Nghiên cứu đặc điểm tổn thương và kết quả can thiệp đặt stent chỗ chia nhánh động mạch vành thủ phạm ở bệnh nhân hội chứng mạch vành cấp TT TIENG ANH

MINISTRY OF EDUCATION ANDTRAINING MINISTRY OF NATIONAL DEFENCE VIETNAM MILITARY MEDICAL UNIVERSITY LE THANH BINH RESEARCH ON CULPRIT CORONARY ARTERY BIFURCATION LESION CHARACTERISTICS AND STENTING IN PATIENTS WITH ACUTE CORONARY SYNDROME Speciality : Internal Medicine Code : 9720107 ABSTRACT OF MEDICAL DOCTORAL THESIS HA NOI - 2022 The thesis has been completed at: VIETNAM MILITARY MEDICAL UNIVERSITY Supervisor: Prof PhD Pham Manh Hung Prof PhD Nguyen Oanh Oanh Reviewer 1: Prof PhD Pham Nguyen Son Reviewer 2: Prof PhD Pham Thi Kim Lan Reviewer 3: Prof PhD Ta Manh Cuong The thesis will be present in front of board of university examiner and reviewer hold at Military Medical University At on / / 2022 The thesis can be found at: - National Library - Library of Military Medical University LIST OF SCIENTIFIC WORKS PUBLISHED RELATED TO THE THESIS Lê Thanh Bình, Phạm Mạnh Hùng, Nguyễn Oanh Oanh (2021) Investigation the Clinical, Laboratory, and Lesion Characteristics in Patients with Acute Coronary Syndrome and Bifurcation Lesion Stenting, Vietnam Medical Journal, 504(1): 61-65 Lê Thanh Bình, Phạm Mạnh Hùng, Nguyễn Oanh Oanh (2021) Patients with Coronary Artery Bifurcation Lesions Treated by Axxess Stent Implantation, Journal of Military Pharmaco – medicine, 46(6): 216-226 INTRODUCTION Acute coronary syndrome (ACS) is one of the serious events of coronary artery disease and is a medical emergency Except for some diseases that cause pandemics (such as COVID-19), ACS is currently still the leading cause of death in the world Today, along with advances in diagnosis and combination drugs, percutaneous coronary intervetion (PCI) is an effective treatment for ACS, which has significantly reduced mortality The prevalence of coronary artery bifurcation lesions is reported to be between 15% and 20% of all performed coronary angiograms and despite progressive development of coronary percutaneous techniques, still those lesions represent a challenge for interventional cardiologists, especially in patients with ACS Complex coronary bifuraction lesions make PCI more challenging and are linked to higher rates of procedural complications, such as side branch loss, as well as higher rates of long-term Major Adverse Cardiovascular Events (MACE) compared to non-bifurcation lesions The use of a provisional side branch (SB) stenting strategy is one of the fundamental philosophies of the European Bifurcation Club (EBC) and consequently the use of a second stent during bifurcation treament is madated only under specific circumstances However, despite these efforts, the gold-standard technique, especially during ACS, has not been yet defined and there is no general consensus on how to restore coronary branches flow due to the presence of complex double coronary bifurcation lesions occurred during ACS In those complex cases, probably most operators would opt for fast coronary flow restoration in the main vessel (MV) with provisional stenting, treating the close major branch only if required by limited flow or residual significant disease after this fist provisional strategy However, the disadvantage of this approach is the difficulty in accessing the SB and the rate of intraprocedural SB closure can be from 7% to 20% The AXXESS stent (Biosensors Europe SA, Morges, Switzerland) is a self-expanding biolimus-A9 eluting stent designed to treat easily the complex anatomy of bifurcation lesions With a conical V shape, the device is positioned at the level of the bifurcation carina without the need for stent recrossing, allowing the treatment of both distal branches with minimum carina strut coverage In order to contribute to understanding the bifucation lesion characteristics as well as the results of stenting at the cuprit lesion in the patients with ACS, we conducted a study on the topic: “Research on coronary artery bifurcation lesion characteristics and stenting in patients with acute coronary syndrome” Objectives of the thesis Investigate some clinical, laboratory and culprit coronary bifurcation lesion characteristics in patients with ACS Evaluate short-term PCI outcomes in culprit coronary bifurcation lesions using provisional stenting technique or dedicated AXXESS stent based on the lesion morphology in patients with ACS The necessity of the study ACS is a common medical emergency today Culprit coronary bifurcation lesions remain one of the most challenging lesions in interventional cardiology, especially in patients with ACS Despite the fast growing scientific literature related to ACS, its optimal management remain a subject of considerable debate One of the main concerns when dealing with ACS is the potential increased risk of late stent thrombosis associated with treatment complexity The use of a provisional side branch (SB) stenting strategy is one of the fundamental philosophies of the European Bifurcation Club (EBC) However, the major drawback of this strategy is the difficulty in accessing the SB (especially in true bifurcation lesions) and the higher rates of long-term MACE The AXXESS stent (Biosensors Europe SA, Morges, Switzerland) is a self-expanding biolimus-A9 eluting stent designed to treat easily the complex anatomy of bifurcation lesions With a conical V shape, the device is positioned at the level of the bifurcation carina without the need for stent recrossing, allowing the treatment of both distal branches with minimum carina strut coverage Published results from international long-term studies have confirmed the safety and efficacy of AXXESS stent in patients with bifurcation lesions Therefore, it is necessary to conduct a study to evaluate the results of PCI in coronary bifurcation lesions using provisional stenting technique or AXXESS stent based on lesion morphology in Vietnamese patients New Contribution of the thesis Results of the thesis have shown that coronary artery bifurcation lesions were common in the left anterior descending (LAD) (79.4%) Medina 1.1.1 bifurcation and Medina 1.1.0 bifurcation were the most common with 48.2% and 30.5%, respectively The majority of the patients (79.4%) had a bifurcation angle < 700 Culprit coronary bifurcation lesion treatment with using provisional stenting technique or dedicated bifurcation AXXESS stent based on lesion morphology in patients with ACS is feasible and highly successful The short-time clinical outcome are very promising Structure of the thesis The thesis consists of 132 pages with main chapters: Introduction (02 pages); Overview (34 pages); Methodology (24 pages); Results (31 pages); Discussion (37 pages); limitation (1page); Conclusions (2 pages) and proposal (1 page) The thesis contains 45 tables, charts and graphs, 32 figures and diagrams The thesis also includes 124 references; 13 of them are written in Vietnamese while 114 are in English CHAPTER 1: LITERATURE REVIEW 1.1 Definition of coronary artery bifurcation lesion According to the EBC consensus, a bifurcation coronary lesion is a lesion occurring at, or adjacent to, a significant division of a major epicardial coronary artery, being “significant” usually referred to a SB of  mm in diameter, is often arbitrarily defined based upon the subjective angiographic judgement of the operator 1.2 Coronary artery bifurcation classifications Figure 1.4 The Medina classification for bifurcation lesions The Medina classification: - Type 1.1.1: lesions located in the PMV, DMV, and SB - Type 1.1.0: lesions located in the PMV and DMV - Type 1.0.1: lesions located in the PMV and SB - Type 0.1.1: lesions located in the DMV and SB - Type 1.0.0: lesions located only in the PMV - Type 0.1.0: lesions located only in the DMV - Type 0.0.1: lesions located only in the SB 1.3 Coronary artery bifurcation lesion intervention 1.3.1 Interventional techniques in the treament of bifurcation lesions with drug eluting stent *Provisional stenting technique  Indication: - Nontrue bifurcation lesions (Medina classification: Type 1.1.0; Type 1.0.0; Type 0.1.0; Type 0.0.1) - True bifurcation lesions: + SB is not suitable for stenting, or + The lesions on the SB is very focal, localized within mm from the ostium of the SB, or + Patient’s condition is severe 1.3.2 Interventional technique with using AXXESS stent in the treament of bifurcation lesions *The AXXESS Self-Expanding Bifurcation DES: AXXESS consists of a conical-shape self-expanding nitinol (nickel/titanium) stent flatform, especially designed to conform to the shape of the bifurcation anatomy It has been tailored to reconstruct the bifurcation without creating a false carina, lowering the risk of uncovered struts at the flow divider The stent is coated with an abluminal-applied biodegradable poly-lactic acid polymer that releases Biolimus A9TM, an anti-restenotic drug designed by Biosensors specifically for use with DES  Indication: - De novo bifurcation lesions, and - PMV reference diameter  2.75 mm, and - SB reference diameter  2.5 mm, and - Bifurcation angle < 70, and - The patient’s condition is stable 1.4 Summary of studies on coronary artery bifurcation lesion intervention Internationally, there have been many studies on coronary artery bifurcation lesion interventions using the provisional stenting technique or dedicated bifurcation AXXESS stent However there have been no Vietnamese studies on coronary artery bifurcation lesion interventions in patients with ACS CHAPTER 2: SUBJECTS AND METHODOLOGY 2.1 RESEARCH SUBJECTS Patients who were clinically diagnosed with ACS admitted to Vietnam National Heart Institute, Bach Mai Hospital, and Hanoi Medical University Hospital from 5/2014 to 12/2017 2.1.1 Patient inclusion criteria Clinical: - Patients with ACS (including ST-segment elevation myocardial infarction, non-ST segment elevation myocardial infarction and Unstable Angina) who were underwent percutaneous coronary angiography as stated by the AHA/ACC 2014 Guidelines Coronary angiography: - Culprit de novo bifurcation lesions - MV reference diameter  2.75 mm (by QCA) - SB reference diameter ≥ 2.5 mm (by QCA) Coronary artery bifurcation lesion intervention: by 2014 Consensus from the EBC, patients were selected into groups: - Group 1: using provisional stenting technique with secondgeneration DES Selection criteria: + Nontrue bifurcation lesions, or + True bifurcation lesions with: SB is not suitable for stenting, or the lesions on the SB were very focal, or the patient’s condition is severe - Group 2: using AXXESS stent, plus 2nd-generation DES (if needed) Selection criteria: + Large difference in diameter of PMV and DMV + Bifurcation angle < 70° + The patient’s condition is stable 2.1.2 Patient exclusion criteria: - Patients with cardiogenic shock - Acute pulmonary edema - Left main disease (stenosis > 50%, by QCA) - Culprit coronary lesions with severe tortuosity or heavy calcification SYNTAX score ≥ 33 (except in case of refusal of CABG) Contraindications to prolonged dual-antiplatelet therapy - Life expectancy < year 2.2 RESEARCH METHODS 2.2.1 Study design: Prospective, non-randomized, interventional study 2.2.2 Sample selection and sample size All consecutive patients with ACS and culprit de novo bifurcation lesions, who were suitable for inclusion/exclusion criteria were categorized into groups Sample size: 141 patients including 90 patients in Group and 51 patients in Group (calculated according to the sample size formula) 2.2.3 Technical protocol and standard in study 2.2.3.1 Medical treatment: Patients were treated adopting the 2014 AHA/ACC Guideline for the Management of Patients With Non-STElevation Acute Coronary Syndromes 2.2.3.2 PCA and culprit coronary artery bifurcation lesion intervention: : Through adhering to the 2014 AHA/ACC Guidelines and 2014 Consensus from the EBC Provisional stenting technique Placement of two wires (MV and SB) Predilatation, when needed Stent the MV leaving a wire in the SB Proximal optimal technique (POT) in the proximal MV stent Rewire the SB passing through the struts of the MV stent Remove the jailed wire and dilate in the SB Performance of kissing balloon inflation with moderate pressure (8 atm) in the SB, until the balloon is fully expanded POT in the proximal MV stent Placement of a second stent in the SB only if the result is inadequate (dissection, TIMI flow < 3) Figure 2.5 Provisional stenting technique 12 PAD COPD (%) n (%) n (0.0) (0.0) (0.0) (3.6) (4.4) (2.0) > 0.05 Hypertension was the most common risk factor, accounting for 78.7% Moreover, diabetes and smokings were present in 29.8% and 24.1% of the patients, respectively Table 3.4 Characteristics of the reason for hospitalization All patients Group Group p Parameter n=141 n=90 n=51 Angina n (%) 135 (95.7) 86 (95.6) 49 (96.1) Shortness of breath (0.8) (1.1) (0.0) > n (%) 0.05 Another reason (3.5) (3.3) (3.9) n (%) Angina is the main reason for hospitalization with 135 patients, accounting for 95.7% No statistically significant difference was observed between the two groups Table 3.5 Diagnosis All patients Group Group p Parameter n=141 n=90 n=51 STEMI n (%) 39 (27.7) 34 (37.8) (9.8) NSTEMI n (%) 11 (7.8) 10 (11.0) (2.0) 0.05 (%) 16 Major bleeding n (%) (0.7) (0.0) (2.0) > 0.05 In-hospital death occurred in patient (1.1%) in the Group and did not occur in any the Group Major bleeding occurred in patient (2%) in the Group and did not occur in any the Group Angiographic success without any in-hospital MACE were obtained in 80 patients (92.2%) in the Group and in 50 patients (98%) in the Group Procedural success was obtained in 88.9% of patients in the Group and in 98% of patients in the Group (p = 0.057) Table 3.32 Clinical status at hospital discharge All Group Group Parameter p patients n=90 n=51 n=141 Clinical status: Stable n (%) 140 (99.3) 89 (98.9) 51(100.0) Unstable n (%) (0.0) (0.0) (0.0) > 0.05 Death n (%) (0.7) (1.1) (0.0) Stable clinical condition at hospital discharge was obtained in 89 patients (98.9%) in the Group and in all patients in the Group (p > 0.05) Procedural success with a stable clinical condition at hospital discharge was obtained in 80 patients (88.9%) in the Group and in 50 patients (98%) in the Group (p = 0.057) Short-term clinical success were obtained in 80 patients (88.9%) in the Group and in 50 patients (98%) in the Group (p = 0.057) Table 3.33 Procedural failure All Group Group patients p Parameter n=90 n=51 n=141 Inaccurate stent deployment (0.0) (0.0) (0.0) n (%) TIMI flow grade < 3: 17 MV n (%) (1.4) (2.2) (0.0) > 0.05 SB n 10 (7.1) 10 (11.1) (0.0) 0.057 (%) Failure to recross in the SB 19 (13.5) 19 (21.1) (0.0) < 0.05 n(%) Final TIMI flow grade < in the MV occurred in patients (2.2%) in the Group and did not occur in any the Group (p > 0.05) Final TIMI flow grade < in the SB occurred in 10 patients (11.1%) in the Group and did not occur in any the Group (p = 0.057) Failure to recross in the SB occurred in 19 patients (21.1%) in the Group and did not occur in any the Group (p < 0.05) All these procedural failure occurred in 19 patients (21.1%) in the Group and did not occur in any the Group (p < 0.05) 3.3.2 Results at the 6-month follow-up Table 3.34 Results at the 1-month follow-up All Group Group Complications p patients n=90 n=51 n=141 Death n (%) (2.13) (3.33) (0.00) > 0.05 Non-fatal MI n (%) (1.42) (1.11) (1.96) > 0.05 Repeat TVR n (%) (1.42) (1.11) (1.96) > 0.05 Stroke n (%) (0.00) (0.00) (0.00) Cumulative MACE n (3.55) (4.44) (1.96) > 0.05 (%) Stent thrombosis n (%) (1.42) (1.11) (1.96) > 0.05 Re-hospitalized for heart (2.22) (0.0) > 0.05 failure n (%) (1.42) Non target vessel revascularization n (%) 16 (11.35) 14 (15.56) (3.92) > 0.05 Death occurred in patients (3.33%) in the Group and did not occur in any the Group (p > 0.05) Non-fatal MI occurred in patient (1.11%) in the Group and in patient (1.96%) in the Group (p > 0.05) Cumulative 1-month MACE rate was 4.44% in the Group versus 1.96% in the Group (p > 0.05) Re-hospitalized for heart failure occurred in patients (2.22%) in the Group and did not occur in any the Group (p > 0.05) 18 Table 3.35 Results at the 6-month follow-up All Group Group Complications patients p n=87 n=51 n=138 Death n (%) (2.9) (5.00) (0.00) > 0.05 Non-fatal MI n (%) (1.45) (1.15) (1.96) > 0.05 Repeat TVR n (%) (2.17) (1.15) (3.92) > 0.05 Stroke n (0.00) (0.00) (0.00) (%) Cumulative MACE (5.07) (5.75) (3.92) > 0.05 n (%) Stent thrombosis n (%) (1.45) (1.15) (1.96) > 0.05 Re-hospitalized for heart (6.52) (10.34) (0.00) < 0.05 failure n (%) Non target vessel 31(35.63 35(25.36) (7.84) < 0.05 revascularization n (%) ) After months, patients were lost to follow-up in the Group Death occurred in (patients 5.0%) in the Group and did not occur in any the Group (p > 0.05) Non-fatal MI occurred in patient (1.15%) in the Group and in patient (1.96%) in the Group (p > 0.05) Repeat TVR occurred in patient (1.15%) in the Group and in patients (3.92%) in the Group (p > 0.05) Cumulative 6-month MACE rate was 5.75% in the Group versus 3.92% in the Group (p > 0.05) Re-hospitalized for heart failure occurred in patients (10.34%) in the Group and did not cocur in any the Group (p < 0.05) CHAPTER 4: DISCUSSION 4.1 General characteristics of research subjects 4.1.1 Gender In 141 patients with ACS who received stenting at the culprit coronary artery bifurcation lesion in the study, there were 103 male (73%) and 38 females (27%) The male/female ratio in the two 19 groups was not different This result was similar to other studies in patients with ACS and showed that the male/female ratio was 2.7/1 Bui Long (2019) performed a similar study on 227 patients with ACS, out of which male accounts for 86.34% Moreover, Trinh Viet Ha (2021) studied 125 patients with non-STE ACS, with male subjects accounting for 71.2% and a male/female ratio of 2.5/1 Furthermore, Vu Ngoc Trung (2021) studied 195 patients with ACS, male accounts for 76.92% The Carinax Registry (2016) showed that male accounts for 81% 4.1.2 Age The average age in the present study is 66.1 ± 9.4 (age), and the average age in the Group is higher than that in the Group The percentage of patients aged 60 and over accounts for 78.0% However, no statistically significant age difference was observed between the two groups This result was similar to other studies in patients with ACS and showed that the average age is over 60 years old, and with increasing age, the risk of coronary heart disease increases In the study of Bui Long, the average age is 70.1  7.8 (age) In addition, Nguyen Quang Toan (2020) studied on 579 patients with acute MI, the average age is 65.55  10.89 (age) Similarly, Hoang Viet Anh (2020) studied 80 patients who received Absorb stent, the average age is 63.6  9.2 (age) In another study reported by Trinh Viet Ha, the average age is 65.5  10.5 (age) Furthermore, Vu Ngoc Trung and co-workers reported a similar study in which the average age is 64.03  11.24 (age) In the DEFINITION II trial (2020), the average age in the Two-stent group is 63  11 and in Provisional group is 64  10 4.2 Clinical, subclinical and bifurcation lesions characteristics 4.2.1 Characteristics of cardiovascular risk factors Hypertension was the most common risk factor, accounting for 78.7% In addition, diabetes and smokings were present in 29.8% and 24.1% of the patients, respectively These observations are similar 20 to those reported in patients with ACS and show that hypertension is the most common risk factor 4.2.2 Characteristics of the reason for hospitalization In this study, angina was observed as the main reason for hospitalization with 135 patients, accouting for 95.7% and there was no difference between the two groups Angina is the classic and most important clinical symtom of ACS that primarily causes patient hospitalization 4.2.3 Diagnosis We studied on patients with ACS, including STEMI, non-STEMI and UA STEMI and UA were present in 27.7 and 64.5% of the patients, respectively This result is similar to other studies in patients with ACS In a study by Bui Long, STEMI and UA were present in 26% and 65.2% of the patients, respectively Moreover, in a study reported by Vu Ngoc Trung, STEMI and UA were present in 44.1% and 36.4% of the patients, respectively 4.2.4 Coronary bifurcation lesions classifications 4.2.4.1 Locations of culprit bifurcation lesions In this study, a total of 79.4% of the culprit bifurcation lesions were localized in the LAD This result is similar to other studies and show that the bifurcation lesions localized in the LAD were the most common In the AXXESS Plus trial, the bifurcation lesions localized in the LAD were present in 73.4% of the patients Similarly, a study by Nguyen Hoang Minh Phuong reported the bifurcation lesions localized in the LAD to be present in 77.6% of the patients Moreover, a study by Marc-Alexander Ohlow concluded the bifurcation lesions localized in the LAD to be present in 80.9% of the patients in the AXXESS group versus in 80.4% of the patients in the control A group (Two-stent technique) and 81.5% of the patients in the control B group (Provisional stenting technique) In the CARINAX Registry, the results showed that the bifurcation lesions localized in the LAD were present in 61% in the 21 AXXESS group and in 58% in the control group In the DEFINITION II trial, the bifurcation lesions localized in the LAD were present in 62.5% in the Two-stent group and in 60.6% in the Provisional stenting group 4.2.4.2 Multivessel disease The multivessel disease is a risk factor to predict outcome in patient with ACS, and is also an important factor in deciding the choice of treatment strategy for patients In the present study, 34% of the patients had the multivessel disease while 66% of the patients had the single-vessel disease with culprit bifurcation lesions 4.2.4.3 Medina classification In this study, we observed that Medina 1.1.1 and Medina 1.1.0 were present in 48.2% and 30.5% of the patients, respectively In the DIVERGE study, Stefan Verheye observed that Medina 1.1.1 was present in 64.5% of the patients Meanwhile, in the CARINAX Registry, Medina 1.1.1 was present in 47% of the patients in the AXXESS group and in 59% of the patients in the Provisional stenting group Moreover, in a study by Marc-Alexander Ohlow, Medina 1.1.1 was present in 50.1% of the patients in the AXXESS group versus in 62.5% of the patients in the control A group (Two-stent technique) and 55.5% of the patients in the control B group (Provisional stenting technique) 4.2.4.4 Bifurcation angle In this study, bifurcation angle < 70 was present in 79.4% of the patients Similarly, in the CARINAX Registry, the results showed that bifurcation angle < 70 was the most common with the bifurcation angle  = 59  17 in the AXXESS group and the bifurcation angle  = 58  21 in the Provisional stenting group 4.2.4.5 SYNTAX score In this study, the SYNTAX score (mean  SD) is 18  6.3 and SYNTAX < 23 was observed in 80.9% of the patients This result is 22 similar to other studies For example, in the CARINAX Registry, the results showed that the SYNTAX < 23 was the most common Moreover, in the DEFINITION II trial, SYNTAX score was higher than our study because the subjects in this study only included patients with Medina 1.1.1 and Medina 0.1.1 classifications 4.3 PCI RESULTS AT CULPRIT CORONARY BIFURCATION LESIONS 4.3.1 Immediate PCI results at culprit coronary bifurcation lesions 4.3.1.1 Device Success In this study, accurate stent deployment was obtained in all patients in the two groups Delivery device failure or device-related complication did not occur in any patients Therefore, device success was obtained in all patients in the two groups in our study This result is similar to other studies in patients who undergoing PCI at coronary artery bifurcation lesion In the CARINAX registry, the results showed that device success was obtained in 99.5% of patients in the AXXESS group and in all in the Provisional stenting group In the COBRA trial, device success was obtained in 90% of patients in the AXXESS group and in all patients in the Culotte group (using Xience stent) As a results, device success is very high in PCI at coronary artery bifurcation lesions 4.3.1.2 Intra-procedural complications and angiographic success In this study, the results showed that TIMI flow in the SB was present in 92.9% of the patients TIMI flow in the SB were obtained in all patients in the Group and in 80 patients (88.9%) in the Group (p = 0.057) Intra-procedural complications may be to increase the risk of patient mortality When evaluating the angiographic success, besides a < 20% residual stenosis in both MV and SB with final TIMI flow in both vessels, it is very important to limit intra-procedural complications In our study, intra-procedural complications included: coronary perforation occurred in patient (2%) in the Group (type I 23 perforation) This complication was caused by AXXESS stent deformation, which was caused by high-pressure balloon The management was successful by additional DES implantation in the MV The patient was discharged in stable clinical condition after days of treatment and follow-up SB occlusion occurred in 10 patients (11.1%) in the Group and did not occured in the Group In this study, the result show that TIMI flow in the both vessels (MV and SB) was obtained in 130 patients (92.2%) without any complications in the target lesion Therefore, angiographic success was obtained in 92.2% patients in total, 88.9% patients in the Group and in 98% patients in the Group (p = 0.057) 4.3.1.3 In-hospital Complications and Procedural Success In-hospital death occurred in (1.1%) patient in the Group and did not occur in any the Group Major femoral bleeding complication (access site bleeding) occurred in patient (2%) in the Group and did not occur in any the Group The patient was subjected to blood transfusion and was discharged in stable clinical condition In this study, angiographic success was obtained in 130 (92.2%) patients without any in-hospital MACE, Therefore, procedural success was obtained in 92.2% patients Procedural success was obtained in 88.9% of patients in the Group and in 98% of patients in the Group (p = 0.057) 4.3.1.4 Short-term clinical success In the short time, a clinically successful PCI requires both anatomic and procedural success along with the relief of signs and/or symptoms of myocardial ischemia In this study, procedural success with stable clinical condition at hospital discharge was obtained in 80 patients (88.9%) in the Group and in 50 patients (98%) in the Group Short-term clinical success was obtained in 80 patients (88.9%) in the Group and in 50 patients (98%) in the Group (p = 0.057) 4.3.1.5 Procedural failure 24 Procedural failure is considered in many cases including unsuccessful deployment of the stent into the target lesion, failure to recross in the SB, or SB occlusion (TIMI flow grade < after MV stenting) In this study, all these procedural failure occurred in 19 patients (21.1%) in the Group and did not occured in any the Group (p < 0.05) In the CARINAX registry, trouble in SB access did not occur in any AXXESS group patient but in 16 patients (9.5%) in the control group (p < 0.001) In this study, final TIMI flow grade < in the SB occured in 10 patients (11.1%) in the Group and did not occured in any the Group (p = 0.057) 4.3.2 Result at the 6-month follow-up In this study, patients were lost to follow-up at months in the Group Cumulative rates of major adverse cardiovascular event (MACE) at the 6-month follow-up, including death, stroke, myocardial infarction, and repeat target vessel revascularization occurred in 5.75% of the patients in the Group and in 3.92% of the patients in the Group (p > 0.05) Death occurred in patients (5.0%) in the Group and did not cocur in any the Group (p > 0.05) Stent thrombosis occurred in patient (1.15%) in the Group and in patient (1.96%) in the Group (p > 0.05) Heart failure is one of the reasons why patients need to be hospitalized after PCI In this study, the result showed that rehospitalized for heart failure occurred in patients (10.34%) in the Group and did not cocur in any the Group (p < 0.05) CONCLUSION From research on culprit coronary artery bifurcation lesion stenting in 141 patients with acute coronary syndrome, we have some conclusions: Clinical, subclinical and culprit coronary artery bifurcation lesions characteristics in patients with acute coronary syndrome 25 - The average age was 66.1  9.4 (age) and the percentage of patients aged 60 and over accounted for 78.0% The male/female ratio was 2.7/1 - Hypertension was the most common risk factor, accounting for 78.7% Diabetes and smokings were present in 29.8% and 24.1% of the patients, respectively - Angina was the main reason for hospitalization with 135 patients, accouting for 95.7% - ST-segment elevation myocardial infarction, non- ST-segment elevation myocardial infarction and unstable angina were present in 27.7; 7.8% and 64.5 of the patients, respectively - A total of 79.4% of the culprit bifurcation lesions localized in the left anterior descending - Medina 1.1.1 and Medina 1.1.0 were present in 48.2% and 30.5% of the patients, respectively Multivessel disease present in 34% of the patients - True bifurcation lesions were present in 59.6% of the patients - Bifurcation angle < 70 was observed in 79.4% of the patients - Multivessel disease was present in 34% of the patients - SYNTAX score (mean SD) is 18  6.3 and SYNTAX < 23 were observed in 80.9% of the patients Short-term percutaneous coronary intervetion outcomes in culprit coronary bifurcation lesions using stenting technique based on lesion morphology in patients with acute coronary syndrome 2.1 Provisional stenting technique - Device success was obtained in all patients - Angiographic success was obtained in 88.9% of patients - Procedural success was obtained in 88.9% of patients - Short-term clinical success was obtained in 88.9% of patients - Cumulative rates of major adverse cardiovascular events (MACE) at the 6-month follow-up, including death, stroke, 26 myocardial infarction, and repeat target vessel revascularization occurred in 5.75% of the patients - Re-hospitalized for heart failure occurred in 10.34% of the patients at the 6-month follow-up 2.2 Using dedicated AXXESS stent - Device success was obtained in all patients - Angiographic success was obtained in 98% of patients - Procedural success was obtained in 98% of patients - Short-term clinical success was obtained in 98% of patients - Cumulative rates of MACE at the 6-month follow-up occurred in 3.92% of the patients - Re-hospitalized for heart failure did not occurred in any the patients at the 6-month follow-up PROPOSAL From research on culprit coronary artery bifurcation lesion stenting in 141 patients with acute coronary syndrome, using provisional stenting technique or dedicated AXXESS stent based on lesion morphology and clinical condition, we have some proposals: - Provisional stenting technique should be chosen in patients with nontrue bifurcation lesions or true bifurcation lesions with SB which is not suitable for stenting, or the lesions on the SB are very focal, or the patient’s condition is severe - The technique of using a dedicated AXXESS stent could be chosen in patients with a stable clinical condition, true bifurcation lesions with appropriate anatomical size, bifurcation angle < 70 and exposed clear on angiogram ... Bifurcation Lesion Stenting, Vietnam Medical Journal, 504(1): 61-65 Lê Thanh Bình, Phạm Mạnh Hùng, Nguyễn Oanh Oanh (2021) Patients with Coronary Artery Bifurcation Lesions Treated by Axxess Stent Implantation,... thesis can be found at: - National Library - Library of Military Medical University LIST OF SCIENTIFIC WORKS PUBLISHED RELATED TO THE THESIS Lê Thanh Bình, Phạm Mạnh Hùng, Nguyễn Oanh Oanh (2021)... UNIVERSITY Supervisor: Prof PhD Pham Manh Hung Prof PhD Nguyen Oanh Oanh Reviewer 1: Prof PhD Pham Nguyen Son Reviewer 2: Prof PhD Pham Thi Kim Lan Reviewer 3: Prof PhD Ta Manh Cuong The thesis will be