Stent vs. Bypass in Long Femoropopliteal Lesions - Stent vs. Bypass in Long Femoropopliteal Lesions

Contribution To Literature:

This trial showed that nitinol stents compared to saphenous vein bypass grafts resulted in similar outcomes for treatment of long femoropopliteal lesions.

Description:

The goal of the trial was to evaluate nitinol stents compared with bypass surgery with saphenous vein bypass grafts among patients with long femoropopliteal lesions.

Study Design

  • Randomized
  • Parallel
  • Stratified

Patients with long femoropopliteal lesions were randomized to endovascular nitinol stenting (n = 50) versus surgery with saphenous vein bypass graft (n = 53).

  • Total number of enrollees: 103
  • Duration of follow-up: Median 23 months
  • Mean patient age: 70 years
  • Percentage female: 30%
  • Percentage with diabetes: 32%

Inclusion criteria:

Patients ≥30 years of age with:

  • Severe intermittent claudication or critical limb ischemia
  • Femoropopliteal Trans-Atlantic Inter-Society Consensus (TASC) II type C and D lesions
  • Symptoms ≥2 months

Exclusion criteria:

  • Acute ischemia
  • Any form of vasculitis, embolic or traumatic femoropopliteal occlusions
  • Previous ipsilateral bypass surgery
  • Use of a prosthetic conduit
  • Chronic kidney disease without requiring dialysis
  • Advanced frailty
  • Pregnancy

Other salient features/characteristics:

  • Lesion length, 272 mm
  • Chronic total occlusion, 82%

Principal Findings:

Primary study endpoints:

  • Primary patency for the stent group was 60% vs. 56% in the bypass group at 24 months (p = 0.42).
  • Primary assisted patency for the stent group was 63% vs. 71% in the bypass group at 24 months (p = 0.09).
  • Secondary patency for the stent group was 72% vs. 73% in the bypass group at 24 months (p = 0.25).
  • Freedom from target lesion revascularization was 75% in the stent group vs. 67% in the bypass group at 24 months (p = 0.29).

Secondary outcomes:

  • Limb salvage: 100% in the stent group vs. 88% in the bypass group (p = 0.057)
  • Survival at 24 months: 90% in the stent group vs. 87% in the bypass group (p = 0.27)
  • Amputation: 1 in the stent group vs. 4 in the bypass group (p = 0.17)

Interpretation:

Among patients with long femoropopliteal lesions, endovascular treatment with nitinol stents resulted in similar outcomes compared to surgery with saphenous bypass grafts. An endovascular-first strategy for femoropopliteal lesions up to 300 mm appears to be a promising treatment strategy.

References:

Enzmann FK, Nierlich P, Aspalter M, et al. Nitinol Stent Versus Bypass in Long Femoropopliteal Lesions: 2-Year Results of a Randomized Controlled Trial. JACC Cardiovasc Interv 2019;Nov 27:[Epub ahead of print].

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Aortic Surgery, Interventions and Vascular Medicine

Keywords: Amputation, Cardiac Surgical Procedures, Cardiology Interventions, Coronary Artery Bypass, Coronary Occlusion, Endovascular Procedures, Intermittent Claudication, Ischemia, Myocardial Revascularization, Stents, Vascular Diseases


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