Late-breaking clinical trial results presented at the VIVA (Vascular InterVentional Advances) 2024 symposium showcase advancements in treating peripheral artery disease (PAD) and chronic limb-threatening ischemia (CLTI). The studies address various aspects of PAD management, from novel bypass techniques to drug-eluting technologies and the importance of diversity in clinical trials.
LimFlow System Shows Promise in No-Option CLTI Patients
The PROMISE II trial evaluated the LimFlow System for transcatheter arterialization of the deep veins (TADV) in CLTI patients unsuitable for conventional revascularization. Two-year results from 105 patients with Rutherford class 5/6 disease showed a 65% limb salvage rate. Additionally, 65.8% of patients improved to Rutherford class 4 or below, and 82% achieved complete or ongoing wound healing. When combined with the PROMISE I trial, the 2-year limb salvage rate was 68%, with consistent results across various subgroups. These findings suggest TADV with the LimFlow System offers a durable solution for patients with limited treatment options.
DETOUR System Demonstrates Long-Term Efficacy in Complex Femoropopliteal Disease
The DETOUR2 study investigated percutaneous transmural arterial bypass (PTAB) using the DETOUR System for complex femoropopliteal disease, including long lesions and chronic total occlusions (CTOs). Three-year results from 202 patients, 96% of whom had CTOs with a mean lesion length of 327 mm, showed a primary patency rate of 58.2%. The freedom from clinically driven target lesion revascularization (CD-TLR) rate was 66.8%, with a major index limb amputation rate of 1.5% and an all-cause mortality rate of 8.9%. The data suggest PTAB with the DETOUR System provides a viable alternative to open surgical bypass in challenging cases.
DEEPER OUS Trial Assesses Retrievable Scaffold Therapy
The DEEPER OUS trial, a prospective, nonrandomized, multicenter, single-arm trial, evaluated the safety and efficacy of the Spur Peripheral Retrievable Scaffold System (Reflow Medical, Inc.) in conjunction with a commercially available drug-coated balloon (DCB) in patients with symptomatic infrapopliteal arterial disease. At 24 months, the secondary safety endpoint of freedom from major amputation of the target limb was met in 98.8% (79/80), all-cause mortality was 14% (15/107), and freedom from CD-TLR was 83.5% (71/85).
SIRONA Trial Post Hoc Analysis Compares Sirolimus and Paclitaxel DCBs
A post hoc analysis of the SIRONA trial compared the efficacy of sirolimus-coated balloons (MagicTouch, Concept Medical) with various paclitaxel-coated balloons for femoropopliteal lesions. The primary efficacy endpoint of 12-month primary patency was noninferior for sirolimus versus paclitaxel DCBs (73.8% vs 75%, P = .022). The study suggests sirolimus DCBs may be a suitable alternative to paclitaxel DCBs in femoropopliteal angioplasty.
LIFE-BTK Trial: GLASS System Predicts Outcomes in CLTI
The LIFE-BTK trial examined the impact of the Global Limb Anatomic Staging System (GLASS) on outcomes in CLTI patients treated with percutaneous transluminal angioplasty (PTA) and the Esprit BTK Drug-Eluting Resorbable Scaffold (Abbott). Patients in GLASS stage I had significantly better outcomes compared to those in stages II-III, with a freedom from events rate of 72.1% vs 53.3% (P = .0068). The study demonstrates the GLASS system effectively identifies patients at higher risk for adverse clinical events.
LIFE-BTK Trial Emphasizes Diversity and Inclusion
The LIFE-BTK trial implemented initiatives to ensure diverse patient enrollment, including translation services, patient reimbursement for travel, and home follow-up visits. The trial enrolled 261 patients across multiple countries, with 12.3% identifying as Black or African American, 18% as Asian, 59% as White, and 16.5% as Hispanic. Results were consistent across various race/ethnicity groupings, demonstrating the importance of diversity in clinical research.
STRIDE Study Analyzes Outcomes in Acute Limb Ischemia
The STRIDE study assessed the Indigo Aspiration System for lower extremity acute limb ischemia (LE-ALI). At 30 days, target limb salvage (TLS) was 98.2% and patency was 89.4%. While no sex differences were observed, African American patients had an increased risk of limb loss. The study highlights the need for further research into risk factors and efforts to achieve equity in LE-ALI treatment.
ELEGANCE Registry Focuses on Underrepresented Populations
The ELEGANCE registry examines endovascular drug-eluting PAD treatment in underrepresented populations, with 41.6% female patients and 41.6% from underrepresented racial/ethnic groups. Despite differing disease characteristics, 12-month outcomes of paclitaxel-based revascularization with the Ranger Drug-Coated Balloon or Eluvia Drug-Eluting Stent showed excellent effectiveness and safety results, suggesting these treatments can generalize to underrepresented groups.
