Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Percutaneous Coronary Intervention, Drug Eluting Stent, Optical Coherence Tomography, Thrombosi, Long lesions in native vessels requiring overlap
Brief 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 assigned to receive multiple zotarolimus eluting stents (Resolute Sprint). The completeness of stent struts coverage and/or late malapposition are evaluated by Optical Coherence Tomography at 6 months follow-up.Data will be compared to the historical arm of ODESSA trial (patients treated with multiple sirolimus-,paclitaxel polymer-or zotarolimus eluting stents).
Detailed description
It is not unknown whether overlapping drug-eluting stents provide increased vessel toxicity. 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 detects 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 assigned to receive multiple Resolute Sprint™. 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. Obtained data will be compared with the data from a historical comparator (ODESSA trial that presented results from TAXUS Libertè™ vs Cypher Select™ vs Endeavor™ stents implanted in overlap to treat long lesions.
Interventions
DEVICEResolute Sprint
Zotarolimus Eluting Stent (Resolute Sprint) implanted in overlap
DEVICESirolimus Eluting Stent
Cypher stents implanted in overlap
DEVICEPaclitaxel Eluting Stent
Taxus stents implanted in overlap
Endeavor stents implanted in overlap
Sponsors
Case Western Reserve University
Medtronic Vascular
A.O. Ospedale Papa Giovanni XXIII
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be at least 18 years of age * Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia) * Native coronary artery disease with \>75% diameter stenosis (no prior stent implant, no prior brachytherapy) * Lesion length \> 20 mm * Vessel size between 2.5 and 3.5 mm * Multiple, overlapped Endeavor Resolute stents placement (intention to overlap \> 4 mm).
Exclusion criteria
* Left main coronary artery disease * Lesions in coronary artery bypass grafts * Acute myocardial infarction * Killip class IV * Recent major bleeding (6 months) * Renal failure with creatinine value \> 2.5 mg/dl * Left ventricular global ejection fraction ≤ 30%. * Allergy to aspirin and or clopidogrel/ticlopidine * Patient in anticoagulant therapy * No suitable anatomy for OCT scan: (only ostial location, very tortuous anatomy, very distal or large vessels \[\> 3.5 mm in diameter\]) * Target lesion(s) located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy) \< 9 months prior to index procedure * Target lesion restenotic from previous stent implantation * Any lesion (target or non-target) that has been previously treated with brachytherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In stent NIH at overlapping vs non overlapping sites | 6 month | In-stent neointimal hyperplasia (NIH) thickness at 6 months, as measured by OCT, at overlapping vs non overlapping sites: superiority of Endeavor Resolute stent compared to Endeavor Sprint |
| Percent uncovered and malapposed struts in OCT | 6 month | Proportion of stent struts uncovered and/or malapposed at 6 months, as measured by OCT, at overlapping vs non overlapping sites: non inferiority of Endeavor Resolute compared to Endeavor Sprint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of > 30% uncovered struts/total number of struts per section. | 6 months | — |
| MACE Rates | 1-6 and 12 months | All specific components of MACE (cardiac death, myocardial infarction (Q wave and non Q wave), and target vessel revascularization) will be summarized. MACE shall be assessed at, discharge (or within 7 days, whichever comes first), 1, 6 and 12 months post index procedure. |
| IVUS parameters | 6 months | Based on IVUS Core Lab analysis including: * Neointimal volume, stent volume, lumen volume and percent net volume obstruction * Neointimal Thickness: Neointimal hyperplasia (NIH) inside all struts (mean, median, max) * Percent NIH Area= (\[stent area-lumen area\]/stent area) X 100 * Rate of \> 30% uncovered struts/total number of struts per section. |
| QCA Parameters | 6 months | Based on Angiographic Core Lab analysis utilizing Quantitative Coronary Angiography (QCA) including: Mean lumen diameter, acute gain, late loss through 6 months, and binary restenosis (≥ 50% diameter stenosis) rate at 6 months post index procedure. |
Countries
Italy
Outcome results
None listed