Myocardial Infarction, Myocardial Ischemia, Non ST Segment Elevation Myocardial Infarction
Conditions
Keywords
left main stem, angioplasty, optical coherence tomography, myocardial infarction
Brief summary
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
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.
Interventions
DEVICEUse of OCT to guide the angioplasty procedure
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.
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome of the procedure (absolute value) | At the end of the procedure, once the operator judges the result to be satisfactory. | Functional outcome as assessed by the Fractional flow reserve (FFR) at the end of the procedure (average of at least 3 consecutive measures) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in final FFR value | At the end of the angioplasty procedure | Relative change in final FFR value as compared to initial FFR value at the start of the procedure in each patient |
| Percentage of patients in whom OCT after stent implantation reveals a suboptimal result | Immediately after stent implantation | 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 |
| Functional outcome of the procedure (dichotomized) | At the end of the procedure, once the operator judges the result to be satisfactory. | Percentage of patients with a final fractional flow reserve (FFR) value \>=0.90 |
| Safety of OCT in angioplasty of the left main stem | At the end of the angioplasty procedure | Safety of OCT in angioplasty of the left main stem, as assessed by duration of procedure (minutes) |
| OCT data that predict final FFR value >=0.90 | At the end of the angioplasty procedure | Thresholds for minimal lumen diameter and minimal stent area on OCT that best predict a final FFR value \>=0.90 |
| Percentage of patients in whom a change in procedural strategy is decided based on OCT data | Immediately after stent implantation | 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 |
Countries
France
Outcome results
None listed