New Delhi: Six-month clinical trial data shows world’s first thin strut fully dissolvable stent, developed in India, is safe, said Dr Ashok Seth, eminent interventional cardiologist and principal investigator of the study, while presenting the study findings at the Transcatheter Cardiovascular Therapeutics (TCT) Conference 2016 in Washington DC, on Monday.
The study titled MeRes-1 is the first-in-man study of the novel thin-strut PLLA-based sirolimus-eluting bioresorbable vascular stent (MeRes100). It considered six-month clinical, angiographic, intravascular ultrasound (IVUS), and optical coherence tomography (OCT) results in patients with coronary artery disease.
Presenting the findings of the study, Dr Ashok Seth, chairman of the Fortis Escorts Heart Institute, New Delhi and chairman of the cardiology council, Fortis Group of Hospitals, said, “The MeRes-1, first-in-man study demonstrates that this new generation thinner strut sirolimus eluting BRS (bioresorbable stents) is both safe and effective at six months. These encouraging results provide the basis for further studies using wider range of length and sizes in more complex and larger patient population.”
“The innovative design of the MeRes100 scaffold, developed in India by Meril Life Sciences, addresses some of the limitations of currently available bioresorbable stents (dissolvable stents) and may have higher success and lower complication rates in the long term. It would also cost much lesser than the currently available dissolvable stents and therefore give more benefit to higher number of patients,” added Dr Seth.
The MeRes100 is a low profile 100µm thin strut PLLA based BRS with a unique hybrid design featuring open cells at the centre and closed cells at the edges resulting in improved track-ability and access to side branches. It also has enhanced visibility with three circumferential radio opaque markers at each end.
In this prospective, multicentre, single arm trial of MeRes100 BRS, a total of 108 patients (116 lesions) were enrolled at 16 Indian sites from May 2015 to April 2016. The primary end-point was Major Adverse Cardiac Events (MACE), a composite of cardiac death, myocardial infarction, Ischaemia Driven Target Lesion Revascularization (ID-TLR), and Ischaemia Driven Target Vessel Revascularization (ID-TVR) at six months. The secondary end-point was scaffold thrombosis at six months.
According to Dr Seth, the study found no MACE or stent thrombosis (ST) after the deployment of the scaffold up to six-month follow-up. Quantitative Coronary Analysis (QCA) data at six months demonstrated very favourable in scaffold late lumen loss of 0.15±0.26mm. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) analysis showed no scaffold recoil and near complete strut coverage (99.3%) with neointima.
“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,” said Dr Ajay Kirtane, co-director of TCT; director of the Cardiac Catheterization Laboratories at NewYork-Presbyterian Hospital/Columbia University Medical Centre and an associate professor of medicine at Columbia University College of Physicians and Surgeons. “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.”
TCT is an annual scientific symposium of the Cardiovascular Research Foundation (CRF) featuring a number of first report investigations on novel stents that could become the next generation of bioresorbable stents in patients.