VIVA24: Late-Breaking Trials Highlight Advances in Vascular Intervention
核心洞察
The PROMISE II trial demonstrates sustained limb salvage and wound healing at 2 years using the LimFlow System (搜索) for no-option CLTI (搜索) patients.
DETOUR2 study reveals the durability of percutaneous transmural arterial bypass with the DETOUR System (搜索) for complex femoropopliteal disease (搜索), showing promising 3-year outcomes.
SIRONA trial's post-hoc analysis suggests sirolimus-coated balloons as a viable alternative to paclitaxel-coated balloons in femoropopliteal angioplasty.
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 (搜索) (CLTI (搜索)) and femoropopliteal disease (搜索), 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 (搜索) (Inari Medical) in patients with no-option CLTI (搜索). 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 (搜索) (Endologix) for percutaneous transmural arterial bypass (PTAB) in complex femoropopliteal disease (搜索). 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 (搜索), Concept Medical (搜索)) 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 (搜索) (Abbott) versus percutaneous transluminal angioplasty (PTA) in CLTI (搜索) patients with infrapopliteal peripheral artery disease (搜索), 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 (搜索) (Penumbra, Inc. (搜索)) 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 (搜索) (PAD (搜索)) treatment in underrepresented patient populations, using the Ranger Paclitaxel-Coated Balloon (搜索) and/or Eluvia Paclitaxel-Eluting Stent (搜索) (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.