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, Cardiovascular Care Team, 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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