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)

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 mu m) biodegradable abluminal polymers. Methods and Results-In this pilot trial, 60 patients with de novo lesions (<= 25 mm) in native coronary vessels were randomly assigned to receive either TAXUS Liberte PES or JACTAX PES, a Liberte stent with polymer deposited abluminally as microdots (JACTAX HD: 9.2 mu g each of polymer and paclitaxel per 16-mm stent; JACTAX LD: 5 mu g 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 Liberte, 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 Liberte