Coronary Artery Disease Clinical Trial
Official title:
A Prospective Randomized Study to Compare Vascular Healing After Deployment of the Abluminal Sirolimus Coated Bio-Engineered (Combo) Stent Versus the Everolimus Eluting Stent in Patients With Acute Coronary Syndrome by Means of OCT
OBJECTIVE It is the objective of the REMEDEE OCT study to assess vascular healing after
deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered
Sirolimus Eluting Stent) in patients with Acute Coronary Syndrome (ACS) with single de novo
native coronary artery lesions ranging in diameter from ≥2.5 mm to ≤3.5 mm and ≤ 20 mm in
length.
STUDY DESIGN The REMEDEE OCT study is a prospective, multicenter, randomized study designed
to enroll 60 patients with ACS who will be randomized 1:1 to be treated with the Combo stent
versus the commercially available everolimus eluting stent (Xience V or Promus). Patients
will receive Optical Coherence Tomography (OCT) and Quatitative Coronary Angiography (QCA)
follow-up imaging at 60 days post procedure. Clinical follow-up is scheduled at 30, 60, 180,
360 and 540 days. Furthermore, QCA and OCT will also be performed at baseline in all
participants of the study.
BACKGROUND The implantation of bare-metal stents (BMS) has significantly reduced clinical
and angiographic restenosis compared to balloon angioplasty alone after PCI due to
eliminating elastic recoil and reducing arterial remodeling. However, in-stent restenosis
still occurred frequently after BMS implantation in 20% to 40% of patients due to neointimal
proliferation. The development, clinical validation and widespread use of drug-eluting
stents (DES) have revolutionized the treatment of patients with coronary artery disease.
Large-scale, prospective, multicenter double-blind randomized trials have provided strong
evidence that drug-eluting stents significantly reduce angiographic restenosis and enhance
event-free survival compared with BMS after implantation in native coronary arteries
(3-6).However, despite an improved efficacy in the prevention of restenosis and target
vessel failure safety concerns have been raised for DES, focusing on a small but clinically
important increase in stent thrombosis occurring greater than one year after the index
procedure.
In patients receiving drug-eluting stents, the acute coronary syndrome has been identified
as one of the major risk factors of stent thrombosis (10). Therefore, concerns about the
long-term outcome and safety after drug-eluting stent implantation due to late stent
thrombosis and late stent malapposition have been raised.
Stent thrombosis, in particular late stent thrombosis, has been related to an impaired stent
healing, most of all to a reduced endothelial repair, i.e. reduced stent strut coverage,
after implantation of drug-eluting stents. This has resulted in the recommendation of a
prolonged 12-month double antiplatelet therapy with aspirin and clopidogrel after
drug-eluting stent implantation, however, how long double antiplatelet therapy is needed is
unknown at present. These observations have resulted in an intense search for alternative
strategies to promote stent healing and endothelial repair, rather than to inhibit the
endothelialisation of the stent, that is common to the substances used to prevent neointima
formation.
Notably, endothelial repair can be substantially stimulated by CD34+ endothelial progenitor
cells. The Combo stent is therefore covered with a CD34+ antibody to attract endothelial
progenitor cells to promote endothelial and stent healing, and on the abluminal side
releases sirolimus to prevent neointima formation and restenosis. Several preclinical
studies in the porcine coronary artery model have shown, that endothelialisation and stent
healing are accelerated in the Combo stent. The present study has therefore been designed to
compare stent healing of the Combo stent with the everolimus-eluting stent by optical
coherence tomography analysis (optical frequency domain imaging; OFDI), a high resolution
intracoronary imaging technique allowing accurate evaluation of stent coverage and healing,
in patients with an acute coronary syndrome. Previous studies have indicated, that coronary
stent healing after DES implantation is particularly impaired in patients with ACS, and
therefore this patient population is in a particular need of improved "pro-healing" stent
concepts with a high efficacy.
RATIONALE An important limitation of stents eluting only growth-inhibiting substances is,
that also the desirable endothelial cell growth over the stent struts is prevented, that is
thought to represent a major cause of "late-stent-thrombosis". The rationale for the design
of the "combo-stent" is therefore to combine a growth inhibiting substance with abluminal
release with an endothelial progenitor cell attracting design to promote endothelial repair.
In the pre-clinical studies, the "Combo Stent" demonstrated significantly lower neointimal
hyperplasia, while also showing improved endothelial coverage relative to other commercially
available DES. There was also a noticeably lower presence of inflammation and foreign body
reaction.
OCT- Examination of Vessel Healing Optical coherence tomography (OCT) is a novel
intravascular imaging modality based on infrared light emission that has a 10-20 fold higher
resolution (10-20 µM) as compared to current intravascular ultrasound systems, and allows a
detailed examination of stent healing. Strut coverage, strut apposition and neointima can be
quantified at a micron-scale level with a resolution 10-20 times higher than conventional
intravascular ultrasound. The quantification of stent healing by intravascular OCT analysis
has recently been validated against histology, demonstrating an excellent accuracy of the
OCT examination. Moreover, the safety and feasibility of OCT examination in a multicenter
study has been demonstrated. Newer modalities of OCT image acquisition, as used in this
study, have been reported to further simplify the technique and reduce procedural time.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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