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 microm) biodegradable abluminal polymers.


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.


BACKGROUND
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00776204.
Guagliumi
Giulio
G
Division of Cardiology, Cardiovascular Department, Ospedali Riuniti di Bergamo, Italy. guagliumig@gmail.com
Sirbu
Vasile
V
Musumeci
Giuseppe
G
Bezerra
Hiram G
HG
Aprile
Alessandro
A
Kyono
Hiroyuki
H
Fiocca
Luigi
L
Matiashvili
Aleksandre
A
Lortkipanidze
Nikoloz
N
Vassileva
Angelina
A
Popma
Jeffrey J
JJ
Allocco
Dominic J
DJ
Dawkins
Keith D
KD
Valsecchi
Orazio
O
Costa
Marco A
MA
D020341:Absorbable Implants / Q000009:adverse effects*; D000368:Aged; D017130:Angioplasty / Q000009:adverse effects*; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000473:pathology / Q000503:physiopathology; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology* / Q000517:prevention & control; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000627:therapeutic use*; D010865:Pilot Projects; D011108:Polymers / Q000378:metabolism; D011183:Postoperative Complications; D041623:Tomography, Optical Coherence; D018084:Ultrasonography, Interventional
D011108:Polymers; D017239:Paclitaxel