|Year : 2018 | Volume
| Issue : 3 | Page : 887-893
Primary percutaneous coronary intervention versus fibrinolytic therapy combined with early coronary catheterization using the left radial approach
Walaa F Abdel Aziz1, Mahmoud K Gaber1, Mohamed M Mandour2, Assem M Hassan1
1 Department of Cardiovascular Medicine, Faculty of Medicine, Menoufia University, Menoufia, Egypt
2 Department of Cardiovascular Medicine, National Heart Institute, Cairo, Egypt
|Date of Submission||16-Mar-2017|
|Date of Acceptance||07-May-2017|
|Date of Web Publication||31-Dec-2018|
Assem M Hassan
Department of Cardiovascular Medicine, Faculty of Medicine, Menoufia University, Shebin El Kom, Menoufia
Source of Support: None, Conflict of Interest: None
The objectives of this study were to compare primary percutaneous coronary intervention (PCI) with the strategy of fibrinolysis combined with coronary angiography within 6–24 h in ST-segment elevation myocardial infarction (STEMI) patients who presented within 3 h of symptom onset.
Guidelines for acute STEMI patients recommend primary PCI as the favorable reperfusion strategy. This approach is contingent on performing PCI in a timely manner. Most patients do not attend PCI-capable hospitals; this factor has led to major challenge in many regions.
Patients and methods
This was a prospective, single-center study that included 100 consecutive STEMI patients admitted to the ER Unit at the National Heart Institute between June 2013 and December 2015. Cases were divided into the following groups: group A included 50 STEMI patients with onset of symptoms within 3 h and received fibrinolysis with streptokinase followed by timely coronary artery with or without PCI using the left redial approach, and group B included 50 patients who underwent primary PCI. In-hospital outcomes were reviewed and reported after 30 days.
No statistically significant differences among groups were found with respect to mean age, sex, pulse, blood pressure, prevalence of previous stroke, peripheral arterial disease, previous myocardial infarction, previous PCI or previous coronary artery bypass graft, the duration from onset of symptoms to emergency department (ED) arrival, number of vessels treated, maximum inflation pressure, use of drug eluting stents, number of stents at target lesion, stent length, total stent length, mean nominal stent diameter, and incidence of cardiac deaths. In contrast, highly significant differences were observed in both groups regarding the prevalence of visible thrombus (P = 0.00), initial diameter stenosis (P = 0.031), total occlusion (P = 0.00), and baseline TIMI flow grade (P = 0.00) as the incidence was significantly higher in group B compared with group A. Highly significant differences were observed among group A and group B regarding severe bleeding, heart failure, and overall complications (P = 0.00 for all).
Left radial strategy for primary/delayed PCI in acute elevation of ST patients with previous myocardial infarction is feasible, safe, and successful with low incidence of complications. Early fibrinolytic therapy combined with early percutaneous intervention is a favorable choice for management of acute STEMI patients.
Keywords: coronary catheterization, fibrinolytic therapy, left radial approach
|How to cite this article:|
Abdel Aziz WF, Gaber MK, Mandour MM, Hassan AM. Primary percutaneous coronary intervention versus fibrinolytic therapy combined with early coronary catheterization using the left radial approach. Menoufia Med J 2018;31:887-93
|How to cite this URL:|
Abdel Aziz WF, Gaber MK, Mandour MM, Hassan AM. Primary percutaneous coronary intervention versus fibrinolytic therapy combined with early coronary catheterization using the left radial approach. Menoufia Med J [serial online] 2018 [cited 2019 Jun 19];31:887-93. Available from: http://www.mmj.eg.net/text.asp?2018/31/3/887/248728
| Introduction|| |
Primary percutaneous coronary intervention (PCI) is a favorable reperfusion approach for patients with ST-segment elevation myocardial infarction (STEMI) that has to be applied in a timely manner and by expert operators. For patients with STEMI, primary PCI is preferred over fibrinolytic therapy for reducing composite end points such as death, reinfarction, intracranial bleeding, reclusion of the infarct artery, and recurrent ischemia. Fibrinolytic therapy is the alternative when primary PCI is not available, but bleeding complications occur in many patients, and some patients are resistant to infarct artery reperfusion.
Patients who failed to respond to reperfusion fibrinolytic therapy were transferred to a PCI hospital for rescue PCI, which has emerged as the standard of care. Thus, the aim of contemporary reperfusion therapy is early, sustained, and complete reperfusion, which has been known for decades to lead to short-term and long-term better outcomes.
The radial strategy for coronary interventions is a safe alternative to femoral access. Indeed, the radial trend nearly abolishes complications at vascular entry sites and it permits a wide range of diagnostic and therapeutic interventions. The left radial strategy was a statistically shorter learning curve with progressive reduction in cannulation and fluoroscopy times as the operator volume increased compared with the right radial access. The difference may be because of anatomical variation between the left and the right vasculature, and the higher incidence of loops in the right radial artery and the right subclavian artery was more tortuous than the left in patients with a short stature and in elderly patients.
Therefore, the aim of the present study was to compare primary PCI with the strategy of fibrinolysis combined with coronary angiography within 6–24 h using the left radial approach in STEMI patients who presented to the hospital within 3 h of symptom appearance.
| Patients and Methods|| |
This was a prospective, single-center study that included 100 consecutive STEMI patients admitted to the ER Unit at the National Heart Institute between June 2013 and December 2015.
- Age more than or equal to 18 years
- Onset of symptoms less than 3 h before randomization
- 12-Lead ECG indicative of an acute STEMI [ST elevation was measured from the J point. If ≥2 mm ST elevation across two contiguous precordial leads (V1–V6) or leads I and aVL or ≥3 mm ST elevation in two contiguous inferior leads (II, III, aVF) ST elevation].
Exclusion criteria were as follows: hospitalization related to cardiac events within the past 48 h, recent administration of any intravenous or subcutaneous anticoagulants within 12 h, including unfractionated heparin, enoxaparin, or other anticoagulants, presence of any bleeding disorder, any history of central nervous system damage and recent head and cranium trauma (i.e., <3 m), known acute and/or subacute bacterial endocarditis, severe hepatic dysfunction including hepatic failure, cirrhosis, portal hypertension (esophageal varices), and active hepatitis, long-term dialysis/known renal insufficiency, arterial aneurysm and known arterial/venous malformation, and known hypersensitivity to any of the drug regimens prescribed.
All patients participating in this study signed an informed written consent before study initiation. Approval was obtained from the Research Ethics Committee of the Faculty of Medicine, Menoufia University.
All study patients were divided into two groups according to the availability of primary PCI.
Group A: this group included 50 STEMI patients who presented within 3 h of symptom onset. Patients were chosen for fibrinolysis with streptokinase combined with clopidogrel and aspirin, along with combined timely cardiac catheterization from 6 to 24 h using the left radial approach or a rescue coronary intervention if reperfusion failed within 90 min of fibrinolysis. Group B: this group included 50 patients scheduled to undergo standard primary PCI.
Major adverse cardiac events (MACE) scores within 30 days were recorded.
Complete history taking of all patients including atherosclerotic risk factors, previous ischemic events, and previous coronary interventions was carried out. However, complete cardiological examinations were performed before and after PCI.
A 12-lead resting ECG (using Fukuda Denshi III ECG machine; Fukuda Denshi, Kita Ueno, Taito-Ku, Tokyo 110-0014, Japan) was performed before the procedure, after the procedure, and before discharge. Echocardiography was performed for all patients using a General Electric vivid 5 machine (General Electric). Patients received detailed information about the potential risks of the procedure and signed an informed consent form.
Inspection of the potential areas of cannulation was carried out looking for signs of infection, skin breakdown, accessibility, and importantly the presence of the radial pulse. The physical examination included a bilateral evaluation of pulse quality and of blood pressure in both arms. The quality of the pulse was noted and whether a blood pressure differential exists, which provides important clues to both ease of arterial cannulation and accuracy of the measurement.
End point data of the study (composite efficacy end points within 30 days)
The following composite end points were considered: all-cause mortality, congestive heart failure, reinfarction, cardiogenic shock, rehospitalization for cardiac reasons, rehospitalization for noncardiac reasons, total stroke (fatal, disabling, and nondisabling), ischemic stroke, intracranial hemorrhage, nonintracranial bleeding, serious clinical events (e.g., resuscitated ventricular fibrillation), and repeat target vessel revascularization.
Severe bleeding was considered as a bleeding event that led to a hemodynamic compromise requiring intervention (e.g., blood or fluid replacement, inotropic support, ventricular assist device, and surgical repair) or life-threatening or fatal bleeding.
Moderate bleeding was considered as an event requiring transfusion of blood but that does not lead to hemodynamic compromise requiring intervention.
Minor bleeding included gingival bleeding, epistaxis, or hematuria.
Results were tabulated and statistically analyzed using a personal computer with Microsoft Excel 2016 (HeadquartersOne Microsoft Way, Redmond, Washington, U.S) and SPSS (v. 20; SPSS Inc., Chicago, Illinois, USA). Descriptive statistics are expressed as percentages, means, and SDs. Analytical statistics were carried out using a χ2 test and paired Student's t test. A P value of less than 0.05 was considered statistically significant.
| Results|| |
The mean age of patients in group A was 55.8 ± 10.5 years, whereas the mean age of patients in group B was 52.8 ± 9.2 years. The number of male patients was 36 and 38 in group A and group B, respectively. Insignificant differences were found among the studied groups regarding pulse, systolic and diastolic blood pressures (P = 0.061), prevalence of previous stroke (P = 0.071), peripheral arterial disease (P = 0.054), previous myocardial infarction (P = 0.55), previous PCI or previous coronary artery bypass graft (P = 0.120), the number of diseased vessels (P = 0.070), the infarct-related artery (P = 0.058), complex C lesion (P = 0.55), calcific lesion (P = 0.61), bifurcation lesion (P = 0.80), reference vessel diameter (P = 0.74), and lesion length (P = 0.067) [Table 1] and [Figure 1].
|Table 1: Baseline general and clinical characteristics and history of associated medical conditions of the two groups|
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|Figure 1: Initial diameter stenosis, incidence of total coronary occlusion and TIMI flow at baseline coronary angiography in the two groups at baseline angiography.|
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The prevalence of visible thrombus and initial diameter stenosis was lower in group A [11 (22%) patients and 87.5 ± 6.7%] compared with group B [28 (56%) patients and 94.5 ± 4.3]. However, the prevalence of total coronary occlusion was lower in group A [12 (24%) patients] compared with group B [29 (58%) patients]. There was a significant difference among the studied groups with regard to baseline TIMI flow grade: the TIMI flow grade was superior in group A compared with group B [Table 2] and [Figure 2].
Three patients (two of group A and one of group B) crossed over from the left radial technique to the femoral strategy. The incidence of the use of glycoprotein IIb/IIIa inhibitors (GPIIb/IIIa) was higher in group B compared with group A [18 (36%) patients and seven (14%) patients]. The incidence of direct stenting occurred in 28 (56%) patients in group A and 14 (28%) patients in group B. The final TIMI flow grade, the maximal inflation pressure, number of vessels treated, use of drug eluting stents, number of stents at the target lesion, stent length, total stent length, and mean nominal stent diameter were insignificantly different in both groups [Table 3] and [Figure 3].
Death occurred in five (10%) patients of group A and four (8%) patients of group B. Death related to cardiac events occurred in three (6%) patients in group A. Similar results were found in group B, and thus the difference among them was not significant (P = 1.00). The incidence of minimal bleeding was 16% (eight patients) in group A versus 6% (three patients) in group B. The incidence of severe bleeding was 8% (four patients) in group A versus 2% (one patient) in group B, and the difference was statistically significant. Overall complications occurred in 32 (64%) patients in group A versus 23 (46%) patients in group B [Table 4] and [Figure 4].
|Figure 4: In-hospital and follow-up clinical complications in the two groups. CABG, coronary artery bypass graft; HF, heart failure; MI, myocardial infarction; TLR, target lesion revascularization.|
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The univariate analysis of the different predictors of major cardiovascular events showed that increase in age by 10 years was associated with high risk of MACE [hazard ratio: 2.1, 95% confidence interval (CI): 1.4–4.9, P = 0.023]. Diabetes mellitus was a significant indicator of MACE (hazard ratio: 2.4, 95% CI: 1.7–5.2, P = 0.017). In addition, both left ventricular ejection fraction less than 40% and bare-metal stent utilization were also significant indicators of MACE (hazard ratio: 3.2, 95% CI: 1.9–5.8, P = 0.000, and hazard ratio: 1.8, 95% CI: 1.2–2.9, P = 0.031), respectively. Reference vessel diameter, lesion length (1 mm increase), and one treated lesion were insignificant predictors of MACE [Table 5].
| Discussion|| |
STEMI occurs because of acute thrombotic occlusion of a major pericardial artery. Guidelines for acute STEMI patients recommend primary PCI as the preferred reperfusion approach; this approach is contingent on performing PCI in a timely manner. As most patients do not present to a PCI-capable hospital, this factor showed a major logistic challenge in many regions. Despite substantial efforts addressing this issue, most of the patients with STEMI present to non-PCI facilities, and thus do not subsequently receive primary PCI within guideline-recommended times. This delay caused a commensurate increase in morbidity and mortality.
In the present study, we compared the strategy of early fibrinolysis combined with coronary angiography within 6–24 h or rescue PCI if needed with standard primary PCI in patients with STEMI presenting with symptom onset within 3 h and unable to undergo primary PCI within 1 h. One hundred consecutive STEMI patients admitted to the ER unit at the National Heart Institute between June 2013 and December 2015 were studied.
In this study, three patients crossed over from the left radial technique to the femoral strategy. There was no reported entry site or thrombotic complications to the radial approach. These results demonstrated the safety, feasibility, and high success rate of the left radial strategy in performing either primary/rescue PCI. Our results agree with the meta-analysis performed by Pier Francesco et al.. They concluded that the transradial strategy for coronary procedures is safe and effective for transcatheter therapeutic and diagnostic procedures.
We found that an approach alignment of early fibrinolysis and contemporary antithrombotic cotherapy coupled with timely coronary angiography resulted in effec'tive reperfusion in STEMI patients who presented 3 h after symptom onset who could not undergo PCI within 1 h after the first medical contact. However, early fibrinolysis was combined with increased risk of bleeding complications slightly.
In this study, bleeding complications ranged from minimal bleeding such as bleeding gums, epistaxis, and hematuria to severe bleeding such as intracranial hemorrhage, severe epistaxis, and hemoptysis from that reported in the STREAM trial, and this could be illustrated by the fact that they used tectophase (in this study we used streptokinase).
Our study found that patients who had early fibrinolysis had better TIMI blood flow compared with the primary PCI group and were less likely to complete occlusion of an artery. Five patients of group A were referred for rescue PCI because of failed thrombolytic therapy. Our results showed less failure compared with that recorded by Dennis et al., who found a higher incidence of fibrinolytic failure in 50% of their studied population. One of the major obstacles of fibrinolytic therapy is complete restoration of coronary blood flow that can be achieved only in 50% of STEMI patients, with lower success rates in older patients or patients with cardiogenic shock. The results show that group A had the highest incidence of minimal bleeding, severe bleeding (22%), and complication rates (64%) versus 8 and 46% in group P, respectively, and the difference was statistically significant. A review of randomized trials emphasized that, in patients who fail to have their coronary blood flow restored with fibrinolysis, rescue PCI reduces the risks of recurrent myocardial infarction and possibly death compared with conservative therapy.
In the present study, we found that increase in age by 10 years, presence of diabetes mellitus, left ventricular ejection fraction less than 40%, and bare-metal stent utilization were significant indicators of MACE. In contrast, reference vessel diameter, lesion length (1 mm increase), and one treated lesion were insignificant predictors of MACE; these results are in agreement with the study by Nikolaou et al..
Our findings showed that early fibrinolysis combined with planned PCI from 6 to 24 h had a similar success rate. Incidence of MACE and bleeding complications were higher in the fibrinolysis compared with the primary PCI group. Incidence of heart failure and lower systolic function was recorded in the fibrinolysis group. In the STREAM trial, Armstrong and Boden found that prehospital fibrinolysis combined with routine angiography from 6 to 24 h in stable patients or immediate rescue PCI in the remainder is a substitute to primary PCI when delayed by >1 h. In addition, Addo et al. found that primary PCI is a favorable perfusion strategy with the best outcomes demonstrated in several large meta-analyses, provided it is applied in a timely manner by an experienced team. Moreover, Nikolaou et al. revealed that the benefit is mostly driven by reduced rates of recurrent myocardial infarction and intracranial hemorrhage in the primary PCI treated patients compared with those receiving fibrinolysis. The optimum timing has not been monitored, but intervention within 24 h showed reduction in reinfarction rates. This may be because of situations and geography, where transfer within 24 h may be difficult or not possible.
| Conclusion|| |
Left radial strategy for primary/delayed PCI in acute STEMI patients was feasible, safe, and successful with a few incidences of complications. Early fibrinolytic therapy combined with early percutaneous intervention is a favorable option for managing acute STEMI patients. Primary PCI is still the favorable option for treating acute STEMI patients, but if there is delay from the recommended time factor early fibrinolysis when applied promptly can be a good option for preserving myocardial contractility with a few complications.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]