Surgery or endovascular therapy for patients with chronic limb-threatening ischemia requiring infrapopliteal interventions.

The recent publication of randomized trials comparing open bypass surgery to endovascular therapy in patients with chronic limb-threatening ischemia, namely, Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) and Bypass versus Angioplasty in Severe Ischaemia of the Leg-2 (BASIL-2), has resulted in potentially contradictory findings. The trials differed significantly with respect to anatomical disease patterns and primary end points. We performed an analysis of patients in BEST-CLI with significant infrapopliteal disease undergoing open tibial bypass or endovascular tibial interventions to formulate a relevant comparator with the outcomes reported from BASIL-2. The study population consisted of patients in BEST-CLI with adequate single segment saphenous vein conduit randomized to open bypass or endovascular intervention (cohort 1) who additionally had significant infrapopliteal disease and underwent tibial level intervention. The primary outcome was major adverse limb event (MALE) or all-cause death. MALE included any major limb amputation or major reintervention. Outcomes were evaluated using Cox proportional regression models. The analyzed subgroup included a total of 665 patients with 326 in the open tibial bypass group and 339 in the tibial endovascular intervention group. The primary outcome of MALE or all-cause death at 3 years was significantly lower in the surgical group at 48.5% compared with 56.7% in the endovascular group (P = .0018). Mortality was similar between groups (35.5% open vs 35.8% endovascular; P = .94), whereas MALE events were lower in the surgical group (23.3% vs 35.0%; P<.0001). This difference included a lower rate of major reinterventions in the surgical group (10.9%) compared with the endovascular group (20.2%; P = .0006). Freedom from above ankle amputation or all-cause death was similar between treatment arms at 43.6% in the surgical group compared with 45.3% the endovascular group (P = .30); however, there were fewer above ankle amputations in the surgical group (13.5%) compared with the endovascular group (19.3%; P = .0205). Perioperative (30-day) death rates were similar between treatment groups (2.5% open vs 2.4% endovascular; P = .93), as was 30-day major adverse cardiovascular events (5.3% open vs 2.7% endovascular; P = .12). Among patients with suitable single segment great saphenous vein who underwent infrapopliteal revascularization for chronic limb-threatening ischemia, open bypass surgery was associated with a lower incidence of MALE or death and fewer major amputation compared with endovascular intervention. Amputation-free survival was similar between the groups. Further investigations into differences in comorbidities, anatomical extent, and lesion complexity are needed to explain differences between the BEST-CLI and BASIL-2 reported outcomes.

Giles KA ，Farber A ，Menard MT ，Conte MS ，Nolan BW ，Siracuse JJ ，Strong MB ，Doros G ，Venermo M ，Azene E ，Rosenfield K ，Powell RJ ... -  《-》

The impact of revascularization strategy on clinical failure, hemodynamic failure, and chronic limb-threatening ischemia symptoms in the BEST-CLI Trial.

Menard MT ，Farber A ，Doros G ，McGinigle KL ，Chisci E ，Clavijo LC ，Kayssi A ，Schneider PA ，Hawkins BM ，Dake MD ，Hamza T ，Strong MB ，Rosenfield K ，Conte MS ... -  《-》

Reduction of Major Amputations after Surgery versus Endovascular Intervention: The BEST-CLI Randomised Trial.

Venermo MA ，Farber A ，Schanzer A ，Menard MT ，Rosenfield K ，Dosluoglu H ，Goodney PP ，Abou-Zamzam AM ，Motaganahalli R ，Doros G ，Creager MA ... -  《-》

Mid-Term Results of Popliteal-Pedal Inframalleolar Vein Bypasses in Chronic Limb-Threatening Ischemia Patients After Previous Failed Tibial Endovascular Recanalization.

Inframalleolar bypass still preserves its role in the modern endovascular era. Aim of this study was to evaluate the mid-term outcomes of "short" inframalleolar vein bypasses in patients with chronic limb-threatening ischemia (CLTI) after the previously failed tibial endovascular recanalization. Between January 2015 and December 2021,107 CLTI patients in 3 Italian Departments of Vascular Surgery underwent "short" inframalleolar vein bypass after failed tibial endovascular recanalization. Early (30-day) and 3-year outcomes were evaluated in terms of survival, primary patency, primary assisted patency, secondary patency, and amputation-free survival. Univariate analysis of the perioperative factors affecting outcomes were performed by the means of log-rank test. The associations of procedure variables were sought based on a multivariate Cox regression analysis. Distal anastomosis (inframalleolar) was mostly performed on dorsal pedis (64, 59.8%). At 30 days, bypass occlusion was recorded in 5 cases (4.6%). The mean follow-up period was 20.5 ± 17.9 months. The estimated 3-year overall survival was 66.7%. Three-year estimates of primary patency, primary assisted patency, secondary patency, and amputation-free survival were 68.5%, 70.1%, 70.2%, and 76.7%, respectively. Multivariate analysis showed a negative association of insulin treatment with primary patency (HR 4.3, P = 0.04), primary assisted patency (HR 5.1, P = 0.02), and secondary patency (HR 5.1, P = 0.02). The negative association of long-term corticosteroid use was also found with primary patency (HR 7.8, P = 0.005), primary assisted patency (HR 8.7, P = 0.003), secondary patency (HR 8.7, P = 0.003), and amputation-free survival (HR 3.9, P = 0.05). Short" vein bypasses to the foot arteries in CLTI patients yielded good mid-term overall patency and limb salvage rates after a failed tibial endovascular recanalization. Insulin-dependent diabetes mellitus and long-term corticosteroid use seemed to affect the outcomes.

Troisi N ，Stilo F ，Adami D ，De Caridi G ，Montelione N ，Bertagna G ，Barillà C ，Berchiolli R ，Spinelli F ，Benedetto F ... -  《-》

Great Saphenous Vein Arterialization in Patients with Severe Chronic Limb Threatening Ischemia: A Last Resort for Limb Salvage.

Maas R ，Rowell SA ，Lankheet S ，Kappert KDR ，Botman JMJ ... -  《-》