Optical Coherence Tomography in Long Lesions (LONG OCT)

• 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.

  
  

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.