First-in-man study shows feasibility of bioresorbable scaffold

Researchers for the DESolve study recommended testing the latest iteration of the device in a larger group of patients, based on results of a first-in-man-study published in the December issue of the Journal of the American College of Cardiology: Cardiovascular Interventions.

The first-in-man DESolve (DESolve Myolimus Eluting Bioresorbable Coronary Stent in the Treatment of Patients with De Novo Native Coronary Artery Lesions) study is a prospective trial that enrolled 16 patients in three centers to evaluate a poly-L-lactic acid-based polymer scaffold system (Elixir Medical). The scaffold is coated with a matrix of myolimus and a polyactide-based polymer. It is reabsorbed in approximately one year after implantation.

The study was led by Stefan Verheye, MD, PhD, of the Antwerp Cardiovascular Center at ZNA Middelheim Hospital in Antwerp, Belgium.

Enrolled patients had evidence of MI, a single de novo native coronary artery lesion and a reference vessel diameter of 3 mm or less. The principal safety endpoint was a composite of cardiac death, MI and clinically indicated target lesion revascularization. They assessed clinical endpoints at 30 days, six months and 12 months, and will continue annually to five years.

The study group used quantitative coronary angiography (QCA), intravascular ultrasound (IVUS) and optical coherence tomography imaging studies at baseline and six months, and multislice computed tomography (MSCT) at 12 months. The principal imaging endpoint was in-scaffold late lumen loss (LLL) assessed at six months by QCA.

One patient was excluded after the device didn’t cross the lesion within the limit set by the protocol. Procedural success was met in the other 15 patients. Assessments at 12 months found no scaffold thrombosis. At six months, in-scaffold LLL was 0.19 mm and the percent neointimal obstruction assessed by IVUS was 7.18 percent.

A thin, uniform layer of neotima covered the struts in 98.7 percent of the patients and the researchers described luminal patency at 12 months as “excellent.” No clinical events were directly attributable to the scaffold at one year.   

The mean lumen area within the scaffold assessed by MSCT at 12 months was larger than what was seen by IVUS at baseline and six months. “This early change in lumen growth is an important finding in vascular restoration therapy and may have significant clinical importance in the treatment of diffuse coronary artery disease in patients with diabetes mellitus or with acute MI, but also in the treatment of pediatric congenital vascular abnormalities where bioresorbable scaffolding will not interfere with vascular growth over time,” Verheye et al wrote.

The newer generation scaffold uses novolimus as an antiproliferative drug. They concluded that their findings “provided the necessary impetus to test the next iteration of this novel device in a larger cohort of patients.”