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

LITERATURE REVIEW

Coronary artery disease

Coronary artery disease (CAD) is a significant health issue globally, accounting for one-third of all deaths in adults over 35 years old In Vietnam, CAD has emerged as a leading cause of mortality, with a 2016 WHO report indicating that 31% of deaths in the country were linked to cardiovascular diseases, over half of which were attributed to coronary artery disease.

Atherosclerotic coronary artery disease includes two clinical syndromes:

Figure 1 1 Diagnosis of acute coronary syndromes [53]

Chronic coronary syndrome is a new term introduced at the European Society of Cardiology (ESC) 2019, instead of stable angina pectoris, stable CAD, chronic ischemic cardiomyopathy, or coronary insufficiency

Acute coronary syndromes (ACS) include ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), unstable angina (UA) (Figure 1.1)

2 Approach to acute coronary syndromes (Figure 1.2)

Figure 1 2 Approach to acute coronary syndromes [53]

Percutaneous coronary artery imaging and intervention (PCI)

Percutaneous coronary angiography and intervention are the gold standards in the diagnosis and treatment of coronary artery disease

1.2.1 Intravascular access in coronary angiography and intervention

Vascular access selection is a crucial step in percutaneous coronary angiography and intervention, with common entry sites including the femoral, brachial, and radial arteries The success of the procedure and the reduction of complications depend significantly on the choice of artery, the instruments used, the techniques employed, and the surgeons' experience.

Complications at the puncture site can significantly impact both the effectiveness of medical interventions and patient outcomes Research conducted by Mamas et al in 2013, which analyzed 46,128 patients undergoing coronary angiography and intervention, revealed that radial bypass is an independent factor associated with a reduction in 30-day mortality, demonstrating a hazard ratio of 0.71.

A meta-analysis conducted in 2012 involving 2,977 patients with ST-segment elevation myocardial infarction (STEMI) demonstrated that utilizing a radial approach for intervention significantly decreased overall mortality (OR 0.53, 95% CI 0.33 – 0.94, p = 0.008) and minimized complications associated with the puncture site (OR 0.30, 95% CI 0.19 – 0.48, p < 0.0001) Additionally, a separate study indicated that the radial approach was linked to lower rates of major bleeding events (HR 0.37, 95% CI: 0.18 - 0.74, p < 0.01) and complications at the puncture site (HR 0.38, 95% CI: 0.19 – 0.75, p < 0.01).

Proficient vascular access skills are essential for all interventional cardiologists, as well as for intervention room nurses and ward nurses These medical professionals must possess the knowledge and understanding necessary to effectively manage and monitor complications related to vascular access following imaging and coronary intervention procedures.

1.2.2.2 The femoral and radial arteries

The femoral artery has traditionally been the preferred access route for coronary interventions due to its advantages, including easy access, a straightforward technique, and a larger size that facilitates the use of sheaths and guiding catheters with less spasm While many interventionists in the United States continue to utilize the femoral artery, the use of the radial artery is rapidly increasing, with some intervention rooms in the U.S and Europe reporting radial artery intervention rates exceeding 90%.

Table 1 1 Comparison of femoral and radial arteries in percutaneous coronary angiography and intervention [19]

Criteria Femoral arteries Radial arteries

Rare, loss of rotator cuff

Motionless At least 4 hours Comfortable movement

Time Shorter Not significantly longer irradiation time Shorter Not significantly longer

Access to the left internal mammary artery

Difficult, mainly through the right internal mammary artery

Use a large catheter Easy Under 7F

Obesity, lower extremity vascular disease

In 1989, Campeau pioneered diagnostic coronary angiography via the radial artery, followed by Kemeneij and Laarman, who in 1993 successfully conducted the first coronary intervention through this approach, marking a significant advancement in imaging and intervention techniques While radial access is associated with fewer complications at the puncture site, it demands a higher level of surgical skill and presents more technical challenges A summary of the advantages and disadvantages of these two interventional vascular access sites can be found in Table 1.1.

Numerous studies highlight the benefits of utilizing the radial artery over the femoral artery for coronary interventions Two randomized controlled trials specifically support the use of radial access in patients with STEMI undergoing such procedures The RIFLE STEACS study, which involved 1,001 patients, demonstrated that the radial access route significantly reduced cardiovascular mortality (5.2% compared to 9.2%) and bleeding complications (7.8% versus 12.2%) when compared to the femoral artery.

The RIVAL trial (Radial Versus Femoral Access for Coronary Intervention) evaluated the effectiveness and bleeding complications of radial versus femoral access in patients with ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI) Findings indicated that radial artery intervention led to a decrease in all-cause mortality (1.3% compared to 3.2%) and a reduction in death, myocardial infarction, or stroke (2.7% versus 4.6%) among STEMI patients, although no significant benefits were observed in NSTEMI patients Additionally, the radial approach significantly lowered the incidence of major bleeding and complications at the angiography site in both patient groups.

The 2017 European Society of Cardiology (ESC) guidelines endorse radial artery intervention over femoral artery intervention for STEMI patients, provided it is conducted by experienced surgical staff (IIa, level of evidence b) Additionally, the American Society of Angiography and Cardiovascular Intervention supports best practices for utilizing the radial artery in diagnosing and treating coronary artery disease, emphasizing the importance of preventing radial artery occlusion.

The debate over the optimal access route for interventions continues, with proponents of femoral artery access highlighting several advantages: it offers rapid procedures, significantly reduced bleeding complications due to the use of vascular closure devices, and greater flexibility in catheter size adjustments and the use of assistive devices like aortic balloon counterpulsation Additionally, using the radial artery can hinder its future use in coronary artery bypass surgery and presents challenges in cases of small radial pulses or anatomical variations such as constriction, torsion, or twisting of the brachial and subclavian arteries.

Surgeons and technicians in the intervention room can easily access both the radial and femoral arteries In coronary angiography and percutaneous coronary interventions, it is recommended to prioritize the radial artery over the femoral artery whenever feasible, except in specific circumstances.

1.2.2 Hemostasis after removal of sheaths and other types of compression and vascular closure devices

Various devices, such as the Radistop by St Jude Medical and the TR ring by Terumo Medical Corp, are specifically designed to control bleeding at the radial puncture site These instruments are applied directly over the puncture site, allowing for gradual inflation of the cuff as the sheath is slowly withdrawn This method ensures that by the time the sheath is fully removed, the bandage remains taut, effectively preventing any bleeding from occurring at the site.

The Vietnam National Heart Institute and various intervention rooms across Vietnam routinely utilize radial compression with gauze and tape due to its effectiveness, speed, and low cost The radial artery's smaller size and its position over a hard bone facilitate easier withdrawal and hemostasis at the puncture site, making the procedure more efficient for surgeons, technicians, and nurses.

To ensure proper hemostasis at the puncture sites, gently press the pre-rolled gauze, which is layered with iodine alcohol, along the blood vessel path using your thumb, applying pressure about 0.5 to 1 cm apart Once the sheath is fully withdrawn, apply additional pressure with the bandages, wrapping them securely around the compress to prevent any bleeding (Figure 1.2) [19].

Figure 1 3 Compression by TR band at Terumo Medical Corp [19]

Figure 1 4 Radial artery compression bandage at the Vietnam National Heart

The manual compression technique involves the surgeon, technician, and nurse applying pressure with three fingers along the femoral artery when withdrawing the sheath The standard compression duration is "5 minutes per 1F," meaning a 5F sheath requires 25 minutes of pressure, while a 6F sheath necessitates 30 minutes However, this duration may be extended for patients with obesity, loose subcutaneous tissue, or those on antiplatelet agents such as Aspirin, Clopidogrel, or Ticagrelor, as well as anticoagulants.

Research on local vascular complications after intervention and/or angiograpgy

angiograpgy in Vietnam and worldwide

The 2012 RIFLE STEACS study, which involved 1,001 patients, found that 4.7% experienced bleeding events at the puncture site, with 34 patients affected in the femoral artery intervention group compared to only 13 in the radial artery intervention group.

The 2011 RIVAL study, which involved 7,021 patients with acute coronary syndrome, found that bleeding at the puncture site occurred in only 1.4% of patients undergoing radial artery bypass, compared to 3.7% in those receiving percutaneous intervention via the femoral artery.

Research by Binh T.Q et al in 2002 at the interventional and cardiac catheterization room of Chulalongkorn University, Bangkok, Thailand, titled

"Survey on local vascular complications of procedures and coronary interventions"

13 with In 1100 patients, MI of the group of transfemoral artery procedures was: bleeding 0%, large hematoma (>10 cm) in 10 patients (1.17%), small hematoma (5-

In a study involving 19 patients, complications from femoral artery procedures included a 2.24% incidence of hematomas greater than 10 cm, a 0.12% occurrence of pseudoaneurysms, and a 10.12% rate of artery occlusion In contrast, the radial artery procedure group reported no bleeding or significant complications, with only 1.58% experiencing small hematomas (5-10 cm) Statistical analysis revealed no significant differences in acute myocardial infarction (AMI) rates between the femoral and radial artery groups Notably, risk factors for atherosclerotic cardiovascular disease (ASCVD) in the femoral artery group included age, female gender, and blood pressure, whereas elevated blood pressure was the sole risk factor identified for the radial artery procedures.

A study conducted by Tuan A.D and Hung M.P in 2010 at the Vietnam Heart Institute evaluated the effectiveness of local hemostasis methods in patients undergoing coronary interventions via the radial artery The findings revealed that 8% of patients experienced complications, specifically hematomas measuring less than 3 cm.

A study conducted by Nhan T.V and Huynh Trung Cang in 2010 at Cho Ray Hospital examined the effectiveness and safety of percutaneous coronary intervention The research revealed that complications such as hematoma measuring 5-10 cm occurred in 1.58% of cases involving the radial artery and 3.41% in cases involving the femoral artery.

A 2013 study conducted by Dung Q.T and colleagues at An Giang Hospital investigated local complications following catheter removal in patients who underwent percutaneous coronary intervention Out of 83 patients, only 5 (6%) experienced minor hematomas The research found no statistically significant correlation between local vascular complications and factors such as procedure duration, manual compression time, or cuff compression time.

Research by Anh H.V at Q3B in 2019, a project titled "Evaluation of bleeding at the puncture site in patients after percutaneous coronary intervention at room Q3B

- Heart Institute” with 50 patients, only 3 patients (6%) had small hematomas and no major bleeding complications (such as retroperitoneal bleeding) or late bleeding complications (pseudoaneurysm, arteriovenous catheterization were recorded)

Statistically significant factors were shown to be the sheath withdrawal time and the average total compression time [19]

A 2021 study conducted by Thu T.H.N at Medical University Hospital examined the complications following coronary angiography and interventions in 61 patients The research revealed a significant complication rate of 23%, primarily due to puncture wounds, which included hematomas (11.5%), bleeding (8.2%), embolisms (6.6%), and pseudoaneurysms (3.3%) The study found that the likelihood of vascular puncture wound complications was notably associated with arterial procedures (OR=0.029, 95% CI: 0.003-0.2744), highlighting that angioplasty is more prone to complications from arterial access, particularly with the femoral artery compared to the radial artery.

SUBJECTS AND METHODS

Subjects

- The patient underwent coronary angiography and/or interventional coronary intervention

- Time: From September 2022 to November 2022

- Location: Coronary Care Unit, Vietnam National Heart Institute, Bach Mai Hospital

Meet all of the following criteria

- Consent to participate in the study before successful angiography and/or percutaneous coronary intervention and then transferred to room C7, in the following conditions:

+ Non-ST-segment elevation myocardial infarction (Non - STEMI)

+ ST-segment elevation myocardial infarction (STEMI)

- The patient did not consent to participate in the study

- The patient diagnosed with an anomaly of the access artery had preprocedural ultrasonography and still followed that approach

- The patient has a bleeding disorder

- The patient could not withdraw the sheath as the patient died, or was kept for a long time and was transferred to another department

- The patients were discharged early before the compression bandage was

16 removed (either by the patient's family or by the patient's own request or because the serious condition was transferred to another department or hospital)

2.1.5 The criteria used in the study

2.1.5.1 Diagnostic criteria for coronary artery disease

Chest pain typically occurs behind the sternum and can radiate to various areas, including the neck, shoulders, hands, jaw, epigastrium, and back The most common pattern involves pain spreading to the left shoulder and then to the inside of the left hand, occasionally extending down to the fourth and fifth fingers.

Chest pain commonly arises during physical exertion, intense emotions, exposure to cold, after consuming a heavy meal, or smoking, and typically subsides quickly within minutes as these triggers lessen Additionally, it can occur spontaneously without any apparent cause.

In some cases, angina attacks may occur at night, when changing positions, or when accompanied by a rapid heartbeat

Chest pain can manifest as constriction, strangulation, pressure, or burning sensations, often accompanied by symptoms such as shortness of breath, fatigue, headache, nausea, and sweating Typically, this pain lasts between 3 to 5 minutes, but it can extend up to 20 minutes If the pain persists at rest, it may indicate unstable angina or a myocardial infarction Emotional pain often endures longer than pain from physical exertion, while pain lasting less than one minute should prompt investigation for non-cardiac causes.

Typical coronary angina is characterized by three key elements: poststernal chest pain that has a typical nature and duration, an increase in intensity during physical exertion or emotional stress, and relief of pain when at rest or through the use of sublingual nitroglycerin, which provides relief within five minutes.

- Atypical angina: Consists of only the above two factors Unlike angina: Only one or none of the factors mentioned above

- Classification of stable angina: according to the Canadian Heart Association or Canadian Cardiovascular Society (CCS)

Table 2 1 Classification of angina (Canadian Cardiovascular Society) [15]

I Angina occurs with heavy work or exertion

Angina occurs only with very vigorous, rapid physical activity or normal but prolonged physical activity (walking, climbing stairs)

II Angina occurs with moderate physical activity

Routine activities can be performed with fewer restrictions when done quickly, after meals, in cold or windy conditions, during stress, or several hours after waking However, individuals can still ascend uphill and climb more than one floor at a normal pace under typical circumstances.

III Angina occurs with light physical activity

Difficulty walking 1-2 blocks or climbing 1 floor at normal pace and conditions

IV Angina occurs at rest

There is no need for exertion to trigger angina b Subclinical investigations

- Test for hs troponin to rule out acute coronary syndrome

- Blood tests recommended in all patients with ASCVD:

- Complete blood cell analysis, paying attention to hemoglobin

- Test for creatinine and evaluate kidney function

- Blood lipid bilan (LDL-C, total cholesterol, HDL-C; Triglyceride)

- Screening for type 2 diabetes in patients with suspected or pre-existing ASCVD with HbA1c, fasting blood glucose

- Glucose tolerance test if HbA1c and fasting blood sugar are inconclusive

- Assess thyroid function if thyroid disease is clinically suspected

An electrocardiogram (ECG) at rest is essential for all patients with acute coronary syndrome (ACS), as up to 60% of those with stable angina may exhibit a normal ECG It can reveal significant findings, including Q waves that suggest a prior myocardial infarction (MI), ST depression, and other abnormalities Additionally, the ECG is valuable for identifying conditions such as left ventricular hypertrophy, bundle branch block, pre-excitation syndrome, arrhythmias, and conduction disturbances.

During episodes of pain, ECG changes such as ST segment depression and negative T waves may occur; however, a normal ECG does not exclude ischemic heart disease It is important to note that ST segment alterations observed during supraventricular tachycardia should not be interpreted as indicators of coronary artery disease (CAD), according to the European Society of Cardiology (ESC).

In 2019, recommendations for Holter electrocardiogram monitoring emphasized its use in patients experiencing chest pain and suspected arrhythmias It is particularly advised for those with suspected coronary artery spasms However, routine screening using Holter monitoring is not recommended for patients with suspected coronary heart disease (CHD).

A chest X-ray is essential for assessing heart chamber dilation, pulmonary circulation stagnation, and differentiating from other conditions It is particularly recommended for patients exhibiting atypical clinical signs, symptoms of heart failure, or suspected respiratory diseases.

Echocardiography, including 2D transthoracic Doppler echocardiography, is essential for evaluating heart structure and function It aids in distinguishing heart conditions that may cause chest pain, such as aortic valve stenosis and hypertrophic cardiomyopathy, as well as conditions like left ventricular outflow tract obstruction and pericarditis Additionally, it assesses the ischemic area, providing crucial insights for accurate diagnosis and treatment.

Echocardiography can be performed during or immediately after chest pain to assess hypomobility, while Tissue Doppler ultrasound and myocardial tension evaluation aid in detecting heart failure with preserved ejection fraction (EF), particularly in patients experiencing exercise-related symptoms Stress echocardiography, utilizing physical exertion (such as cycling or treadmill) or medication (like dobutamine), is effective in diagnosing ischemic heart disease and myocardial recovery The latest generation of ultrasound machines has significantly enhanced the reliability of stress echocardiography in diagnosing coronary artery disease.

Figure 2.1 Diagram of 6 steps to diagnose coronary artery disease of ESC 2019

2.1.5.1.2 Non-ST segment acute coronary syndrome a Clinical

- Clinical features of patients with ACS without ST-elevation:

Patients with acute coronary syndrome (ACS) without ST-segment elevation tend to be older and frequently have multiple comorbidities, including diabetes, hypertension, and dyslipidemia Additionally, these patients are more commonly observed following myocardial infarctions (MI) or coronary interventional procedures.

Typical coronary angina pectoris is characterized by poststernal squeezing pain that may radiate to the left shoulder, chin, or both shoulders This type of angina often occurs after physical exertion but can also manifest during periods of rest The discomfort typically lasts for more than 20 minutes.

- Increased angina (on the basis of the patient's history of stable angina)

Angina can manifest following events like myocardial infarction, coronary interventions, or coronary artery bypass graft surgery, often without distinct pain symptoms Instead, individuals may experience a sensation of heavy pressure and difficulty breathing, known as silent pain.

Clinical examination plays a limited role in definitively diagnosing acute coronary syndrome (ACS) in the absence of ST-segment elevation; however, it is crucial for differential diagnosis and evaluating risk factors and complications It aids in distinguishing ACS from various other causes of chest pain, including cardiac conditions like hypertrophic cardiomyopathy and pericarditis, pulmonary issues such as pulmonary embolism and pleurisy, as well as aortic aneurysm-dissection, musculoskeletal disorders, and gastrointestinal diseases Additionally, clinical examination helps identify symptoms of heart failure, the presence of a third heart sound (S3), and heart valve stenosis.

Research Methods

The sample size was calculated according to the formula:

- n: Minimum sample size (number of subjects to be studied)

- α: Statistical significance level = 0.05 (95% confidence level)

- p: Estimated rate of complications after angiography and coronary intervention (in Anh H.V.'s study, the rate of complications at the puncture site was 6%)

- d: The desired absolute accuracy is 95% -> d = 0.05

So, the sample size is 87 patients

The actual sample size obtained was 106 patients

2.2.3 Research process i Patient selection and pre-procedural assessment:

- Patients were clinically examined (Measurement of blood pressure, heart rate, height, and weight) and did laboratory tests according to the research medical record

- The patient was explained about the procedure and signed a commitment to

26 coronary angiography and/or intervention ii During procedure:

- Place of procedure: Interventional Cardiology Unit – Heart Institute

- The patient was photographed and performed percutaneous coronary intervention (if indicated) according to the technical procedure

- Data were recorded: vascular access location, sheath size, procedure time, and amount of unfractionated heparin used during the procedure iii After the procedure:

Following the procedure, the patient received pressure treatment using gauze and bandages, or was closed with an instrument such as Angioseal or Perclose The area was then covered with a gauze bandage and secured before the patient was transferred to room C7.

- The patients who save the sheath will have the sheath removed and the bleeding stopped according to the doctor's prescription in room C7

Upon patient admission, the nurse will closely monitor vital signs, including pulse and blood pressure, as well as assess for any bleeding or hematoma This monitoring will occur at the time of admission, when bleeding is detected, and prior to bandage removal.

- The procedure to remove the sheath, compress and remove the compression bandage is as follows:

To access the radial artery, the sheath is immediately withdrawn post-procedure, with manual compression lasting 1-2 minutes for coronary angiography patients and 1-5 minutes for those with coronary artery disease Following cardiac catheterization, compression is applied using a roll bandage, which is monitored every 2 hours and removed after a minimum of 6 hours.

For femoral artery access, the sheath is removed immediately following the coronary angiography procedure In interventional cases, the sheath is typically withdrawn after 1-2 hours, utilizing the pressure of three fingers (2, 3, and 4) while ensuring a straightened position.

To ensure proper care after an arm puncture, apply firm pressure on the site about 1 cm above the puncture for at least 15 minutes without releasing or moving your hand After confirming there is no further bleeding, secure the area with a roll-up bandage and monitor the site It is essential to keep the compression bandage in place for a minimum of 12 hours before removal.

Main research variable

2.3.1 Characteristics of the research object

- Parameters on clinical characteristics: age, gender, height, weight, pulse rate and blood pressure at admission

- Parameters on clinical features: hemoglobin, platelet count, PT-INR, APTT b/c, Creatinine, GOT, GPT

- Drug parameters and dosage used in relation to bleeding: Aspirin, Plavix, Brilinta, Lovenox, vitamin K antagonists, new generation anticoagulants

- Place of puncture: radial artery, femoral artery

- Intraprocedural unfractionated heparin dose (units UI)

- Procedure start and end time, total procedure time

2.3.3 Variables for follow-up in the ward

- The monitoring indicators with the corresponding time of initial reception, the time of detecting bleeding, and the time of removing the compression bandage: pulse, blood pressure

- Bleeding: blood continues to ooze from the compression gauze after the dressing or bleeding occurs after the compression bandage is removed

- Hematoma: hematoma around the puncture site, the largest diameter of the

28 hematoma Small hematoma when size < 5 cm, large hematoma when size >

- Retroperitoneal bleeding: size on ultrasound or other imaging methods such as computed tomography (CT) or magnetic resonance imaging (MRI)

Complications of late bleeding include:

- Pseudoaneurysm: measuring size on ultrasound or other imaging methods such as CT or MRI

Monitoring at the ward: early bleeding complications, late bleeding complications.

Analyzing data

- Data collection was carried out according to the unified study case

- The data was entered on Excel software and processed on SPSS Statistics 20 software

- Quantitative variables were calculated as mean, median, and standard deviation

- Qualitative variables are presented as percentages or absolute frequency values

- Using T-test to compare mean values, paired T-test for paired variables, using Chi-square operation

- The results were considered statistically significant when the p-value < 0.05.

Research media

The data were collected according to the reaseach medical record (Appendix)

Research Ethics

Patients voluntarily participate in the study after receiving comprehensive information about its purpose, with assurances that their personal data will remain confidential Those who choose not to participate still receive careful examination, consultation, and treatment.

- The research is only to evaluate and improve the quality of health care for patients, not for any other purpose

RESULTS

3.1 General characteristics of the study population

3.1.1 Distribution of age and gender a Age

Table 3 1 Age distribution by age group

- The age group 61-80 accounted for the highest percentage (67%) compared to the age group 80

Comment: The male/female ratio is approximately 7/3 (men = 74, women = 32)

3.1.2 Distribution characteristics of coronary artery disease

Table 3 2 Distribution of coronary artery disease

The proportion of patients with myocardial infarction without ST-segment elevation accounted for the highest rate (67%) compared with STEMI (19%) and UA (20%)

• The rate of patients with comorbidities was 79.2%, in which the rate of

32 hypertension was the highest (74%), followed by diabetes (28%), dyslipidemia (13%) and 8% had other comorbidities

• The prevalence of 2 or more comorbidities was 30.2%

3.1.4 Characteristics of clinical indicators of the study group

Criteria General (X±SD) Male Female

The study revealed a mean systolic blood pressure of 122.87 ± 15.63 mmHg and a mean diastolic blood pressure of 76.90 ± 8.38 mmHg, both falling within normal ranges No statistically significant difference was observed between men and women (p > 0.05) The overall prevalence of hypertension was found to be 84%, with men exhibiting a hypertension rate of 70.3% and women at 29.7% (p > 0.05).

Table 3 4 Prevalence of hypertension by age group

• Age 61-80 has the highest rate of increase in SBP and SBP

• Rate of increase in SBP at age 80: 5%

• The rate of increase in HAT at age 80: 6.9%

Table 3 5 BMI characteristics by gender

Table 3 6 BMI characteristics by age group

The study group had a mean BMI of 22.80 ± 2.94 kg/m², which falls within the normal range for Asians (18.5 – 22.9) There was no statistically significant difference in mean BMI between the sexes (p > 0.05) However, the rate of BMI increase over 23 kg/m² was 72.2% higher in men compared to women, with this difference being statistically significant (p < 0.05).

• The rate of BMI increase at age 61-80 was the highest with 61.1%, age < 60

34 was 37.0%, and age over 81 was 1.9% (p > 0.05)

3.1.7 Characteristics of the test indicators of the study group

Table 3 7 Characteristics of some subclinical test of research subjects

The study revealed that while the average serum creatinine and platelet count were within normal limits, the average plasma glucose levels in the group exceeded the normal range of 4-6 mmol/L Additionally, the mean INR of the patients was slightly above the normal range, although these differences were minimal and not statistically significant.

3.1.5 Features of coronary angiography and intervention:

Table 3 8 Characteristics of coronary angiography and coronary intervention

Cases of coronary intervention accounted for the majority of cases with 81%

3.1.6 Features of the use of anticoagulants and antiplatelet agents

Table 3 9 Prevalence of use of anticoagulants, anticoagulants

Combine Aspirin + Clopidogrel + Ticargrelor + Lovenox 0.94

In the study, all patients received at least one medication, with Aspirin being the most frequently prescribed at 98% Additionally, P2Y12 receptor antagonists were utilized, including Clopidogrel at 84% and Ticagrelor at 14.2% Notably, neither Vitamin K antagonists nor new-generation anticoagulants were administered.

Considering dual platelet aggregation therapy (DAPT), the combination of Aspirin and Clopidogrel (71%) was significantly superior to the combination of Aspirin and Ticagrelor (29%)

In addition, combinations of more than 3 drugs only 0.94%, but 100% of combinations include Aspirin

3.1.7 Use of unfractionated heparin in the procedure

In a study involving 106 patients, unfractionated heparin demonstrated a significant antihypertensive effect in 97.17% of cases The average dose administered for patients undergoing only coronary angiography was 4567.9 ± 1896.5 UI, while those receiving coronary interventions required a higher average dose of 5933.5 ± 680.9 UI, with a statistically significant difference (p0.05)

Table 3 19 Relationship between complications and having two or more comorbidities

A statistically significant difference was observed in the proportion of patients with complications, with 9.4% of those having two or more co-occurring conditions compared to 0% of patients without such conditions (p=0.026).

Table 3 20 Distribution of complications according to hypertension

The proportion of patients with hematoma with hypertension (4.1%) was

42 higher than the proportion of patients with hematoma without hypertension (0%), the difference was not statistically significant

Table 3 21 Distribution of complications by diabetes

• The proportion of patients with hematoma with diabetes (7.1%) was higher than the rate of patients with hematoma without diabetes (1.30%), the difference was not statistically significant

• Diabetic patients have 5,923 times higher risk of hematoma than the non- diabetic group, but this difference is not statistically significant

Table 3 22 Hematoma characteristics according to dyslipidemia

• The proportion of patients with hematoma with dyslipidemia (15.40%) was higher than the rate of patients with hematoma without dyslipidemia (1.10%), the difference was not statistically significant

• Patients with dyslipidemia have 16.73 times the risk of hematoma compared with the without group, this difference is statistically significant with p=0.039 General comments on complication rates by comorbidities:

• The complication rate of people with 2 comorbidities was higher than the complication rate of the group with 1 comorbidity and no comorbidities, the difference was statistically significant 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

3.3.4 The relationship between some clinical indicators with hematoma complications:

Table 3 23 Average comparison of some clinical indicators between the two groups with and without complications

In a comparative analysis, the group experiencing complications exhibited higher mean age, systolic blood pressure (BP), and body mass index (BMI) compared to the group without complications However, the mean diastolic BP in the complications group was lower than that of the non-complications group, although this difference did not reach statistical significance.

3.3.5 The relationship of complications with drug use

Table 3 24 Comparison of rates of use of anticoagulants and ARBs between the two groups with and without complications

In a comparison of complication rates, the clopidogrel group experienced a rate of 3.57%, which was higher than the 2.04% observed in the Aspirin group; however, this difference was not statistically significant Additionally, no complications were reported among patients treated with Ticagrelor and Lovenox, with the difference also lacking statistical significance.

*Relationship of complications with the use of unfractionated heparin:

The dose of unfractionated heparin in patients with hematoma was higher than in patients without hematoma (corresponding to 6000 ± 1000, 5329.8 ± 1456.9), the difference was not statistically significant (p>0.05)

Table 3 25 Complication rates between different DAPT groups

The rate of complications in patients with the combination of Aspirin + Clopidogrel (1.35%) was higher than that of the combination group of Aspirin + Ticargrelor (0%), the difference was not statistically significant

3.3.6 Comparison of mean values of some paraclinical indicators in the group with complications and without complications

Table 3 26 Comparison of mean values of some paraclinical indicators in the group with complications and without complications

Creatinine (form/l) 75.33 ± 12.42 93.53 ± 27.80 >0.05 Glucose (mmol/L) 8.61 ± 5.84 6.40 ± 1.88 >0.05 Platelets (G/L) 265.67 ± 63.08 252.816 ± 6.22 >0.05

• The mean creatinine concentration of the group with complications (75.33 ± 12.42) was lower than that of the None group (93.53 ± 27.80), both were within normal limits, the difference was not statistically significant

The average blood glucose concentration in the group with complications was 8.61 ± 5.84, significantly higher than the 6.40 ± 1.88 observed in the group without complications However, both groups exceeded the normal blood glucose limits, and the difference between them was not statistically significant.

• The average platelet count of the group with complications (265.67 ± 63.08) was higher than that of the group without complications (252,816 ± 6.22), both were within normal limits, the difference was not statistically significant

• The mean PT-INR of the group with complications (1.03 ± 0.44) was lower than that of the group without complications (1.05 ± 0.68), all within normal limits, the difference was not statistically significant

3.3.7 Relationship of complications with the performing artery

Table 3 27 Complications by access artery

• In the radial artery intervention group, there were 2 patients with complications, the rate was 1.98%

• In the group of femoral artery intervention, 1 patient had complications, the rate was 20.0%

• Intervention through the femoral artery has a risk of hematoma 12.38 times higher than the radial intervention group

3.3.8 Relationship of complications with the procedure performed:

Table 3 28 Complications with the procedure performed

Comment: 100% of hematoma cases are coronary intervention

3.3.9 Comparison of mean procedure time in the hematoma group and no hematoma

Table 3 29 Comparison of mean procedure time in the hematoma group and no hematoma

Index Hematoma ( ± SD) None ( ± SD) p

• 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

1 Gender distribution

Comment: The male/female ratio is approximately 7/3 (men = 74, women = 32)

3.1.2 Distribution characteristics of coronary artery disease

Table 3 2 Distribution of coronary artery disease

The proportion of patients with myocardial infarction without ST-segment elevation accounted for the highest rate (67%) compared with STEMI (19%) and UA (20%)

• The rate of patients with comorbidities was 79.2%, in which the rate of

32 hypertension was the highest (74%), followed by diabetes (28%), dyslipidemia (13%) and 8% had other comorbidities

• The prevalence of 2 or more comorbidities was 30.2%

3.1.4 Characteristics of clinical indicators of the study group

Criteria General (X±SD) Male Female

The study found that the mean systolic blood pressure was 122.87 ± 15.63 and the mean diastolic blood pressure was 76.90 ± 8.38, both of which fall within normal ranges There was no statistically significant difference in blood pressure readings between men and women (p > 0.05) Hypertension prevalence was notably high at 84%, with men experiencing a hypertension rate of 70.3% and women at 29.7%, again showing no significant difference (p > 0.05).

Table 3 4 Prevalence of hypertension by age group

• Age 61-80 has the highest rate of increase in SBP and SBP

• Rate of increase in SBP at age 80: 5%

• The rate of increase in HAT at age 80: 6.9%

Table 3 5 BMI characteristics by gender

Table 3 6 BMI characteristics by age group

The study group had a mean BMI of 22.80 ± 2.94 kg/m², which falls within the normal range for Asians (18.5 – 22.9) There was no statistically significant difference in mean BMI between the sexes (p > 0.05) However, the rate of BMI increase over 23 kg/m² was significantly higher in men, showing a 72.2% increase compared to women, with a statistical significance of p < 0.05.

• The rate of BMI increase at age 61-80 was the highest with 61.1%, age < 60

34 was 37.0%, and age over 81 was 1.9% (p > 0.05)

3.1.7 Characteristics of the test indicators of the study group

Table 3 7 Characteristics of some subclinical test of research subjects

The study revealed that the average serum creatinine and platelet counts were within normal limits However, the average plasma glucose levels in the study group exceeded the normal range of 4-6 mmol/L Additionally, while the mean INR of the patients was slightly above the normal range, the differences observed were minimal and not statistically significant.

3.1.5 Features of coronary angiography and intervention:

Table 3 8 Characteristics of coronary angiography and coronary intervention

Cases of coronary intervention accounted for the majority of cases with 81%

3.1.6 Features of the use of anticoagulants and antiplatelet agents

Table 3 9 Prevalence of use of anticoagulants, anticoagulants

Combine Aspirin + Clopidogrel + Ticargrelor + Lovenox 0.94

In a recent study, it was found that all patients were prescribed at least one medication, with Aspirin being the most frequently used at 98% Additionally, P2Y12 receptor antagonists were also utilized, including Clopidogrel at 84% and Ticagrelor at 14.2% Notably, neither vitamin K antagonists nor new-generation anticoagulants were administered in this patient population.

Considering dual platelet aggregation therapy (DAPT), the combination of Aspirin and Clopidogrel (71%) was significantly superior to the combination of Aspirin and Ticagrelor (29%)

In addition, combinations of more than 3 drugs only 0.94%, but 100% of combinations include Aspirin

3.1.7 Use of unfractionated heparin in the procedure

In a study involving 106 patients treated with unfractionated heparin, an antihypertensive effect was observed in 97.17% of cases The average dose of unfractionated heparin for patients undergoing only coronary angiography was 4567.9 ± 1896.5 UI, while those receiving coronary intervention required a higher average dose of 5933.5 ± 680.9 UI, with a statistically significant difference (p0.05)