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Subintimal revascularization with biomimetic stent feasible in long femoropopliteal CTOs
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In patients with critical limb ischemia with long femoropopliteal chronic total occlusions, subintimal revascularization with a biomimetic stent appears to be a feasible strategy and superior to validated efficacy performance goals, according to results from the SUPERSUB study.
In the prospective, single-center, single-arm clinical trial, researchers evaluated 34 consecutive patients with CLI (32 men; mean age, 76 years) who underwent endovascular therapy of Trans-Atlantic Inter-Society Consensus (TASC) type C and D CTOs by subintimal revascularization and stenting (Supera, Abbott Vascular) of the neolumen between January 2014 and August 2015.
Patients eligible for inclusion were Rutherford classes 4 to 6, with transcutaneous partial pressure of oxygen (TCPO2) ≤ 30 mm Hg and no evidence of iliac disease. All had femoropopliteal CTOs of at least 15 cm in length (TASC II C-D) that were crossed subintimally.
Patients underwent follow-up visits at 3, 6, 9 and 12 months, which included performance of clinical, sonographic and X-ray monitoring.
The primary efficacy endpoint was the 12-month primary patency rate, defined as freedom from restenosis and freedom from clinically driven target lesion revascularization. Kaplan-Meier analysis was used to assess patency rates. The researchers defined secondary patency as freedom from restenosis and clinically driven TLR after the patient underwent a second endovascular therapy in the target lesion. The primary safety endpoint was the composite rate of freedom from death at any cause, major amputations and 12-month TLR. Secondary safety endpoints included stent integrity, clinical improvement, amputation-free survival, quality of life, cost efficiency and primary patency rate by lesion subtype at 12 months.
Positive outcomes
The researchers found that, by Kaplan-Meier analysis, the primary patency rate was 94.1%, and the standard error was 4%. The mean peak systolic velocity ratio was 1.2 at 3 months and 1.3 at 12 months. Freedom from clinically driven TLR was 97.1% with a standard error of 6.1%.
In 100% of patients, acute technical success and precise stent deployment was achieved; 21.4% of stents were deployed at nominal length; 60.7% had a mean elongation of 2.2% and 17.8% had a mean shortening of 2.2% relative to their nominal length. The rate of freedom from any-cause death and major amputations was 97.1%. All patients achieved and maintained clinical improvement during follow-up (100%), demonstrating wound healing (TCPO2 increased from 12.7 mm Hg to 54.8 mm Hg; P < .0001), and shift in Rutherford class 0 at 12 months. Additionally, patients demonstrated improvements in quality-of-life metrics in terms of mobility, ability to perform daily tasks and pain.
The rate of freedom from intraprocedural complication was 85.3%, with five patients (14.7%) experiencing superficial femoral artery pseudoaneurysms from the aggressive predilatation approach. There were no deaths related to the procedure, no stent fractures and no major amputations; the limb salvage rate was 100%. Six patients (17.6%) underwent preplanned minor amputations, resulting in an 82.4% rate of amputation-free survival.
More studies needed
“Caution should be exercised before considering this as a new standard of care,” the researchers wrote. “Larger multicenter studies are needed to validate the efficacy and safety of this proposed alternative treatment option, which for now just represents another ‘tool in the armamentarium’ of the CLI specialist.” – by Jennifer Byrne
Disclosure: Three researchers report consulting for Abbott Vascular.
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