Local vascular complications after coronary angiography and or percutaneous coronary intervention and related factors at coronary care unit of vietnam national heart institute bachmai hospital

VIETNAM NATIONAL UNIVERSITY SCHOOL OF MEDICINE AND PHARMACY ANH THI NGOC VU LOCAL VASCULAR COMPLICATIONS AFTER CORONARY ANGIOGRAPHY AND/OR PERCUTANEOUS CORONARY INTERVENTION AND RELATED FACTORS AT CORONARY CARE UNIT OF VIETNAM NATIONAL HEART INSTITUTE GRADUATE THESIS OF GENERAL MEDICINE Hanoi– 2023 VIETNAM NATIONAL UNIVERSITY SCHOOL OF MEDICINE AND PHARMACY Thesis maker: ANH THI NGOC VU LOCAL VASCULAR COMPLICATIONS AFTER CORONARY ANGIOGRAPHY AND/OR PERCUTANEOUS CORONARY INTERVENTION AND RELATED FACTORS AT CORONARY CARE UNIT OF VIETNAM NATIONAL HEART INSTITUTE GRADUATE THESIS OF GENERAL MEDICINE Class year: QH.2017Y Suppervisor 1: M.Sc Dr HIEU BA TRAN Suppervisor 2: M.Sc Dr NHUNG THI HUYNH Hanoi– 2023 ACKNOWLEDGMENT On the occasion of completing my graduation thesis, with deep respect and gratitude, I would like to express my gratitude to: The Board of Directors, Department of Internal Medicine, University of Medicine and Pharmacy - Hanoi National University have created favorable conditions for me during my study and research I would like to express my sincerest thanks to my Ph.D Hoai Thi Thu Nguyen, head of the Internal Affairs Department, University of Medicine and Pharmacy VNU, Deputy Director of the Institute of Cardiology opened up the opportunity for me to participate in research and complete this thesis In particular, I would like to express my deep respect and gratitude to M.Sc Hieu Ba Tran, doctor of C7 - Coronary Care Unit - Vietnam Heart Institute and teacher of Internal Affairs Department, VNU You are the one who wholeheartedly guided and created all conditions for me in the process of studying and researching I am also deeply thankful to M.Sc Nhung Thi Huynh, Internal Academic Affair, Department of Internal Medicine - University of Medicine and Pharmacy VNU has wholeheartedly supported me and enthusiastically facilitate to help me complete this thesis Thank you sincerely: Doctors, nurses, and staff of Vietnam Heart Institute, Bachmai Hospital I also thank my family who encouraged me and prayed for me throughout the time of my research Hanoi, day month 2023 Thesis maker Anh Thi Ngoc Vu GUARANTEE I hereby declare that all the data in this thesis is my own and has not been used or published in any other document If something goes wrong, I take full responsibility Hanoi, day month 2023 Thesis maker Anh Thi Ngoc Vu TABLE OF CONTENTS ACKNOWLEDGMENT LIST OF ACRONYMS INTRODUCTION CHAPTER 1: LITERATURE REVIEW 1.1 Coronary artery disease 1.2 Percutaneous coronary artery imaging and intervention (PCI) 1.2.1 Intravascular access in coronary angiography and intervention 1.2.2 Hemostasis after removal of sheaths and other types of compression and vascular closure devices 1.2.3 Local Vascular Complications 1.3 Research on local vascular complications after intervention and/or angiograpgy in Vietnam and worldwide 12 1.3.1 Studies in the world 12 1.3.2 Studies in Vietnam 12 CHAPTER II: SUBJECTS AND METHODS 15 2.1 Subjects 15 2.1.1 Object 15 2.1.2 Time, place 15 2.1.3 Selection Criteria 15 2.1.4 Exclusion criteria 15 2.1.5 The criteria used in the study 16 2.2 Research Methods 25 2.2.1 Research design 25 2.2.2 Sample size 25 2.2.3 Research process 25 2.3 Main research variable 27 2.3.1 Characteristics of the research object 27 2.3.2 Procedure variables: 27 2.3.3 Variables for follow-up in the ward 27 2.4 Analyzing data 28 2.5 Research media 28 2.6 Research Ethics 29 CHAPTER 3: RESULTS 30 3.1 General characteristics of the study population 30 3.1.1 Distribution of age and gender 30 3.1.2 Distribution characteristics of coronary artery disease 31 3.1.3 Characteristics of the comorbidities 31 3.1.4 Characteristics of clinical indicators of the study group 32 3.1.5 Features of coronary angiography and intervention: 34 3.1.6 Features of the use of anticoagulants and antiplatelet agents 35 3.1.7 Use of unfractionated heparin in the procedure 36 3.1.8 Rate of radial and femoral artery intervention 36 3.1.9 Sheath size ratio 37 3.1.10 Procedure time and sheath withdrawal time 37 3.2 Complications of vascular puncture wound complications 37 3.2.1 Rate of some complications of puncture wound 37 3.2.2 Percentage of hematoma by size 38 3.3 Factors associated with vascular complications: 38 3.3.1 The relationship of complications with age 38 3.3.2 Complications relationship with gender 39 3.3.3 The relationship of complications with the comorbidities 40 3.3.4 The relationship between some clinical indicators with hematoma complications: 43 3.3.5 The relationship of complications with drug use 44 3.3.6 Comparison of mean values of some paraclinical indicators in the group with complications and without complications 45 3.3.7 Relationship of complications with the performing artery 46 3.3.8 Relationship of complications with the procedure performed: 47 3.3.9 Comparison of mean procedure time in the hematoma group and no hematoma 47 CHAPTER 4: DISCUSSION 48 4.1.1 Characteristics of age and sex 48 4.1.2 Features of cardiovascular disease 48 4.1.3 Characteristics of comorbidities 49 4.1.4 Clinical features 49 4.1.5 Paraclinical features 50 4.1.6 Features of using anticoagulants and antiplatelet drugs 50 4.1.7 Features of the intervention process 51 4.2 Factors related to local vascular complications 52 4.2.1 Complication rate 52 4.2.2 The relationship between clinical parameters and complications of hematoma 52 4.2.3 The relationship between paraclinical parameters and complications of hematoma 54 4.2.4 Relationship between complications and access: 54 4.2.5 Relationship of complications with the procedure performed: 55 4.2.6 Relationship of complications with antiplatelet therapy used: 55 4.2.7 The relationship between the parameters of the procedure and after the procedure with local bleeding complications: 55 CONCLUSION 57 REFERRENCE LIST OF ACRONYMS WHO World Health Organization CT Computer Tomography MSCT Multislice Computer Tomography MRI Magnetic Resonance Imaging ACS Acute coronary syndrome CCS Chronic coronary syndrome STEMI ST Elevation Myocardial Infarction ESC European Society of Cardiology BMI Body Mass Index BP Blood pressure SBP Systolic blood pressure DBP Diastolic blood pressure PCI Percutaneous Coronary Intervention Non – STEMI Non -ST Elevation Myocardial Infarction UA Unstable angina DAPT Dual antiplatelet therapy MI Myocardial Infraction LIST OF TABLES Table 1 Comparison of femoral and radial arteries in percutaneous coronary angiography and intervention Table Classification of angina CCS 17 Table Age distribution by age group 30 Table 3 Distribution of coronary artery disease 31 Table Comorbidity characteristics 31 Table Blood pressure characteristics 32 Table Prevalence of hypertension by age group 32 Table BMI characteristics by gender 33 Table BMI characteristics by age group 33 Table Characteristics of some subclinical test of research subjects 34 Table 10 Characteristics of coronary angiography and coronary intervention 34 Table 11 Prevalence of use of anticoagulants, anticoagulants 35 Table 12 Doses of unfractionated heparin used in the procedure 36 Table 13 Characteristics of the vascular access routes 36 Table 14 Characteristics of using a sheath 37 Table 15 Procedure time 37 Table 16 Rate of some complications at the puncture site 38 Table 17 Proportion of hematomas by size 38 Table 18 Distribution of complications by age group 39 Table 19 Distribution of complications by gender 39 10 bleeding complications, earlier walking, and improved patient comfort [26] For this reason, transradial is the preferred interventional procedure in Europe, Canada, and the United States 4.2.5 Relationship of complications with the procedure performed: Our study and Anh H.V both showed that 100% of hematoma patients were patients with coronary intervention Coronary intervention requires more time, and the dose of unfractionated heparin used increases, so the risk of bleeding is more obvious [19] 4.2.6 Relationship of complications with antiplatelet therapy used: Regarding dual platelet therapy, Huynh Quoc Binh's study showed a higher rate of bleeding events (1.35%) in the group using Aspirin plus Clopidogrel than Aspirin + Ticargrelor (0%) (p>0.05) [48] Our study also showed that the rate of MI in the group of patients with the combination of Aspirin + Clopidogrel (1.35%) was higher than that of the group with the combination of Aspirin + Ticargrelor (p>0.05) However, this does not confirm that Ticargrelor is safer than Clopidogrel Wenjun Goan et al in a review research of the safety between clopidogrel and ticagrelor in 25,632 ACS patients confirmed ticagrelor was associated with significantly higher bleeding (OR: 1.52, 95% Cl: 1.01-2.29; P = 0.04) [64] This difference may be reasonable because our sample size and that of Huynh Quoc Binh are quite small plus the use of Ticagrelor is less 4.2.7 The relationship between the parameters of the procedure and after the procedure with local bleeding complications: The average procedure time of the hematoma group (55.00 ± 8.66) was longer than that of the non-hematoma group (46.21 ± 8.03), p=0.024 The longer the procedure, the longer the impact on the inlet blood vessels, during the manipulation, the sheath may be displaced more in and out These factors also contribute to an increased risk of future local bleeding A study by De Andrade 55 et al in 2015 also showed that prolonged procedure time (especially in cases where it is difficult or impossible to insert an instrument into the target lesion) is a risk factor for increased bleeding [58] 56 CONCLUSION Through the study of 106 patients undergoing coronary intervention and/or coronary imaging at C7 – Cardio Care Unit, Vietnam National Heart Institute, Bach Mai Hospital, we point out these following conclusions: The rate of bleeding at the puncture site after coronary angiography and intervention: • Complication rate is 2.83%, all cases are hematoma, under 10cm • All patients with complications were patients with coronary intervention • No major bleeding complications (eg retroperitoneal bleeding) or late bleeding complications (pseudoaneurysm, arteriovenous catheterization) were noted Some factors related to bleeding complications at the puncture site: • The average procedure time of the hematoma group (55.00 ± 8.66) was longer than that of the non-hematoma group (46.21 ± 8.03), the difference was statistically significant p=0.024 • Having two comorbidities is a risk factor for LVC, with p= 0.026 • The complication rate of people with dyslipidemia was higher than the complication rate of the group without dyslipidemia, the difference was statistically significant with p=0.039 57 REFERRENCE Khải Q.H., Tuấn Q.N et al (2008), “Khuyến cáo Hội Tim mạch học Việt Nam can thiệp động mạch vành qua da”, Khuyến cáo 2008 bệnh lý Tim mạch Chuyển hóa, Hội Tim mạch học Việt Nam, Nhà xuất Y học, tr 512531., Cang H.T., Nhân T.V (2009), “Các yếu tố nguy thủ thuật can thiệp động mạch vành qua da”, 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Transradial Palmaz- Schatz coronary stenting on an out-patient basis: Results of a prospective pilot study J Invas Cardiol 7: 5A-11A,1995 73 Kiemneij F, Laarman GJ: Percutaneous transradial artery approach for coronary stent implantation Cathet Cardiovasc Diagn 30: 173-178, 1993 74.Guan W., Lu H., and Yang K (2018) Choosing between ticagrelor and clopidogrel following percutaneous coronary intervention: A systematic review and Meta-Analysis (2007-2017) Medicine (Baltimore), 97(43), e12978 75 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes: The Task Force for the diagnosis and management of chronic coronary syndromes of the European Society of Cardiology (ESC) APPENDEX 01 RESEARCH MEDICAL RECORD GENERRAL INFORMATION No Medical record code: Patient's name: Age: Occupation: Address: Gender: Contact: Date and time of admission: Diagnosis on admission: ⬜ STEMI ⬜ Non-STEMI ⬜ CCS ⬜ UA COMOBIDITY: ⬜Increase BP ⬜Diabetes ⬜RL lipid blood ⬜Other:………… CLINICAL CHARACTERISTICS: Systolic blood pressure (mmHg) …………………………………… Diastolic blood pressure (mmHg) …………………………………… BMI= … …/…… (kg/m2) …………………………………… DESCRIPTION OF INTERVENTION/ CIRCUIT CATCH: 4.1 Laboratory tests and drug use Parameter Information Creatinin (μmol/l) Glucose (mmol/l) Platelets (G/L) PT-INR APTT b/c Aspirin Clopidogrel Ticagrelor Lovenox Unfractionated heparin(dose: UI) 4.2 Artery approach, procedure duration: Time Units (minutes) Intervention ⬜ Angiography ⬜ Radial access ⬜ Femoral access ⬜ COMPLICATION: Symptoms Yes No Hematoma >10 cm ⬜ ⬜ Hematoma 5-10 cm ⬜ ⬜ Bleeding ⬜ ⬜ Occlusion ⬜ ⬜ Pseudoaneurysm ⬜ ⬜ Arteriovenous catheterization ⬜ ⬜ Retroperitoneal bleeding ⬜ ⬜ CONCLUSION Complications:……………………………………………………………… ………………………………………………………………………………… Day Month Year Medical record maker APPENDEX 02 PATIENT DATA No 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 Malee Nguyễn Thanh N Lê Văn N Đoàn S Đinh Thị C Nguyễn Văn N Trần Thị L Lê Thị L Nguyễn Thị V Trần Xuân T Trần Thị L Bùi Văn Q Nguyễn Thị L Hoàng Thị T Nguyễn Tiến M Lê Thị Trần Anh T Trần Ngọc S Nguyễn Văn N Trần Văn V Lê Hồng P Nguyễn Thị Q Nguyễn Văn N Tăng Văn T Trần Ngọc S Bùi Xuân D Nguyễn Thị P Nguyễn Thị T Trương Văn V Nguyễn Văn Đ Nguyễn Văn T Lê Mai S Nguyễn Đức H Phạm Văn H Age 60 59 77 73 55 51 69 70 70 75 49 70 56 59 75 76 83 55 62 59 75 77 75 83 73 83 58 75 64 64 84 58 83 Gender Male Male Male Female Male Female Female Female Male Female Male Female Female Male Female Male Male Male Male Male Female Male Male Male Male Female Female Male Male Male Male Male Male Admission time 20-09-22 20-09-22 20-09-22 20-09-22 20-09-22 24-09-22 22-09-22 22-09-22 23-09-22 20-09-22 22-09-22 20-09-22 20-09-22 20-09-22 21-09-22 07-09-22 15-09-22 20-09-22 22-09-22 20-09-22 19-09-22 21-09-22 30-09-22 27-09-22 23-09-22 29-09-22 27-09-22 30-09-22 30-09-22 30-09-22 01-10-22 27-09-22 22-09-22 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 Vũ Thị V Trần Văn L Lê Giang N Nguyễn Văn B Trương Thị É Phạm Văn T Nguyễn Văn C Đoỗ Thiện T Nguyễn Văn H Đỗ Văn N Cù Văn S Nguyễn Văn Đ Bế Thị T Trần Văn V Dương Văn B Vũ Đình Đ Hồng Đình P Nguyễn Văn L Nguyễn Tiến H Đinh Thị H Phạm Xuân M Nguyễn Đình T Nguyễn Văn Đ Đỗ Trọng H Phan Trọng K Nguyễn Công Đ Trịnh Xuân H Nguyễn Văn G Ngô Văn Đ Nguyễn Thị T Nguyễn Thị H Vũ Đình Đ Lơ Thị D Ngô Văn T Nguyễn Thị H Bùi Đức T Đỗ Thiện T 93 62 60 60 56 78 57 69 73 61 71 52 76 62 80 56 84 70 69 67 74 74 56 72 70 62 69 79 60 73 69 56 64 67 68 74 69 10 Male Male Male Male Female Male Male Male Male Male Male Male Female Male Male Male Male Male Male Female Male Male Male Male Male Male Male Male Male Female Female Male Male Male Female Male Male 22-09-22 26-09-22 27-09-22 26-08-22 27-09-22 19-09-22 30-09-22 14-09-22 26-09-22 28-09-22 26-09-22 26-09-22 27-09-22 28-09-22 05-10-22 07-10-22 06-10-22 07-10-22 06-10-22 25-08-22 06-10-22 06-10-22 28-09-22 27-09-22 06-10-22 03-10-22 22-09-22 04-10-22 03-10-22 06-10-22 30-09-22 03-10-22 05-10-22 03-10-22 05-10-22 04-10-22 14-09-22 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 Chu Thế H Phaạm Văn T Hà Thị H Bùi Thị T Nguyễn Văn N Phạm Văn H Trần Văn L Hồng Thị L Vũ Đình Đ Đỗ Thi B Lê Thị T Đào Thị D Phạm Phú P Văn Thị Bích T Lưu Thị L Đỗ Thành K Nguyễn Thị B Phạm Văn H Pham Văn D Hồng Khắc D Nguyễn Văn T Lê Chí S Nguyễn Đức M Nguyễn Thế T Nguyễn Bỉnh C Nguyễn Thị T Nguyễn Thị Q Nguyễn Văn N Lý Văn Q Sa Ngọc K Nguyễn Thị L Lê Quí Đ Vũ Văn T Cao Văn S Trần Văn S Đào Hồng D 50 78 73 70 55 59 62 71 59 80 79 59 60 60 75 68 59 83 44 60 70 62 69 79 60 73 66 55 64 67 68 74 69 50 78 73 11 Male Male Female Female Male Male Male Female Male Female Female Female Male Female Female Male Female Male Male Male Male Male Male Male Male Female Female Male Male Male Female Male Male Male Male Female 26-09-22 19-09-22 04-10-22 04-10-22 05-10-22 29-09-22 26-09-22 04-10-22 20-09-22 29-09-22 03-10-22 05-10-22 05-10-22 06-10-22 05-10-22 04-10-22 04-10-22 30-09-22 03-10-22 28-09-22 13-10-22 19-10-22 18-10-22 19-10-22 12-10-22 14-10-22 18-10-22 18-10-22 18-10-22 12-10-22 19-10-22 18-10-22 19-10-22 18-10-22 14-10-22 12-10-22