(Luận văn) 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 concern globally, accounting for one-third of all deaths in adults over 35 In Vietnam, CAD is a leading cause of mortality, with a 2016 WHO report indicating that 31% of deaths in the country were attributed to cardiovascular diseases, over half of which were due to CAD.

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) n

Approach to acute coronary syndromes (Figure 1.2)

Figure 1 2 Approach to acute coronary syndromes [53] n

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 options including the femoral, brachial, or radial arteries The success of the procedure and the reduction of associated complications depend significantly on the choice of artery, as well as the instruments used, the techniques employed, and the surgeons' experience.

Complications at the puncture site can significantly impact the effectiveness of interventions and patient outcomes A 2013 study by Mamas et al., involving 46,128 patients who underwent coronary angiography and intervention, found that radial bypass was an independent factor associated with a reduction in 30-day mortality, with a hazard ratio of 0.71.

A 2012 meta-analysis 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 complications associated with the puncture site (OR 0.30, 95% CI 0.19 – 0.48, p < 0.0001) Furthermore, findings indicated a reduction in major bleeding events (HR 0.37, 95% CI: 0.18 - 0.74, p < 0.01) and puncture site complications (HR 0.38, 95% CI: 0.19 – 0.75, p < 0.01).

Proficient access to blood vessels is essential for interventional cardiologists, while intervention room nurses and ward nurses must also be equipped with the knowledge and skills to manage and monitor vascular access complications following imaging and coronary interventions.

1.2.2.2 The femoral and radial arteries

The femoral artery has long been the preferred access route for coronary interventions due to its numerous advantages, including easy access, straightforward manual procedures, and a larger artery 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, there is a growing trend towards radial artery access, with some intervention rooms in the U.S and Europe reporting radial 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’s successful coronary intervention through this approach in 1993, marking a significant advancement in imaging and intervention techniques While radial access offers fewer complications at the puncture site, it demands a higher level of technical skill from surgeons A comprehensive comparison of the advantages and disadvantages of these interventional vascular sites is detailed 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 radial access in patients with STEMI undergoing these procedures The RIFLE STEACS study, which involved 1,001 patients, demonstrated that radial access significantly reduced cardiovascular mortality (5.2% compared to 9.2%) and bleeding complications (7.8% versus 12.2%) when compared to femoral artery access.

The RIVAL trial (Radial Versus Femoral Access for Coronary Intervention) assessed the efficacy and bleeding events of radial versus femoral interventions in patients with ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI) Findings revealed that radial artery intervention led to a lower all-cause mortality rate (1.3% compared to 3.2%) and a decrease in combined death, myocardial infarction, and stroke (2.7% versus 4.6%) in STEMI patients, although no significant benefits were observed in NSTEMI cases Additionally, the radial approach significantly minimized 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 that the procedures are 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 approach for arterial intervention remains contentious, with proponents of the femoral artery citing several advantages: it offers faster procedures, significantly reduced bleeding complications due to vascular closure devices, and greater flexibility in catheter size adjustments Additionally, femoral access facilitates the use of assistive devices like aortic balloon counterpulsation In contrast, using the radial artery poses challenges, including its unsuitability for subsequent coronary artery bypass grafting and difficulties arising from anatomical variations such as small radial pulses, constriction, and twisting of the brachial and subclavian arteries.

Surgeons and technicians in the intervention room find it relatively easy to access both the radial and femoral arteries In coronary angiography and percutaneous coronary intervention, it is advisable to prioritize the radial artery approach before considering the femoral artery, except in specific circumstances.

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

Various devices are designed to control bleeding at the radial puncture site, including the Radistop from St Jude Medical and the TR ring from Terumo Medical Corp These instruments work by covering the puncture site; as the sheath is slowly withdrawn, the cuff is gradually inflated By the time the sheath is fully removed, the bandage should be tight enough to prevent any visible bleeding at the puncture 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 This method benefits from the radial artery's smaller size and its position over a hard bone, making the withdrawal and hemostasis at the puncture site more manageable for surgeons, technicians, and nurses.

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

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 during sheath withdrawal The standard compression duration is based on the size of the sheath, adhering to the guideline of “5 minutes per 1F”; for instance, a 5F sheath requires 25 minutes of pressure, while a 6F sheath necessitates 30 minutes However, in patients who are obese, have loose subcutaneous tissue, or are on antiplatelet (such as Aspirin, Clopidogrel, Ticagrelor) or anticoagulant medications, the compression time may need to be extended.

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, totaling 47 patients Notably, 34 of these patients were in the femoral artery intervention group, while only 13 patients were in the radial artery intervention group.

The 2011 RIVAL study, which involved 7,021 patients with acute coronary syndrome, revealed that the incidence of bleeding at the puncture site was significantly lower in patients undergoing radial artery bypass, at just 1.4%, 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" n

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% occurrence of hematomas greater than 10 cm, a 0.12% rate of pseudoaneurysms, and a 10.12% incidence of artery occlusion In contrast, the radial artery procedure group reported no cases of bleeding, hematomas over 10 cm, pseudoaneurysms, or arterial obstruction, with only a 1.58% rate of small hematomas (5-10 cm) in four patients Statistically, there was no significant difference in acute myocardial infarction (AMI) rates between the femoral and radial artery groups Risk factors for atherosclerotic cardiovascular disease (ASCVD) in the femoral artery procedure included age, female gender, and blood pressure, while only blood pressure was a risk factor for the radial artery procedure.

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 in the form of 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 findings revealed that complications, such as hematomas measuring 5-10 cm, occurred in 1.58% of cases involving the radial artery and 3.41% in cases involving the femoral artery.

In a 2013 study conducted by Dung Q.T and colleagues at An Giang Hospital, titled "Local Complications After Catheter Removal in Patients with Percutaneous Coronary Intervention," it was found that among 83 patients, only 5 (6%) experienced minor hematomas The research indicated 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) n

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

A 2021 study by Thu T.H.N at Medical University Hospital examined complications following coronary angiography and interventions in 61 patients, revealing a significant complication rate of 23% related to puncture wounds The specific complications included hematoma (11.5%), bleeding (8.2%), embolism (6.6%), and pseudoaneurysm (3.3%) The study found that arterial procedures were significantly linked to these vascular puncture complications (OR=0.029, 95% CI: 0.003-0.2744), with angioplasty procedures showing a higher risk of complications when accessed via 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 n

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 prevalent pattern involves pain spreading to the left shoulder and then extending to the inner part of the left hand, occasionally reaching the fourth and fifth fingers.

Chest pain typically arises during physical exertion, intense emotions, exposure to cold, after consuming a heavy meal, or smoking This discomfort often subsides quickly, usually within minutes, once these triggering factors are alleviated In some cases, the pain may occur spontaneously without any obvious 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 like shortness of breath, fatigue, headache, nausea, and sweating Typically, this discomfort lasts between 3 to 5 minutes, though it can extend up to 20 minutes Persistent pain at rest may indicate unstable angina or a myocardial infarction Emotional pain often endures longer than pain resulting 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 either at rest or through the rapid administration of sublingual nitroglycerin 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 Individuals are still capable of climbing uphill and ascending 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 n

- 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 it can reveal critical heart conditions Notably, up to 60% of patients with stable angina may present with a normal ECG However, some may show Q waves, indicating a previous myocardial infarction (MI), while others may exhibit ST depression or other abnormalities Additionally, an ECG is valuable for identifying other cardiac issues, including left ventricular hypertrophy, bundle branch block, pre-excitation syndrome, arrhythmias, and conduction disturbances.

Electrocardiogram (ECG) changes, such as ST segment depression and negative T waves, may occur during episodes of pain; 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, it is recommended that Holter electrocardiogram monitoring be utilized for patients experiencing chest pain and suspected arrhythmias, particularly in those with potential coronary artery spasms However, it should not be used as a routine screening tool for patients suspected of having coronary heart disease (CHD).

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

Echocardiography, particularly 2D transthoracic Doppler echocardiography, plays a crucial role in assessing heart structure and function This imaging technique helps differentiate various heart conditions that may cause chest pain, such as aortic valve stenosis, hypertrophic cardiomyopathy, and left ventricular outflow tract obstruction, as well as pericarditis Additionally, it aids in evaluating the ischemic areas of the heart, providing valuable insights for accurate diagnosis and treatment.

Echocardiography can be performed during or immediately after episodes of chest pain to assess hypomobility Tissue Doppler ultrasound and myocardial tension evaluation are effective in identifying heart failure with preserved ejection fraction, which relates to the patient's exercise-induced symptoms Additionally, stress echocardiography—utilizing physical exertion or medication like dobutamine—plays a crucial role in diagnosing ischemic heart disease and evaluating myocardial recovery With advancements in modern ultrasound technology, stress echocardiography has emerged as a highly reliable tool for 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: n

Patients with acute coronary syndrome (ACS) without ST-segment elevation tend to be older and frequently present with multiple comorbidities, including diabetes, hypertension, and dyslipidemia Moreover, it is common for these patients to experience ACS following myocardial infarction (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 discomfort typically occurs after physical exertion but can also arise during periods of rest The pain generally lasts longer than 20 minutes and is associated with common clinical conditions.

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

Angina may arise following events like myocardial infarction, coronary interventions, or coronary artery bypass graft surgery, often presenting not as distinct pain but rather as a sensation of heavy pressure and difficulty breathing, commonly referred to as silent pain.

Clinical examination plays a limited role in definitively diagnosing Acute Coronary Syndrome (ACS) without ST-segment elevation; however, it is crucial for differential diagnosis and assessing risk factors and complications It aids in distinguishing ACS from other causes of chest pain, including cardiac conditions like hypertrophic cardiomyopathy and arrhythmias, pulmonary issues such as pulmonary embolism, and gastrointestinal disorders Additionally, clinical examination can detect symptoms of heart failure, the presence of a third heart sound, 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 n

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 was stabilized using gauze and bandages or secured with an instrument such as Angioseal or Perclose The area was then covered with a gauze bandage and rolled up 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 attending nurse will monitor vital signs, including pulse and blood pressure, while assessing the bleeding status and any hematoma present This evaluation will occur at the time of admission, upon detection of bleeding, and prior to bandage removal.

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

To ensure proper access to the radial artery during procedures, the sheath should be withdrawn immediately after the intervention For patients undergoing coronary angiography, manual compression is required for 1-2 minutes, while those with coronary artery disease need compression for 1-5 minutes Following cardiac catheterization, a roll bandage is applied, with monitoring every 2 hours, and the compression bandage should remain in place for at least 6 hours before removal.

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

To ensure proper post-puncture care, apply firm pressure on the puncture site of the arm, approximately 1 cm above the skin entry point, for at least 15 minutes without releasing or moving your hand After confirming there is no further bleeding, use a roll-up bandage for compression and monitor the site Remove the compression bandage after a minimum of 12 hours to promote healing.

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 n

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) n

Research Ethics

Patients voluntarily participate in the study, receiving comprehensive information about its purpose while ensuring their personal data remains confidential Those who choose not to participate are still given 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) n

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 n

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 mmHg, and the mean diastolic blood pressure was 76.90 ± 8.38 mmHg, both of which fall within normal ranges There was no statistically significant difference in blood pressure between men and women (p > 0.05) Additionally, the prevalence of hypertension was reported at 84%, with men exhibiting a hypertension rate of 70.3% and women at 29.7%, also 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 n

• 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 increase in BMI over 23 kg/m² was significantly higher in men, with a rate 72.2% greater than that of women, and this difference was statistically significant (p < 0.05).

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

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 of the participants exceeded the normal blood glucose range of 4-6 mmol/L Additionally, while the mean International Normalized Ratio (INR) of the patients was slightly above the normal range, the differences observed were minimal and statistically insignificant.

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% n

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, Vitamin K antagonists and new-generation anticoagulants were not 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 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)

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

A significant difference was observed in the proportion of patients experiencing complications, with 9.4% of those having two or more co-occurring conditions compared to none (0%) among patients without such conditions, yielding a statistically significant result (p=0.026).

Table 3 20 Distribution of complications according to hypertension

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

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

The group with complications exhibited a 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% rate observed in the Aspirin group; however, this difference was not statistically significant Additionally, patients treated with Ticagrelor and Lovenox reported no complications, with no significant differences noted among the groups.

*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 exhibited levels above the normal limit, 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 n

• 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 n

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 n

1 Gender distribution

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

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 n

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 that the mean systolic blood pressure was 122.87 ± 15.63 mmHg and the mean diastolic blood pressure was 76.90 ± 8.38 mmHg, both within normal ranges No statistically significant difference was found between men and women, with p > 0.05 The overall prevalence of hypertension was 84%, with men exhibiting a hypertension rate of 70.3% and women at 29.7%, also 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 n

• 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, falling 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 increase in BMI over 23 kg/m² was 72.2% higher in men compared to women, with this finding being statistically significant (p < 0.05).

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

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 count 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% n

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

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, Vitamin K antagonists and new-generation anticoagulants were not 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 treated with unfractionated heparin, an antihypertensive effect was observed in 97.17% of cases The average dose of unfractionated heparin administered was 4567.9 ± 1896.5 UI for patients undergoing only coronary angiography, while those receiving coronary interventions were given 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).