OCTDESI Studies Boston Scientific's Jactax PES

July 20, 2010—Giulio Guagliumi, MD, et al published findings from OCTDESI (Optical Coherence Tomography Drug-Eluting Stent Investigation), a study of strut coverage and vessel wall response to Jactax (Boston Scientific Corporation, Natick, MA), a new-generation paclitaxel-eluting stent (PES) with an ultrathin biodegradable abluminal polymer. The findings were published online ahead of print in Circulation: Cardiovascular Interventions.

According to the investigators, the background of the study is that polymer-coated drug-eluting stents are effective in preventing restenosis but have been associated with delayed healing and incomplete strut coverage. It is unknown whether PES with minimal biodegradable abluminal coating enhances strut coverage while preventing neointimal hyperplasia.

Using optical coherence tomography (OCT) as the primary imaging modality, the investigators assessed the proportion of uncovered struts at 6-month follow-up in PES coated with durable versus ultrathin (< 1 µm) biodegradable abluminal polymers.

In this pilot trial, 60 patients with de novo lesions (25 mm) in native coronary vessels were randomly assigned to receive either Boston Scientific's Taxus Liberté PES or the Jactax PES, which is a Liberté stent with polymer deposited abluminally as microdots (Jactax HD, 9.2 µg each of polymer and paclitaxel per 16-mm stent; Jactax LD, 5 µg each). OCT follow-up occurred at 6 months, with clinical follow-up through 1 year. The primary endpoint was the percent of uncovered struts as seen on OCT. An independent core laboratory blinded to stent assignment analyzed the images.

The investigators found that the 6-month rate of uncovered struts per patient was 5.3% ± 14.7% for Taxus Liberté, 7% ± 12.2% for Jactax HD, and 4.6% ± 7.3% for Jactax LD (P = .81). The percentage of malapposed struts was 1.4% ± 4.4%, 0.8% ± 1.9%, and 1.1% ± 2.8%, (P = .86); strut-level intimal thickness was 0.2 ± 0.1 mm, 0.22 ± 0.15 mm, and 0.24 ± 0.15 mm (P = .64); and percent volume obstruction by OCT was 22.2% ± 12.8%, 22.5% ± 16.2%, and 25.8% ± 15.2 % (P = .69), respectively. There were no deaths, Q-wave myocardial infarctions, or stent thromboses through 1 year.

From these data, the investigators concluded that the Jactax PES with an ultrathin microdot biodegradable abluminal polymer did not result in improved strut coverage at 6 months compared with Taxus Liberté.