Bioresorbable Vascular Scaffolds (BVS) could change the paradigm of peripheral angioplasty according to several small studies suggesting these everolimus eluting devices could significantly improve symptoms in patients with intermittent claudication.
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Three year outcomes of the ESPRIT I trial, presented at VIVA 2016 (held in Las Vegas) showed there were no new events between the second and the third year of follow up, which shows good results at long term.
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The key to keeping events rate low seems to be proper sizing of vessel diameter prior to placing the scaffold.
The ESPRIT I, which was a first-in-human, included 35 patients from 7 centers in Europe with lesions both in the superficial femoral (89%) and the external iliac (11%) arteries. Previously, there had been no reports of procedure or device related deaths, or amputations, at 2 year follow up with the ESPRIT everolimus eluting scaffold.
Data at 3 years expand and confirm the latter, showing sustained patency and symptom relief. Freedom form TLR was 88.1% at 2 years and it was sustained at 3 years.
Four patients from the study received scaffolds with improper sizing given their artery diameters exceeded the 6.5 mm upper limit cutoff set by researchers. If these patients were removed from the analyzis, TLR rate would drop form 13.8% to 8% at 3 years. There was only one thrombosis observed in one of the four patients receiving oversized scaffolds.
All treated lesions were relatively simple and we should not forget the cost/benefit ratio.
Original Title: ESPRIT I Trial: Three-year results of the evaluation of the ESPRIT bioresorbable vascular scaffold (ESPRIT BVS) in the treatment of patients with occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Reference: Jaff MR. VIVA 2016. Las Vegas, NV. September 21, 2016.
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