Boston Scientific has announced results from sub-analyses of the Imperial clinical trial for the Eluvia Drug-Eluting Vascular Stent System.
Data demonstrated that the efficacy and safety performance of the polymer-coated Eluvia drug-eluting stent does not appear to be affected by challenging lesions, defined as being severely to moderately calcified or completely blocked within the superficial femoral and proximal popliteal arteries.
One of the analyses from the global, randomised, controlled Imperial trial, which evaluated the Eluvia Stent System in patients with symptomatic peripheral artery disease, assessed outcomes of patients diagnosed with moderate to severely calcified lesions. Highlights of the findings include:
- A primary patency rate – a measure of the target vessel remaining unobstructed at 12 months – for patients diagnosed with moderate to severe lesion calcification of 89.2%;
- A low rate (2.8%) of target lesion revascularisation in study participants with moderate to severe lesion calcification at 12 months;
- A low rate of stent thrombosis (1.1%) for patients treated with the Eluvia stent who were diagnosed with moderate to severe lesion calcification.
Frank Vermassen, Ghent University Hospital, Gent, Belgium, an investigator in the Imperial trial, said: “Our analysis demonstrated the Eluvia stent is a highly effective treatment option for some of the most complex lesion classifications commonly associated with femoropopliteal disease. The findings underscore the ability of this stent to successfully treat varying lesion characteristics, and its performance will continue to be observed in ongoing patient follow-up.”
Investigators also analysed the safety and performance of the Eluvia Stent System for patients diagnosed with having 100% blockage – or chronic total occlusions – at the target lesion and found that these patients experienced 83.9% primary patency at 12 months.
Ian Meredith, executive vice president and global chief medical officer, Boston Scientific, said: “The data adds to the clinical evidence supporting the Eluvia Stent System as a viable first-line treatment option for patients suffering from debilitating peripheral artery disease. Designed with a controlled release of the lowest possible drug dose to seek the best clinical outcomes, we believe the Eluvia stent can become a preferred therapy option and look forward to continued clinical successes with this product.”
The Eluvia Stent System received approval from the U.S. Food and Drug Administration in September of 2018 and CE Mark in February of 2016.