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Delayed vs. immediate stenting in STEMI with a high thrombus burden

A systematic review and meta-analysis
  • B. Sun
  • J. Liu
  • H. Yin
  • S. Yang
  • Z. Liu
  • T. Chen
  • J. Li
  • C. Guo
  • Z. Jiang
Original articles
  • 87 Downloads

Abstract

Background

The results of several large-scale randomized controlled trials are controversial regarding the advantages of delayed stenting (DS) compared with immediate stenting (IS). We sought to determine whether DS has benefits for patients with ST-segment elevation myocardial infarction (STEMI) with a high thrombus burden compared with IS.

Methods

We systematically searched four electronic databases. Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow, TIMI myocardial blush grade (TMBG), complete ST-segment resolution (>70%), major adverse cardiac events (MACE), and major bleeding complications were studied as outcomes. Data analysis was performed using a random-effects model utilizing the Review Manager 5.3 software.

Results

Our meta-analysis included eight studies involving 744 patients. DS showed greater benefits than IS in terms of TIMI grade 3 flow (odds ratio [OR]: 5.09, 95% confidence interval [CI]: 1.98–13.02, p < 0.001), TMBG (OR: 4.17, 95% CI: 1.87–9.31, p < 0.001), complete ST-segment resolution (OR: 2.16, 95% CI: 1.36–3.43, p = 0.001), and MACE (OR: 0.48, 95% CI: 0.25–0.94, p = 0.03). No significant difference was observed regarding major bleeding events (OR: 1.76, 95% CI: 0.40–7.66, p = 0.45).

Conclusion

DS yielded satisfactory outcomes regarding myocardial tissue reperfusion, demonstrated by the improved TIMI flow grade, TMBG, complete ST-segment resolution, and decreased MACEs without increasing major bleeding events in patients with STEMI and a high thrombus burden. DS may be preferred to IS for treating patients with this characteristic presentation.

Keywords

Stents Thrombosis ST-segment elevation myocardial infarction No-reflow phenomenon Randomized controlled trials 

Abbreviations

CI

Confidence interval

DS

Delayed stenting

GPIs

Glycoprotein IIb/IIIa inhibitors

IRA

Infarct-related artery

IS

Immediate stenting

MACE

Major adverse cardiac event

MI

Myocardial infarction

MVO

Microvascular obstruction

OR

Odds ratio

PCI

Percutaneous coronary intervention

RCT

Randomized controlled trial

STEMI

ST-segment elevation myocardial infarction

TIMI

Thrombolysis in Myocardial Infarction

TMBG

TIMI myocardial blush grade

Verzögerte vs. unmittelbare Stentimplantation bei STEMI mit hoher Thrombuslast

Systematische Übersicht und Metaanalyse

Zusammenfassung

Hintergrund

Die Ergebnisse verschiedener großangelegter randomisierter kontrollierter Studien sind widersprüchlich hinsichtlich der Vorteile verzögerter Stenteinlage („delayed stenting“, DS) verglichen mit unmittelbarer Stenteinlage („immediate stenting“, IS). Ziel der Autoren war, zu untersuchen, ob die DS Vorteile für Patienten mit ST-Strecken-Hebungs-Infarkt („ST-segment elevation myocardial infarction“, STEMI) mit einer hohen Thrombuslast im Vergleich zur IS aufweist.

Methoden

Die Autoren durchsuchten 4 elektronische Datenbanken systematisch. Als Endpunkte wurden ein Fluss des Grades 3 gemäß Thrombolysis in Myocardial Infarction (TIMI), der Myokardperfusionsgrad gemäß TIMI („TIMI myocardial blush grade“, TMBG), die vollständige Rückbildung der ST-Stecken-Hebung (>70%), schwere unerwünschte kardiale Ereignisse („major adverse cardiac events“, MACE) und schwere Blutungskomplikationen untersucht. Die Datenanalysis erfolgte unter Verwendung eines Random-Effects-Modells mit der Software Review Manager 5.3.

Ergebnisse

Die vorliegende Metaanalyse umfasste 8 Studien mit 744 Patienten. Eine DS erbrachte größere Vorteile als eine IS in Bezug auf einen Fluss des Grades 3 gemäß TIMI (Odds Ratio, OR: 5,09; 95%-Konfidenzintervall, 95%-KI: 1,98–13,02; p < 0,001), TMBG (OR: 4,17; 95%-KI: 1,87–9,31; p < 0,001), vollständige Rückbildung der ST-Strecken-Hebung (OR: 2,16; 95%-KI: 1,36–3,43; p = 0,001) und MACE (OR: 0,48; 95%-KI: 0,25–0,94; p = 0,03). Es fand sich kein signifikanter Unterschied hinsichtlich schwererer Blutungen (OR: 1,76; 95%-KI: 0,40–7,66; p = 0,45).

Schlussfolgerung

Die DS führte zu zufriedenstellenden Ergebnissen in Bezug auf die Reperfusion des Myokards; dies zeigte sich durch eine Verbesserung beim TIMI-Flussgrad, TMBG, bei der vollständigen Rückbildung der ST-Strecken-Hebung und weniger MACE ohne zunehmende schwerere Blutungen bei Patienten mit STEMI und einer hohen Thrombuslast. Die DS ist möglicherweise gegenüber der IS bei der Behandlung von Patienten mit solchen typischen Symptomen zu bevorzugen.

Schlüsselwörter

Stents Thrombose ST-Strecken-Hebungs-Infarkt No-Reflow-Phänomen Randomisierte kontrollierte Studien 

Percutaneous coronary intervention (PCI) with stenting has emerged as the most effective treatment strategy for the management of ST-segment elevation myocardial infarction (STEMI; [1]). However, the mechanical interventions are associated with a heightened risk of dislodging thrombotic and thrombogenic materials, which could result in microvascular obstruction (MVO) or in the no-reflow phenomenon—a condition strongly associated with a large infarct size and higher mortality rate [2].

Immediate stenting (IS) has a greater risk in a thrombotic environment because of a higher possibility of the rapid onset of a no-reflow phenomenon or distal thrombus embolization leading to a poor prognosis [3, 4, 5, 6, 7]. Delayed stenting (DS) is a two-step revascularization approach that allows the body a fair period of time to recover microvascular function, and may thus be superior to IS, although re-infarction is observed in 5–8% of these patients within the first 30 days [5, 8, 9, 10, 11]. A mounting body of clinical studies and meta-analyses comparing DS versus IS reported varying results, indicating that DS as a treatment strategy did not significantly reduce infarct size or MVO and improve clinical outcomes [12, 13, 14, 15, 16, 17].

Notably, those studies and meta-analyses did not focus only on patients presenting with a high thrombus burden. Thus, we performed this meta-analysis to assess the efficacy and safety of DS versus IS in STEMI patients, with an exclusive focus on patients with a high thrombus burden.

Methods

Because all analyses were based on previous studies, no patient consent or ethical committee approval was required for our study.

Search strategy

Medline, Embase, the Cochrane Central Register of Controlled Trials, and the Chinese BioMedical Literature Database were searched to identify all comparative trials reporting on the efficacy and safety of DS versus IS in patients presenting with STEMI and a high thrombus burden between January 2000 and October 2017. Randomized controlled trials (RCTs) are usually the best data sources for meta-analyses; however, owing to a paucity of RCTs, observational studies were also included in our meta-analysis. The search terms used included “immediate”, “delayed”, “deferred”, “postponed”, “stent*”, “percutaneous coronary intervention”, “ST-segment elevation myocardial infarction”, “high or heavy thrombus burden”, “no- or slow-reflow”, and “microvascular obstruction”. In addition to the search for electronic records, we augmented our search with manual examination of additional publications to identify relevant trials.

Eligibility criteria

A study was considered eligible if it met each of the following criteria: patients studied were those who presented with STEMI and a high thrombus burden and demonstrated a Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow after initial reperfusion following aspiration thrombectomy, percutaneous transluminal coronary angioplasty, or other methods; studies involving those who underwent PCI; studies reporting a comparison between DS versus IS (DS strategy involved an intention-to-stent 4 h to 14 days after initial coronary reperfusion); those reporting one of the following outcomes: TIMI grade 3 flow, TIMI myocardial blush grade (TMBG), complete ST-segment resolution (>70%), major adverse cardiac events (MACE), or major bleeding events; and all RCTs or observational studies. A high thrombus burden was defined as a thrombus score ≥2 [18]. The exclusion criteria were: patients with coagulopathies; patients with left bundle branch block; patients with malignancies.

Data extraction and quality assessment

A standardized form was used to extract the following data from each study: name of the first author, year of publication, number of patients studied, age, gender, comorbidities, study design, inclusion and exclusion criteria, drug and intervention protocol, outcomes, and follow-up. To reduce bias, all data were independently extracted by two investigators (B.S. and J.L.). Discrepancies were resolved through discussion or via the intervention of a third investigator. In a few cases, we consulted with the corresponding author of the original article. The quality of RCTs was assessed based on the Cochrane Collaboration’s tool to assess the risk of bias. The Newcastle–Ottawa Scale was used to assess observational studies.

Outcomes and definitions

The primary outcomes were the final TIMI flow grade, TMBG, and complete ST-segment resolution (>70%). The secondary outcomes were MACE comprising re-infarction, target vessel revascularization, and cardiac death. The safety outcome was major bleeding complications based on definitions of bleeding recommended by the Global Use of Strategies to Open Occluded Arteries [19]. The secondary and safety outcomes were assessed at the time of the longest available follow-up.

Statistical analysis

The Cochrane Collaboration Review Manager Version 5.3 software (The Nordic Cochrane Center, The Cochrane Collaboration, Copenhagen, Denmark) was utilized to perform all analyses. The pooled data of the odds ratios (ORs) and 95% confidence intervals (CIs) were calculated to express dichotomous outcomes. Statistical heterogeneity was quantified using I2 statistics with values of <50% and ≥50% indicating acceptable and substantial heterogeneity, respectively. Random effects models were used to perform all analyses, given that they are likely to be the most appropriate and conservative methodology to interpret between-trial heterogeneity within each comparison [20]. If statistical heterogeneity was observed, sensitivity analyses and subgroup analyses were carried out to detect the potential source. Sensitivity analyses were performed by removing a study at a time to assess the individual contribution of each study to the total estimate. Subgroup analyses were performed after splitting all studies into subgroups (RCT and observational study group) for inter-group comparison.

Results

Search results and basic information

We identified and reviewed 442 potential studies from the following databases: Medline (n = 204), Embase (n = 113), the Cochrane Central Register of Controlled Trials (n = 72), and the Chinese BioMedical Literature Database (n = 53). A detailed flow diagram of the article selection process is shown in Fig. 1. Our meta-analysis included eight studies comprising four RCTs and four observational studies involving 744 patients, among whom 335 and 409 patients underwent DS and IS, respectively [5, 21, 22, 23, 24, 25, 26, 27]. The baseline characteristics of individual studies are summarized in Table 1.
Fig. 1

Flow diagram of study selection

Table 1

Characteristics of patients and interventions in included studies

  

No. of patients

Mean

age (years)

Male (%)

Hypertension (%)

Diabetes

(%)

Previous

MI (%)

Previous

PCI (%)

Multivessel

disease (%)

Deferral

interval

Follow-up

Study

Study design

DS

IS

DS

IS

DS

IS

DS

IS

DS

IS

DS

IS

DS

IS

DS

IS

  

Cafri et al.

(2004)

Prospective registry

24

82

60.3

58.2

79

73

50

37

38

17

62

65

NR

NR

50

57

Mean 4.9 days

In-hospital

Harbaoui et al.

(2015)

Prospective registry

40

58

60.1

68

80

63.8

37.5

49.1

7.5

15.8

NR

NR

15

3.5

50

55.2

Median of 3 days

In-hospital

Hu et al.

(2011)

RCT

29

29

58.3

61.0

37.9

55.2

58.6

51.7

27.6

31.0

NR

NR

NR

NR

69

62.1

7 days

1 month

Ke et al.

(2012)

Retrospective cohort study

53

50

57.5

60.8

81.1

76

35.8

30

17

14.6

14.0

11.3

7.5

6.0

66

60

At least 7

days

1 year

Luo et al.

(2014)

RCT

64

65

57.2

59.7

59.4

61.5

43.8

40.0

26.6

36.9

4.7

7.7

7.8

10.8

73.4

63.1

7 days

6 months

Meneveau et al.

(2009)

Matched case-control

39

39

64

60

77

74

44

49

21

18

NR

NR

46

46

44

54

Mean 16 h

In-hospital

Wu et al.

(2015)

RCT

41

41

61.7

60.8

80.5

71.4

22.5

31.0

22.5

21.4

NR

NR

NR

NR

65.9

63.4

10–14

days

6 months

Yin et al.

(2011)

RCT

45

45

68.5

65.3

71.2

66.7

34.5

36.2

28.6

32.7

16.2

19.5

NR

NR

67.9

72.3

7 days

1month

DS delayed stenting, IS immediate stenting, MI myocardial infarction, NR not reported, PCI percutaneous coronary intervention, RCT randomized controlled trial

Assessment of study quality

The quality assessment of each RCT and observational study is shown in Fig. 2 and Table 2, respectively. Considering the small number of eligible studies, no study was excluded on the basis of its quality assessment.
Fig. 2

Summary assessments of risk of bias. a Risk of bias graph: review authors’ judgments (“Yes”, “No”, “Unclear”) according to each risk of bias item presented as percentages across all included studies. b Risk of bias summary: review authors’ judgments according to each risk of bias item for each included study

Table 2

Newcastle–Ottawa Scale scoring

 

Cafri et al.

(2004)

Harbaoui et al. (2015)

Ke et al.

(2012)

Meneveau et al. (2009)

Selection

Representativeness of exposed cohort

+

+

+

+

Selection of non-exposed cohort

+

+

+

+

Ascertainment of exposure

+

+

+

+

Demonstration outcome of interest

was not present at start of study

+

+

+

Comparability

Study controls for age

+

+

+

+

Controls for additional factor

+

+

+

+

Outcomes

Assessment of outcome

+

+

+

Was follow-up long enough for outcomes to occur

+

+

+

+

Adequacy of cohort follow-up

+

+

+

+

Score

8

9

8

9

Outcomes measures

Of note, two RCTs and four observational studies reported TIMI flow grade outcomes. No statistical heterogeneity was observed in the six studies investigated (I2 = 0%). Compared with IS, DS showed better efficacy in improving the TIMI flow grade (OR: 5.09, 95% CI: 1.98–13.02, p < 0.001; Fig. 3). Only two RCTs and one observational study contributed to the analysis of TMBG outcomes. DS was associated with a significant augmentation of TMBG (OR: 4.17, 95% CI: 1.87–9.31, p < 0.001) without statistical heterogeneity (I2 = 0%) across these RCTs (Fig. 4). We noted that three RCTs and one observational study provided data regarding complete ST-segment resolution (>70%) outcomes. No statistical heterogeneity was observed in the four studies (I2 = 0%). The pooled result revealed a significant difference in the incidence of complete ST-segment resolution, indicating a higher resolution rate in the DS group (OR: 2.16, 95% CI: 1.36–3.43, p = 0.001; Fig. 5). MACE outcomes were pooled from three RCTs and four observational studies. No statistical heterogeneity was observed in the seven studies (I2 = 0%). The pooled analysis showed a decrease in MACE in the DS group (OR: 0.48, 95% CI: 0.25–0.94, p = 0.03; Fig. 6). Data pertaining to major bleeding outcomes were available from two RCTs and four observational studies. No significant differences were observed in terms of major bleeding events between the DS and IS groups (OR: 1.76, 95% CI: 0.40–7.66, p = 0.45) without statistical heterogeneity (I2 = 0%; Fig. 7).
Fig. 3

Pooled odds ratios of delayed stenting (DS) versus immediate stenting (IS) for TIMI grade 3 flow. CI confidence interval

Fig. 4

Pooled odds ratios of delayed stenting (DS) versus immediate stenting (IS) for TIMI, myocardial blush grade. CI confidence interval

Fig. 5

Pooled odds ratios of delayed stenting (DS) versus immediate stenting (IS) for complete ST-segment resolution. CI confidence interval

Fig. 6

Pooled odds ratios of delayed stenting (DS) versus immediate stenting (IS) for major adverse cardiac event. CI confidence interval

Fig. 7

Pooled odds ratios of delayed stenting (DS) versus immediate stenting (IS) for major bleeding events. CI confidence interval

Sensitivity and subgroup analyses

Because no analysis revealed any statistical heterogeneity, sensitivity and subgroup analyses were not performed in our meta-analysis.

Publication bias

Owing to the small number of eligible studies (<10) included in our meta-analysis, publication bias was not determined, in accordance with the Cochrane Handbook for Systematic Reviews of Interventions version 5.1.0.

Discussion

PCI has been considered the first-choice reperfusion treatment strategy in patients presenting with STEMI [28]. Despite re-establishing infarct-related artery (IRA) patency, PCI may fail to restore complete myocardial reperfusion, as evidenced by low TMBG and the low incidence of complete ST-segment resolution [29]. This phenomenon is referred to as no-reflow, which serves as an independent predictor of a higher prevalence of heart failure, malignant arrhythmia, pericardial tamponade, and mortality following myocardial infarction [30, 31, 32]. The no-reflow phenomenon is evaluated based on a final TIMI flow grade of <3 and TMBG of ≤2 [32]. The underlying pathological mechanisms are attributable to distal thromboembolism, ischemia-reperfusion injury, diffuse myocardial edema, endothelial dysfunction, spasms of the microcirculation, and neutrophilic plugging. Distal thromboembolism has been shown to be a predominant factor contributing to the no-reflow phenomenon [33].

Although thrombus aspiration, use of distal protection devices, and administration of glycoprotein IIb/IIIa inhibitors (GPIs) are currently employed as common pretreatment strategies for STEMI patients with a high thrombus burden to prevent the phenomenon of no-reflow, unfortunately, these approaches fail to remove the entire thrombus [34, 35]. Subsequent stenting that could be required may cause rupture of the clot and atherosclerotic plaque, leading to distal thromboembolism [35]. Patients with STEMI demonstrate a state of stress and hypercoagulability, and excessive intravascular instrumentation may precipitate an inflammatory response and coagulation cascade that can trigger thrombosis and even a thrombotic storm [36]. Under such conditions, use of excessive contrast agent may aggravate the no-reflow phenomenon, although this is only our hypothesis and has not yet been confirmed. Additionally, optimal preparation of IRA may be ignored in those undergoing IS, which causes a series of undesirable outcomes such as stent malposition, stent under-sizing, and thus increases the incidence of stent thrombosis and restenosis [18, 37].

Thus, DS is considered a more attractive strategy to reduce the incidence of the no-reflow phenomenon and optimize the benefits of stenting. Several potential mechanisms contribute to the advantages of DS: (1) Intensive treatment using antithrombotics and statins before performing DS can facilitate residual thrombus dissolution and stabilization of the atherosclerotic plaque, which can reduce the risk of distal thromboembolism [38]. Simultaneously, the microcirculation gradually eliminates any residual thrombus and plaque via its innate scavenging ability, which we define as microvascular self-purification. (2) It can prevent unnecessary stenting in the absence of significant residual stenosis after pretreatment with antithrombotics and statins [11]. (3) Because of the release of spasm by the time the DS is performed, an optimal stent with the most suitable length and diameter can be selected [11]. (4) Patients with multivessel disease could have greater benefits as non-IRA can be solved simultaneously when the acute phase has resolved.

Our meta-analysis additionally demonstrated that DS scores over IS in improving myocardial tissue reperfusion, which was reflected by the significant improvements noted in the TIMI flow grade, TMBG, complete ST-segment resolution, and MACE.

Theoretically, the disadvantages of DS could be stated as: (1) Acute coronary re-occlusion may occur in the time lapse until the DS is performed [39]. However, the event was not observed in the eight studies included in our meta-analysis. Although the Minimalist Immediate Mechanical Intervention (MIMI) trial has reported similar events, all events reported in that study were attributed to coronary artery dissection or inadequate administration of GPIs [15]. (2) Prolonged administration of low-molecular-weight heparin and GPIs may increase the risk of major bleeding [39]. However, our meta-analysis did not find a statistically significant difference between the DS and IS groups in terms of major bleeding events. This result is not surprising in light of the popularity of radial artery access, extreme caution exercised during administration of medication therapy, and close attention paid to patient management in routine clinical settings. (3) DS may prolong the hospitalization period and increase interventional costs.

We observed that three large-scale RCTs (MIMI, the Third Danish Study of Optimal Acute Treatment of Patients with ST-elevation Myocardial Infarction [DANAMI-3-DEFER], and the Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients with ST-Segment-Elevation Myocardial Infarction [INNOVATION]) and three meta-analyses did not detect obvious benefits of DS compared with IS, which is inconsistent with our outcomes [12, 13, 14, 15, 16, 17]. These published studies led to confusion among physicians regarding the superiority of DS over IS. Our meta-analysis might resolve the controversy. These published studies had in common that patients had not been selected on the basis of a high thrombus burden. Therefore, some benefits of DS in patients with a high thrombus burden could not be ruled out. Our study is the first meta-analysis to include only those patients who were known to definitively demonstrate a high thrombus burden. We showed that a high thrombus burden is closely associated with the no-reflow phenomenon and should be considered the primary criterion for selecting DS as a treatment strategy. Large-scale RCTs focusing on patients with a high thrombus burden are warranted in the future to perform further research aimed at resolving controversies regarding the role of DS versus IS.

Study limitations

Potential limitations of this meta-analysis are: (1) Our meta-analysis comprised observational studies; thus, the low level of evidence associated with such studies might have influenced the reliability of outcomes. (2) Pooling the analysis of studies with variable designs (RCTs and non-RCTs) might weaken the effect of model fitting. Because of a small number of studies available for the meta-analysis and lack of heterogeneity among them, subgroup analyses were not performed. (3) The heterogeneity in deferral time and follow-up may influence the findings with respect to risk of no-reflow and recurrent ischemia. (4) The no-reflow phenomenon, which is a complex process, could be influenced by several measured and unmeasured factors, such as the role of drugs, clinical experience of the cardiologist performing the intervention, and use of specific equipment—factors that were not addressed in detail. (5) Cost-effectiveness analysis was ignored owing to lack of sufficient data. Therefore, we propose that large-scale and high-quality studies concentrating on patients with a high thrombus burden be designed in future to comprehensively assess the merits of DS versus IS.

Conclusion

DS yielded satisfactory outcomes in terms of myocardial tissue reperfusion, as demonstrated by the improved TIMI flow grade, TMBG, complete ST-segment resolution, and decreased MACE without increasing major bleeding events in patients with STEMI and a high thrombus burden. DS may be preferred to IS for treating patients with this characteristic presentation.

Notes

Acknowledgements

We thank all patients who participated in the original studies and the authors providing the relevant data.

Compliance with ethical guidelines

Conflict of interest

B. Sun, J. Liu, H. Yin, S. Yang, Z. Liu, T. Chen, J. Li, C. Guo, and Z. Jiang declare that they have no competing interests.

This article does not contain any studies with human participants or animals performed by any of the authors.

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Copyright information

© Springer Medizin Verlag GmbH, ein Teil von Springer Nature 2018

Authors and Affiliations

  1. 1.Department of CardiologyThe Third Hospital of Hebei Medical UniversityShijiazhuangChina
  2. 2.Department of Occupational and Environmental Health, Xiangya School of Public HealthCentral South UniversityChangshaChina
  3. 3.Center for Disease Control and Prevention of Hebei Province; NO.97 Huaian RoadDepartment of Epidemiology and Health StatisticsShijiazhuangChina

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