By Laura Cowen
A first-in-human trial of an everolimus-eluting bioresorbable vascular scaffold (BVS) has shown that the device can achieve a high 2-year patency rate and low 2-year target lesion revascularisation (TLR) rate in patients with peripheral artery disease (PAD) involving the external iliac artery (EIA) and superficial femoral artery (SFA).
The researchers, led by Johannes Lammer (Medical University of Vienna, Austria), say that the trial, conducted in 35 patients with symptomatic claudication, "demonstrated no safety concerns", while the efficacy data were "encouraging".
The ESPRIT BVS device, which consists of an everolimus-eluting poly-l-lactide scaffold, was successfully deployed, without recoil, to the SFA in 31 (88.6%) patients and to the EIA in four (11.4%) patients.
Pre-procedure, the minimum lumen diameter (MLD) was 1.01 mm, on average, and the mean in-segment percent diameter stenosis (%DS) 80.0%. After implantation, the mean in-scaffold MLD increased to 4.46 mm and the mean %DS fell to 9.2%. At 1 year these values were 3.24 mm and 31.8%, respectively.
The researchers report three procedure-related adverse events: two groin haematomas which resolved without intervention and one flow-limiting dissection that required bare-metal stent implantation during the index procedure.
These were described as "minor complications" by the authors, who also note that, at 2 years, there were no amputations within the cohort and only one death, which was unrelated to the device.
Furthermore, at 1 and 2 years, 87.9% and 83.9% of patients were free from binary restenosis, respectively, while 91.2% and 88.2%, respectively, had not needed TLR.
"The 1-year and 2-year freedom from TLR seems comparable to results of drug-eluting balloons and drug-eluting metal stents for peripheral arteries", remark Lammer et al in JAAC: Cardiovascular Interventions.
In addition, the ankle brachial index improved from 0.75 pre-procedure to 0.96 at 2 years, at which time 93.5% of patients achieved a maximum walking distance of 1500 feet.
Finally, 71% of patients were asymptomatic at 2 years, according to a Rutherford-Becker (RB) 0 classification. This compared with 57.1% having severe claudication (RB 3) and 34.3% having moderate claudication (RB 2) before the device was inserted.
Lammer and co-authors say that the small size and inclusion of patients with short (mean 35.7 mm) mild-to-moderately calcified TransAtlantic Inter-Society Consensus (TASC) A lesions only is a limitation of the study.
They conclude: "The scaffold needs to be tested in TASC B and C lesions as well and should be compared to other drug-eluting technologies."
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JACC Cardiovasc Interv 2016; 9: 1178-1187