Optical Coherence Tomography for Drug Eluting Stent Safety
Summary
Increasing lesion complexity in percutaneous coronary interventions (PCI) has warranted the use of overlapping drug-eluting stents. Whether the substantial impairment of arterial healing observed at sites of overlap in preclinical pathologic studies persists in patients undergoing PCI is unknown. Consecutive patients with long lesions in native coronary vessels requiring stents in overlap are prospectively randomized to receive multiple sirolimus-,paclitaxel polymer-or zotarolimus eluting stents versus bare metal stents. The completeness of stent struts coverage and/or late malapposition are evaluated by Optical Coherence Tomography at 6 months follow-up
Description
If overlapping drug-eluting stents provide increased vessel toxicity is not known. Given the association of delayed healing and incomplete endothelialization observed in animal and human autopsy studies at overlapping sites it is unclear why most patients do well with multiple DES implanted. OCT detecs smaller degrees of in-stent neointima more accurately than IVUS and might be a useful method for identify strut coverage and/or malapposition.
Patients if eligible on the basis of clinical and angiographic criteria, are randomized (2:2:2:1) to receive multiple TAXUS Libertè™ vs Cypher Select™ vs Endeavor™ vs Libertè BM stents, in overlap. Stent implantation are done accordingly to the normal interventional practice. QCA and IVUS are performed at the end of optimal stents placement per visual judgement (residual stenosis < 10%, TIMI 3 flow). Stent, lumen size and volume as well as complete stent strut apposal will be determined by IVUS analysis. Clinical follow-up will take place at 1 month (±1 week), 6 months (±2 weeks) and 1 year (±2 weeks). At 6-months follow-up all patients will undergo a quantitative coronary angiography (QCA), IVUS and Optical Coherence Tomography (LightLab OCT Imaging M2, automated pull back and flushing combination)assessments.
OCT images will be acquired at 15-30 frames per second. Blind corelab quantitative strut by strut analysis will be performed using a novel dedicated software at each 0.5 mm section. The following OCT variables will be evaluated:number of visualized strut per section, mean-max neointimal thickness per section, % struts well apposed with neointima at overlapping vs non overlapping sites, % struts without neointima, % struts malapposed, rate of > 30% uncovered struts/total number of struts per section.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Coronary Artery Disease
Intervention
sirolimus drug eluting coronary stent Cypher™ (Cordis Corp, Johnson & Johnson Co), paclitaxel polymer drug eluting stent Taxus Libertè™ (Boston Scientific, Natick MS), zotarolimus drug eluting coronary stent Endeavor™ (Medtronic, Santa Rosa, CA),
Location
Cardiovascular Department Ospedali Riuniti di Bergamo
Bergamo
Italy
24100
Status
Recruiting
Source
Ospedali Riuniti di Bergamo
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00693030
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Coronary Aneurysm
Abnormal balloon- or sac-like dilatation in the wall of CORONARY VESSELS. Most coronary aneurysms are due to CORONARY ATHEROSCLEROSIS, and the rest are due to inflammatory diseases, such as KAWASAKI DISEASE.
Commotio Cordis
A sudden CARDIAC ARRHYTHMIA (e.g., VENTRICULAR FIBRILLATION) caused by a blunt, non-penetrating impact to the precordial region of chest wall. Commotio cordis often results in sudden death without prompt cardiopulmonary defibrillation.
Drug-eluting Stents
Stents that are covered with materials that are embedded with chemicals that are gradually released into the surrounding milieu.
Ectopia Cordis
A rare developmental defect in which the heart is abnormally located partially or totally outside the THORAX. It is the result of defective fusion of the anterior chest wall. Depending on the location of the heart, ectopia cordis can be thoracic, thoracoabdominal, abdominal, and cervical.
Sirolimus
A macrolide compound obtained from Streptomyces hygroscopicus that acts by selectively blocking the transcriptional activation of cytokines thereby inhibiting cytokine production. It is bioactive only when bound to IMMUNOPHILINS. Sirolimus is a potent immunosuppressant and possesses both antifungal and antineoplastic properties.
Clinical Trials
Non-Acute Coronary occlusIon Treated By Everolimus ELuting Stent
Chronic total coronary occlusions (CTO) have an especially high risk of angiographic restenosis, and need for new revascularization procedures. Drug-eluting coronary stents (DES) have demo...
Randomized Study Comparing Endeavor With Cypher Stents (PROTECT)
The PROTECT TRIAL is a randomized stent trial with 8800 patients in approximately 200 hospitals, which is designed to evaluate whether the Endeavor stent PROTECTS against late stent thromb...
The purpose of this study is to establish the safety and long-term effectiveness of coronary stenting with the ABT 578-eluting balloon expandable stent (Medtronic, Minneapolis, MN) vs. the...
ACROSS-Cypher Total Occlusion Study of Coronary Arteries 4 Trial
ACROSS-Cypher® is a prospective, multi-center, open label, single arm study of the Cypher® sirolimus eluting coronary stent in native total coronary occlusion revascularization. The pri...
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III (LONG-DES-III)
This randomized study is a multi-center, randomized, study to compare the efficacy of sirolimus versus everolimus-eluting stent implantation for long coronary lesions.
PubMed Articles
New developments in drug-eluting stents.
Although the use of balloon catheters or stents for the treatment of coronary artery lesions shows good short-term results, long-term prognosis due to the occurrence of restenosis in 20%-30% of patien...
Fracture of coronary artery sirolimus eluting stent with formation of four aneurysms.
Coronary stent fracture is a relatively rare but potentially serious complication of coronary artery stenting, in particular with sirolimus-eluting stents. It has been recognized as one possible cause...
Drug release from and coating morphology on a CYPHER sirolimus-eluting coronary stent (SES) during in vitro elution were studied by correlated confocal Raman and atomic force microscopy (CRM and AFM,...
The goal of this study was to compare the efficacy and safety of second-generation everolimus-eluting stents (EES) with first-generation sirolimus-eluting stents (SES) in primary percutaneous coronary...
Aims: Restenosis after PCI and/or stent implantation is still one of the challenging problems in the field of interventional cardiology. Different approaches to prevent and to treat restenosis include...
