Abstract 14282: A Prospective Randomized Trial Using Optical Coherence Tomography to Compare the Xience V Everolimus-Eluting Stent with a Bare Metal Stent Postdilated with a Paclitaxel-Eluting Balloon (OCTOPUS Trial)
Background: We evaluated the Xience V® everolimus eluting stent (DES; Abbott Vascular) against the bare metal stent Coroflex Blue® postdilated with the paclitaxel-eluting balloon Sequent Please® (BMS+DEB; B Braun) regarding endothelialisation and neointimal proliferation using optical coherence tomography (OCT). (ClinicalTrials.gov identifier: NCT01056744)
Methods: Ninety-one patients with de novo lesions scheduled for elective percutaneous coronary intervention (PCI) were openly randomized to either Xience V or Coroflex Blue/Sequent Please. Angiographic follow-up (f/u) and intracoronary OCT were attempted after 6 months in all patients. OCT endpoints were: (1) endothelial coverage, expressed as % of uncovered struts, and respectively (2) neointimal proliferation, given as total volumetric proliferation within the stent and as peak focal area proliferation. A quantitative OCT algorithm was applied to each stent by steps of one mm.
Results: Stent implantation was successful in 116 lesions (n=52 DES and n=64 BMS+DEB) and 6-month f/u with OCT was completed for 87 lesions (n=46 DES and n=41 BMS+DEB). Significant restenosis of the treated lesion occurred in 3 patients (2: BMS+DEB, 1: DES, n.s.). Stent expansion evaluated by OCT was optimal in both device groups. OCT analysis showed significantly more neointimal tissue growth measured in mm³ proliferation volume/cm stent length in BMS postdilated with DEB (15.69 ± 7.6 mm³/cm) compared to DES (11.21 ± 5.3 mm³/cm, p = 0.002). However, we found no differences regarding peak focal in-stent stenosis (39.39 ± 13.5 % in BMS+DEB vs. 36.95 ± 15.9 % in DES, n.s.). Both devices showed comparable results for stent endothelialization (uncovered stent struts: 4.1 ± 8.9 % in DES vs. 3.8 ± 7.3 % in BMS+DEB, n.s.) allowing discontinuation of clopidogrel therapy after 6 months.
Conclusion: The Xience V® stent and the Coroflex Blue stent postdilated with a Sequent Please balloon showed similar results regarding peak focal in-stent stenosis and endothelial coverage 6 months after implantation. Further studies are required to evaluate the clinical impact of stronger neointimal proliferation in bare metal stents postdilated with paclitaxel eluting balloons.
- Percutaneous coronary intervention
- Drug eluting stents
- Coronary artery disease
- Local delivery
- © 2012 by American Heart Association, Inc.