Insulin Therapy and Outcomes of Revascularization Procedures for Chronic Limb Threatening Ischemia in the Best-CLI Trial.

Objectives: Diabetes mellitus (DM) is a major risk factor for amputation in patients with chronic limb-threatening ischemia (CLTI) undergoing lower extremity revascularization (LER). Observational studies comparing patients with DM based on insulin therapy have reported inconsistent findings. This study compares the outcomes of patients with insulin-requiring DM (IRDM) and non-insulin requiring DM (NIRDM) based on high quality prospective data.

Characteristics of Multidisciplinary Limb Preservation Teams and their Impact on Outcomes in the BEST-CLI Trial.

Objective: Multidisciplinary care of chronic limb threatening ischemia (CLTI) through specialized CLTI teams has been associated with improved outcomes, including decreased major amputations. Our goal was to characterize CLTI teams and examine their association with outcomes in the Best Endovascular versus Surgical Therapy in Patients with CLTI (BEST-CLI) trial.

Methods: Responses from a previously described post-trial electronic survey were used to describe CLTI care providers and characterize centers based on the presence of a "formally defined team dedicated to the care of CLTI patients".

Optimizing Hospital Billing by Using Data from the Vascular Quality Initiative.

Introduction: Hospitals are reimbursed for inpatient admissions by Medicare based on the principal Medicare severity diagnostic related group (MS-DRG) assigned to that admission. MS-DRGs with complication or comorbidity (CC) or major complication or comorbidity (MCC) increase reimbursement to reflect the added cost of caring for complex patients. Under-coding DRG complexity has been shown to result in unrecovered reimbursement and financial losses for hospitals.

Prediction of 1-Year Major Adverse Cardiovascular Events in Chronic Limb Threatening Ischemia.

Background: Patients with chronic limb threatening ischemia (CLTI) are at risk for major adverse cardiovascular events (MACE), yet few tools exist for risk stratification.

Objectives: The purpose of this study was to derive and validate a CLTI MACE risk prediction model.

Methods: Participants in the BEST-CLI (Best Endovascular vs.

Anatomic profile of arterial occlusive disease in the BEST-CLI trial.

Objective: The results of BEST-CLI trial indicated that, when eligible for both open surgical or endovascular therapy, a single-segment great saphenous vein bypass is the superior revascularization strategy for patients with chronic limb-threatening ischemia (CLTI). Having detailed anatomic information about the burden of arterial occlusive disease is important in understanding the technical difficulty of the cases performed in the trial, and what trial investigators considered equally suitable for either revascularization strategy.

Methods: The BEST-CLI trial, an international multi-site randomized controlled trial (RCT) comparing endovascular with open surgical revascularization in patients who were candidates for both, was analyzed.

Antiproliferative endovascular drug technology is associated with fewer major reinterventions after femoropopliteal interventions for chronic limb-threatening ischemia.

Objective: Conflicting data exist regarding the benefits of paclitaxel-based endovascular interventions (ENDO-Drug) for patients with chronic limb-threatening ischemia (CLTI). This analysis aims to evaluate the effect of such therapy in the Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial.

Methods: The as treated dataset from the BEST-CLI Trial, a prospective randomized trial comparing surgical and endovascular revascularization for infrainguinal CLTI, was used to assess the association of ENDO-Drug (drug-coated balloons or drug-eluting stents) use and 3-year outcomes after initial technical success in the femoropopliteal (FP) segment.

Association of Lipoprotein(a) With Major Adverse Limb Events and All-Cause Mortality Following Revascularization for Chronic Limb-Threatening Ischemia: A Substudy of the BEST-CLI Trial.

Background: The BEST-CLI (Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia) trial tested the optimal initial revascularization strategy in patients with chronic limb-threatening ischemia. Little is known about the prognostic relevance of Lp(a) (lipoprotein[a]) and its modification by renal function in patients with chronic limb-threatening ischemia. We investigated the relationship between Lp(a) and prespecified cardiovascular outcomes.

Editor's Choice - Bypass After Failed Endovascular Intervention Is Associated with an Increased Risk of Above Ankle Amputation Among Patients with Chronic Limb Threatening Ischaemia in a Randomised Trial Population.

Objective: One concern about the endovascular first (ENDO) approach for chronic limb threatening ischaemia (CLTI) is whether bridges are burned for a secondary bypass (SB) if required in the future. This secondary analysis of a prospective randomised trial aimed to compare above ankle amputation rates in patients with CLTI treated with primary bypass (PB) compared with those treated with SB after an initial ENDO approach.

Methods: Data from the randomised unblinded Best Endovascular versus Best Surgical Therapy of Patients with CLTI (BEST-CLI) trial were analysed.

Age-Related Outcomes After Revascularization for Chronic Limb-Threatening Ischemia: An Analysis of BEST-CLI.

Background: The impact of age on outcomes after revascularization for chronic limb-threatening ischemia has not been studied in a prospective trial.

Methods: A total of 1780 patients were grouped into age quartiles (≤55 years, 55< age ≤65 years, 65< age ≤75 years, and >75 years) and by type of revascularization (open bypass or endovascular). The primary outcome was major adverse limb events (MALE) or death, and the secondary outcomes were above-ankle amputation, reintervention, and major adverse cardiovascular events.

Impact of Bypass Conduit and Early Technical Failure on Revascularization for Chronic Limb-Threatening Ischemia.

Background: The optimal strategy for lower extremity revascularization (surgical bypass versus endovascular intervention) in patients with chronic limb-threatening ischemia (CLTI) is unclear. We examined the effectiveness of open surgical bypass using single-segment great saphenous vein conduit (SSGSV), alternative conduits (AC), or endovascular interventions (ENDO) among patients with CLTI deemed acceptable for either open surgical bypass or ENDO treatment.

Methods: This was a planned as-treated analysis of the multicenter BEST-CLI (Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia) randomized controlled trial comparing open surgical bypass and ENDO for CLTI due to infrainguinal peripheral artery disease.

The Incidence and Consequences of Endovascular Technical Failure in Patients with Chronic Limb-Threatening Ischemia: Results from the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb-Threatening Ischemia (BEST-CLI) Trial.

Purpose: To analyze the causes and clinical impacts of endovascular technical failure (ETF) in the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb-Threatening Ischemia (BEST-CLI) trial, which compared endovascular therapy with bypass surgery in patients with chronic limb-threatening ischemia (CLTI).

Materials And Methods: Patients with CLTI were randomized to infrainguinal bypass or endovascular therapy. ETF was defined as the inability to complete the endovascular procedure.

An assessment of the BEST-CLI Trial demonstrates that infrainguinal bypass offers a potential advantage in smokers with chronic limb-threatening ischemia.

Objective: Smoking is an established risk factor in many pathologies of the cardiovascular system. The Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial affords an in-depth evaluation into the effect of smoking on patients with chronic limb-threatening ischemia (CLTI). BEST-CLI's prospective, randomized design evaluated outcomes in patients suitable for both open or endovascular intervention and randomized patients between endovascular intervention (ENDO) vs open surgical bypass (OPEN).

Outcomes of chronic limb-threatening ischemia revascularization in patients with chronic kidney disease in the BEST-CLI trial.

Background: Chronic limb-threatening ischemia (CLTI) in patients with chronic kidney disease (CKD) has a high risk of poor outcomes. We aimed to compare the outcomes of lower extremity revascularization in patients with CLTI stratified by CKD severity in patients enrolled in the prospective, randomized Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial.

Methods: The BEST-CLI trial dataset was queried to categorize patients into three groups according to CKD stage.

Advanced Wound, Ischemia, and Foot Infection stage is associated with poor outcomes in the BEST-CLI trial.

Objective: Wound, Ischemia, and foot Infection (WIfI) staging was established to provide objective classification in patients with chronic limb-threatening ischemia (CLTI) and to predict 1-year major amputation risk. Our goal was to validate WIfI staging using data from the Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial.

Methods: Data from the BEST-CLI Trial, a prospective randomized trial comparing surgical revascularization (OPEN) and endovascular revascularization (ENDO), were used to assess the association of WIfI stage on long-term outcomes in an intention-to-treat analysis.

The impact of diabetes mellitus on the outcomes of revascularization for chronic limb-threatening ischemia in the BEST-CLI trial.

Objective: Several observational studies have demonstrated an association between diabetes mellitus (DM) and above-ankle amputation after lower extremity revascularization (LER). However, data from prospective randomized trials is lacking. This analysis compares the outcomes of patients with and without DM enrolled in the Best Endovascular vs Best Surgical Therapy in patients with Chronic Limb-Threatening Ischemia (BEST-CLI) trial.

Prosthetic conduits have worse outcomes compared with great saphenous vein conduits in femoropopliteal and infrapopliteal bypass in patients with chronic limb-threatening ischemia.

Objective: Single segment great saphenous vein (SSGSV) traditionally has been considered the gold standard conduit for infrainguinal bypass. There are data supporting similar outcomes with prosthetic femoral-popliteal bypass. Moreover, some investigators have advocated for prosthetic conduit for femoral tibial bypass when GSV is inadequate or unavailable.

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

Objective: Sustained clinical and hemodynamic benefit after revascularization for chronic limb-threatening ischemia (CLTI) is needed to resolve symptoms and prevent limb loss. We sought to compare rates of clinical and hemodynamic failure as well as resolution of initial and prevention of recurrent CLTI after endovascular (ENDO) vs bypass (OPEN) revascularization in the Best-Endovascular-versus-best-Surgical-Therapy-in-patients-with-CLTI (BEST-CLI) trial.

Methods: As planned secondary analyses of the BEST-CLI trial, we examined the rates of (1) clinical failure (a composite of all-cause death, above-ankle amputation, major reintervention, and degradation of WIfI stage); (2) hemodynamic failure (a composite of above-ankle amputation, major and minor reintervention to maintain index limb patency, failure to an initial increase or a subsequent decrease in ankle brachial index of 0.

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

Objective: BEST-CLI, an international randomised trial, compared an initial strategy of bypass surgery with endovascular treatment in chronic limb threatening ischaemia (CLTI). In this substudy, overall amputation rates and risk of major amputation as an initial or subsequent outcome were evaluated.

Methods: A total of 1 830 patients were randomised to receive surgical or endovascular treatment in two parallel cohorts: patients with adequate single segment great saphenous vein (SSGSV) (n = 1 434) were assigned to cohort 1; and patients without adequate SSGSV (n = 396) were assigned to cohort 2.

Real-World Vein Mapping Practice Patterns Before Endovascular Treatment of Limb Ischemia.

Introduction: The Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial results suggest that in patients with chronic limb-threatening ischemia (CLTI) and adequate single-segment great saphenous vein (SSGSV) by preoperative duplex ultrasonography, a surgical-first treatment strategy is superior to an endovascular-first strategy. However, the utilization of vein mapping prior to endovascular-first revascularization for CLTI in actual clinical practice is not known.

Methods: Data from a multicenter clinical data warehouse (2008-2019) were linked to Medicare claims data for patients undergoing endovascular-first treatment of infra-inguinal CLTI.