Late-breaking clinical trial results presented at the VIVA24 conference showcase advancements in vascular medicine and intervention. The studies address critical challenges in treating chronic limb-threatening ischemia (CLTI) and femoropopliteal disease, while also emphasizing the importance of diversity and inclusion in clinical research.
PROMISE II Trial: Two-Year Outcomes of Transcatheter Arterialization for CLTI
The PROMISE II trial investigated transcatheter arterialization of the deep veins (TADV) using the LimFlow System (Inari Medical) in patients with no-option CLTI. The two-year results demonstrated a limb salvage rate of 65% in 105 patients with Rutherford class 5/6 disease who were ineligible for conventional revascularization. Significant improvements were observed in Rutherford classification, with 65.8% of patients achieving class 4 or below and 54.3% reaching class 0. Wound healing was also notable, with 82% of patients showing complete or ongoing healing, a mean wound area of 0.1 cm2, and a mean pain score of 1.2 out of 10. Combining PROMISE I and II data, the two-year limb salvage rate was 68%, with consistent results across various demographic subgroups.
DETOUR2 Study: Durability of Percutaneous Transmural Arterial Bypass for Femoropopliteal Disease
The DETOUR2 study evaluated the DETOUR System (Endologix) for percutaneous transmural arterial bypass (PTAB) in complex femoropopliteal disease. The three-year results from 202 patients with lesions >20 cm, including 96% with chronic total occlusions (CTOs), showed a primary patency rate of 58.2%. The freedom from clinically driven target lesion revascularization (CD-TLR) rate was 66.8%, the major index limb amputation rate was 1.5%, and the all-cause mortality rate was 8.9%. The findings suggest that PTAB with the DETOUR System offers a durable alternative to open surgical bypass when traditional endovascular therapy is not feasible.
DEEPER OUS Trial: Retrievable Scaffold Therapy with Drug-Coated Balloon for Infrapopliteal Arterial Disease
The DEEPER OUS trial assessed the Spur Peripheral Retrievable Scaffold System (Reflow Medical, Inc.) combined with a drug-coated balloon (DCB) in patients with symptomatic infrapopliteal arterial disease. At 24 months, the freedom from major amputation of the target limb was 98.8%, all-cause mortality was 14%, and freedom from CD-TLR was 83.5%. The study concludes that the Spur System is a safe and effective treatment option when used with a DCB.
SIRONA Trial: Sirolimus-Coated Balloon Angioplasty vs. Paclitaxel-Coated Balloons
A post-hoc analysis of the SIRONA trial compared sirolimus-coated balloons (MagicTouch, Concept Medical) with various paclitaxel-coated balloon (DCB) types for femoropopliteal lesions. The primary efficacy endpoint of 12-month primary patency was noninferior for sirolimus DCB compared to paclitaxel DCB (73.8% vs. 75%, P = .022). The analysis indicated that sirolimus DCBs could be a valuable alternative, given sirolimus's wider therapeutic window compared to paclitaxel.
LIFE-BTK Trial: Impact of GLASS on Outcomes with Esprit BTK Scaffold
The LIFE-BTK trial examined the Esprit BTK Drug-Eluting Resorbable Scaffold (Abbott) versus percutaneous transluminal angioplasty (PTA) in CLTI patients with infrapopliteal peripheral artery disease, using the Global Limb Anatomic Staging System (GLASS). Patients in GLASS stage I had significantly better outcomes compared to those in stages II to III (72.1% vs. 53.3%, P = .0068). The Esprit BTK scaffold improved outcomes regardless of GLASS classification.
LIFE-BTK Trial: Diversity, Equity, and Inclusion
The LIFE-BTK trial implemented several initiatives to promote diversity, including translation services, patient reimbursement for travel, and home follow-up visits. The trial enrolled a diverse patient population, with 12.3% Black or African American, 18% Asian, 59% White, and 16.5% Hispanic participants. The primary effectiveness endpoint of limb salvage and primary patency at 1 year was met, demonstrating the superiority of the Esprit BTK scaffold over PTA, with consistent results across various race/ethnicity groupings.
STRIDE Study: Outcomes in Acute Limb Ischemia Treated with Mechanical Aspiration Thrombectomy
The STRIDE study assessed the Indigo Aspiration System (Penumbra, Inc.) for lower extremity acute limb ischemia (LE-ALI). At 30 days, the target limb salvage (TLS) rate 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 supports the Indigo system as a safe and effective first-line treatment for LE-ALI, while also highlighting the need for further research into racial disparities.
ELEGANCE Registry: Endovascular PAD Treatment in Underrepresented Minorities and Women
The ELEGANCE registry focused on endovascular drug-eluting peripheral artery disease (PAD) treatment in underrepresented patient populations, using the Ranger Paclitaxel-Coated Balloon and/or Eluvia Paclitaxel-Eluting Stent (both Boston Scientific Corporation). The registry enrolled 41.6% women and 41.6% underrepresented racial/ethnic groups. Despite differing disease characteristics, the 12-month above-ankle amputation incidence was low at 0.8%, and the overall freedom from clinically driven target lesion revascularization rate was 89.6%. The findings suggest that paclitaxel-based revascularization is effective and safe in diverse patient groups.
