Does Optical Coherence Tomography Optimise Results of Stenting

Centre Hospitalier Universitaire de Besancon240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Acute Coronary Syndromes

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (8)

Annecy Hospital

Annecy, Metz-Tessy, France

Centre Hospitalier

Belfort, France

University Hospital Jean Minjoz

Besançon, France

Centre Hospitalier de Chambery

Chambéry, France

Hôpital Gabriel Montpied

Clermont-Ferrand, France

Centre Hospitalier Universitaire Régional

Lille, France

Institut Mutualiste Montsouris

Paris, France

Nouvel Hôpital Civil

Strasbourg, France

Outcomes

Primary Outcomes

Functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR)

Evaluation of the functional result of the angioplasty procedure as assessed by fractional flow reserve (FFR) at the end of the procedure. The average of three consecutive FFR measures will be recorded.

Time frame: Measured at the end of the angioplasty procedure

Secondary Outcomes

Percentage of patients in whom OCT revealed a sub-optimal result of angioplasty

Assessed by the presence of any one or more of the following criteria: Incomplete coverage of the lesion by the stent, Residual stenosis upstream or downstream from the stent, Edge dissection, Presence of thrombus, Tissue protrusion through the stent struts, Stent Malapposition.

Time frame: Assessed during the initial angioplasty procedure (Day 0)

Percentage of patients in whom a change in procedural strategy was decided based on the information obtained from OCT images

Any one or more of the following criteria based on the information obtained from OCT images: Diameter and length of implanted stents Supplementary balloon inflations Implantation of supplementary stent(s) Use of glycoprotein (GP) IIb/IIIa inhibitors Use of thrombo-aspiration Use of rotational atherectomy

Time frame: During the initial angioplasty procedure, as soon as the operator decides whether or not to proceed with additional interventions based on OCT data (Day 0)

Safety of OCT in the context of angioplasty for ACS

Safety as assessed by the following criteria: * Duration of the procedure * Fluoroscopy time * Quantity of contrast medium used * Procedural complications (no reflow, coronary perforation, occlusive dissection, spasm, stent occlusion, troponin peak at 24 hours, creatinine clearance at 24 hours)

Time frame: At the end of the angioplasty procedure (Day 0) and up to 24 hours (for peak troponin and creatinine clearance)

Adverse cardiac events at 6 months

Any one or more of the following: * Death * Recurrent MI * Stent thrombosis * Repeat revascularisation of the target vessel

Time frame: Recorded by telephone contact with the patient, the treating physician or general practitioner or cardiologist at 6 months after initial angioplasty

Determination of a threshold value for quantitative OCT measures (i.e. minimal lumen diameter and minimal lumen area) that best predict a fractional flow reserve value >=0.90.

Determination of a threshold value for quantitative OCT measures (i.e. minimal lumen diameter and minimal lumen area) that best predict a fractional flow reserve (FFR) value \>=0.90.

Time frame: At the end of the initial angioplasty procedure (Day 0)

Identification of quantitative OCT (i.e. minimum lumen diameter and minimum lumen area) variables that predict FFR as measured at the end of the initial angioplasty procedure.

Identification of quantitative OCT (i.e. minimum lumen diameter and minimum lumen area) variables that predict the value of fractional flow reserve as measured at the end of the initial angioplasty procedure on day 0.

Time frame: At the end of the initial angioplasty procedure (Day 0)

Comparison between online and offline analyses of OCT data

Comparison between results of online and offline analyses of OCT data.

Time frame: Analysis of offline data is performed centrally, and comparison will be performed once both online and offline analysis data are performed (Day 90)