scholarly journals A multi-center, international, randomized, 2-year, parallel-group study to assess the superiority of IVUS-guided PCI versus qualitative angio-guided PCI in unprotected left main coronary artery (ULMCA) disease: Study protocol for OPTIMAL trial

PLoS ONE ◽  
2022 ◽  
Vol 17 (1) ◽  
pp. e0260770
Author(s):  
Giovanni Luigi De Maria ◽  
Luca Testa ◽  
Jose M. de la Torre Hernandez ◽  
Dimitrios Terentes-Printzios ◽  
Maria Emfietzoglou ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Intravascular Ultrasound ◽  
Left Main Coronary Artery ◽  
Academic Research ◽  
International Study ◽  
Composite Endpoint ◽  
Coronary Intervention ◽  
Primary Outcome Measure ◽  
Left Main ◽  
Repeat Revascularization

Background Percutaneous coronary intervention (PCI) is used increasingly for revascularization of unprotected left main coronary artery (LMCA) disease. Observational studies and subgroup analyses from clinical trials, have suggested a possible benefit from the use of intravascular ultrasound (IVUS) guidance when performing unprotected LMCA PCI. However, the value of imaging with IVUS has never been proven in an appropriately powered randomized clinical trial. The OPtimizaTIon of Left MAin PCI With IntravascuLar Ultrasound (OPTIMAL) trial has been designed to establish whether IVUS-guided PCI optimization on LMCA is associated with superior clinical outcomes when compared with standard qualitative angiography-guided PCI. Methods The OPTIMAL trial is a randomized, multicenter, international study designed to enroll a total of 800 patients undergoing PCI for unprotected LMCA disease. Patients will be randomized in a 1:1 fashion to IVUS-guided PCI versus angiogram-guided PCI. In patients allocated to the angiogram-guided arm, use of IVUS is discouraged, unless there are safety concerns. In patients allocated to the IVUS guidance arm, pre-procedural IVUS assessment is highly recommended, whilst post-procedural IVUS assessment is mandatory to confirm appropriate stenting result and/or to guide stent result optimization, according to predefined criteria. Patients will be followed up to 2 years after the index procedure. The primary outcome measure is the Academic Research Consortium (ARC) patient-oriented composite endpoint (PoCE) which includes all-cause death, any stroke, any myocardial infarction and any repeat revascularization at 2 years follow-up. Discussion The OPTIMAL trial aims to provide definitive evidence about the clinical impact of IVUS-guidance during PCI to an unprotected LMCA. It is anticipated by the investigators, that an IVUS-guided strategy will be associated with less clinical events compared to a strategy guided by angiogram alone. Trial registration ClinicalTrials.gov: NCT04111770. Registered on October 1, 2019.

scholarly journals Use of Intravascular Ultrasound Imaging in Percutaneous Coronary Intervention to Treat Left Main Coronary Artery Disease

2017 ◽  
Vol 12 (01) ◽  
pp. 8 ◽  
Author(s):  
Giovanni Luigi De Maria ◽  
Adrian P Banning ◽  
◽  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Coronary Artery ◽  
Intravascular Ultrasound ◽  
Left Main Coronary Artery ◽  
Artery Bypass ◽  
Coronary Intervention ◽  
Careful Consideration ◽  
Intravascular Imaging ◽  
Left Main ◽  
Percutaneous Coronary

Due to its potential prognostic implications and technical complexity, revascularisation of left main coronary artery (LMCA) disease requires careful consideration. Since publication of the results of the SYNTAX study, and more recently the EXCEL and NOBLE trials, there has been particular interest in percutaneous revascularisation of the LMCA. It is becoming clear that percutaneous revascularisation of LMCA disease requires appropriate lesion preparation and carefully optimised stenting in order to offer patients a treatment option as effective as coronary artery bypass grafting. For this reason intravascular imaging, and especially intravascular ultrasound, is becoming a key procedural step in LMCA percutaneous coronary intervention. In the current review paper we analyse the role of intravascular imaging with intravascular ultrasound in LMCA percutaneous coronary intervention, focusing on the main applications in this context from lesion assessment to stent sizing and optimisation.

Unprotected Left Main Coronary Artery Percutaneous Coronary Intervention-Our Experiences at a Tertiary Hospital

2014 ◽  
Vol 6 (2) ◽  
pp. 107-111
Author(s):  
S Munwar ◽  
AHMW Islam ◽  
S Talukder ◽  
AQM Reza ◽  
T Ahmed ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Coronary Artery ◽  
Left Main Coronary Artery ◽  
Coronary Intervention ◽  
Drug Eluting Stent ◽  
Bare Metal ◽  
Coronary Artery Diseases ◽  
Left Main ◽  
Percutaneous Coronary ◽  
Drug Eluting

Background: Aim of the study was to evaluate the primary procedural success of percutaneous coronary intervention of unprotected left main coronary artery stenosis using either Bare-metal stents or drug eluting stent. Methods: Total 33 patients were enrolled in this very preliminary non-randomized prospective cohort study. Among them, Male: 25 and Female: 8. Total 35 stents were deployed. Mean age were for Male: 59 yrs, for Female: 62 yrs. Associated coronary artery diseases risk factors were dyslipidemia, High Blood pressure, Diabetes Mellitus, Positive family history for coronary artery diseases and smoking. Results: Among the study group; 26 (78%) were Dyslipidemic, 24(70%) were hypertensive; 17 (51.5%) patients were Diabetic, 11(33%) were smoker and 7(21%) patients had family history of Ischaemic heart disease. Female patients were more obese (BMI M 26: F 27) and developed coronary artery diseases in advance age. Common stented territory were left main: 20 (60%), Left main to left anterior descending artery 7 (22%) and Left main to left circumflex artery 6 (18%). Average length and diameter of stent was 3.5 and 18 mm respectively. Stent used: Bare Metal Stent 5 (15%), Drug Eluting Stent: 28 (85%). Among the different Drug Eluting Stents, Everolimus eluting stents were 11 (39.3%), Sirolimus eluting 10(35.7%), Paclitaxel eluting 3 (10.7%), Biolimus eluting 3 (10.7%) and Zotarolimus eluting1 (3.6%). In the present study, overall survival outcome was 94% (31 patient), mortality of cardiac cause 3% (1 patient) and 1 patient (3%) died of hepatocellular carcinoma. Conclusion: Our study has shown that percutaneous coronary intervention of the unprotected left main is a safe and effective alternative to Coronary Artery Bypass Graft (CABG). DOI: http://dx.doi.org/10.3329/cardio.v6i2.18349 Cardiovasc. j. 2014; 6(2): 107-111

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