Bioresorbable stents: Reva Medical’s Fantom II, Meril Life Science’s MeRes100, MicroPort’s Firesorb
Fantom II: In the 240-patient Fantom II study of Reva Medical‘s Fantom bioresorbable stent, patients were compared over 6 months or 9 months for a primary endpoint of major adverse cardiac events and late lumen loss. At 6 months, the incidence of MACE in both cohorts was 2.1% while the mean LLL in cohort A was 0.25 ± 0.40mm.
“Results of the Fantom II trial demonstrate sustained performance and safety through 6 months of this novel bioresorbable scaffold,” Dr. Alexandre Abizaid, of São Paulo’s Instituto Dante Pazzanese de Cardiologia, said in prepared remarks. “This preliminary clinical data indicates good acute performance, as well as enhanced device deliverability, minimal residual stenosis and acute recoil.”
MeRes-1: This 1st-in-human study of the MeRes100 made by Meril Life Science showed that the device is safe and effective, with no major adverse cardiac events at 6 months. The study enrolled 108 patients in India, with a primary composite endpoint of major adverse cardiac events (cardiac death, myocardial infarction, ischemia-driven target lesion revascularization and ischemia-driven target vessel revascularization. The secondary endpoint was scaffold thrombosis. The study found no MACE or stent thrombosis after the deployment of the scaffold up to 6-month follow-up. Quantitative coronary analysis data showed in-scaffold late lumen loss of 0.15±0.26mm; intravascular ultrasound and optical coherence tomography showed no scaffold recoil and near complete strut coverage (99.3%) with neointima.
“The innovative design of the MeRes100 scaffold developed in India addresses some of the limitations of currently available [bioresorbable scaffolds]. The MeRes-1 1st-in-human study demonstrates that this new-generation, thinner-strut sirolimus-eluting BRS is safe and effective at 6 months,” Dr. Ashok Seth, of New Delhi’s Fortis Escorts Heart Institute, said in prepared remarks. “These encouraging results provide the basis for further studies using wider range of length and sizes in more complex and larger patient population moving to a randomized pivotal trial against the second generation metallic drug-Eluting stents by mid-2017.”
Future-I: Another 1st-in-human study, this trial enrolled 45 patients for treatment with the Firesorb BRS made by MicroPort, with a primary endpoint of 30-day target lesion failure and a patient-oriented composite endpoint of all death, all MI or any revascularization. The rate of 30-day TLF was 0% with no scaffold thrombosis; at six months, the composite endpoint was 3.3%. One patient underwent non-target vessel revascularization the day after the index procedure due to NSTEMI. The in-scaffold late loss was 0.15mm, the percentage of late recoil by IVUS was 0.76% and the proportion of covered struts was 98.4% including 100% in 7 patients by OCT, at 6-month follow-up, respectively.
“The six-month clinical, angiographic, IVUS, and OCT results of the Future-I study demonstrated the feasibility and preliminary safety and efficacy of the thin-strut PLLA-based sirolimus-eluting Firesorb BRS in the treatment of patients with single de novo coronary lesions,” Dr. Bo Xu, of Beijing’s Fu Wai Hospital, said in prepared remarks. “Long-term imaging follow-up is needed to provide more information, and a pivotal randomized controlled trial (Future-II) will be initiated soon.”
“Bioresorbable stents have the potential to be greatly impactful in the treatment of coronary artery disease, and it is exciting to see these first report investigations of several new and novel stents advancing the technology forward,” Dr. Ajay Kirtane, of the New York-Presbyterian Hospital/Columbia University Medical Center, said in a press release. “These results give us the first insights into their safety and efficacy, but larger randomized trials are necessary in order to establish their role in clinical practice.”