, Aspalter M, et al. Nitinol stent versus bypass in long femoropopliteal lesions: 2-year results of a randomized controlled trial [published online November 20, 2019]. JACC Cardiovasc Interv. doi: 10.1016/j.jcin.2019.09.006