A company that believes removing the polymer from drug-eluting stents (DES) is at least one way of addressing the safety concerns surrounding the technology reported that the Journal of the American College of Cardiology Intervention (JACC) published preliminary results from its first human trial.

The VESTASYNC I trial, which evaluated MIV Therapeutics' (Atlanta) polymer-free DES, appears in the Oct. 21 issue of JACC and is available online at http://interventions.onlinejacc.org. Author J. Ribamar Costa Jr., MD, describes the results from the four-month follow-up of a multicenter, 15-patient, first-in-man study led by principal investigator Alexandre Abizaid, MD, PhD, chief of coronary intervention at the Institute Dante Pazzanese of Cardiology (Sao Paulo, Brazil).

"The publication of the preliminary VESTASYNC I trial results in such a prestigious, peer-reviewed journal as JACC is clearly a vote of confidence in the soundness of our science," said Mark Landy, MD, president/CEO of MIV. "We are very proud to be included and to receive this tremendous recognition by the scientific community."

DES makers have been in a race to address the safety issues surrounding DES ever since it became associated with a higher rate of thrombosis, or blood clotting. Before a company can truly solve the problem, however, it will have to get to the bottom of what is causing the higher rate of thrombosis – is it the drug itself or the polymer used to attach the drug to the stent?

"From our perspective the one way to try and solve these issues is to eliminate the polymer and then once and for all we know if it's a drug issue or a polymer issue," Landy told Medical Device Daily.

In the VESTASYNC I trial, MIV said, the VESTAsync DES was successfully implanted in all cases, and there were no procedure and in-hospital complications. Life-long aspirin and five-month clopidogrel therapy were prescribed for all patients. At four months, in-stent late lumen loss was 0.30 + 0.25 mm and percent of stent obstruction was 2.8 + 2.2%.

The VESTAsync DES late loss of 0.30 mm situates this new device among the highest-efficacy DES, with the advantage of a polymer-free system using less drug than first-generation equivalents, MIV said. After up to six months of clinical follow-up, no major adverse cardiac event was registered, the company added.

"The VESTAsync stent's been designed to address the safety issue that has arisen with polymer-based stents," Landy said.

Giving MDD an overview of what makes the stent unique – or, as he put it, "a 30,000-feet view putting it into three buckets" – Landy said the VESTAsync stent's benefits fall into three broad categories: biocompatibility, accelerated healing, and a more efficient drug-delivery system.

First, Landy said, MIV removed all polymers and other unnatural materials and replaced those with a drug-delivery system comprised of materials that occur naturally. Second, he said, "we've made sure that we accelerate healing and don't interfere with the normal healing process." So MIV came up with what it considers a more efficient drug-delivery system and were able to reduce the amount of drugs required to get the desired results. Third, Landy added, the coating is "much, much thinner" which also ensures that the stent heals in a "very normal and we believe expedited manner."

MIV hopes its VESTAsync also will reduce the length of time the patient requires anti-platelet therapy after the procedure. In the VESTASYNC I trial, for example, patients received anti-platelet therapy for five months, and in the VESTASYNC II trial patients were given anti-platelet therapy for just three months. The current anti-platelet standard is a minimum duration of one year and in many cases is life-long therapy, the company noted.

MIV said its VESTASYNC II trial is a 120 randomized controlled study designed to demonstrate the safety and efficacy of the VESTAsync where patients are given anti-platelet medication (Plavix) for only three months.

"That's the thing about peer-reviewed articles, while they're fantastic they're kind of always about a year behind where you really are," Landy said, noting that the JAAC article only reported results from the VESTASYNC I trial even though the company is already working on the second trial.

He told MDD that MIV was the first company to prove there is a direct correlation between the amount of drug used and the efficiency of the drug-delivery system. Also, he said, while other companies have tried to develop a polymer-free DES, Landy says MIV has the lead data.

"We're really the first company that is taking a bold step and addressing the concerns we have with polymer-based stents," Landy said.