Study demonstrates safety of Esprit bioresorbable vascular scaffolds with no deaths or amputations

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A clinical study has demonstrated the feasibility of the Esprit drug-eluting bioresorbable vascular scaffold (Abbott), with no deaths or amputations, in patients with symptomatic atherosclerotic disease of the superficial femoral artery or iliac arteries.  

The one year results of ESPRIT I were presented by Johannes Lammer of the Departments of Cardiovascular and Interventional Radiology, Medical University Vienna, Vienna, Austria, at the Leipzig Interventional Course (LINC; Leipzig, Germany; 28–30 January).

Thirty five patients with symptomatic atherosclerotic disease of the superficial femoral arteries or iliac arteries were included in the ESPRIT I clinical study. The key inclusion criteria were Rutherford category one to three; single de novo lesion of the superficial femoral artery or common or external iliac arteries; lesion length ≤50mm; and vessel diameter ≥5.5mm to ≤6.5mm.

At the start of the study, no patients were classed at Rutherford 0, 8.6% at Rutherford 1, 34.3% at Rutherford 2, and 57.1% at Rutherford 3. One month post-procedure, 84.9% of patients were classed at Rutherford 0, 12.1% at Rutherford 1, 3% at Rutherford 2, and 0% at Rutherford 3. After six months, 67.6% of patients were classed at Rutherford 0, 23.5% at Rutherford 1, 8.8% at Rutherford 2, and 0% at Rutherford 3. After one year, 73.5% of patients were classed at Rutherford 0, 11.8% at Rutherford 1, 8.8% at Rutherford 2, and 5.9% at Rutherford 3.

“Safety was demonstrated, there was no death or amputation; there was low occurrence of revascularisation (TLR rate at one year 8.8%); there was a sustained improvement in Rutherford one category (at one year 85% of the patients were in Rutherford 1); at duplex ultrasound we have a binary restenosis rate of 12.9%; and what we have learned when we saw the angiograms, was that it was important that the vascular scaffold matched appropriately with the vessel diameter. Therefore, in the smaller vessels the results were better,” said Lammer.

Importantly, Lammer commented, it was found that in patients with smaller vessels, where the average vessel diameter was equal to or less than the median diameter of all 35 patients, there was less in-scaffold restenosis than in those patients with larger vessels, and likely the scaffold had no full wall attachment and therefore the drug could not do its job. “Therefore, obviously it is very important that you have good embedment of the vascular scaffold into the vascular wall after treatment so that everolimus can do its job,” Lammer added. 

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