Paris, France: Promising results were reported in late-breaking trials with novel bioresorbable stent technologies at EuroPCR 2017, paving the way for ongoing developments in stents that are dissolved or reabsorbed after achieving vessel expansion in percutaneous coronary intervention procedures.
Researchers reported results with seven bioresorbable stent technologies:
- Nine-month clinical and imaging outcomes of a novel ultra-high molecular weight poly-L-lactide BRS. A prospective multicenter international investigation: The RENASCENT II study.
Results from the prospective multicentre RENASCENT II study of the Amaranth Medical APTITUDE BRS stent, a novel ultra-high molecular weight poly-L-lactide BRS with a new, thinner strut (120 μm), reported no events at one year in 60 patients treated for single lesion coronary artery stenosis. Coronary artery imaging with optical coherence tomography (OCT) demonstrated excellent wall apposition and full, homogenous endothelial wall coverage, with no valleys and peaks between regions with struts and those without struts. "The results are very positive. The scaffold delivers a very low medium-term event rate and the stent favours good laminar flow in blood vessels," said lead author Antonio Colombo, from San Raffaele Scientific Institute, Milan, Italy, although he cautioned that the study was small.
- Prospective, multicentre evaluation of the DESolve Novolimus-Eluting coronary BRS: imaging outcomes and four-year clinical and imaging results
The key imaging results from the DESolve Nx Study, a prospective registry including 126 patients, showed a mean lumen gain of 9% at six months, as measured by intravascular ultrasound (IVUS), and an angiographic late luminal loss (LLL) of 0.2mm. "This is a clinical breakthrough as no other BRS technology has been successful in achieving such impressive results and, at the same time, degrading in six months with near complete resorption (mass loss) in one year," said lead author Stefan Verheye, from ZNA Middelheim, Antwerpen, Belgium. He added that the 18-month and 36-month imaging data showed sustained efficacy and confirmed the degradation and complete resorption (mass loss) in one year. There were no late or very late definite or probable scaffold thromboses and no target lesion revascularisations from years two to four. Verheye concluded, "Early degradation and early resorption is not only an intuitive wish, it is a must for a BRS technology in order to succeed. Companies attempted but failed to achieve clinical effectiveness, primarily due to chronic recoil of their scaffolds. In an effort to resolve this issue, companies had to revert to much longer degradation and resorption profiles. The Elixir DESolve scaffold is the only technology to date to resolve the chronic recoil issue, as evidenced by the Nx trial data."
- One-year clinical and multislice computer tomography results with a thin-strut poly-L-lactic acid-based sirolimus-eluting bioresorbable vascular scaffold in patients with coronary artery disease: MeRes-1 study
One-year results from the first-in-man MeRes-1 study of the safety and efficacy of the novel MeRes 100 scaffold in 108 patients with 116 de novo coronary artery lesions showed that the composite endpoint of cardiac death, myocardial infarction (MI) and ischaemia-driven target lesion revascularisation (ID-TLR) occurred in one patient (0.93%). There was no scaffold thrombosis. One-year computed tomography (CT) angiography demonstrated that all scaffolds were patent. Six-month quantitative coronary angiography showed a low rate of late lumen loss and no restenosis. Intravascular ultrasound and OCT analyses also gave favourable results, reported Ashok Seth, from Fortis Escort Heart Institute, New Delhi, India. He said, "The positive results of this study provide the basis for a larger, randomised trial against a second-generation metallic drug-eluting stent."
Data were also reported for the following studies, but results were not available to include in the press release:
- The FANTOM II study: first report for the 12-month clinical outcomes of the Fantom sirolimus-eluting bioresorbable scaffold - Alexandre Abizaid, Instituto Dante Pazzanese, Sao Paulo, Brazil
- Multicentre evaluation of a novel 120μm novolimus-eluting, fully coronary BRS: first report of six-month clinical and imaging endpoints - Alexandre Abizaid, Instituto Dante Pazzanese, Sao Paulo, Brazil
- Short and midterm safety, clinical performance and multi-modality imaging results of the drug-eluting absorbable metal scaffold: combined data of the BIOSOLVE-II and BIOSOLVE-III trials - Michael Haude, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany
- A first-in-man study of the Firesorb Sirolimus Target Eluting Bioresorbable Vascular Scaffold in patients with coronary artery disease (FUTURE-I): one-year clinical and imaging outcomes - Bo Xu, Fu Wai Hospital, Beijing, China
San Raffaele Scientific Institute
Fortis Escorts Heart Institute
New Delhi, India
Städtische Kliniken Neuss
Instituto Dante Pazzanese
Sao Paulo, Brazil
Fu Wai Hospital
EuroPCR 2017 session: Tuesday 16 May 12.00-13.30, Hot Line/Late-breaking Trials, Coronary Interventions, Stents and Scaffolds; Room 351
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Notes to Editors
What is EuroPCR?
EuroPCR, the official annual meeting of the European Association for Percutaneous Cardiovascular Interventions (EAPCI), a registered branch of the European Society of Cardiology, is the world-leading course in interventional cardiovascular medicine. PCR has established a distinctive format for educational activities in the field of cardiovascular interventions. Beyond its flagship course in Paris that gathers more than 11,500 participants every year, PCR organises annual courses in Singapore, London UK, Dubai EAU, Johannesburg RSA, Milan Italy, Chengdu China and Tokyo Japan.
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