Wpływ manualnej trombektomii na krótkoterminową skuteczność przezskórnej rewaskularyzacji u pacjentów z zakrzepicą tętnicy wieńcowej

Maksim Y. Sokolov1, Dmytro I. Besh2,3, Olesya M. Besh2, Oleg I. Rafaluk3, Oleg O. Kapustynskyy2

1 Institute of Cardiology M.D. Strazhesko, Kiev, Ukraine

2 Danylo Halytsky Lviv National Medical University, Lviv, Ukraine

3 Lviv Regional Cardiology Center, Lviv, Ukraine

Abstract

Introduction: Percutaneous coronary intervention (PCI) is one of the main issues in treatment of acute coronary syndrome with ST segment elevation (STEMI). The manual thrombus aspiration was believed to improve the results of intervention especially in patients with coronary thrombosis.

The aim: To explore the influence of manual thrombus aspiration on the short-termed prognosis after PCI in patients with STEMI and visible coronary thrombosis.

Materials and methods: 50 patients with STEMI and visible coronary thrombosis were included for exploration. Main group (MG) consists of 25 patients to whom manual thrombus aspiration was performed and comparison group (CG) of 25 patients whom were performed just conventional PCI.

Results: In the 84% patients of the MG and in 72% CG was gained ТІМІ 3 flow grade after the procedure (р=0.5). MBG 3 was reached in similar number of patients from both groups ( р=0.37). Comparison of the ejection fraction of the LV and its’ wall motion score brought the same results. The trend to better indexes of glomerular filtration rate was observed in the patients of the MG (р=0.18). Need of the balloon angioplasty before stenting was the unique index improved by the manual thrombus aspiration (р=0.02).

Conclisions: No significant advantages of the manual thrombus aspiration usage weren’t revealed compearing to conventional PCI in our study in the patients with STEMI and visible coronary thrombosis. At the same time few insignificant trends were reveled. So the more powerful trial is needed to solve this problem.

Wiad Lek 2018, 71, 1 cz. II, -143

Introduction

Myocardial revascularization is one of the main issues in treatment of acute coronary syndrome with ST segment elevation (STEMI). The percutaneous coronary intervention (PCI) is the most effective method of the revascularization in such patients according to the update data [1]. But the adequate perfusion can’t be gained every time even after usage of last ones. The distal embolisation is the main reasons of that. It leads to the microvascular obstruction resulting in the worsening of the diseases’ prognosis [2]. The microvascular obstruction causes increasing of the incidents of the early complication, negative remodeling of the left ventricle (LV), late rehospitalization cased by the heard failure and mortality [3].

It was proposed different methods for the prevention of the distal embolisation during PCI. The manual thrombus aspiration, mechanical thrombectomy and embolicprotection were the most promising of them. Recently published meta-analysis of the trials comparing effectiveness above mention methods showed just manual thrombus aspiration to bring some advantage to ordinary PCI. Two other methods are useless or in some cases harmful [4]. Such results stimulated performance of sime trials exploring the effectiveness of the manual thrombus aspiration in patients with STEMI. The Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) was one of the first of them. It was single center trial. Their results showed the patients to have better myocardial blush grade (MBG) and ST segment resolution in the case of performing manual thrombus aspiration. Moreover they had significantly lower mortality, cardiac death and end point of mortality or non fatal myocardial infarction [5]. That led to the manual thrombus aspiration to gain the high II A class and B level of evidence in “The ESC Guidelines for the Management of Acute Myocardial Infarction in Patients Presenting with ST-segment Elevation” [6]. The American heart association and American college of cardiology had the same opinion on it at that time [7].

Two other large multicenter trials were performed for the investigation of the benefit of manual thrombus aspiration in the treatment of the patient with STEMI. Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia (TASTE) was the first of them. It didn’t reveal any advantages of the manual thrombus aspiration performing during PCI neither for frequency of re-infarction or stent thrombosis nor major adverse cardiac event. Furthermore the manual thrombus aspiration was ineffective in different patients’ sub-groups differed by age, gender, duration, the chest pain, infarctrelated coronary artery or concomitant medication [8]. The result led to downgrade of the class of evidence for the procedure from IIa to IIb in “The ESC/EACTS Guidelines on Myocardial Revascularization” published in 2014 [1].

The Trial Of routine aspiration Thrombectomy with PCI versus PCI ALone in patients with STEMI (TOTAL) was the most numerous trial exploring the effectiveness of the manual thrombus aspiration in the revascularization in STEMI patients. It didn’t find any benefit of this kind of intervention over conventional PCI neither in the general population nor in the different patients’ sub-groups. Moreover it was reviled significantly increased of the stroke rate in the patients after manual thrombus aspiration. Unexpectedly it occurred not only for the first 30 days but also in the period from 30 to 180 days after the disease onset (after procedure). Increasing of the stroke frequency for the first 30 days could be explained with the thrombus or air embolisation during the procedure. But increasing of it for the period from 30 to 180 days after intervention remained unexplained by the authors of the trial [9].

The American heart association and American college of cardiology were the first who reacted for the results of the TOTAL trial. They published in “2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction” the following:

Class ІІb – The usefulness of selective and bailout aspiration thrombectomy in patients undergoing primary PCI is not well established (level of evidence С)

Class ІІІ – Routine aspiration thrombectomy before primary PCI is not useful (level of evidence і А) [10].

But despite the routine manual thrombus aspiration in primary PCI isn’t recommended the special sub-groups of the patients can have benefit from it. Patients with visible coronary thrombosis are possible amount them. Above mention became the reasons of our investigation.

The aim

To explore the influence of manual thrombus aspiration on the short-termed prognosis after PCI in patients with STEMI and visible coronary thrombosis or totally occluded infarct-related artery.

MATERIALS and methods

50 patients with STEMI hospitalized in the “therapeutic window” for PCI were included for exploration. Totally occluded infarct-related artery or its’ huge thrombosis were revealed in every of them at the coronary angiography. They were divided into two groups. Main group (MG) consists of 25 patients to whom manual thrombus aspiration was performed during the conventional PCI. Comparison one (CG) consists of 25 patients whom were performed conventional PCI without manual thrombus aspiration. The patients were prescribed similar medicines according to the update guidelines. Treatments’ efficacy was evaluated by the next indexes: blood flow in the infarct-related coronary by Thrombolysis In Myocardial Infarction (ТІМІ) grade, MBG, ST segment resolution in 60 minutes after the procedure, ejection fraction of the LV and its’ wall motion score, development of the Q wave on ECG at the discharge and glomerular filtration rate in two days after the PCI. TIMI flow grade was established according the follow definition: TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion; TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed; TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory; TIMI 3 is normal flow which fills the distal coronary bed completely. Myocardial blush was defined by the criteria proposed by Van’t Hof and co-authors: MBG 0, no myocardial blush or contrast density; MBG 1, minimal myocardial blush or contrast density; MBG 2, moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral non–infarct-related coronary artery; and MBG 3, normal myocardial blush or contrast density, comparable with that obtained during angiography of a contralateral or ipsilateral non–infarct-related coronary artery [12]. Good ST segment resolution was diagnosed if ST segment declined for more than 50% as compared to the baseline in 60 minutes after the PCI. The wall motion score of the LV was determined by the formula:

wall motion score = total contractility of the myocardium / 16

Total contractility of the myocardium is a sum of the points of each of the 16 segments of the LV. 1 point is given for the normal contractility, 2 – hypokinesia, 3 – akinesia and 4 – dyskinesia.

Glomerular filtration rate was calculate by means Modification of Diet in Renal Disease Study (MDRD) equation [14].

Statistical analyses of the study results were performed using the Statistica 10 (StatSoft, USA).

Results

Patients from both groups didn’t differ significantly according age (55.44±1.45 vs. 59.04±2.22 years old, р=0.11) and gender (р=0.17). Any differences weren’t revealed during the frequency of the ischemic heart disease risk factors comparison between the two groups: diabetes (р=0.67), arterial hypertension (р=1), obesity (р=1), dyslipidemia (р=0.59), smoking (р=0.77) and frequent contact with xenobiotics (р=1). Thrombolysis was performed in 4 (16%) patients of the MG and 5 (20%) of the CG (р=1). Presentation with cardiogenic shock was twice as high in the MG vs. CG but the difference was statistically insignificant (р=0.46). It was found in both groups similar frequency of the infarct-related lesion located in left anterior descendents artery (р=0.78) and of the multivessel disease (р=0.36) evaluating the coronary angiography data. Baseline TIMI 0 flow grade was diagnosed in nearly identical number of patients in the MG and CG (р=0.2). Time to reperfusion therapy, i.e. time from the symptom onset to balloon inflation (or thrombus aspiration or stenting) was similar in both groups (5.48±0.62 vs. 6.32±0.78; р=0.43) (Table I).

In the 21 (84%) patients of the MG and in 18 (72%) CG was gained ТІМІ 3 flow grade after the procedure (р=0.5). MBG 3 was reached in similar number of patients from both groups at the end of PCI (72% vs. 56%; р=0.37). Frequency of the good ST segment resolution in 60 minutes after the intervention (54% for both, р=1) and of the development of the Q wave on ECG (80% for both; р=1) were identical in MG and CG. Evaluation of the echocardiography indexes didn’t show any difference in ejection fraction of the LV (48.75±1.81 vs. 46.44 ±1.68; р=0.89) and its’ wall motion score (1.42±0.06 vs. 1.49±0.07; р=0.73) at the discharge from the hospital. The trend to better indexes of glomerular filtration rate was observed in the patients of the MG, but it didn’t reach the statistical significance (76.12±4.0 vs. 68.2±4.59; р=0.18). Need of the balloon angioplasty before stenting was the unique index differed in both group. It was performed in 40% of patients from the MG and in 76% – from the CG (р=0.02).

Discussion

Influence of the manual thrombus aspiration on the angiographic results of the PCI such as TIMI flow grade and MBG were researched in some trials. Significant influence of the intervention wasn’t found on the frequency of TIMI 3 after the revascularization in the above mention TAPAS trial (86.0% vs. 82.5%; р=0.12). But it usage led to the lowering of the MBG 0-1 appearance according to the results of the last one (17.1% vs. 23.6%; р<0.001) [5,15]. The same result was gained in the Thrombectomy With Export Catheter in Infarct-Related Artery During Primary Percutaneous Coronary Intervention (EXPIRA). It was revealed in it the manual thrombus aspiration to increase probability of MBG 2-3 (р=0.0001) without influence on the TIMI 3 frequency (р=0.9) after the intervention [16]. The improvement of the both indexes was revealed meta-analysis of the seven randomized trials published by U.U. Tamhane and co-authors in 2010. It included 3909 patients. There was shown significant increasing of TIMI 3 flows grade (р=0.007) and MBG 3 (р<0.001) achievement in the cases of manual thrombus aspiration usage [17]. The influence of the intervention including to PCI wasn’t detected on the coronary blood flow after revascularization in TOTAL and EXAMINATION trials [9, 18]. We didn’t reveal improvement of both above mention indexes after the manual thrombus aspiration in our study. But it can be caused by the low patients’ number. .

More successful ST-segment resolution was revealed in the most trials and meta-analysis exploring this issue in the cases of the manual thrombus aspiration usage [5,9,17]. Significant improvement of that index of efficacy wasn’t find just in the EXAMINATION trial (р=0.31) [18]. The lower frequency of the Q wave formation on ECG at the discharge was shown after the researched procedure in the TAPAS (р=0.001). Even any trends weren’t found in both indexes in our work.

As we already mention the ejection fraction of the LV at the discharge was compared in both groups. The difference wasn’t found. The same result had been gained in theTASTE trial [8]. We couldn’t find any other trials exploring this index at the same circumstance.

The lowering of need of the balloon angioplasty before stenting was revealed not only in our work but also in the EXAMINATION trial (р<0.001) [18]. It can lead to the decline of the vessel wall injury.

Unfortunately we couldn’t find trials to explore the influence of the manual thrombus aspiration usage on the renal function. The index can be related with contrast medium load. Moreover it can be related with the diseases course.

Conclusions

No significant advantages of the manual thrombus aspiration usage weren’t revealed compearing to conventional PCI in our study in the patients with STEMI and visible coronary thrombosis or totally occluded infarct-related artery. At the same time few insignificant trends were reveled. So the more powerful trial is needed to solve this problem.

References

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3. Crea F. Coronary microvascular obstruction — a puzzle with many pieces. NEJM. 2015;372(15):1464-1465.

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5. Vlaar P, Svilaas T, Van der Horst I et al. 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;371:1915-1920.

6. Steg P, James S, Atar D et al. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. European Heart Journal. 2012; 33:2569–2619.

7. O’Gara P, Kushner F, Ascheim D et al. 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction. Circulation. 2013;127(4):362-425.

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9. Jolly S, Cairns J, Yusuf S et al. Randomized Trial of Primary PCI with or without Routine Manual Thrombectomy. NEJM. 2015;372(15):1389-1398.

10. Levine G., Bates E, Blankenship J et al. 2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction. Catheter Cardiovasc Interv. 2016;87(6):1001-1019.

11. TIMI Study Group. The Thrombolysis in Myocardial Infarction (TIMI) trial. Phase I findings. N. Engl. J. Med. 1985;312(14):932–936.

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13. Шиллер Н. Осипов М Клиническая эхокардиография. Второе издание / Москва: Практика. 2005;c. 344.

14. Levey AS, Coresh J, Greene T, et al. Chronic Kidney Disease Epidemiology Collaboration. Expressing the Modification of Diet in Renal Disease Study Equation for Estimating Glomerular Filtration Rate with Standardized Serum Creatinine Values. Clin Chem. 2007;53(4):766-772.

15. Svilaas T, Vlaar P, Van der Horst I et al Thrombus Aspiration during Primary Percutaneous Coronary Intervention. N Engl J Med. 2008; 358(6): 557-567.

16. Sardella G, Mancone M, Bucciarelli-Ducci C et al. Thrombus Aspiration During Primary Percutaneous Coronary Intervention Improves Myocardial Reperfusionand Reduces Infarct Size. Journal of the American College of Cardiology. 2009;53(4):309-315.

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18. Fernández-Rodríguez D, Regueiro A, Brugaletta S et al. Optimization in Stent Implantation by Manual Thrombus Aspiration in ST-Segment–Elevation Myocardial Infarction. Circulation: Cardiovascular Interventions. 2014;7(3):294-300.

Address for correspondence

Dmytro Besh

22/1 Kharkivska str., 79010 Lviv, Ukraine

tel. +380505423158

e-mail: beshd@hotmail.com

Received: 25.08.2017

Accepted: 12.12.2017

Table I. Baseline characteristics of patients included in the study

Main group

n=25

Comparison group

n=25

р

Age, years

55.44±1.45

59.04±2.22

0.11

Male gender,%

88

68

0.17

Diabetes, %

8

16

0.67

Arterial hypertension , %

52

56

1.0

Obesity, %

36

36

1.0

Dyslipidemia, %

40

28

0.59

Smoking, %

60

68

0.77

Frequent contact with xenobiotics, %

52

52

1.0

Thrombolysis , %

16

20

1.0

Cardiogenic shock, %

24

12

0.46

Left anterior descendents artery thrombosis , %

40

48

0.78

Multivessel disease, %

24

40

0.36

ТІМІ ٠ before PCI, %

84

64

0.20

Time to reperfusion therapy , hour

5.48±0.62

6.32±0.78

0.43