BACKGROUND: The recommendations for the use of and selection of covered stent grafts in patients with aortoiliac occlusive disease are limited.
OBJECTIVE: The GORE VBX FORWARD clinical study aims to demonstrate the superiority of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX device) for primary patency when compared to bare metal stenting (BMS) for the treatment of complex iliac artery occlusive disease.
METHODS: A prospective, multicenter, randomized control study in the United States, European Union, United Kingdom, Australia, and New Zealand will enroll patients with symptomatic, complex iliac artery occlusive disease. In this study, iliac artery occlusive disease is defined as a unilateral or bilateral disease with single or multiple lesions (with >50% stenosis or chronic total occlusion) each between 4 and 11 cm in length. In an attempt to more closely match real-world practices, patients with minor tissue loss (Rutherford class 5) and patients requiring hemodialysis will be included. Baseline aortoiliac angiography will be performed to assess target lesion characteristics and determine final patient eligibility. Once the patient is confirmed and guidewires are in place across the target lesions, the patient will be randomized in a 1:1 format to treatment with either the VBX device or a BMS. The BMS can be balloon- or self-expanding and must be approved for the iliac artery occlusive disease indication. Patients, the independent core laboratory reviewers, and Clinical Events Committee members will be blinded from the assigned treatment. Dual antithrombotic medical therapy is required through a minimum of 3 months post procedure. The primary end point is 12‑month primary patency and will be adjudicated by an independent imaging core laboratory and Clinical Events Committee. Key secondary end points will be tested for superiority and include technical, acute procedural, and clinical success; changes in Ankle-brachial index; patient quality of life; primary patency; freedom from restenosis; primary-assisted patency; secondary patency; freedom from target lesion revascularizations; cumulative reintervention rate; amputation-free survival; survival; and change in Rutherford category. Study follow-up will continue through 5 years.
RESULTS: Outcomes will be reported following study completion. Enrollment is anticipated to start in October 2023.
CONCLUSIONS: The results of this study will provide definitive, level 1 clinical evidence to clinicians on the optimal choice of stent device to use for the treatment of complex iliac artery occlusive disease. The FORWARD study is powered for superiority and includes only complex, unilateral, or bilateral lesions involving the common or external iliac arteries. This study is a multidisciplinary endeavor involving vascular surgery, interventional cardiology, and interventional radiology across multiple countries with a blinded core laboratory review of end points in hopes that the outcomes will be widely accepted and incorporated into practice guidelines for optimal treatment of patients with complex iliac artery occlusive disease.
BACKGROUND: ClinicalTrials.gov NCT05811364; https://clinicaltrials.gov/study/NCT05811364.
UNASSIGNED: PRR1-10.2196/51480.

Racial differences in access to allergen-free food have not been fully described among children with food allergy (FA).
To examine access to allergen-free foods among Black and White children with FA.
Black and White children with FA were enrolled in Food Allergy Outcomes Related to White and African American Racial Differences (FORWARD), a multisite prospective cohort study at 4 urban US centers. Caregivers completed questionnaires regarding access to allergen-free foods. Univariable statistics described demographics. Bivariable statistics evaluated crude associations with access to allergen-free foods. Multivariable logistic regression evaluated the adjusted effect of race on access to allergen-free foods. Geospatial analyses examined the distribution of race, socioeconomic status, and food desert residence.
Among participants (n = 336), White caregivers (88.1%) were more likely to report access to allergen-free foods than Black caregivers (59%) (P < .001). White caregivers were more likely to purchase allergen-free foods online (35.2%) than Black caregivers (12%) (P < .001). Although Black children were more likely to live in a food desert, access to allergen-free food was not related to food desert residence. In the unadjusted analysis, White children were 5.2 times as likely to have access than Black children (P < .001); after adjusting for demographics, this increase in access was no longer significant (P = .08). Other predictors of access to allergen-free foods included online food purchasing, annual household income, respondent education level, milk allergy, and child age >5 years.
In the FORWARD cohort, Black children have less access to allergen-free foods than White children, but much of the difference is accounted for by socioeconomic status and other participant characteristics.

Despite major differences in health profiles and rates of health care utilization between African American and White children with food allergy (FA), the detailed phenotypic variables that can potentially impact these outcomes have not been thoroughly studied.
We aimed to characterize phenotypic differences such as allergies to different foods and allergic comorbidities between African American and White children with FA enrolled in the Food Allergy Outcomes Related to White and African American Racial Differences study.
Our active, prospective, multicenter cohort study is currently enrolling African American and White children aged 0 to 12 years diagnosed with FA and followed by allergy/immunology clinics at 4 urban tertiary centers in the United States. To evaluate associations between race and phenotypic variables, we used multivariable logistic regression, adjusting for important demographic and confounding factors, as well as potential household clustering.
As of May 2020, there were 239 African Americans and 425 Whites with complete intake information enrolled in the study. In comparison with Whites, we found that African Americans had significantly higher adjusted odds of allergy to finfish (odds ratio [OR]: 2.54, P < .01) and shellfish (OR: 3.10, P < .001). African Americans also had higher adjusted odds of asthma than Whites (asthma prevalence of 60.5% in African Americans and 27.2% in Whites; OR: 2.70, P < .001). In addition, shellfish allergy was associated with asthma, after controlling for race.
Among a diverse cohort of children with physician-diagnosed FA, we observed that African American children had higher odds of allergy to shellfish and finfish, and higher rates of asthma. Interestingly, having asthma was independently associated with allergy to shellfish, after controlling for race.

This study sought to report the 1-year safety and efficacy outcomes in the FORWARD (CoreValve Evolut R FORWARD) study following transcatheter aortic valve replacement (TAVR) with the next-generation Evolut R device (Medtronic, Minneapolis, Minnesota) in routine clinical practice.
The FORWARD study reported low incidences of mortality, disabling stroke, and significant paravalvular leak following TAVR in routine clinical practice at 30 days. Longer-term results in large patient populations with the Evolut R self-expanding, repositionable transcatheter heart valve (THV) are lacking.
This was a prospective, single-arm, multinational, multicenter, observational study investigating efficacy and safety following TAVR with the next-generation self-expanding THV. Between January and December 2016, 1,040 patients underwent attempted implant of the Evolut R self-expanding repositionable valve at 53 sites worldwide. An independent Clinical Events Committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms.
The mean age was 81.8 ± 6.2 years, 64.8% were women, and patients had a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.5 ± 4.5% and EuroSCORE II of 5.7 ± 5.0%. The 1-year all-cause mortality rate was 8.9%, with a cardiovascular mortality rate of 6.9%. At 1 year, the incidence of disabling stroke was 2.1%, and a pacemaker was implanted in 19.7% of patients. The incidence of more than mild paravalvular leak was 1.2%.
The FORWARD study demonstrated good safety and efficacy profiles for the next-generation Evolut R THV up to 1-year follow-up, with very low mortality and adverse events. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369).