Does OCT Optimise Results of Stenting on the Left Main Stem (DOCTORS-LM)

Centre Hospitalier Universitaire de Besancon

Status: Active, not recruiting

Conditions: Myocardial Ischemia; Myocardial Infarction; Non ST Segment Elevation Myocardial Infarction

Treatments: Device: Use of OCT to guide the angioplasty procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT04391413

2020-A00532-37

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

OCT group

Experimental group

Description:

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.

Treatment:

Device: Use of OCT to guide the angioplasty procedure

Control group

No Intervention group

Description:

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.