|Year : 2017 | Volume
| Issue : 3 | Page : 850-854
Thrombus aspiration versus standard technique in patients with ST-elevation myocardial infarction
AbdAlla M Kamal1, Ghada M Sultan1, Karim S Sobhy2
1 Department of Cardiology, Faculty of Medicine, Menoufia University, Menoufia, Egypt
2 Department of Cardiology, National Heart Institute, Giza, Egypt
|Date of Submission||24-Aug-2016|
|Date of Acceptance||06-Dec-2016|
|Date of Web Publication||15-Nov-2017|
Karim S Sobhy
400N, Hadayek El Ahram, Giza, 12511
Source of Support: None, Conflict of Interest: None
The aim of this study was to assess the efficacy of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI).
The idea of an occluding thrombus as an etiology for ST-elevation myocardial infarction (STEMI) and its dissolution as a treatment had been around since the 1950s.
Patients and methods
The study included 70 patients with STEMI undergoing PPCI within 12 h from symptoms. These patients were divided equally into two groups (35 patients each): TA group and standard PPCI (SP) group. Primary endpoints were ST-segment resolution 90 min after procedure and thrombolysis in myocardial infarction flow and myocardial blush grade at the end of procedure. Secondary endpoint was in-hospital major adverse cardiovascular effects.
ST-segment resolution more than 70%, that is, complete reperfusion, was seen in 42.9% of patients in the TA group in comparison with 8.6% in the SP group (P < 0.005). Myocardial blush grade more than or equal to 2 was seen in 91.4% in TA group in comparison with 54.3% in SP group (P < 0.005). We reported death of three patients in the SP group; however, this did not reach statistical significance (P = 0.120).
TA has significantly improved the reperfusion in patients with STEMI and significantly decreased the incidence of no reflow. Thus, we recommend TA as a routine procedure in PPCI.
Keywords: myocardial blush grade, no reflow, primary percutaneous coronary intervention, ST-elevation myocardial infarction, ST-segment resolution, thrombus aspiration
|How to cite this article:|
Kamal AM, Sultan GM, Sobhy KS. Thrombus aspiration versus standard technique in patients with ST-elevation myocardial infarction. Menoufia Med J 2017;30:850-4
|How to cite this URL:|
Kamal AM, Sultan GM, Sobhy KS. Thrombus aspiration versus standard technique in patients with ST-elevation myocardial infarction. Menoufia Med J [serial online] 2017 [cited 2020 Mar 30];30:850-4. Available from: http://www.mmj.eg.net/text.asp?2017/30/3/850/218283
| Introduction|| |
The idea of an occluding thrombus and its dissolution had been stated since the 1950s. Thrombus is present in the infarct-related artery in 88% of patients undergoing coronary artery angiography within the first 4 h of acute myocardial infarction (AMI) .
Embolization of vasoactive thrombotic or plaque debris distal into the coronary circulation remains a relatively frequent (15–20% incidence) complication during primary percutaneous coronary intervention (PPCI). Although most patients have only transient reduction in coronary flow as a consequence of distal embolization, adverse clinical outcomes have been associated with even minimal reductions in coronary microvascular flow during PPCI .
Attempts to improve the results of primary angioplasty have been thrombectomy and distal protection. The beneficial effects of thrombectomy are encouraging, whereas distal protection studies have been negative ,.
| Patients and Methods|| |
From March 2014 to September 2015, 70 consecutive patients with ST-elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI) at the Egyptian National Heart Institute.
The study population was divided into two groups:
Thrombus aspiration (TA) group included 35 patients who underwent PPCI with TA.
Standard PPCI (SP) group included 35 patients who underwent PPCI or rescue PCI without TA.
The patients with ST-elevation AMI within 12 h since pain onset, with more than or equal to 1-mm ST-segment elevation in at least two consecutive leads, were included.
The following patients were excluded based on contraindications to PCI (contrast allergy and no possibility of stent implantation), aspirin, thienopirydins, or group IIb/IIIa inhibitors and those with active bleeding or coagulopathy, known thrombocytopenia (platelets <100 000), renal insufficiency (creatinine >220 μmol/ml = 2.5 mg/dl), hemodialysis, liver insufficiency, left bundle branch block, pacemaker rhythm (owing to difficult analysis of ST-segment), and known existence of life-threatening diseases with a life expectancy less than 6 months, for example, cancer disease.
A study questionnaire was administered to all patients, which included personal history such as age, sex, etc.; risk factor profile such as hypertension, diabetes mellitus, dyslipidemia, ischemic heart disease, cerebrovascular disease, and current smoking; clinical examination such as blood pressure, heart rate, and respiratory rate; and regional examination of the chest, heart, etc.
ECG analysis was done for all patients: preprocedural and postprocedural ECGs (90 min after PCI) were performed for all patients. ST-segment resolution (STR) was evaluated according to the extent of ST-segment elevation resolution: a simple but strong predictor of outcome in patients with AMI. A 12-lead ECG was recorded at admission and at 90 min after the procedure. Two observers analyzed ECG recordings. Disagreement was resolved by consensus.
The ST-score, defined as the sum of ST-segment elevation in mm, measured at 20 ms from the J-point in the leads V1–V6, I, and aVL for anterior and II, III, aVF, and V5–V6 for nonanterior infarctions. Reciprocal changes of ST-segment depression were not considered. STR was calculated from admission and postprocedure ECG and categorized as complete resolution (>70%), partial resolution (30–70%), and no resolution (<30%) ,.
Laboratory investigations included the following: for routine laboratory examinations, random blood sugar, urea, and creatinine levels were withdrawn on admission, and for cardiac enzymes, creatinine phosphokinase MB fraction (CK-MB) was withdrawn before and after the procedure.
Coronary angiograms before intervention and at the end of the procedure were reviewed and analyzed by two independent interventional cardiologists to assess the following:
- Anterograde coronary flow according to the standard thrombolysis in myocardial infarction (TIMI) grade criteria : TIMI 0: If there is no penetration of the contrast across the lesion. TIMI 1: If there is some penetration of the contrast across the lesion. TIMI 2: If the artery is completely visualized but the flow is slower than the flow in the normal branch. TIMI 3: If there is a strong and brisk flow
- Myocardial blush grade (MBG) : Blush grade 0: No myocardial blush apparent. Blush grade 1: myocardial blush is apparent during contrast injection but washes out immediately after dye washout from the epicardial artery. Blush grade 2: myocardial blush persists mildly for less than three cardiac cycles after dye washout from the epicardial artery. Blush grade 3: myocardial blush persists for more than three cardiac cycles after dye washout from the epicardial artery but has resolved before the next contrast media injection. Blush grade 4: myocardial blush persists long after dye washout from the epicardial artery and is present before the next injection of contrast media.
Other procedural details
All patients were accessed using the femoral approach with a 6 Fr system. The TA protocol was as follows: aspiration catheter were used for the procedure. Aspiration was done before stenting or balloon predilatation. In the aspiration attempts, the catheter was introduced while in negative pressure just before the site of thrombus till the distal of the infarct-related artery and then withdrawn inside the guiding catheter. This technique was repeated for three times.
Before intervention, all patients were pretreated with aspirin 300 mg orally or intravenously, clopidogrel 300 mg orally, and unfractionated heparin 10 000 IU intravenously. During the intervention, all patients received glycoprotein IIb/IIIa inhibitor, and dose was reduced for those with diabetes mellitus, renal impairment, and cardiogenic shock.
Continuous variables were expressed as mean ± SD. The c2-test for categorical data or the unpaired Student's t-test for continuous variables were used for analyzing population characteristics and comparing the variables representing the clinical evolution in the two groups. Statistical analysis was formed using SPSS 12.0 for Windows (Illinois, Chicago, USA). P value less than 0.05 was considered significant.
| Results|| |
We analyzed 70 patients, 35 of whom belonged to the TA group and 35 belonged to the SP group.
The patients in our study were predominantly male (77.4%) with a mean age of more than 52 years. There were no statistical significant differences between patients in both groups regarding age, sex, smoking, and hypertension as well as for the previous history of myocardial infarction (MI), stroke, or PCI.
There were no statistical significant differences between patients in both groups regarding clinical presentation: onset of chest pain, heart rate, and systolic blood pressure, as shown in [Table 1].
Postintervention STR more than 70%, that is, complete reperfusion, was seen in 25 (72.9%) cases in TA group, in comparison with three (8.6%) cases in SP group (P < 0.005) [Table 2].
There were no significant statistical differences between patients in both groups regarding preprocedural CK-MB, serum creatinine level, and random blood sugar. But the peak of postprocedural CK-MB (83.9 vs. 126.1 U/l, P = 0.034) was significantly lower in the TA group than in the SP group [Table 3].
Procedural data and angiographic analysis
Thrombolysis in myocardial infarction flow in infarct-related artery
There was a statistical significant difference between patients in both groups regarding postintervention TIMI flow: 34 (97.1%) patients in TA group versus 27 (77.1%) patients in SP group had TIMI flow equal or more than 2 (P = 0.005) as shown in [Figure 1].
|Figure 1: Postintervention TIMI flow in both groups. TIMI, thrombolysis in myocardial infarction.|
Click here to view
Myocardial blush grade in infarct-related artery
When assessing postintervention MBG: 32 (91.4%) patients in group A versus 18 (54.3%) patients in group B had MBG flow more than or equal to 2 (P < 0.005) as shown in [Figure 2].
|Figure 2: Postintervention MBG in both groups. MBG, myocardial blush grade.|
Click here to view
In-hospital major adverse cardiac event
Regarding the incidence of death as well as for the total major adverse cardiovascular and cerebrovascular event, it was found to be higher in the SP group, but the difference did not reach statistical significance; three patients died in SP group at the National Heart Institute.
| Discussion|| |
Our results show that 34 (97.1%) patients in group A versus 27 (77.1%) patients in group B had TIMI flow more than or equal to 2 (P = 0.005). In a recent study that included 299 patients, 150 patients were randomized to TA; patients randomized to TA had significantly better final TIMI grade 3 flow (P = 0.02) .
The results of our study show that effective manual aspiration of atherothrombotic material is feasible in a large majority of patients presenting with MI with ST-segment elevation. As compared with balloon angioplasty as an initial step in PPCI, aspiration results in improved myocardial reperfusion, documented by a clear improvement in the MBG, and increased resolution of ST-segment elevation (our primary endpoints).
The patients randomized to TA had significantly better rates of early STR more than or equal to 70% (P < 0.005), final TIMI grade 3 flow (P = 0.005), and final MBG 2–3 (P < 0.005) than patients randomized to SP.
In the REMEDIA trial, which enrolled 100 patients, aspiration thrombectomy improved myocardial perfusion (MBG and STR). They found a significant improvement in complete (70%) STR (58 vs. 36%) and MBG 2 (68 vs. 45%) .
In another recent study included 299 patients: 150 patients randomized to TA. Patients randomized to TA had significantly better rates of early STR more than or equal to 70% (P = 0.01), final MBG 2–3 (P = 0.001), and optimal myocardial reperfusion (P < 0.001) than patients randomized to SP .
In our study, the in-hospital major adverse cardiac event (MACE) rates were similar (P = 0.120); however, we reported 3 mortality cases in the non-TA group (our secondary endpoint). De Vita et al. , reported in a study of 299 patients that in-hospital MACE rates were similar in both groups (P = 0.21).
In TAPAS trial, death, reinfarction, and target vessel revascularization rates at 30 days were not significantly different (6.8 vs. 9.4%) . However, at 1 year, rates of cardiac death (3.6 vs. 6.7%, P = 0.02) and cardiac death or nonfatal reinfarction (5.6 vs. 9.9%, P = 0.009) were lower with TA. Low MBG and incomplete STR were associated with clinical events .
In our study, we noticed that TA decreased the enzymatic infarct size; the peak of postprocedural CK-MB (83.9 vs. 126.1 U/l, P = 0.034) was significantly lower in the TA group than in the SP group. In the DEAR-MI study, the peak CK-MB release was significantly lower in patients with thrombus removal compared with the control group (790 ± 132 vs. 910 ± 128 μg/l, P < 0.0001) .
Our study has few limitations
First, it represents a single-center experience using surrogate endpoints. However, the fact that the surrogate endpoints of MBG and the ECG variables of reperfusion were clearly associated with the rates of death and MACE supports the validity of using such endpoints in studies of patients who have MI with ST-segment elevation. Second, the study had a relatively small sample size. Third, the long-term follow-up of the patients was not done. Fourth, we did not make a detailed echocardiography for the study groups. Fifth, we did not assess the effect of TA on the infarct size. Sixth, we did not estimate the TIMI grades and thrombus score after the guide wire passed through the culprit lesions. We depended on the preprocedure and postprocedure scores, thus we did not fully evaluate the patients who may benefit from direct stenting. Finally, histopathological analysis of the extracted thrombus was not done.
| Conclusion|| |
We found that manual TA can be performed in a large majority of patients presenting with MI with ST-segment elevation, and it results in improved myocardial reperfusion (defined as MBG ≥ 2 and STR > 70%) as compared with conventional PCI. Thus, we recommend TA for all patients with STEMI undergoing revascularization with PCI.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
DeWood MA, Spores J, Notske R. Prevalence of total coronary occlusion during the early hours of transmural myocardial infarction. N
Engl J Med 1980; 303
Reffelmann T, Hale SL, Dow JS, Kloner RA. No-reflow phenomenon persists long-term after ischemia/reperfusion in the rat and predicts infarct expansion. Circulation 2003; 108
De Luca G, Suryapranata H, Stone GW, Antoniucci D, Neumann FJ, Chiariello M. Adjunctive mechanical devices to prevent distal embolization in patients undergoing mechanical revascularization for acute myocardial infarction: a meta-analysis of randomized trials. Am Heart J 2007; 153
Vlaar P, Svilaas T, van der Horst I. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet 2008; 371
Schröder R, Dissmann R, Bruggemann T. Extent of early ST-segment elevation resolution: a simple but strong predictor of outcome in patients with acute myocardial infarction. J Am Coll Cardiol 1994; 24
Schröder R, Wegscheider K, Schroder K, INJECT Trial Group. Extent of early ST segment elevation resolution: a strong predictor of outcome in patients with acute myocardial infarction and a sensitive measure to compare thrombolytic regimens. A substudy of the International Joint Efficacy Comparison of Thrombolytics (INJECT) trial. J Am Coll Cardiol 1995; 26
TIMI Study Group. The thrombolysis in myocardial infarction (TIMI) trial. Phase I findings. N
Engl J Med 1985; 312
Van't Hof AW, Liem A. Angiographic assessment of myocardial reperfusion in patients treated with primary angioplasty for acute myocardial infarction: Myocardial blush grade. Zwolle Myocardial Infarction Study Group. Circulation 1998; 97
De Vita M, Burzotta M. Thrombus aspiration in ST elevation myocardial infarction: comparative efficacy in patients treated early and late after onset of symptoms. Heart 2010; 96
Burzotta F, Trani C, Romagnoli E, Mazzari MA, Rebuzzi AG, de Vita M, et al.
Manual thrombus-aspiration improves myocardial reperfusion: the randomized evaluation of the effect of mechanical reduction of distal embolization by thrombus-aspiration in primary and rescue angioplasty (REMEDIA) trial. J Am Coll Cardiol 2005; 46
Svilaas T, Vlaar PJ, van der Horst IC, Diercks GF, de Smet BJ, van den Heuvel AF, et al.
Thrombus aspiration during primary percutaneous coronary intervention. N
Engl J Med 2008; 358
Silva-Orrego P, Colombo P, Bigi R. Thrombus aspiration before primary angioplasty improves myocardial reperfusion in acute myocardial infarction: the DEAR-MI (Dethrombosis to Enhance Acute Reperfusion in Myocardial Infarction) study. J Am Coll Cardiol 2006; 48
[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]