Clinical Trial: TRANSFORM OCT TRiple Assessment of Neointima Stent FOrmation to Reabsorbable polyMer With Optical Coherence Tomography

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Prospective Optical Coherence Tomography (OCT) Study on Coronary Vessel Wall Response to Stent Eluting Everolimus From a Biodegradable Polymer (EES SYNERGY™) Compared With Stent Eluting Zotaro

Brief Summary: First prospective randomized controlled study to evaluate in an 'all-comers' population with coronary artery disease whether treatment with a novel everolimus eluting stent (EES) with a biodegradable polymer is superior to a durable polymer zotarolimus eluting stent (ZES), with respect to the long term vascular response to treatment These data are important to ascertain the superiority of a new generation DES with bioabsorbable polymer coating to reduce the long term development of in-stent neoatherosclerosis.

Detailed Summary: During the last decade a considerable clinical experience has been accumulated with the use of drug eluting coronary stents with durable polymers, that permanently cover the metallic stent scaffold, allowing the local delivery of anti-restenotic agents. However durable polymers have been associated with an increased risk of late and very late stent thrombosis and the anticipated development of in stent neo-atherosclerosis. Since permanent polymer coatings may have pro-inflammatory effects, with delayed healing and prolonged endothelial dysfunction, current research on DES has focused on the use of biodegradable polymer coatings, which disappear after a short period of drug-release (3-4 months). Current clinical guidelines recommend at least 6-12 months of dual antiplatelet therapy (DAPT) after DES implantation,in order to prevent ST. Recent data obtained by pooled analyses of ZES, support a significant reduction of the DAPT to the same range used with bare metal stents. The substantial delays in DES healing observed from multiple human pathology series and in-vivo studies using Optical Coherence Tomography (OCT) were not assessed as risk factors for prolonged used of DAPT. However different patient cohorts might have different responses to stent implantation. In addition, there is no comparative evidence on long term development of neo-atherosclerosis in bioabsorbable versus permanent polymer DES. OCT allows precise assessment of stent strut apposition and coverage and accurate measures of different tissue components of neoatherosclerosis. This study is the first attempting to characterize the early and late vascular responses to novel bioabsorbable polymer EES (SYNERGY™) compared with a permanent polymer benchmark novel generation ZES (RESOLUTE INTEGRITY™) .The stent comparator has been selected due to the large use across the interventional cardiology community and the recent approval from European Regulators Authorities to update the CE (Conformit
Sponsor: A.O. Ospedale Papa Giovanni XXIII

Current Primary Outcome:

  • percentage of frames with in stent-lipid laden neointima, neovascularization, calcification and thin-cap fibro-atheroma (TFCA) [ Time Frame: 18 months ]
    OCT finding of neoatherosclerosis, counted as percentage of frames with in stent-lipid laden neointima, neovascularization, calcification and thin-cap fibro-atheroma (TFCA) (18 month primary end-point)
  • length of consecutive frames with uncovered struts [ Time Frame: 3 and 18 months ]
    OCT derived maximum length of consecutive frames with uncovered struts in the two stent arms at 3 and 18 month (3 month primary end-point and 18 months co-primary end-points)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • percent well apposed struts at implant without neointima [ Time Frame: 3 and 18 months ]
    OCT derived proportion of well apposed struts at implant without neointima (% uncovered struts) at 3 and 18 months
  • Acquired stent malapposition [ Time Frame: 3 and 18 moths ]
    Number and extent (max area-volume) of newly acquired malapposed struts at 3 and 18 months.
  • OCT derived abnormal intraluminal tissue [ Time Frame: 3 and 18 months ]
    Presence of any abnormal intraluminal protruding mass at 3 and 18 months
  • percentage OCT frames with uncovered struts [ Time Frame: 3 and 18 months ]
    Number/percentage of OCT frames with > 30% uncovered struts at 3 and 18 months
  • Neointimal tissue thickness [ Time Frame: 3 and 18 months ]
    OCT calculated thickness of tissue covering stents at 3 and 18 months
  • OCT derived percentage of frames with mature neointima [ Time Frame: 3 and 18 months ]
    Percentage of frames with evidence of mature neointimal coverage in the two stent arms
  • OCT derived tissue heterogeneity in neointima deposition [ Time Frame: 3 and 18 moths ]
    Segmental tissue heterogeneity in neointima deposition across the entire stent length (as assessed by OCT tissue properties parameters - including normalized intensity, attenuation, tissue contrast) at 3 and 18 months


Original Secondary Outcome: Same as current

Information By: A.O. Ospedale Papa Giovanni XXIII

Dates:
Date Received: October 24, 2013
Date Started: November 2013
Date Completion: September 2016
Last Updated: July 2, 2015
Last Verified: March 2015