Strut coverage and vessel wall response to a new-generation paclitaxel-eluting stent with an ultrathin biodegradable abluminal polymer: Optical Coherence Tomography Drug-Eluting Stent Investigation (OCTDESI)

Abstract

Background: 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 paclitaxel-eluting stents (PES) with minimal biodegradable abluminal coating enhances strut coverage while preventing neointimal hyperplasia. Using optical coherence tomography (OCT) as a primary imaging modality, we assessed the proportion of uncovered struts at 6-month follow-up in PES coated with durable versus ultrathin (<1 microm) biodegradable abluminal polymers.

Methods and results: In this pilot trial, 60 patients with de novo lesions (< or =25 mm) in native coronary vessels were randomly assigned to receive either TAXUS Liberté PES or JACTAX PES, a Liberté stent with polymer deposited abluminally as microdots (JACTAX HD: 9.2 microg each of polymer and paclitaxel per 16-mm stent; JACTAX LD: 5 microg each). OCT follow-up occurred at 6 months with clinical follow-up through 1 year. The primary end point was percent uncovered struts by OCT. An independent core laboratory blinded to stent assignment analyzed images. The 6-month rate of uncovered struts per patient was 5.3+/-14.7% for TAXUS Liberté, 7.0+/-12.2% for JACTAX HD, and 4.6+/-7.3% for JACTAX LD (P=0.81); percent malapposed struts was 1.4+/-4.4%, 0.8+/-1.9%, and 1.1+/-2.8%, respectively (P=0.86). Strut-level intimal thickness was 0.20+/-0.10, 0.22+/-0.15, and 0.24+/-0.15 mm (P=0.64); percent volume obstruction by OCT was 22.2+/-12.8, 22.5+/-16.2, and 25.8+/-15.2 (P=0.69). There were no deaths, Q-wave myocardial infarctions, or stent thromboses through 1 year.

Conclusions: JACTAX PES with an ultrathin microdot biodegradable abluminal polymer did not result in improved strut coverage at 6 months compared with TAXUS Liberté.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00776204.