Although advances in drug-eluting stents (DES) have substantially reduced the risk of coronary in-stent restenosis (ISR) and the need for target lesion revascularisation (TLR), ISR persists. There are several treatment options for ISR (conventional balloon angioplasty, cutting or scoring balloons, drug-coated balloons, repeat DES implantation or bypass surgery). Coronary imaging is mandatory to perform PCI on ISR. Optimal coherence tomography (OCT) is an excellent option to guide PCI, but its role in ISR-PCI remains unclear. The INSIDE OCT Trial aims to compare the acute performance of PCI for ISR, either guided by OCT and angiography or by angiography alone.
Informed consent signed
Age ≥ 18 years
Referred for angiography either in stable or ACS setting suitability for PCI through femoral or radial access
A coronary in-stent restenosis between 70% and 99% in at least two projections in a vessel with a lumen diameter ≥ 2.25 - ≤ 5.75 mm (The severity of the stenosis should be based on visual estimation, with current online state-of-the-art angiographic equipment of the participating centres and after a mandatory dose of 50-200 mcg intracoronary of nitroglycerine.
Inability to give informed consent
Participation in another clinical study with an investigational product
OCT pullback not technically feasible in vessel site
Parallel
Percutaneous Coronary Intervention
Procedure/SurgeryUsing OCT to guide PCI in ISR
Imaging Outcome (powered): Delta MSA defined as: cross Sectional Area (CSA,mm2) post-PCI minus CSA (mm2) at baseline in the same coronary restenotic segment, continuous measure
Delta MSA assessed by OCT (same frame) in each randomized arm, measured at an independent OCT core laboratory blinded to imaging modality assignment.
Clinical outcome: MACE (Major Adverse Cardiovascular Events) in experimental vs control group
Time-to-first-event rate of the composite outcome of all cause of death, non-fatal MI, ID-TLR at 1 year in experimental group vs control group
Imaging Outcome: Delta MSA defined as: cross Sectional Area (CSA,mm2) post-PCI minus CSA (mm2) at baseline in the same coronary restenotic segment, continuous measure
Delta MSA assessed by OCT (same frame) in control (angio-guided) arm, in patients treated with additional manouvers after OCT disclosure, measured at an independent OCT core laboratory blinded to imaging modality assignment.
Number of cases in which additional PCI maneuvers was performed after disclosure of OCT pullback in the entire population
Additional PCI manouvers performed by operators after OCT disclosure including changings in size of balloons, any balloon dilatations, cutting/scoring, IVL, DEB, DES implantation
Number of intracoronary devices used in experimental vs control group (continuous, mean)
number of devices used including balloons stents and debulking devices
Number of patient with device-related (OCT) complications in the whole population
number of cases with perforations, dissections, abrupt vessel closure, TIMI flow reduction or other coronary complications related to advancement or retrieval or OCT probe pullback
Number of patient with acute kidney injury in the entire study population.
Acute kidney injury (AKI) was defined as the presence of any of the following (not graded): elevation in the serum creatinine level by \>= 0.3 mg/dl within 48hours; or increase \>= 1.5 times tnat at baseline or urine volume \< 0.5 ml/kg/h for 6 hours
Clinical outcome: MACE (Major Adverse Cardiovascular Events)
Time-to-first-event rate of the composite outcome of all cause of death, non-fatal MI, ID-TLR at 1 year in experimental group vs historical cohort of patients with ISR treated with angio-only guided PCI in the current DES generation
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