Final Round of Late-Breaking Clinical Trial Results Announced at VIVA24

The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, announces the results for the final round of Late-Breaking Clinical Trials presented at the VIVA24 conference, at Wynn Las Vegas.

VIVA (Vascular InterVentional Advances) is an annual vascular education symposium that brings together a global, multispecialty faculty to present a variety of lectures and live case presentations from clinical centers around the world. The audience is composed of interventional cardiologists, interventional radiologists, vascular surgeons, and endovascular medicine specialists. Below are highlights of this afternoon's 3 late-breaking clinical trial presentations.

Diversity, Equity, and Inclusion in the LIFE-BTK Trial Evaluating the Esprit BTK Drug-Eluting Resorbable Scaffold for Treatment of Infrapopliteal Lesions in Patients With CLTI

Presented by: Lawrence A. Garcia, MD

In the LIFE-BTK trial, several initiatives were implemented to facilitate enrollment of diverse populations, ensuring that patients most affected by the disease were represented. Initiatives geared toward the patients and research staff at the sites included: (1) a study website providing information on clinical trials, disease state, and the LIFE-BTK trial; (2) patient and site brochures with information on disease state and the trial; (3) translation services in > 48 languages with interpreters available 24/7; (4) patient reimbursement for travel and assistance in booking airfare and hotel; and (5) option to conduct follow-up visits in the patient’s home. The primary effectiveness endpoint, as well as the two powered secondary endpoints, were evaluated based on various groupings of race and ethnicity.

LIFE-BTK enrolled a total of 261 patients in the United States, Australia, New Zealand, Taiwan, Hong Kong, and Singapore, of which 12.3% identified as Black or African American, 18% as Asian, 59% as White, and 16.5% as Hispanic. The trial met its primary effectiveness endpoint of limb salvage and primary patency at 1 year, demonstrating superiority of Esprit BTK Drug-Eluting Resorbable Scaffold (Abbott) over percutaneous transluminal angioplasty. The primary safety endpoint was also met. Analysis of the primary effectiveness endpoint in various race/ethnicity groupings showed consistent results with the overall population, with risk ratios between 0.32 and 0.62 in favor of Esprit BTK compared to a risk ratio of 0.45 in the overall population. The same trend was observed for both powered secondary endpoints, with risk ratios ranging from 0.32 to 0.68 and 0.30 to 0.72 for the first and second powered secondary endpoints, respectively.

The LIFE-BTK trial enrolled a patient population whose race distribution was comparable to Centers for Medicare & Medicaid Services patients with a diagnosis of chronic limb-threatening ischemia undergoing endovascular procedures. Primary effectiveness and powered secondary endpoint results in the various race and ethnicity subgroups analyzed were consistent with the overall population as to outcome with the Esprit BTK device. LIFE-BTK’s focus on ethnic and racial diversity was an important and successful goal.

STRIDE Study Suggests Race, Not Sex, Is Associated With Outcomes in Acute Limb Ischemia Treated With Mechanical Aspiration Thrombectomy

Presented by: Alex Powell, MD

STRIDE assessed safety, efficacy, and quality of life (QoL) outcomes through 365 days for lower extremity acute limb ischemia (LE-ALI) patients treated first line with mechanical aspiration thrombectomy using the Indigo Aspiration System (Penumbra, Inc.). STRIDE was a prospective, single-arm study that enrolled 119 patients across 16 sites (United States and Europe).

The primary outcome was target limb salvage (TLS) at 30 days postprocedure. Secondary outcomes included device-related serious adverse events, technical success (postprocedure thrombolysis in myocardial infarction flow grades 2/3), mortality, and 30-day patency. In these subgroup analyses, sex differences were analyzed, and a multivariate Cox proportional hazards model was developed to identify predictors of time to primary and secondary outcomes.

For all patients (mean age, 66.3 years; 46.2% female; 20.2% African American), TLS and patency at 30 days were 98.2% (109/111) and 89.4% (101/113), respectively. No sex differences were observed for 30-day TLS (P > .999), 30-day patency (P = .220), 365-day mortality (P = .223), or change in QoL (P = .372). Periprocedural major bleeding (not device related) occurred at a higher rate in females (9.1% vs 0%; P = .019), but all had below-normal range of preprocedural hemoglobin and hematocrit levels or a chronic history of anemia. In the multivariate model, race and sex were not associated with 30-day patency or 365-day mortality. However, African American patients had increased risk of limb loss (hazard ratio, 13.2; 95% CI, 2.5-68.6) and a reduced QoL improvement at 365 days (∆ -3.1; 95% CI, -6.7 to 0.4).

Data from STRIDE continue to support Indigo as a safe and effective option for first-line treatment of LE-ALI in a diverse patient population. Males and females experienced good efficacy, safety, and improved QoL outcomes, despite literature reporting females having a history of poorer outcomes than males. Multivariate analyses identified increased risks for African American patients, underscoring the need for continued research into underlying baseline risk factors and efforts to achieve equity in LE-ALI treatment.

Endovascular PAD Treatment With Drug-Eluting Devices in a Registry Focused on Underrepresented Minorities and Women: 12-Month Clinical Results From the First 500 ELEGANCE Registry Patients

Presented by: Jay Giri, MD, MPH

The ELEGANCE registry examines endovascular drug-eluting peripheral artery disease (PAD) treatment with a focus on historically underrepresented patient populations. Study participants underwent peripheral drug-eluting device interventions with the Ranger Paclitaxel-Coated Balloon and/or Eluvia Paclitaxel-Eluting Stent (both Boston Scientific Corporation). Through novel recruitment mechanisms, the study aims to enroll at least 40% women and 40% underrepresented racial and ethnic groups globally.

Characteristics of the first 500 patients who completed a 12-month follow-up visit aligned with ELEGANCE enrollment objectives, with 41.6% female patients and 41.6% from underrepresented racial/ethnic populations. Patient characteristics and disease presentation differed among sex and race/ethnicity groups. Females were significantly older than males on average and more likely to present with advanced Rutherford category 4 to 6 disease. All underrepresented population groups presented as Rutherford category 4 to 6 at a greater frequency than the non-Hispanic White group.

Despite differing and advanced disease characteristics, the 12-month above-ankle amputation incidence was low at 0.8%; reintervention rates were low and did not differ significantly by sex or race and ethnicity. The overall site-reported 12-month freedom from clinically driven target lesion revascularization rate was 89.6%.

Although the PAD presentation of the diverse patients enrolled in ELEGANCE reflects significant disparities, 1-year outcomes of paclitaxel-based revascularization with the Ranger Drug-Coated Balloon or Eluvia Drug-Eluting Stent suggest that excellent effectiveness and safety results may generalize to underrepresented patient groups.

About the VIVA Foundation

The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, strives to be the premier educator in the field. Our team of specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery is driven by the passion to advance the field and improve patient outcomes. Educational events presented by the VIVA Foundation have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide.