Design and Rationale of the Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST-CLI) Trial.

BACKGROUND: Critical limb ischemia (CLI) is increasing in prevalence, and remains a significant source of mortality and limb loss. The decision to recommend surgical or endovascular revascularization for patients who are candidates for both varies significantly among providers and is driven more by individual preference than scientific evidence. METHODS AND RESULTS: The Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST-CLI) Trial is a prospective, randomized, multidisciplinary, controlled, superiority trial designed to compare treatment efficacy, functional outcomes, quality of life, and cost in patients undergoing best endovascular or best open surgical revascularization. Approximately 140 clinical sites in the United States and Canada will enroll 2100 patients with CLI who are candidates for both treatment options. A pragmatic trial design requires consensus on patient eligibility by at least 2 investigators, but leaves the choice of specific procedural strategy within the assigned revascularization approach to the individual treating investigator. Patients with suitable single-segment of saphenous vein available for potential bypass will be randomized within Cohort 1 (n=1620), while patients without will be randomized within Cohort 2 (n=480). The primary efficacy end point of the trial is Major Adverse Limb Event-Free Survival. Key secondary end points include Re-intervention and Amputation-Free-Survival and Amputation Free-Survival. CONCLUSIONS: The BEST-CLI trial is the first randomized controlled trial comparing endovascular therapy to open surgical bypass in patients with CLI to be carried out in North America. This landmark comparative effectiveness trial aims to provide Level I data to clarify the appropriate role for both treatment strategies and help define an evidence-based standard of care for this challenging patient population. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02060630.

Report on endograft management of traumatic thoracic aortic transections at 30 days and 1 year from a multidisciplinary subcommittee of the Society for Vascular Surgery Outcomes Committee.

OBJECTIVES: The Society for Vascular Surgery Outcomes Committee, including ad hoc members from Society of Thoracic Surgeons, American Association of Thoracic Surgery, and Society for Interventional Radiology, collected outcomes of patients with traumatic thoracic aortic transections treated with endovascular grafts. Results through 1 year of follow-up are reported. METHODS: Data from five physician-sponsored investigational device exemption clinical trials from 2000 to 2008 were entered using standardized forms and definitions. Adverse events were reported early (≤30 days) and late (>30 days) by body system. Major adverse events included one or more of the following: death, stroke, myocardial infarction, renal failure, respiratory failure, paralysis, or bowel ischemia. RESULTS: There were 60 symptomatic patients (68.3% men; mean age, 46 years) with traumatic aortic transections, of which 97% were due to a motor vehicle accident and 3% were related to other blunt trauma. The average total injury severity score was 39, most with involvement of the chest and abdomen. The average surgical time was 125 minutes. The mean hospital length of stay was 17 days. Associated procedures for the management of nonaortic injuries occurred in 51.7%. All-cause mortality was 9.1% at 30 days and 14.4% at 1 year. One or more major adverse events occurred in 23.3% of the patients, major adverse events occurred early in 20.0% and late in 3.6%. Death accounted for 41.7% of the early and all of the late major adverse events. Early adverse events included 16.7% pulmonary, 13.3% neurologic, and 11.7% vascular complications. Late adverse events included one patient (1.8%) with pulmonary failure and one patient (1.8%) who died of an unknown cause. CONCLUSIONS: One-year results of endograft placement for the management of patients with traumatic aortic injury are acceptable. Most cases treated were due to motor vehicle accident and associated with multiple coexisting injuries. Approximately three-quarters of the deaths occurred ≤30 days, indicating the acute severity of the condition. Although the relatively low rates of adverse and major adverse events are consistent with what is anticipated in an otherwise healthy population, future device and procedural developments may facilitate improved outcomes in the future.

Report on the results of thoracic endovascular aortic repair for acute, complicated, type B aortic dissection at 30 days and 1 year from a multidisciplinary subcommittee of the Society for Vascular Surgery Outcomes Committee.

OBJECTIVE: This study analyzed 1-year outcome after thoracic endovascular aortic repair (TEVAR) in patients with complicated type B aortic dissection (cTBAoD) who had rupture or malperfusion and symptom onset ≤14 days (acute), 15 to 30 days (subacute), and 31 to 90 days (chronic) until required intervention. The main focus of this report is primarily on the acute cohort. METHODS: Clinical data were systematically collected from five physician-sponsored investigational device exemption (IDE) clinical trials between 2000 and 2008 using standardized definitions and forms. Adverse events were reported early (≤30 days) and late (>30 days) by body system. Major adverse events included death, stroke, myocardial infarction, renal failure, respiratory failure, paralysis, and bowel ischemia. RESULTS: There were 99 cTBAoD patients: 85 were acute, 11 were subacute, and 3 were chronic. Among the acute patients, 31.8% had rupture and 71.8% had malperfusion, including 55.7% lower extremity, 36.1% renal, 19.7% visceral, 8.2% other, and 3.3% spinal cord (patients may have more than one source). Rupture and malperfusion were both reported for three acute patients. Additional findings for the acute cohort included pain (76.5%), hypertension (43.5%), and bleeding (8.2%); comorbidities included hypertension (83.5%), current/past smoking history (69.8%), and diabetes (12.9%). The main focus of this analysis was the acute cohort (n = 85). Age averaged 59 years (72.9% male). Early adverse events included pulmonary (36.5%), vascular (28.2%), renal (25.9%), and neurologic (23.5%). Early major adverse events occurred in 37.6% of patients, including death (10.6%), stroke (9.4%), renal failure (9.4%), and paralysis (9.4%); late adverse events included vascular (15.8%), cardiac (10.5%), gastrointestinal (6.6%), and hemorrhage (5.3%). The point-estimate mortality rate was 10.8 (95% confidence interval [CI], 4.1-17.5) at 30 days and 29.4 (95% CI, 18.4-40.4) at 1 year, when 34 patients remained at risk. CONCLUSIONS: Emergency TEVAR for patients with cTBAoD (malperfusion or rupture) provided acceptable mortality and morbidity results out to 1 year. Manufacturers can use this 30-day mortality point-estimate of 10.8 (95% CI, 4.1-17.5) for the acute cohort to establish a performance goal for use in single-arm commercial IDE trials if the Food and Drug Administration and other regulatory bodies concur.

Society of vascular surgery vascular registry comparison of carotid artery stenting outcomes for atherosclerotic vs nonatherosclerotic carotid artery disease.

OBJECTIVE: The Vascular Registry (VR) on carotid procedures collects long-term outcomes on carotid artery stenting (CAS) and carotid endarterectomy (CEA) patients. The purpose of this report is to describe in-hospital and 30-day CAS outcomes in patients with atherosclerotic carotid artery disease (CAD; atherosclerosis [ATH]) compared to recurrent carotid stenosis (RES) and radiation-induced stenosis (RAD). METHODS: The VR collects provider-reported data on CAS using a Web-based data management system. For this report, data were analyzed at the preprocedure, procedure, predischarge, and 30-day intervals. RESULTS: As of November 20, 2008, there were 4017 patients with CAS with discharge data, of which 72% were due to ATH. A total of 2321 patients were available for 30-day outcomes analysis (1623 ATH, 529 restenosis, 119 radiation, 17 dissection, 3 trauma, and 30 other). Baseline demographics showed that ATH occurred in older patients (72-years-old), had the greatest history of coronary artery disease (CAD; 62%), myocardial infarction (MI; 24%), valvular heart disease (8%), arrhythmia (16%), congestive heart failure (CHF; 16%), diabetes mellitus (DM; 35%), and chronic obstructive pulmonary disease (COPD; 20%). RES had a higher degree of baseline stenosis (87.0 vs 85.8 ATH; P = .010), were less likely to be symptomatic (35.5% vs 46.3% ATH; P < .001), but had a greater history of hypertension, peripheral vascular disease (PVD), and smoking. RAD was seen in younger patients (66.6 vs 71.7 ATH; P < .001), were more likely to be male (78.2% vs 60.9% ATH; P < .001), and had less comorbidities overall, with the exception of amaurosis fugax, smoking, and cancer. The only statistically significant difference in perioperative rates was in transient ischemic attack (TIA; 2.7% ATH vs 0.9% RES; P = .02). There were no statistically significant differences in in-hospital death/stroke/MI (ATH 5.4%, RES 3.8%, RAD 4.2%) or at 30 days (ATH 7.1%, RES 5.1%, RAD 5.0%). Even after adjusting for age, gender, symptomatology, CHF, and renal failure, the only statistically significant difference at 30 days was amaurosis fugax between ATH and RAD (odds ratio [OR] 0.13; P = .01). CONCLUSION: Although patients with ATH have statistically significant comorbidities, they did not have statistically significant increased rates of death/stroke/MI during hospitalization or within 30 days after discharge when compared to RES or RAD. The CAS event rates for ATH vs RES and RAD are similar, despite prior published reports. Symptomatic ATH have statistically significant higher rates of death/stroke/MI compared to asymptomatic cohort. Finally, consistent and accurate entry of long-term data beyond initial hospitalization is essential to fully assess CAS outcomes since a significant number of adverse events occur in the interval from hospital discharge to 30 days.

CaRESS: carotid revascularization using endarterectomy or stenting systems.

The primary objective of the CaRESS Phase I trial is to determine the sample size needed to reliably test the hypothesis that carotid stenting systems with distal embolic protection (CAS) is equivalent to carotid endarterectomy (CEA) in the treatment of symptomatic and asymptomatic carotid artery disease in a broad-risk population. A total of 397 patients were treated at 14 clinical centers. The primary endpoint results of combined all-cause mortality and stroke at 30-days and 1-year are presented. The CaRESS Phase I study was able to closely resemble clinical practice and results suggest equivalence between treatment groups.