Does Optical Coherence Tomography Optimise Results of Stenting

Does Optical Coherence Tomography Optimise Results of Stenting: The DOCTORS Study

Optical Coherence Tomography (OCT) is a recent imaging modality that yields cross-sectional images with a resolution 10 times greater than that of intravascular ultrasound (IVUS). OCT uses a near-infra-red light source to obtain images of the interior walls of the coronary arteries and is increasingly used to evaluate vulnerable atherosclerotic plaques and assess placement and response to stenting. - To date, no study has evaluated whether optical coherence tomography (OCT) contributes to optimizing percutaneous coronary intervention (PCI) and stenting.

The DOCTORS study is a randomized, open label study to evaluate whether OCT-guided angioplasty would provide useful clinical information beyond that obtained by angiography, and whether this information would subsequently modify physician behavior and treatment choices. In particular, we will evaluate the impact of changes in procedural strategy resulting from the use of OCT on the value of fractional flow reserve (FFR) obtained after angioplasty and stent implantation of a lesion responsible for non-ST segment elevation acute coronary syndromes.

Inclusion Criteria:

Patients aged 18 to 80 years inclusive, admitted for acute coronary syndrome (ACS) with the following symptoms :

• Clinical signs of ischemia (chest pain) at rest lasting for at least 10 minutes in the previous 72 hours;

• AND at least one of the following two criteria :

  • New ST segment depression ≥1 mm or transitory ST segment elevation (<30 minutes) (≥1 mm) on at least 2 contiguous leads of the ECG; OR
  • Elevation (>upper limit of normal, ULN) of cardiac enzymes (CK-MB, Troponin I or T).

AND Presenting an indication for coronary angioplasty with stent implantation of the target lesion considered to be responsible for the ACS.

AND Written informed consent.

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from the study:

• Left main stem disease
• Presence of coronary artery bypass grafts
• Cardiogenic shock or severe hemodynamic instability
• Severely calcified or tortuous arteries
• Persistent ST segment elevation
• One or more other lesions considered angiographically significant and located on the target vessel
• Severe renal insufficiency (creatinine clearance ≤30 mL/min)
• Bacteraemia or septicaemia
• Severe coagulation disorders
• Patients who refuse to sign the informed consent form