Clinical trial NCT01056744: Optical Coherence Tomography to Evaluate Paclitaxel-Eluting Balloons and Everolimus-Eluting Coronary Stents
Official title: Endothelial Stent Coverage and Neointimal Proliferation at 6 Months After Implantation of a Coronary Everolimus-Eluting Stent Compared With a Bare Metal Stent Postdilated With a Paclitaxel-Eluting Balloon: A Randomised Study Using Optical Coherence Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stents
Neointimal Proliferation
Keywords: coronary stent
optical coherence tomography
drug-eluting
neointimal proliferation
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: B. Braun Melsungen AG
name: Abbott Medical Devices
name: Boston Scientific Corporation
First posted: 2010-01-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background:

Safety concerns regarding use of drug eluting stent systems (DES) are related mostly to late stent thrombosis, which is facilitated by incomplete stent endothelial coverage. Specific information about time course and amount of endothelial strut coverage of different DES is required, in order to further refine the concept of antiplatelet therapy after DES implantation. Optical coherence tomography (OCT) is emerging as a new gold standard for endovascular imaging of stents, atherosclerosis progression, vulnerable plaque and neointimal proliferation. Very limited OCT data about endothelial coverage of DES are currently available. Aim of this study is a comparative evaluation of XIENCE V® everolimus eluting stent (Abbot Vascular) and of the bare metal stent (BMS) Coroflex® Blue postdilated with the drug-eluting balloon (DEB) SeQuent® Please (paclitaxel-eluting balloon, B. Braun Melsungen AG) in terms of endothelial coverage and neointimal proliferation using OCT.

Study Design:

A number of 80 patients scheduled for elective percutaneous coronary intervention (PCI) with a native coronary stenosis suitable for DES implantation and OCT imaging are openly randomized 1:1 to either XIENCE V® or Coroflex® Blue/Sequent® Please. The study is prospectively conducted at a university high-volume PCI center with OCT expertise (Jena, Germany). Angiographic follow-up and OCT imaging with motorized pull-back at 1 mm/s are planned in all patients 6 months after implantation of the study stents. OCT endpoints are: (1) endothelial coverage, expressed as % of struts without coverage and % of stent length containing non-covered struts, and respectively (2) neointimal proliferation, given as % neointimal volumetric proliferation within the whole stent and also as focal peak % neointimal area proliferation. The study is not powered for clinical endpoints, which are: subacute or late stent thrombosis and need for revascularization of the stent segment. Given the high number of measurements (15 cross-section images / 1 mm stent length), OCT endpoints are likely to reach significance at the level P \< 0.05 even at a follow-up drop-out rate up to 20%.


Eligibility criteria: Inclusion Criteria:

* Established indication to PCI according to the guidelines of American Heart Association and American College of Cardiology
* Age \> 18 years, written consent
* Native coronary lesion suitable for stent placement and OCT imaging

Exclusion Criteria:

1. General exclusion criteria:

   * Pregnancy and breast feeding mother
   * Co-morbidity with an estimated life expectancy of \< 50 % at 1 year
   * Scheduled major surgery in the next 6 months
   * Not able to give informed written consent or non-compliance
   * Participation in other PCI trial
2. Procedural exclusion criteria:

   * Acute coronary syndromes and cardiogenic shock
   * Previous subacute or late coronary stent thrombosis
   * Known non-responsiveness / allergy to aspirin or thienopyridines
   * Known allergy against everolimus or against taxol derivates
3. Angiographic exclusion criteria:

   * Culprit lesion within the proximal 10 mm of the right or left coronary artery
   * Saphenous vein grafts
   * Estimated stent length \> 30 mm

Primary outcomes:
measure: Endothelial coverage of the stent struts assessed by optical coherence tomography
timeFrame: 6 months
Secondary outcomes:
measure: Neointimal proliferation within the stent assessed by optical coherence tomography
timeFrame: 6 months
measure: Subacute or late thrombosis of the study stent
timeFrame: 6 months
measure: Need for revascularization of the vessel segment containing the study stent
timeFrame: 6 months
Other outcomes:
Locations:
city: Jena
country: Germany
facility: University Hospital of Jena, 1st Medical Department, Division of Cardiology
Study officials:
affiliation: Jena University Hospital
name: Tudor C Poerner, MD, PhD
role: STUDY_DIRECTOR
affiliation: Jena University Hospital
name: Hans R Figulla, Professor
role: STUDY_CHAIR
References:
citation: Poerner TC, Otto S, Gassdorf J, Nitsche K, Janiak F, Scheller B, Goebel B, Jung C, Figulla HR. Stent coverage and neointimal proliferation in bare metal stents postdilated with a Paclitaxel-eluting balloon versus everolimus-eluting stents: prospective randomized study using optical coherence tomography at 6-month follow-up. Circ Cardiovasc Interv. 2014 Dec;7(6):760-7. doi: 10.1161/CIRCINTERVENTIONS.113.001146. Epub 2014 Nov 4.
citation: Poerner TC, Otto S, Gassdorf J, Janiak F, Danzer C, Ferrari M, Figulla HR. A prospective randomised study using optical coherence tomography to assess endothelial coverage and neointimal proliferation at 6-months after implantation of a coronary everolimus-eluting stent compared with a bare metal stent postdilated with a paclitaxel-eluting balloon (OCTOPUS Trial): rationale, design and methods. EuroIntervention. 2011 May;7 Suppl K:K93-9. doi: 10.4244/EIJV7SKA16.