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MINISTRY OF EDUCATION AND TRAINING MINISTRY OF DEFENCE 108 INSTITUTE OF CLINICAL MEDICAL AND PHARMACEUTICAL SCIENCES NGUYEN HOANG MINH PHUONG RESEARCH RESULTS OF LEFT MAIN CORONARY ARTERY INTERVENTION[.]

MINISTRY OF EDUCATION AND TRAINING MINISTRY OF DEFENCE

108 INSTITUTE OF CLINICAL MEDICAL AND PHARMACEUTICAL SCIENCES

-

NGUYEN HOANG MINH PHUONG

RESEARCH RESULTS OF LEFT MAIN CORONARY

ARTERY INTERVENTION UNDER INTRAVASCULAR ULTRASOUND - GUIDED IN CHRONIC CORONARY ARTERY DISEASE PATIENTS

Speciality: Internal Medicine/ Internal Cardiology

Code: 9720107

ABSTRACT OF MEDICAL PHD THESIS

Hanoi – 2023

THE THESIS WAS DONE IN: 108 INSTITUTE OF CLINICAL MEDICAL AND PHARMACEUTICAL SCIENCES

Supervisor:

1 A Prof PhD Pham Thai Giang

2 A Prof PhD Pham Manh Hung

Reviewer:

1 A Prof PhD Luong Cong Thuc

2 A Prof PhD Nguyen Ngoc Quang

3 A Prof PhD Nguyen Oanh Oanh

This thesis will be presented at Institute Council at: 108 Institute of Clinical Medical and Pharmaceutical Sciences

Day Month Year 2023

The thesis can be found at:

1 National Library of Vietnam

2 Library of 108 Institute of Clinical Medical and Pharmaceutical Sciences

3 Central Institute for Medical Science Infomation and Tecnology

INTRODUCTION

Coronary artery disease is the leading cause of death and disability

in developing and developed countries According to the Vietnam Heart Institute, the hospitalization rate for coronary artery disease increased from 3.4 - 6.0% (in 1994 - 1996) to 11.2 - 24% (in 2003 - 2007) [1]

The main cause of coronary artery disease is coronary atherosclerosis Due to large myocardial involvement, left coronary artery disease is associated with high mortality and disability Therefore, the European Heart Association in 2019 recommended reperfusion in patients with left main coronary stenosis > 50% diameter to improve prognosis at the I-A recommendation In the past, bypass surgery was considered the standard reperfusion approach However, in recent years, coronary intervention has been considered more frequently To avoid misclassification of the disease, many useful adjunct tools are applied to decision making In particular, intravascular ultrasound (IVUS) is the best considered intravascular imaging method in the evaluation of the left coronary artery [7] The clinical guidelines of the European Heart Association have reviewed its use IVUS in the assessment of severity of left main coronary artery disease with recommendation class IIa, level evidence B [7]

In Vietnam, interventional cardiology techniques have been widely deployed in the provinces However, LM intervention is still a challenge for many intervention rooms

Objectives:

1 Survey on clinical, subclinical characteristics and left main coronary artery lesions on intravascular ultrasound in patients with chronic coronary artery disease undergoing intervention

2 Evaluation of early outcomes of left main coronary artery percutaneous intervention under intravascular ultrasound guidance in patients with chronic coronary artery disease

Chapter 1

OVERVIEW 1.1 Diagnosis and treatment of left main coronary artery disease

1.1.1 Anatomy of the left main coronary artery

1.1.2 Left main coronary artery disease

Intermediate LMCA disease: defined when the LM severity is difficult

to assess by angiography but has a narrowing of about 30-50% These patients require additional trials such as FFR or IVUS to guide treatment [14]

Left main equivalent disease is defined as severe (≥70%) stenosis of the left anterior descending and circumflex arteries, with a similar prognosis to true left main disease [15]

1.1.2.3 Classification and causes

1.1.3 Diagnosis of left main coronary artery disease

1.1.4 Treatment of left main coronary artery disease

1.1.4.1 Risk of treatment strategy for systemic disease

1.1.4.2 Strategies for the treatment of LMCA disease

Includes medical treatment, percutaneous coronary intervention, and coronary artery bypass graft surgery

In the past, bypass graft surgery was considered the gold standard in the treatment of left main disease However, with the advancement in technology as well as equipment, percutaneous coronary intervention plays an increasingly important role in the treatment of left main diseases

1.2 Intravascular ultrasound in the diagnosis and treatment of LMCA disease

1.2.1 Intravascular ultrasound

1.2.1.1 Outline

Intravascular ultrasound (IVUS) is a catheter-based invasive imaging

It gives a cross-sectional view of the blood vessel at a time and a series

of images at a predetermined rate Based on the obtained images, people will analyze the structure of atheroma, vascular properties

1.2.1.2 Coronary artery imaging on IVUS

1.2.2 Intravascular ultrasound assessment of left coronary artery lesions

Because the left main coronary artery has an important role in myocardial blood supply, is short in size, and difficult to accurately assess on angiography, invasive imaging studies are recommended (class IIA recommendations according to recommendations) Report

of the American College of Cardiology [12], for intermediate LM injury, and recommended IIA for intervention as recommended by the European Heart Association [36]

1.2.3 Intravascular ultrasound guided intervention of the LMCA 1.2.3.1 Before the intervention

Prior to intervention, IVUS is used to assess: risk of lateral branch stenosis, and determine stent size

1.2.3.2 During the intervention

IVUS after intervention to evaluate the outcome of stents [61]

To decide on a second stent, IVUS (as well as FFR) plays an important role in assessing the extent of the lesion (as well as function) before and after the first stent, and in evaluating the outcome of the intervention [61]

1.2.3.3 After the intervention

After stenting, IVUS is used to evaluate procedural complications and risk of restenosis in the stent

1.2.4 The prognostic role of intravascular ultrasound in interventional guidelines for left main coronary artery disease

Despite the limitations of observational studies, all studies point to IVUS guidelines to improve long-term prognosis and mortality

1.3 Related studies

The LITRO registry study reported 354 patients with LMCA reperfusion in 90.5% (152/168) with MLA over IVUS <6mm2 and delayed in 96% (179/186) with MLA ≥ 6mm2; 2-year survival was 97.7% in the delayed group versus 94.5% in the reperfusion group (p

= 0.5) with event-free survival of 87.3% vs 80.6, respectively % (p = 0.3) [64]

From the EXCEL study, Kim et al reported long stent deformity in 33/506 (6.5%) with 81.8% in the ostium of left main coronary, 15.2%

in the shaft of left main, and 3.0% in LAD, not in POT or LCx After

3 years of follow-up, myocardial infarction associated with the left main coronary artery (18.9% vs 4.6%, p = 0.0005) and ischemic revascularization related to the left main The left main coronary artery (19.6% vs 7.7%, p = 0.02) was larger in lesions with vs without deformity although there was only a tendency for smaller MLA in deformed lesions ( 8.6 (7.1 - 10.9) vs 10.0 (8.3 - 11.5) mm2, p = 0.06) [69]

Recently, Kang et al reported the role of IVUS guidelines for left main interventions on long-term mortality (10 years) and cardiovascular events of left main interventions from the MAIN - COMPARE study [71] Of the 975 patients studied, IVUS guided the intervention used

in 756 patients (77.5%) 10-year observation recorded, compared between the two groups IVUS and guided angiography, mortality (16.4% vs 31.0%, p < 0.001) and cumulative mortality, Q wave myocardial infarction, stroke (19.2% vs 32.9%, p < 0.001) of the IVUS group was statistically significantly lower

In Vietnam, there are no specific studies on the application of intravascular ultrasound in left main coronary artery intervention

2.1.1 Selection criteria

Patients with chronic coronary artery disease are indicated for coronary angiography according to the Ministry of Health [77] and have coronary angiography under DSA

The results of coronary angiography below the DSA showed stenosis of the left main coronary artery (> 50% of the lumen diameter according to the method of quantification of coronary angiography) or severe lesions (≥ 70% of the diameter) of ostium or proximal segment

of the left anterior descending (LAD) and/or left circumflex (LCx) arteries (left main equivalent disease) with left main intermediate disease (30-50% lumen stenosis)

The patient and the patient's family consented to IVUS

When the patient is at high surgical risk and the SYNTAX score

< 32, the patient is indicated for left main intervention when the minimum lumen area (MLA) is 6 mm2 on IVUS according to the majority of previous study authors [6]

Agree to participate in the study

2.1.2 Exclusion criteria

Injury to the LMCA < 30% of the lumen diameter

Injury to the LMCA > 50% has a SYNTAX score ≥ 33 and low surgical risk

The patient underwent coronary artery bypass surgery

Severe comorbidities or survival < 1 year

The patient did not consent to participate in the study

2.1.3 Sample size: Convenient sampling method, regardless of

ethnicity, age and gender The number of patients is equal to 55 patients

2.1.4 Research place: Cardiology Institute, Bach Mai Hospital

2.2 Research Methods

2.2.1 Research Methods: Prospective, descriptive, no control group 2.2.2 Conduct research

2.2.2.1 The method of data collection

Eligible patients were included in the study Conduct data collection on history, medical history, clinical and paraclinical according to the study case

Clinically documented: cardiovascular risk factors (smoking, obesity, dyslipidemia), history of coronary artery disease and coronary intervention, comorbidities, degree of chest pain on admission according to CCS, degree of heart failure on admission according to NYHA

Subclinical: when entering the hospital, the patient has blood drawn for testing at the Department of Hematology/ Biochemistry, Bach Mai Hospital Patients underwent echocardiography at the Ultrasound Room, Cardiology Institute, Bach Mai Hospital

Conduct percutaneous coronary angiography by catheter at the angiography room, Vietnam Heart Institute

The patient's angiogram results will be evaluated by Quantitative Coronary Angiography (QCA) software

The results of coronary angiography with left main lesions ≥ 50%

of the lumen diameter, or left main equivalent disease, explain the indications for IVUS to the patient and family If the patient and family members agree, perform intravascular ultrasound

Based on the results of IVUS and coronary angiography, the intervention team consulted and decided to intervene and the general method of intervention

After placement of the LM stent, intravascular ultrasound was performed to optimize the stent as well as to evaluate complications Successful assessment of imaging based on coronary angiography after intervention When the patient was discharged from the hospital, the clinical assessment of the patient included complications of the intervention procedure, the degree of clinical improvement (chest pain, heart failure)

2.2.2.2 Technical equipment used in the study

2.2.2.3 Technical processes

A Prepare the patient

B Procedure steps

Coronary angiography by DSA

Intravascular ultrasound (IVUS)

Coronary intervention under IVUS guided

IVUS after intervention

Coronary angiography after intervention

The mean age was 68.9 years old, there were no patients younger than

50 years old, the proportion of patients over 70 years old was almost equal Men make up the majority of 61.8%

3.2 Clinical, subclinical characteristics and left main coronary artery lesions on intravascular ultrasound in patients with chronic coronary artery disease undergoing intervention

3.2.1 Cardiovascular risk factors and comorbidities

3.2.2 Clinical manifestations and diagnosis

Table 3.5 Clinical diagnosis

The majorities are stable angina and post myocardial infarction

3.2.3 Subclinical features

3.2.4 Characteristics of lesions of the left main coronary artery on percutaneous coronary angiography

3.2.4.1 Characteristics of LMCA

3.2.4.2 Characteristics of lesions of the LMCA on percutaneous coronary angiography

Table 3.11 Classification of left main diseases

LM disease classifications N = 55 Frequency n (%)

Significant LM stenosis (> 50%) 16 (29.1)

Intermediate LM stenosis (30 – 50%) 39 (70.9)

In our study, intermediate LM disease took part majority Intermediate

LM disease which interventioned because of combination proximal LAD and/or LCx disorders

Table 3.12 Lesion places of LMCA

Lesion places

N = 55

LM stenosis n(%)

Intermediate

LM stenosis n(%)

Lesions of distal LMCA were majority (78.2%)

Table 3.15 Medina classification

0,1,0 0 5 (15.2) 5 (11.6)

At bifurcation, Medina 1,1,0 were majority (44.2%)

Table 3.16 SYNTAX score

of the proximal and distal segments of the common body

3.2.5.2 Parameters on IVUS of the left main coronary artery

Table 3.19 Parameters of diameter and area of lesions on IVUS Parameters (M ± SD) Proximal Shaft Distal

n= 55 n = 51 n = 55 MLD (mm) 2.52  0.11 2,91  0.23 2.70  0.08 MLA (mm2) 5.5  0.14 5,32  0.46 5.47  0.09

Table 3.21 Parameters of atheroma on IVUS

Table 3.24 Comparison of the LM assessment between coronary angiography and IVUS

Parameters N = 55 Angiography IVUS p

Proximal MLD M ± SD (mm) 3.9  0.9 4.2  0.7 < 0.001 Distal MLD M ± SD (mm) 2.7  0.9 3.1  0.8 < 0.001 Proximal LAD disorders (n;

%)

20 (36.4) 12

(21.8)

< 0.001 Kappa = 0.57 Assessment of bifurcation disorder between IVUS and angiography had fairy good consensus Kappa = 0.57 (p<0.001)

3.3 Early outcomes of LMCA intervention under intravascular ultrasound guidance in patients with chronic coronary artery disease

3.3.1 Intervention strategies based on IVUS

Table 3.25 Changing the intervention strategy based on IVUS

Based on IVUS, the two-stent intervention strategy reduced to 12 cases (21.8%) In which, only 1 case from one coronary angiography-

based stent strategy changed to two IVUS-based stents, coronary angiography-based two-stent strategy decreased 8 cases to 11 cases intervention with 2 stents based on IVUS

3.3.2 Interventional technique of left main coronary artery

3.3.2.1 Access to the left main coronary artery

3.3.2.2 Characteristics of the one-stent techniques

Table 3.27 Characteristics of the one-stent techniques

3.2.2.3 Characteristics of the two-stent technique

Table 3.28 Two-stent techniquae of LM intervention