Does OCT Optimise Results of Stenting on the Left Main Stem

Study Overview
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Brief Summary
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The DOCTORS-LM study will investigate the impact of using optical coherence tomography (OCT) to guide the procedure in angioplasty of lesions of the left main stem responsible for myocardial ischemia.

Detailed Description
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Angiographic evaluation of lesions of the left main stem presents particular challenges and high procedural complexity. The clinical sequelae of a suboptimal result in this context may be severe, and thus, it is recommended that patients with left-main lesions be considered for imaging-guided interventions by means of optimal coherence tomography (OCT) in non-ostial left main lesions. The investigators have previously demonstrated in a randomized trial of patients undergoing PCI for a lesion responsible for non ST elevation acute coronary syndromes that OCT provides useful clinical information beyond that obtained by angiography alone, and OCT-guidance for angioplasty in these patients yielded a significantly higher proportion of patients with an optimal functional result after stenting. In this context, the aim of the present study is to evaluate whether OCT-guided left-main angioplasty is superior to left main angioplasty guided by fluoroscopy alone, as assessed by fractional flow reserve (FFR) measured after stent implantation. Eligible patients must be aged 18 years and over, admitted for acute coronary syndrome (ACS) or stable coronary artery disease (CAD); AND present an angiographically significant non-ostial lesion of the left main stem requiring angioplasty with drug eluting stent implantation.

Official Title
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Does Optical Coherence Tomography Optimise Results of Stenting of the Left Main Stem

Conditions
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Myocardial Infarction, Myocardial Ischemia, Non ST Segment Elevation Myocardial Infarction

Intervention / Treatment
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* Device: Use of OCT to guide the angioplasty procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years or over presenting with: NSTEMI or unstable angina or stable angina or documented silent ischemia AND De novo angiographic lesion (% diameter stenosis >=50%) or functionally significant (FFR<=0.80) lesion of the left main stem (median or distal) with or without lesions of the ostia of the LAD and/or circumflex arteries (= Medina classification 1-0-0, 1-0-1, 1-1-0, 1-1-1) or ostial lesion of the LAD and/or circumflex artery requiring angioplasty with stent implantation that will cover the distal left main stem (=Medina classification 0-0-1, 0-1-0 ou 0-1-1) AND SYNTAX score ≤ 22 (or >22 and ≤32 and validated by the Heart Team) Lesion with reference angiographic diameter <=5.5mm Signature of written informed consent form. Exclusion Criteria: Patients with: ST segment elevation myocardial infarction Ostial lesion of the left main stem Technically impossible to perform OCT Creatinine clearance ≤ 30 ml/min/1.73m² Left ventricular ejection fraction <30% Hypotension or cardiogenic shock Unstable ventricular arrhythmia Contraindication to dual antiplatelet therapy for at least 6 (or 12) months (duration depending on the initial clinical presentation). Shorter dual antiplatelet therapy is possible in patients with long-term anticoagulation. Hypersensitivity or contraindication to any of the antithrombotic therapies used during or after the procedure Life expectancy <1 year Persons under judicial protection Subjects with no social security coverage Anticipated non-compliance with the study procedures Pregnant or lactating women Subjects within the exclusion period of another clinical trial Failure to provide written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCT group<br>OCT will be performed after initial coronary angiography and at the end of the procedure. Several OCT runs can be performed. The operator may change procedural strategy, and use additional interventions. The operator must evaluate the following parameters, based on OCT data: Before angioplasty: reference diameter and reference area of distal main vessel; lesion length; presence and extent of thrombus or calcification. Stent implantation: Stent should be sized according to distal reference diameter, and should allow for expansion to the reference diameter of the proximal main vessel. After stent implantation: minimal and reference lumen diameter, minimal and reference lumen area, minimal stent area, presence of thrombus, presence of edge dissection, tissue protrusion, optimal lesion coverage, malapposition, suboptimal stent deployment. | Device: Use of OCT to guide the angioplasty procedure<br>* OCT will be performed and OCT data used to choose and/or modify procedural strategy. The OCT system used will be the Ilumien Optis system, and Dragonfly Optis probe.<br>|
| No Intervention: Control group<br>Angioplasty will be guided by traditional fluoroscopy alone, performed before and after stent implantation. The recommendation for angioplasty of left main stenosis is to use main vessel (MV) stenting with a proximal optimisation technique (POT) and provisional side branch (SB) stenting as a preferred approach. Predilatation of the side branch (SB) may be considered, but is recommended in the following circumstances: extensive ostial SB involvement, heavy calcification, etc. even with a provisional SB stenting approach. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome of the procedure (absolute value) | Functional outcome as assessed by the Fractional flow reserve (FFR) at the end of the procedure (average of at least 3 consecutive measures) | At the end of the procedure, once the operator judges the result to be satisfactory. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome of the procedure (dichotomized) | Percentage of patients with a final fractional flow reserve (FFR) value >=0.90 | At the end of the procedure, once the operator judges the result to be satisfactory. | 
| Relative change in final FFR value | Relative change in final FFR value as compared to initial FFR value at the start of the procedure in each patient | At the end of the angioplasty procedure | 
| Percentage of patients in whom OCT after stent implantation reveals a suboptimal result | Percentage of patients in whom OCT after stenting reveals a sub-optimal result, defined as the presence of any one or more of the following criteria: Stent under expansion Stent malapposition Lesion incompletely covered by the stent Residual stenosis upstream or downstream of the stent Edge dissection Thrombus Tissue protrusion through the stent struts | Immediately after stent implantation | 
| Percentage of patients in whom a change in procedural strategy is decided based on OCT data | Percentage of patients in whom a change in procedural strategy is decided based on OCT data, with use of any one or more of the following: GPIIb/IIIa inhibitors Thrombo aspiration Rotational atherectomy Additional stent implantation Additional balloon inflations Re-opening of strent struts in secondary branch | Immediately after stent implantation | 
| Safety of OCT in angioplasty of the left main stem | Safety of OCT in angioplasty of the left main stem, as assessed by duration of procedure (minutes) | At the end of the angioplasty procedure | 
| Safety of OCT in angioplasty of the left main stem | Safety of OCT in angioplasty of the left main stem, as assessed by - fluoroscopy time (minutes) | At the end of the angioplasty procedure | 
| Safety of OCT in angioplasty of the left main stem | Safety of OCT in angioplasty of the left main stem, as assessed by Radiation dose received (MSv) | At the end of the angioplasty procedure | 
| Safety of OCT in angioplasty of the left main stem | Safety of OCT in angioplasty of the left main stem, as assessed by Quantity of contrast medium used (mL) | At the end of the angioplasty procedure | 
| Safety of OCT in angioplasty of the left main stem | Safety of OCT in angioplasty of the left main stem, as assessed by change in creatinine clearance over the first 24 hours (Creatinine clearance in ml/min) | At the end of the angioplasty procedure | 
| Safety of OCT in angioplasty of the left main stem | Safety of OCT in angioplasty of the left main stem, as assessed by procedural complications | At the end of the angioplasty procedure | 
| OCT data that predict final FFR value >=0.90 | Thresholds for minimal lumen diameter and minimal stent area on OCT that best predict a final FFR value >=0.90 | At the end of the angioplasty procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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left main stem, angioplasty, optical coherence tomography, myocardial infarction