WASHINGTON—MIV Therapeutics CEO, Mark Landy, MD, told Cardiovascular Business News that one of the most important findings from the one-year clinical data for the first-in-man VESTASYNC I trial, assessing its VESTAsync polymer-free drug-eluting stent (DES), was that there was statistically no degradation at 12 months. The data were presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference last week.
Alexandre Abizaid, MD, from the Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil, presented the VESTASYNC I data for the first time in a scientific setting.
The VESTAsync stent combines a stainless steel platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free sirolimus formulation (55 µm) that elutes drug for more than 40 days. Hydroxyapatite shows positive biocompatibility because it occurs naturally in the body.
Among the one-year findings, the VESTAsync had a late lumen loss of 0.36 at 12 months in all 15 patients, compared to 0.3 at four months, which was statistically insignificant, indicating no late-loss catch-up.
The intravascular ultrasound (IVUS) cohort had 14 matched patients. At four months, one IVUS device malfunctioned, so the data was lost for that patient, Landy explained. For the 14 matched patients in the IVUS cohort, VESTAsync showed a progression from 2.6 percent neointimal obstruction to 3.8 percent at four months—which was statistically insignificant and again, showed no late catch-up. At 12 months, the 15 patients showed 4 percent neointimal obstruction.
“These results have put us well within the parameters of where a company needs to be in trialing drug-eluting stents. Our polymer-free design has shown a very good drug effect and safety results,” Landy said.
He said that the next-generation stents can be broken down as either polymeric-based or non-polymeric-based platforms. “All polymeric-based stents are first-generation stents—whether it’s a durable polymer or a bio-absorbable polymer. Within that platform group, there have been attempts to improve the polymer and different iterations. Just because the polymer now erodes, doesn’t mean that you aren’t left with some of the same issues created with the first iterations of polymers.”
Landy notes that “a totally polymer-free system, made from products that occur naturally, is an actual biocompatible system.”
Each of the 15 patients in VESTASYNC I was no longer administered Plavix from five months out. “So far, they are all asymptomatic and event-free,” he said. Of the patient population, the mean age is 64, 60 percent are male, 33 percent are diabetics and 40 percent had a familial history of coronary artery disease.
In a rare editorial choice, the Journal of the American College of Cardiology: Interventions published VESTAsync’s four-month clinical outcomes in its October issue, indentifying it as “third-generation” DES. The authors concluded that the stent “demonstrated excellent acute results in the treatment of de novo coronary lesions.”
Enrollment has begun for the VESTASYNC II trial, which will have 120 patients; 90 of which will get the VESTAsync, 30 of which will get the VESTAcore (the VESTAsync without the drug). The plan is to have a three-month Plavix regime in the treatment arm, and 30 days in the VESTAcore arm. “We are significantly lowering the dual-antiplatelet regime,” Landy noted.
There will be IVUS and an optical coherence tomography sub-studies as components of the VESTASYNC II trials, he added
“We are currently considering the pros and cons of performing physiological sub-study, but there hasn’t been hard evidence that they add value. We are hoping that some literature will emerge in the next six months to prove whether it’s a valuable exercise or not,” Landy said.