Optical Coherence Tomography in Long Lesions (LONG OCT)
Recruitment status was Active, not recruiting
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).
Coronary Artery Disease
Device: Resolute Sprint
Device: Sirolimus Eluting Stent
Device: Paclitaxel Eluting Stent
Device: Zotarolimus eluting stent
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Optical Coherence Tomography in Long Native Coronary Artery Lesions Treated With Multiple Novel Zotarolimus-eluting Stents: LONG OCT STUDY|
- In stent NIH at overlapping vs non overlapping sites [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]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 [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]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.
- Rate of > 30% uncovered struts/total number of struts per section. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- MACE Rates [ Time Frame: 1-6 and 12 months ] [ Designated as safety issue: Yes ]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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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.
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||May 2011|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Active Comparator: ODESSA
ODESSA trial (NCT 00693030)Patients were randomized (2:2:2:1) to receive multiple TAXUS Libertè™ vs Cypher Select™ vs Endeavor™ vs Libertè BM stents, in overlap. At 6-months follow-up coronary angiography (QCA), IVUS and Optical Coherence Tomography assessments were made. Data reported in J. Am. Coll. Cardiol. Intv. 2010;3;531-539. DOI 10.1016/j.jcin.2010.02.008.
Device: Sirolimus Eluting Stent
Cypher stents implanted in overlapDevice: Paclitaxel Eluting Stent
Taxus stents implanted in overlapDevice: Zotarolimus eluting stent
Endeavor stents implanted in overlap
Experimental: Resolute Sprint arm
Zotarolimus Eluting stents (Resolute Sprint) implanted in overlap to treat long coronary lesions
Device: Resolute Sprint
Zotarolimus Eluting Stent (Resolute Sprint) implanted in overlap
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133925
|Cardiovascular Department Ospedali Riuniti di Bergamo|
|Bergamo, BG, Italy, 24128|
|Principal Investigator:||Giulio Guagliumi, MD||Cardiovascular Department Ospedali Riuniti di Bergamo|