Safety and efficacy of intracoronary recombinant human prourokinase administration in patients with acute myocardial infarction and ST‑segment elevation: A meta‑analysis of randomized controlled trials
- Authors:
- Published online on: November 30, 2022 https://doi.org/10.3892/etm.2022.11739
- Article Number: 40
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Copyright: © Fan et al. This is an open access article distributed under the terms of Creative Commons Attribution License.
Abstract
Introduction
Coronary artery disease (CAD) is the most common cardiovascular disease and has a notable impact on global health (1). ST-segment elevation myocardial infarction (STEMI) is one of the most acute manifestations of CAD, which is typically characterized by acute onset and high mortality (2). The recanalization of infarct-associated arteries or culprit vessels and reestablishing myocardial perfusion is the primary treatment for STEMI (3). Percutaneous coronary intervention (PCI) is the most effective and widely used method for reopening occluded vessels (3). With the application of PCI, mortality of STEMI significantly decreased (4). However, a review revealed that certain patients may experience slow blood flow or no reflow following PCI, decreasing the benefits of PCI (5). It has been reported that the incidence of slow blood flow or no reflow after PCI in patients with STEMI is ~30%, which leads to an increase in infarct size, heart failure and mortality rate (6). Slow blood flow and no reflow following PCI in patients with STEMI are independent risk factors for short-time prognosis and long-time major adverse cardiovascular events (MACEs) (6).
High thrombus burden, prolonged reperfusion time, stent diameter and post-stent expansion are all potential factors verified to affect the incidence of slow blood flow and no reflow after PCI (7). Therefore, adequate anticoagulation before and during PCI is key for the prevention of slow blood flow and no reflow. However, anticoagulation may increase the risk of bleeding. How to properly balance decreased slow blood flow and no reflow and the potential increased risk of bleeding is an urgent cardiovascular problem for treatment of acute STEMI.
Recombinant human prourokinase (Pro-UK) is a fibrin-specific plasminogen activator that shares structural similarities with tissue plasminogen activator but functions via a different mechanism (8). Studies show that Pro-UK presents with fewer hemorrhagic complications and lower re-occlusion rate in patients with acute STEMI compared with conventional drugs (9,10). In addition, certain prospective study found that Pro-UK decreases MACEs whereas a retrospective study revealed that Pro-UK does not affect MACEs (11). To date, Pro-UK is not a frequent agent applied to patients for acute STEMI due to lack of evidence. To the best of our knowledge, there are limited studies investigating the efficacy and safety of Pro-UK in patients with acute STEMI (11,12). Therefore, further investigations are needed to assess intracoronary administration of Pro-UK and non-Pro-UK treatment in patients with acute STEMI.
Since Pro-UK is a coronary thrombolytic drug from China, most clinical trials on Pro-UK are led by Chinese scholars or conducted in China. In the present study, a meta-analysis of randomized controlled trials (RCTs) from China was performed to compare the safety and efficacy between Pro-UK and non-Pro-UK for treatment of acute STEMI. This analysis aimed to provide novel evidence-based medical information for the intracoronary application of Pro-UK in patients with acute STEMI.
Patients and methods
Search strategy
Studies published before June 2022 were retrieved from the following databases: PubMed (https://pubmed.ncbi.nlm.nih.gov/), Cochrane Library (https://www.cochranelibrary.com/) and China National Knowledge Infrastructure (CNKI) (https://www.cnki.net/). The terms ‘STEMI’ and ‘PCI’ or ‘Percutaneous coronary intervention’ and ‘Prourokinase’ or ‘Pro-UK’ were used as the key search words.
Selection criteria
Studies were included if the following criteria were met: i) RCT; ii) study subjects were patients with acute STEMI; iii) patients with acute STEMI received Pro-UK intracoronary therapy and iv) efficacy evaluation indicators included at least recanalization indicators, bleeding and MACEs. By contrast, studies were excluded if the following criteria were met: i) Non-RCT; ii) duplicate publication; iii) follow-up <30 days; iv) ongoing or unpublished study; v) the study did not contain the original data or statistical analysis could not be performed and vi) observational or cohort study.
Quality assessment
The included RCTs were assessed using the method of Jadad which is recommended by the Cochrane Library (13). The quality of RCTs was evaluated based on the following components: i) Randomized method; ii) allocation concealment; iii) blinding of participant personnel and outcome assessors; iv) complete outcome data; v) free of selective outcome reporting; and vi) clear causes for loss or quitting of the follow-up.
Data extraction
The data utilized in the present study were extracted by two independent authors (GF and DG) and not blinded. The information regarding first author, publication date, study design, baseline characteristics and endpoints was noted. The study method described in this article refers to previously published research by Fan et al (14). The endpoints included MACE, bleeding, ST-segment resolution (STR), corrected thrombolysis in myocardial infarction (TIMI) frame count (CTFC), TIMI grade 3 (TIMI-3), TIMI myocardial perfusion grade (TMPG), left ventricular ejection fraction LVEF, left ventricular end-diastolic diameter (LVEDd) and cardiac troponin I (cTnI). During extraction, a third reviewer was used to resolve any disagreement between the two authors.
Statistical analysis
The data were analyzed using Review Manager 5.3 software (Cochrane). Continuous effective outcomes are presented as standardized mean difference (SMD) while dichotomous effective outcomes were analyzed using risk ratio (RR). Continuous data were mean with SD in this study. The 95% CI was also calculated. The heterogeneity across studies was analyzed using Q-test. Values of P>0.10 and I2<50% were considered to indicate no significant heterogeneity and the pooled outcomes were estimated using the Mantel-Haenszel fixed-effects model. P≤0.10 and I2≥50% were considered to indicate significant heterogeneity and the pooled analyses were estimated using the Mantel-Haenszel random-effects model. P<0.05 was considered to indicate a statistically significant difference.
Results
Included studies
Studies were screened from PubMed (n=21), Cochrane Library (n=14) and CNKI (n=164) databases. After scanning the publications, 106 of 199 studies were excluded because of irrelevant or duplicate records. After further reading, 15 of the remaining 93 studies were excluded based on the abstract. Among the remaining 78 papers, 11 were review articles, 47 were retrospective studies, five were ongoing studies and two studies were excluded owing to lack of data. Finally, a total of 13 studies comprising 1,797 patients were included in this meta-analysis, including 897 patients who received Pro-UK and 900 patients who were in the control group. The procedure for use in the study is presented in Fig. 1.
Quality assessment and baseline characteristics
The primary characteristics of the included studies are illustrated in Table I. Patient age ranged from 49.0 to 64.9 years. The bias condition of selected studies is illustrated in Fig. 2 and bias summary is indicated in Fig. 3. The quality and grading of the included articles is presented in Table II. The selected reports were RCTs from China. The Jadad scoring of the included studies ranged from 5 to 7, which indicated high quality.
Comparison of MACEs between groups
A total of 13 studies comprising 1,797 patients reported MACEs. There was no significant heterogeneity between studies (P=0.50; I2=0%). The effect size of the pooled RRs was calculated using the Mantel-Haenszel fixed effects model. The results revealed that the Pro-UK group presented a significantly lower incidence of MACEs compared with that in the control group (RR, 0.68; 95% CI, 0.56-0.82; P<0.0001; Fig. 4).
Comparison of bleeding between two groups
A total of 13 studies reported bleeding, including 897 patients who received Pro-UK and 900 patients who in the control group. There was no significant heterogeneity between studies (P=0.83; I2=0%). The results showed that there was no significant difference in bleeding incidence between the two groups (RR, 1.12; 95% CI, 0.85-1.47; P=0.41; Fig. 5).
Comparison of TIMI-3 between groups
A total of 10 studies comprising 1,301 patients reported TIMI-3, including 618 patients who received Pro-UK and 613 patients who were in the control group. There was no significant heterogeneity between studies (P=0.003; I2=64%). The effect size of the pooled RRs was estimated using the random effects model. The Pro-UK group presented a significantly increased TIMI-3 rate compared with that in the control group (RR, 1.16; 95% CI, 1.07-1.25; P=0.0003; Fig. 6).
Comparison of TMPG-3 between groups
A total of five studies comprising 462 patients reported TMPG-3, including 235 patients who received Pro-UK and 227 patients who were in the control group. There was no significant heterogeneity between studies (P=0.02; I2=67%). The effect size of the pooled RRs was calculated using the random effects model. The Pro-UK group presented a significantly increased TMPG-3 rate compared with that in the control group (RR, 1.39; 95% CI, 1.12-1.74; P=0.004; Fig. 7).
Comparison of STR between two groups
A total of nine studies comprising 1,256 patients reported STR, including 625 patients who received Pro-UK and 631 patients who were in the control group. There was no significant heterogeneity between studies (P=0.05; I2=49%). The effect size of the pooled RRs was estimated using the Mantel-Haenszel random effects model. The Pro-UK group presented a significantly increased STR rate compared with that in the control group (RR, 1.23; 95% CI, 1.10-1.36; P=0.0002; Fig. 8).
Comparison of LVEF between groups
A total of 10 studies comprising 1,316 patients reported LVEF, including 655 patients who received Pro-UK and 661 patients who were in the control group. There was no significant heterogeneity between studies (P=0.08; I2=42%). The effect size of the pooled SMD was estimated using the Mantel-Haenszel fixed effects model. The Pro-UK group presented a significantly higher LVEF compared with the control group (SMD: 0.38, 95% CI: 0.27-0.49, P<0.00001, Fig. 9).
Comparison of LVEDd between groups
A total of six studies comprising 796 patients reported LVEDd, including 304 patients who received Pro-UK and 402 patients who were in the control group. There was no significant heterogeneity between studies (P=0.36; I2=9%). The effect size of pooled SMD was estimated using the fixed effects model. The Pro-UK group presented a significantly decreased LVEDd compared with that in the control group (SMD, -0.26; 95% CI, -0.40 – -0.12; P=0.0003; Fig. 10).
Comparison of CTFC between groups
A total of five studies comprising 570 patients reported CTFC, including 286 patients who received Pro-UK and 284 patients who were in the control group. There was no significant heterogeneity between studies (P=0.76; I2=0%). The effect size of pooled SMD was estimated using Mantel-Haenszel fixed effects model. The Pro-UK group presented a significantly decreased CTFC compared with that in the Control group (SMD, -0.45; 95% CI, -0.62 – -0.28, P<0.00001; Fig. 11).
Comparison of cTnI between groups
A total of four studies comprising 722 patients reported cTnI, including 360 patients who received Pro-UK and 362 patients who were in the control group. There was no significant heterogeneity between studies (P=0.67; I2=0%). The effect size of pooled SMD was estimated using the fixed effects model. The Pro-UK group presented a significantly decreased cTnI level compared with that in the control group (SMD, -0.31; 95% CI, -0.46 – -0.17; P<0.0001; Fig. 12).
Discussion
Altogether, 13 RCTs were included in the present meta-analysis. The pooled data estimations revealed that intracoronary Pro-UK administration was associated with decreased MACEs, LVEDd, CTFC and cTnI levels in patients with acute STEMI. Additionally, there were increased TIMI-3, TMPG-3, STR rate and LVEF levels in the Pro-UK group compared with those in the control group. No significant difference was identified regarding the safety indexes (bleeding) between groups.
The primary aim for the treatment of acute STEMI is to restore effective perfusion of the myocardium and minimize ischemic damage. PCI is the first option to reopen infarct-associated arteries and restore coronary blood flow (28). Stent implantation in patients with acute STEMI is beneficial. However, the incidence of slow blood flow or no reflow after PCI in patients with STEMI is ~30%, which usually leads to worse prognosis (29). Patients with STEMI and slow blood flow or no reflow have higher MACE occurrence rate compared with those with optimal flow (30). Delayed reperfusion, high thrombosis burden, glucose levels and stent diameter are factors that contribute to slow blood flow or no reflow following PCI (31).
High-burden thrombosis is the most important risk factor for no reflow or slow blood flow phenomena following PCI (32). Thrombus aspiration (TA) is a common method used for treating intracoronary thrombus, but TA cannot completely remove the thrombus and no reflow rate is still high following emergency PCI (33). Moreover, TA may cause local micro-thrombosis, which leads to no reflow or slowed blood flow and affects myocardial perfusion, increasing the risk of recurrent myocardial infarction, cardiogenic shock and malignant arrhythmia (33). Evidence-based study have suggested that TA is not associated with a decrease in long-term mortality or clinical outcomes in patients with STEMI (34). Currently, drugs such as tirofiban, sodium nitroprusside, nicorandil and diltiazem are widely used to decrease coronary thrombus burden. However, the incidence of no reflow after PCI is still high, which affects the prognosis of acute STEMI (35,36).
Recombinant human Pro-UK is the precursor of urokinase. The activated plasminogen combines with the thrombus Y/E tablet segment. Pro-UK quickly reacts with kininase and selectively activates plasminogen in thrombus fibrin, but it does not activate free plasminogen. Therefore, Pro-UK may decrease or avoid cytotoxicity, coagulation system allergy and systemic hemorrhage and other adverse events (37).
In the current study, 13 relatively high-quality RCTs were included. The present results revealed that intracoronary administration of Pro-UK therapy was associated with a lower incidence of MACEs (RR 0.68; 95% CI, 0.56-0.82; P<0.0001), lower LVEDd (SMD, -0.26; 95% CI, -0.40 – -0.12; P=0.0003), CTFC (SMD, -0.45; 95% CI, -0.62 – -0.28; P<0.00001) and cTnI (SMD, -0.31; 95% CI, -0.46 – -0.17; P<0.0001) in treating patients with acute STEMI. Furthermore, Pro-UK treatment had higher TIMI-3 (RR, 1.16; 95% CI, 1.07-1.25; P=0.0003), TMPG-3 (RR, 1.39; 95% CI, 1.12-1.74; P=0.004), STR (RR, 1.23; 95% CI, 1.10-1.36; P=0.0002) and LVEF (SMD, 0.38; 95% CI, 0.27 – -0.49; P<0.00001). Bleeding incidence (RR, 1.12; 95% CI, 0.85-1.47; P=0.41) was comparable between groups. Based on the present meta-analysis, intracoronary administration of Pro-UK during PCI in treatment of patients with acute STEMI should be recommended in clinical practice.
Certain limitations of the present meta-analysis should be mentioned. First, the meta-analysis was based on published RCTs and some large-scale ongoing trials were not included. Second, the analysis was performed on the trial level, not on the patient level. Third, there was only one multicenter trial in our meta-analysis that evaluated the Pro-UK effect. Additionally, the follow-up duration in studies was not uniform. Use of additional databases (such as Web of Science (https://www.webofscience.com/) and European Molecular Biology Organization (http://www.embo.org/) is required to validate the present results.
Intracoronary administration of Pro-UK not only decreases MACE, LVEDd, and cTnI levels, but also increases TIMI-3, TMPG-3, STR, and LVEF levels in patients with acute STEMI. Pro-UK is safe and effective to combine with PCI in treating patients with acute STEMI. However, more large-scale multicenter RCTs comparing Pro-UK and non-Pro-UK studies are needed to confirm this conclusion.
Acknowledgements
Not applicable.
Funding
Funding: No funding was received.
Availability of data and materials
All data generated and/or analyzed during this study are included in this published article.
Authors' contributions
GF and DG conceived and designed the study. GF, XW and WJ carried out literature search, study selection and quality assessment. WJ and HZ performed data extraction. GF and HZ confirm the authenticity of all the raw data. GF, XW, DG and WJ performed statistical analysis. GF wrote the manuscript. GF and DG interpreted the data and revised the manuscript. All authors have read and approved the final manuscript.
Ethics approval and consent to participate
Not applicable.
Patient consent for publication
Not applicable.
Competing of interests
The authors declare that they have no competing interests.
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