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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Infarction; Myocardial Ischemia; Non ST Segment Elevation Myocardial Infarction
• Intervention / Treatment: Device: Use of OCT to guide the angioplasty procedure

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.

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France
    • Hôpital Privé saint Martin
  • Chartres, France
    • Centre Hospitalier de Chartres - Hôpital Louis Pasteur
  • Clermont-Ferrand, France
    • CHRU Clermont Ferrand
  • Massy, France
    • Institut Cardiovasculaire Paris Sud
  • Nîmes, France
    • CHU Nimes - Hopital Caremeau
  • Paris, France, 75014
    • Institut Mutualiste Montsouris
  • Poitiers, France
    • CHU Poitiers
  • Rouen, France
    • Clinique Saint Hilaire
  • Saint-Laurent-du-Var, France
    • Institut Arnault Tzanck
  • Trévenans, France
    • Hôpital Nord Franche-Comté
  • Please Select
    • Besançon, Please Select, France, 25000
      • CHU Besançon
    • Lille, Please Select, France
      • CHRU Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OCT group; 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; 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.
No Intervention: Control group; 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?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Nicolas Meneveau, MD, PhD, Cardiology Department, CHU Besancon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2020
• Primary Completion (Actual): June 16, 2022
• Study Completion (Anticipated): July 16, 2023

Study Registration Dates

• First Submitted: April 2, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: myocardial infarction; optical coherence tomography; angioplasty; left main stem
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: 2020-A00532-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No