Clinical trial on innovative stent shows ‘encouraging results’

New Delhi: A six-month clinical trial on a new-generation thin strut fully dissolvable stent in the world has thrown up “encouraging results”, in what could be a boon for the treatment of coronary artery disease, which is a global killer.

“The innovative design of the MeRes100 scaffold developed in India addresses some of the limitations of currently available bioresorbable stents (BRS) and may have higher success and lower complication rates in the long-term,” said Dr Ashok Seth, Chairman of the Fortis Escorts Heart Institute (FEHI), who led the study.

Seth presented

the findings of the trial at a global conference — The Cardiovascular Therapeutics (TCT) 2016, which ended yesterday in the US.

Coronary heart disease or ischaemic heart disease is a cardiovascular disease caused by narrowing of coronary arteries by a gradual build-up of fatty material within their walls.

“A total of 108 patients (116 lesions) were enrolled as part of a single-arm trial of ‘MeRes100’ bioresorbable stents (dissolvable stents) spread across 16 sites in the country from May 2015 to April 2016, which included hospitals from both public and private sector,” a senior official from Fortis Hospitals group said.

“It (stent) would also cost much less than the currently available dissolvable stents and therefore give more benefit to higher number of patients,” Seth said.

The Fortis Hospitals group’s official said “the stent was developed by a private company, and the study was commissioned last year by the Drug Controller General of India.”

“The first-in-man study demonstrates that this new generation thinner strut sirolimus-eluting BRS 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,” Seth was quoted as saying in a statement by FEHI.

Cardiovascular diseases (CVDs) are the number one cause of death globally and more people die annually from CVDs than from any other cause, according to WHO.

“An estimated 17.5 million people died from CVDs in 2012, representing 31 per cent of all global deaths. Of these deaths, an estimated 7.4 million were due to coronary heart disease and 6.7 million were due to stroke,” WHO says.

The MeRes100 is a low-profile 100 m 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, according to Fortis Hospital.

A stent a splint placed temporarily inside a duct, canal, or blood vessel to aid healing or relieve an obstruction.

The study considered six-month clinical, angiographic, intravascular ultrasound, and optical coherence tomography results in patients with coronary artery disease.

The TCT is the annual scientific symposium of the US-based 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.

“Bioresorbable stents (dissolvable 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 Ajay Kirtane, Co-Director of TCT.

Kirtane, also an Associate Professor of Medicine at Columbia University College of Physicians and Surgeons, said, “These results give us the first insights into their safety and efficacy, but larger randomised trials are necessary in order to establish their role in clinical practice.”

Other hospitals which participated in the study include AIIMS, G B Pant Hospital, Apollo Hospitals in Chennai and Hyderabad and Sanjay Gandhi Post Graduate Institute of Medical Sciences.

“The primary end-point was Major Adverse Cardiac Events (MACE), a composite of cardiac death, myocardial infarction, Ischaemia Driven Target Lesion Revascularisation (ID-TLR), and Ischaemia Driven Target Vessel Revisualisation (ID-TVR) at six months.

“The secondary end-point was scaffold thrombosis at six months. The study found no MACE or stent thrombosis (ST) after the deployment of the scaffold up to six month follow-up,” Fortis Hospital said.

A first-in-man study is a clinical trial where a medical procedure, previously developed and assessed through in vitro or animal testing, or through mathematical modelling is tested on human subjects for the first time.

PTI