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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCT group | Experimental | 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. |
|
| Control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of OCT to guide the angioplasty procedure | Device | 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Patients aged 18 years or over presenting with:
Exclusion Criteria:
Patients with:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Meneveau, MD, PhD | Cardiology Department, CHU Besancon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Besancon | Besançon | Please Select | 25000 | France | ||
| CHRU Lille |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27573032 | Result | Meneveau N, Souteyrand G, Motreff P, Caussin C, Amabile N, Ohlmann P, Morel O, Lefrancois Y, Descotes-Genon V, Silvain J, Braik N, Chopard R, Chatot M, Ecarnot F, Tauzin H, Van Belle E, Belle L, Schiele F. Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients with Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting). Circulation. 2016 Sep 27;134(13):906-17. doi: 10.1161/CIRCULATIONAHA.116.024393. Epub 2016 Aug 29. |
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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:
| 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:
| 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 |
| Lille |
| Please Select |
| France |
| Hôpital Privé Saint Martin | Caen | France |
| Centre Hospitalier de Chartres - Hôpital Louis Pasteur | Chartres | France |
| CHRU Clermont Ferrand | Clermont-Ferrand | France |
| Institut Cardiovasculaire Paris Sud | Massy | France |
| CHU Nîmes - Hôpital Carémeau | Nîmes | France |
| Institut Mutualiste Montsouris | Paris | 75014 | France |
| CHU Poitiers | Poitiers | France |
| Clinique Saint Hilaire | Rouen | France |
| Institut Arnault Tzanck | Saint-Laurent-du-Var | France |
| Hôpital Nord Franche-Comté | Trévenans | France |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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