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Research Article

Angiographic Outcomes in STEMI Patients: Evaluating Pre-dilatation and Thrombus Aspiration Effects

[version 1; peer review: awaiting peer review]
PUBLISHED 07 Oct 2024
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REVIEWER STATUS AWAITING PEER REVIEW

Abstract

Introduction

ST-elevation myocardial infarction (STEMI) poses significant challenges in cardiovascular care, necessitating rapid and effective reperfusion strategies. The present study assesses the angiographic outcomes of pre-dilatation and thrombus aspiration (PD+TA) versus conventional treatment without thrombus aspiration (NOTA) in patients undergoing PPCI for STEMI.

Methods

This prospective cohort study included a total of 155 patients, with 78 assigned to the PD+TA group and 77 to the NOTA group. Baseline demographics, cardiovascular risk factors, and angiographic assessments including TIMI flow, TMPG flow, corrected TIMI frame count (CTFC), ST segment changes, and ejection fraction were compared between the groups.

Results

The PD+TA group exhibited significantly lower systolic (p-value: 0.021) and diastolic blood pressures (p-value: 0.046), better glucose control (p-value: 0.015), and a more pronounced reduction in ST segment elevation (p-value: 0.027) compared to the NOTA group. Although ejection fraction at presentation was similar between groups, the PD+TA group (52.29±8.80%) demonstrated a statistically significant improvement at one-month follow-up from NOTA (49.14±8.20%). TIMI 3 and TMPG 3 flow rates were comparable between groups before and after drug administration, with significant improvements in CTFC observed in the PD+TA group.

Conclusion

Pre-dilatation and TA during PPCI for STEMI patients may lead to improved acute angiographic outcomes, including enhanced myocardial reperfusion and reduced ischemic burden. The significant improvement in ejection fraction at one-month follow-up further supports the potential benefits of PD+TA in cardiac function recovery. Larger studies with longer-term follow-up are needed to validate these findings and determine the broader clinical implications of TA in STEMI management.

Clinical trial registration: CTRI/2019/02/017520, 7th February 2019, https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=Mjk5Mjc=&Enc=&userName=CTRI/2019/02/017520

Keywords

ST-elevation myocardial infarction, Primary percutaneous coronary intervention, STEMI, Thrombus aspiration, TIMI flow, ST-segment resolution

1. Introduction

STEMI (ST-elevation myocardial infarction) is the most widely occurring type of myocardial infarction that requires immediate medical attention. It is one of the main causes of mortality in patients with cardiovascular diseases.1 STEMI is caused by stenosis that involves the plaque accumulated in the arteries that get ruptured leading to thrombosis formation.2 The complete blockage in one or several coronary arteries leading to transmural myocardial ischemia causing myocardial infarction or necrosis.3

Over 3 million population experience STEMI every year with more than 4 million of the population showing STEMI pathology mostly observed in the countries that are developed.4 According to a study of 19,781 patients with coronary artery disease, the prevalence rate of STEMI was 23.3%.5,6 A study reported among the Asian individuals, showed that the incidence rates observed ranged from 33 to 138 cases per 100,000 individuals annually.7

The occurrence of STEMI varies from different regions and populations and is impacted by various factors.4 Factors like age, where increased age could be a potential risk for an increase in the occurrence of STEMI, commonly experienced by patients over 65 years with conditions like diabetes, high blood pressure, and atherosclerotic disease.6 Coming to genders, Men are at higher risk of suffering from STEMI when compared with women. However, Women after menopause may be on the radar of developing STEMI, reducing the gender gap.8 Furthermore, factors like unhealthy eating habits, lack of physical activity, using tobacco products, and availability of medical services can also be a cause of the increased rate of STEMI cases.9

Over the years, there has been developed various treatment approaches to manage STEMI that have evolved substantially aiming at reducing myocardial infarction and improving the quality of life of the patients. Treatment approaches like Reperfusion therapy include primary Percutaneous Coronary Intervention (PCI) which involves mechanical removal of the thrombus, opening the blockage, and restoring the blood flow by placing a stent at the blocked coronary artery.10 Another method of reperfusion therapy includes Thrombolytic therapy where thrombolytic components like tissue plasminogen activator or reteplase, help to dissolve the blocked coronary artery thrombus and restore the blood flow.11

Along with the standard treatment, adjunctive medical therapies like dual antiplatelet therapy, anticoagulation, Beta-blockers, Angiotensin-converting enzyme (ACE) Inhibitors, angiotensin receptor blockers (ARBs), and Statins are used to treat patients with STEMI by restoring the blood flow and improving the functionality of the arteries.9

Thrombus aspiration (TA) is used to remove the blood clot before the placement of the stent, hence reducing the mobilization of an embolus and improving the function of the arteries.12 However, recent trials have claimed to have uncertainty about the advantages of TA and proposed an increased risk of stroke in patients with no reduction in mortality.13,14 Whereas Autotransfusion involves gathering and infusing the patient’s blood again. This could reduce the requirement of performing allogenic transfusion as it carries a huge risk of infections, immune reactions, and diseases that are transmitted through transfusion.15,16

In a study conducted with 286 number of STEMI patients, those patients undergoing Percutaneous Transluminal Coronary Angioplasty (PTCA) with TA showed better outcomes compared to conventional angioplasty. However, a larger analysis with 19,047 patients showed that routine TA during PCI did not reduce cardiovascular mortality or stroke rates. In high thrombus burden cases, TA lowered cardiovascular deaths but increased stroke risk, that suggested a need for refined strategies.12

Like mentioned previously PPCI emerging as the preferred therapy where available. However, achieving successful myocardial reperfusion remains challenging due to several obstacles. Among these, high thrombus burden is particularly noteworthy, affecting a substantial number of patients. During PPCI, procedures such as wire manipulation, balloon dilatation, and stent placement in culprit vessels with high thrombus burden can lead to distal embolization of thrombus fragments and atherosclerotic plaque debris. This process impairs myocardial perfusion, potentially resulting in poorer short- and long-term outcomes, including heart failure and mortality. The present study aims to address these challenges by assessing the angiographic outcomes of pre-dilatation and TA compared to conventional treatment without TA in patients undergoing PPCI for STEMI

2. Methods

2.1 Study design

This prospective cohort study examines patients who underwent primary PCI for STEMI within the Department of Cardiology. The study spans from April 2021 to April 2023, focusing on the outcomes and characteristics of these patients during this period. The patient recruited only after attaining the ethical clearance from Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee bearing registration number ECR/146/Inst/KA/2013/RR-16 on 12th September 2018 (Approval Number: 539/2018). The study was registered with the Clinical Trials Registry-India (CTRI) (CTRI/2019/02/017520,7th February 2019, https://ctri.nic.in/Clinicaltrials/pmaindet2.php? EncHid=Mjk5Mjc=&Enc=&userName=CTRI/2019/02/017520) as per regulatory requirements. The ethical criteria outlined in the Declaration of Helsinki were followed when conducting this experiment.

The study enrolled patients referred for primary PCI within 24 hours of symptom onset, who exhibited TIMI 0 or 1 flow on angiography, were aged 18 years or older, and met the criteria for acute myocardial infarction (MI) as defined by the American College of Cardiology (ACC) and the American Heart Association (AHA). Patients with a history of prior stent implantation, fibrinolytic therapy for STEMI, or coronary artery bypass surgery were excluded from participation.

Data collection encompassed patient demographics, Etiology, blood investigation profiles, cardiac biomarkers, 12-lead electrocardiograms (ECG), echocardiography (ECHO), and angiographic findings, all documented within a predefined format.

2.2 Patient selection and randomization

The selected individuals were divided into two distinct groups based on the procedural approach: Group A, which underwent pre-dilatation and thrombus aspiration, and Group B, which did not undergo pre-dilatation. A total of 155 patients were recruited, Group 01 had 78 and Group 2 had 77.

2.3 Statistical analysis

Data were presented as Mean ± SD for quantitative variables and proportion with percentage for qualitative variables. Chi-square, Fischer test, t-test, and Mann Whitney U. We assessed statistical interactions at a significance level of 0·05.

Data cleaning and analysis were conducted using Microsoft Excel and the Statistical Package for Social Sciences (SPSS) version 25 (IBM Corp., Armonk, NY, USA), respectively.

3. Results

3.1 Demographics and cardiac parameters

The mean age of participants in the PD+TA group was 60.2±11.5 years, while in the NOTA group, it was 61.6±11.8 years. Systolic blood pressure (SBP) was significantly lower (p-value: 0.021) in the PD+TA group (127.3±29.1 mmHg) compared to the NOTA group (137.9±27.2 mmHg). Similarly, diastolic blood pressure (DBP) was significantly (p-value: 0.046) lower in the PD+TA group (79.16±17.3 mmHg) compared to the NOTA group (84.4±15.2 mmHg) (Table 1).

Table 1. Demographics associated with pre-dilatation and Thrombus aspiration versus NOTA.

VariableTreatment GroupP value
PD +TA (n,78)NOTA (n,77)
Age60.2±11.561.6±11.80.465
SBP127.3±29.1137.9±27.20.021
DBP79.16±17.384.4±15.20.046
Ejection Fraction at presentation47.48 ± 7.8147.59 ± 6.970.863
Ejection Fraction at 1month follow-up52.29±8.8049.14±8.200.029
ST-segment elevation6.22±3.064.90±2.260.003
ST-segment resolution2.05±1.911.41±1.600.027
Drugs used to treat slow flow34 (21.8)28 (17.9)0.359
Gender
Male61 (20)49 (16.1)0.046
Female17 (16.7)28 (27.5)
Smoking18 (18.6)12 (12.4)0.238
Alcohol22 (21.6)9 (8.8)0.010
GRBS202.69±86.5241.18±107.70.015
Risk Factors
HTN29 (16.3)39 (21.9)0.091
DM30 (19.9)35 (23.2)0.378
TIMI flow
Less than grade 318 (23.1)22 (28.6)
TIMI 3 grade60 (76.9)55 (71.4)0.434
TMPG
Less than grade 317 (21.8)13 (16.9)
TMPG 3 grade61 (78.2)64 (83.1)0.439
CTFC before drugs30.14±13.1534.22±17.060.095
CTFC after drug26.56±10.1432.40±16.500.004
MI Location
AWMI40 (17.4)39 (18.9)0.274
IWMI38 (18.3)38 (12.5)
Infract Related Vessel
LAD40 (19.3)39 (18.8)0.612
RCA24 (16)28 (18.7)
LCx14 (28)10 (20)
CAD Status
SVD39 (18.2)42 (19.6)0.698
DVD24 (19.5)21 (17.1)
TVD15 (19.5)14 (15.6)
KILLIP class
I35 (13.6)51 (19.8)
II23 (31.9)12 (16.7)0.050
III8 (26.7)7 (23.3)
IV12 (25.5)7 (14.9)
Time of Presentation
<6 hours56 (20.5)50 (18.3)
6-12 hours16 (15.7)21 (20.6)0.512
>12 hours6 (18.8)6 (18.8)
MACE overall5 (17.2)5 (17.2)0.831

The ejection fraction at presentation was comparable between the two groups, with the PD+TA group having a mean of 47.48±7.81% and the NOTA group having a mean of 47.59±6.97%. However, at the one-month follow-up, the PD+TA group showed a significantly (p-value: 0.029) higher mean ejection fraction (52.29±8.80%) compared to the NOTA group (49.14±8.20%). ST-segment elevation was also significantly (p-value: 0.003) higher in the PD+TA group (6.22±3.06) compared to the NOTA group (4.90±2.26). Additionally, ST-segment resolution was significantly (p-value: 0.027) greater in the PD+TA group (2.05±1.91) than in the NOTA group (1.41±1.60) (Table 1).

Smoking and alcohol consumption were more prevalent in the PD+TA group, but only alcohol use showed a statistically significant difference (PD+TA: 22 [28.2%] vs. NOTA: 9 [11.7%], p=0.010) (Table 1).

The mean glucose levels (GRBS) were significantly (p-value: 0.015) lower in the PD+TA group (202.69±86.5 mg/dL) compared to the NOTA group (241.18±107.7 mg/dL). TIMI flow and TMPG grades were also similar across the groups. The corrected TIMI frame count (CTFC) before and after drug administration showed significant improvement in the PD+TA group, with post-drug CTFC significantly lower (p-value: 0.004) in the PD+TA group (26.56±10.14) compared to the NOTA group (32.40±16.50) (Table 1).

The distribution of myocardial infarction location and the infarct-related vessel (LAD, RCA, LCx) showed no significant differences. Similarly, the CAD status (single, double, or triple vessel disease) was comparable between the groups. KILLIP class distribution approached significance, with more severe cases (class III and IV) being slightly more common in the PD+TA group. Presentation time post-onset of symptoms and major adverse cardiac events (MACE) were similar between the two groups (Table 1).

3.2 Angiographic Outcomes

Before drug administration, no significant difference was observed in TIMI 3 flow. TIMI 3 flow was observed in 55 patients (71.4%) in the NOTA group and 60 patients (76.9%) in the PD+TA group. After drug administration, TIMI 3 flow was present in 24 patients (85.7%) in the NOTA group and 25 patients (73.5%) in the PD+TA group. Without drug administration, TIMI 3 flow was observed in 48 patients (98.0%) in the NOTA group and 44 patients (100.0%) in the PD+TA group (Table 2).

Table 2. Comparison of angiographic outcomes between NOTA group PD+TA.

Angiographic outcomesNOTA (n,77) versus PD+TA (n, 78)
Before drugP valueWith drugP valueWithout drugP value
NOTAPD+TANOTAPD+TANOTAPD+TA
TIMI 3 flow n (%)55 (71.4)60 (76.9)0.43424 (85.7)25 (73.5)0.24148 (98.0)44 (100.0)0.341
TMPG 3 flow n (%)64 (83.1)61 (78.2)0.43924 (85.7)26 (76.5)0.35947 (95.9)38 (86.4)0.101
CTFC (Mean ± SD)34.2 ± 17.0630.14 ± 13.150.10838.2 ± 20.529.5 ± 12.050.04429.08 ± 12.724.2 ± 7.70.031

Similar For TMPG 3 flow, before drug administration no significant difference was observed. Total of 64 patients (83.1%) in the NOTA group and 61 patients (78.2%) in the PD+TA group achieved TMPG 3 flow. With drug administration, TMPG 3 flow was observed in 24 patients (85.7%) in the NOTA group and 26 patients (76.5%) in the PD+TA group. Without drug administration, 47 patients (95.9%) in the NOTA group and 38 patients (86.4%) in the PD+TA group achieved TMPG 3 flow (Table 2).

The corrected TIMI frame count (CTFC) outcomes showed more pronounced significant differences. Before drug administration, the mean CTFC was 34.2±17.06 in the NOTA group and 30.14±13.15 in the PD+TA group. With drug administration (p-value: 0.044), the mean CTFC was 38.2±20.5 in the NOTA group and 29.5±12.05 in the PD+TA group. Without drug administration (p-value: 0.031), the mean CTFC was 29.08±12.7 in the NOTA group and 24.2±7.7 in the PD+TA group (Table 2).

3.3 ST segment outcomes

The difference in ST segment elevation and regression (a-b) highlights the disparities between the groups. The mean difference in the PD+TA group was 4.16±2.17, while in the NOTA group, it was 3.48±1.93. This suggests that the net reduction in ST segment elevation was more pronounced (p-value: 0.015) in the PD+TA group compared to the NOTA group (Table 3).

Table 3. ST segment regression at 90 mins after PCI, P value signifying tests of within-subjects’ effects (time vs. treatment group).

ST segmentTreatment groupsP valve
PD+TA (n, 78)NOTA (n, 77)
(a) Elevation6.22 ± 3.064.90 ± 2.260.015
(b) Regression2.05 ± 1.911.41 ± 1.60
Difference (a-b)4.16 ± 2.173.48 ± 1.93

3.4 Ejection fraction outcomes

In the PD+TA group, the mean difference was 4.80±7.29, indicating a notable improvement in ejection fraction. In contrast, the NOTA group had a mean difference of only 1.55±4.91. Suggesting non-significantly but patients in the PD+TA group experienced a more substantial increase in ejection fraction following treatment compared to those in the NOTA group (Table 4).

Table 4. Ejection fraction measured at the time of presentation to one-month follow-up across the treatment groups.

Ejection fractionTreatment groupsP valve
PD+TA (n, 78)NOTA (n, 77)
(a) Pre47.48 ± 7.8147.59 ± 6.970.080
(b) Post52.29 ± 8.8049.14 ± 8.20
Difference (a-b)4.80 ± 7.291.55 ± 4.91

4. Discussion

In our study, we compared the outcomes of conventional PPCI with those of PPCI combined with TA in patients presenting with STEMI. The main findings highlighted several key differences between the two treatment approaches. In our study, we analysed the baseline characteristics and hemodynamic parameters of patients undergoing PPCI with pre-dilatation and thrombus aspiration (PD+TA) compared to those not receiving thrombus aspiration (NOTA). The mean age of participants in the PD+TA group was 60.2±11.5 years and NOTA group with a mean age of 61.6±11.8 years, indicating comparable age distribution between the two cohorts.

In a study by Elfekky et al.,17 the relationship between HTN and the use of TA in patients undergoing PPCI. The incidence of hypertension was almost identical between the who did not receive thrombus aspiration (50.0%) and of patients who did (50.7%). However, in our study we observed significant differences in blood pressure measurements between the two groups. Patients in the PD+TA group had significantly lower systolic blood pressure (SBP) (127.3±29.1 mmHg vs. 137.9±27.2 mmHg, p=0.021) and diastolic blood pressure (DBP) (79.16±17.3 mmHg vs. 84.4±15.2 mmHg, p=0.046) compared to those in the NOTA group

In the present study we compared the ejection fraction between the two groups, and found that at the one-month follow-up, the PD+TA group showed a significantly (p-value: 0.029) higher mean ejection fraction (52.29±8.80%) compared to the NOTA group (49.14±8.20%). ST-segment elevation was also significantly (p-value: 0.003) higher in the PD+TA group (6.22±3.06) compared to the NOTA group (4.90±2.26).

Additionally, ST-segment resolution was significantly (p-value: 0.027) greater in the PD+TA group (2.05±1.91) than in the NOTA group (1.41±1.60). A study conducted in Egypt showed that ST-segment resolution greater than 70% was achieved in 97.2% of the patients who underwent TA, compared to 86.8% in the patients who did not receive TA. The improved ST-segment resolution could be attributed to the mechanical removal of the thrombus, which may enhance the efficacy of PPCI by reducing the thrombotic burden and facilitating better perfusion of the distal coronary vasculature.

In our study, we observed that Thrombolysis in Myocardial Infarction (TIMI) flow and TMPG grades were similar across both treatment groups, indicating comparable immediate angiographic outcomes. However, the corrected TIMI frame count (CTFC), both before and after drug administration, showed significant improvement in the PD+TA group. Specifically, the post-drug CTFC was significantly lower in the PD+TA group (26.56±10.14) compared to the NOTA group (32.40±16.50), with a p-value of 0.004. Supporting our findings, Gao et al.18 reported that patients in the TA group demonstrated better TIMI flow grade classifications.

In our study, we found no significant differences in the distribution of myocardial infarction (MI) locations or the infarct-related vessels (LAD, RCA, LCx) between the groups. Similarly, the coronary artery disease (CAD) status, categorized as single, double, or triple vessel disease, was comparable across the groups. In contrast, the study by Kazazi et al.19 showed distinct findings. They reported that 33.2% of anterior wall MI patients and 19.6% of inferior wall MI patients had single vessel disease. Additionally, 72.0% of inferior wall MI patients had multi-vessel CAD, while this figure was 59.3% for anterior wall MI patients

In our study, we elaboaretly evaluated the TIMI 3 flow and TMPG 3 flow outcomes, both before and after drug administration, in two groups: These findings suggest that while TIMI 3 and TMPG 3 flow rates before and after drug administration were comparable between the NOTA and PD+TA groups, the PD+TA group showed more pronounced improvements in CTFC outcomes. The significant improvement in CTFC with and without drug administration in the PD+TA group indicates that pre-dilatation and thrombus aspiration may enhance coronary blood flow more effectively than conventional PCI alone.

Ejection fraction is a critical measure of cardiac function, and improvements in EF are associated with better clinical outcomes in patients with STEMI. The mean increase of 4.80±7.29 in the PD+TA group suggests that PD+TA may contribute to more effective myocardial salvage and recovery of left ventricular function. In contrast, the smaller mean increase of 1.55±4.91 in the NOTA group points to less pronounced improvements in cardiac function with conventional PPCI alone.

While the lack of statistical significance means we cannot definitively conclude that PD+TA is superior based on EF improvements alone, the trend observed in our study is consistent with other positive outcomes associated with TA, such as better ST segment regression and improved CTFC. These findings collectively suggest that PD+TA may offer enhanced benefits in the acute management of STEMI.

In the present study, there was no notable contrast observed between patients who received pre-dilatation and those who did not. However, it’s crucial to acknowledge that this study is single cantered. A more extensive prospective study with larger sample size and longer follow-up periods are needed to validate these findings and to determine the full extent of the benefits of thrombus aspiration on cardiac function. Nonetheless, the current results provide encouraging evidence that PD+TA may be a valuable adjunctive technique in improving cardiac outcomes in STEMI patients.

5. Conclusion

Our current study highlights several significant findings regarding the use of pre-dilatation and thrombus aspiration (PD+TA) in STEMI patients undergoing PPCI. The PD+TA group exhibited better acute angiographic outcomes, including improved TIMI 3 flow rates and reduced ST segment elevation compared to the NOTA group. Moreover, the PD+TA group showed a statistically significant improvement in ejection fraction at one-month follow-up, indicating potential benefits in cardiac function recovery. These findings underscore the potential of PD+TA to optimize coronary blood flow, enhance myocardial salvage, and potentially improve clinical outcomes in STEMI patients. Further research with larger cohorts and longer follow-up durations is warranted to confirm these observations and establish definitive guidelines for the use of thrombus aspiration in STEMI management.

Ethical considerations

The study is approved by Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee bearing registration number ECR/146/Inst/KA/2013/RR-16 on 12th September 2018 (Approval Number: 539/2018). The Declaration of Helsinki’s ethical guidelines were adhered to in the conduct of this investigation.

Consent from the participants

Written informed consent for participation in the study was obtained in English/local language as per the participant’s convenient language of understanding.

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V R, Guddattu V, Rao S et al. Angiographic Outcomes in STEMI Patients: Evaluating Pre-dilatation and Thrombus Aspiration Effects [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:1138 (https://doi.org/10.12688/f1000research.156104.1)
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