Endovascular Stenting vs Open Endarterectomy to Treat Peripheral Arterial Occlusive Disease in the Common Femoral Artery

Abstract

Research Question: Do patients with significant lower extremity peripheral arterial occlusive disease (PAD) involving the common femoral artery (CFA) requiring treatment have similar or better patency and safety outcomes with endovascular stent compared to open endarterectomy surgery?

Background, Significance, and Rationale for the Question: For decades, open surgery was the only treatment for PAD. Such treatment included open endarterectomy and bypass, which had excellent outcomes. However, such surgery was traumatic with long recovery times, and many patients had a high body-mass index (BMI) with groins that were difficult to access and maintain cleanliness, leading to high complications rates and infections. In the 1980s-90s, endovascular interventions arose and now have become accepted as standard of care for most vessels in the body. But one area remains controversial and that is the CFA. Initial early attempts with stents at this site were unsuccessful due to bending and misshaping of the stent. Thus endarterectomy remained the standard of care. However, recent reports using new stent materials and techniques have shown that endovascular interventions can be successful. But these reports had small patient numbers and did not have enough data to convincingly show the safety and efficacy of CFA stenting. We report 12 years of data with hundreds of patients from many surgeons to add to the literature to help settle this debate.

Materials and Methods: This is a retrospective chart review study of all consecutive patients with CFA occlusions treated by 15 surgeons in Dallas and Los Angeles from 2012-2021. Patient were evaluated within 30 days, 3, 6, 9, and 12 months and yearly thereafter. We look specifically for Rutherford clinical classification pre- and post-op, postoperative complications, and patency rates. Primary endpoint will be patency. Secondary endpoints will be infection and complication rates, length of hospital stay, and post-operative recovery times. We include comorbidities, such as diabetes mellitus, high blood pressure, and smoking as there may be confounding factors that might explain differences. We analyzed patency using Kaplan-Meier Life tables and ANOVA analysis. The measurements used to compare outcomes include ankle-brachial index (ABI) readings, duplex ultrasound of lower arteries and angiogram outcomes. We also compare our results to those in the literature.

Results: Primary patency was 72.5% and primary assisted patency was 95.7%. 12 limbs (3.9%) thrombosed with 4 failures, achieving a secondary patency of 99.1%. There were 13 (3.7%) 30 day adverse events (see table). Long-term complications include: 2 stent thrombosis, 2 pseudoaneurysms, 1 stent dissection, 1 stent migration, and 1 hematoma >30 days after the procedure. Limb-loss was 4.3% with 8 below knee amputations (BKA) and 7 above knee amputations (AKA) out of the 349 treated limbs. Previous myocardial infarction correlated to loss of primary patency (p = .002). Ulcer/gangrene was 1.8x more likely to lose primary patency compared to claudication (p =.035). Ulcer/gangrene (p=.045) and rest pain (p=.007) compared to claudication were 9.5x and 4.9x more likely to have limb loss, respectively. Survival was 70% up to 75 months. Our results show that CFA stenting is safe and effective and provides durable long-term patency, limb salvage, and survival.

Conclusions: Our results show that CFA stenting is safe and effective and provides durable long-term patency, limb salvage, and survival.