Skip Navigation



European Heart Journal Advance Access published online on September 2, 2009
European Heart Journal, doi:10.1093/eurheartj/ehp348
This Article
Right arrow Abstract Freely available
Right arrow FREE Full Text (PDF) Freely available
Right arrow All Versions of this Article:
30/18/2193    most recent
ehp348v1
Right arrow E-letters: Submit a response
Right arrow E-letters: View responses
Right arrow Alert me when this article is cited
Right arrow Alert me when E-letters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Related articles in EHJ
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrowRequest Permissions
Right arrow Disclaimer
Google Scholar
Right arrow Articles by Burzotta, F.
Right arrow Articles by Zijlstra, F.
PubMed
Right arrow PubMed Citation
Right arrow Articles by Burzotta, F.
Right arrow Articles by Zijlstra, F.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2009. For permissions please email: journals.permissions@oxfordjournals.org

Clinical impact of thrombectomy in acute ST-elevation myocardial infarction: an individual patient-data pooled analysis of 11 trials

Francesco Burzotta1,*,{dagger}, Maria De Vita1,{dagger}, Youlan L. Gu2, Takaaki Isshiki3, Thierry Lefèvre4, Anne Kaltoft5, Dariusz Dudek6, Gennaro Sardella7, Pedro Silva Orrego8, David Antoniucci9, Leonardo De Luca10, Giuseppe G.L. Biondi-Zoccai11, Filippo Crea1 and Felix Zijlstra2

1 Cardiology Institute, Catholic University of Sacred Heart, Rome, Italy
2 University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
3 Department of Cardiology, Teykio University School of Medicine, Tokyo, Japan
4 Institut Cardiovasculaire Paris Sud, Massy, France
5 Department of Cardiology, Aarhus University Hospital, Skejby, Denmark
6 Department of Cardiology, Jagiellonian University, Kracow, Poland
7 Department of Cardiovascular and Respiratory Sciences, La Sapienza University, Rome, Italy
8 Interventional Cardiology, A. De Gasperis Department, Niguarda Hospital, Milan, Italy
9 Division of Cardiology, Careggi Hospital, Florence, Italy
10 Department of Cardiovascular Sciences, European Hospital, Rome, Italy
11 Division of Cardiology, University of Turin, Turin, Italy

Received 30 June 2009; revised 3 August 2009; accepted 7 August 2009 * Corresponding author. Tel: +39 3494295290, Fax: +39 06 3055535, Email: f.burzotta{at}rm.unicatt.it

See page 2180 for the commentary on this article (doi:10.1093/eurheartj/ehp349)


   Abstract
Top
 Abstract
Introduction
 Methods
 Results
 Discussion
 Study limitations
 Conclusions
 References
 
Aims: Thrombectomy in patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) is associated to better myocardial reperfusion. However, no single trial was adequately powered to asses the impact of thrombectomy on long-term clinical outcome and to identify patients at higher benefit. Thus, we sought to assess these issues in a collaborative individual patient-data pooled analysis of randomized studies (study acronym: ATTEMPT, number of registration: NCT00766740 [ClinicalTrials.gov] ).

Methods and results: Individual data of 2686 patients enrolled in 11 trials entered the pooled analysis. Primary endpoint of the study was all-cause mortality. Major adverse cardiac events (MACE) were considered as the occurrence of all-cause death and/or target lesion/vessel revascularization and/or myocardial infarction (MI). Subgroups analysis was planned according to type of thrombectomy device (manual or non-manual), diabetic status, IIb/IIIa-inhibitor therapy, ischaemic time, infarct-related artery, pre-PCI TIMI flow. Clinical follow-up was available in 2674 (99.6%) patients at a median of 365 days. Kaplan–Meier analysis showed that allocation to thrombectomy was associated with significantly lower all-cause mortality (P = 0.049). Thrombectomy was also associated with significantly reduced MACE (P = 0.011) and death + MI rate during the follow-up (P = 0.015). Subgroups analysis showed that thrombectomy is associated to improved survival in patients treated with IIb/IIIa-inhibitors (P = 0.045) and that the survival benefit is confined to patients treated in manual thrombectomy trials (P = 0.011).

Conclusion: The present large pooled analysis of randomized trials suggests that thrombectomy (in particular manual thrombectomy) significantly improves the clinical outcome in patients with STEMI undergoing mechanical reperfusion and that its effect may be additional to that of IIb/IIIa-inhibitors.

Key Words: ST-elevation myocardial infarction • Thrombectomy • Primary PCI • Long-term clinical outcome


   Introduction
Top
 Abstract
 Introduction
Methods
 Results
 Discussion
 Study limitations
 Conclusions
 References
 
Primary percutaneous coronary intervention (PCI) has been shown to provide mortality benefit compared with thrombolysis, mainly because of better and sustained optimal coronary perfusion.1 However, despite epicardial recanalization with TIMI 3 flow, myocardial reperfusion is not achieved in a relevant percentage of ST-elevation myocardial infarction (STEMI) patients, with a significant impact on long-term survival.2–4 Accordingly, a series of adjunctive devices with different design and mechanism of action have been developed and tested in clinical studies with conflicting results.5 A meta-analysis of prospective randomized trials6 suggested that the use of thrombectomy devices, but not of distal protection devices, is associated with a significant reduction of angiographically evident distal embolization and no-reflow (as assessed by post-procedural myocardial blush grade (MBG) and ST-segment resolution). As angiographic and electrocardiographic markers of myocardial reperfusion are well-known predictors of late clinical events,3,7–10 the use of thrombectomy may also translate into improved clinical outcome. Unfortunately, no published study was specifically designed and adequately powered to asses long-term clinical outcome. Yet, recent data from a large single-centre trial showed an advantage of thrombus-aspiration use in terms of mortality at 1 year follow-up11 and a recent meta-analysis of nine randomized trials showed an advantage of thrombus-aspiration in terms of early (up to 30 days) mortality.12 As such promising observations deserve further evaluations,13 we have designed and performed a pooled analysis of the individual patient data of prospective randomized trials comparing standard PCI with or without thrombectomy to evaluate the impact of thrombectomy use on clinical outcome.


   Methods
Top
 Abstract
 Introduction
 Methods
Results
 Discussion
 Study limitations
 Conclusions
 References
 
The study protocol has been registered in the clinicaltrials.gov website (number of registration: NCT00766740 [ClinicalTrials.gov] ), has been drafted and submitted for publication before the first analysis was undertaken and has been published in details in a study design manuscript.14

A systematic MEDLINE database search (www.ncbi.nlm.nih.gov) for studies comparing PCI with thrombectomy with standard PCI was conducted according to a modified Robinson and Dickersin strategy.15 Keywords were ‘STEMI’, ‘randomized’, ‘thrombus aspiration’, and ‘thrombectomy’. Furthermore, the TCT (http://www.tctmd.com), EuroPCR (www.europcr.com), ACC (www.acc.org), AHA (http://www.americaheart.org), and ESC (www.escardio.org) websites were searched for pertinent abstracts and expert slides presentations between October 2003 and February 2008. No language restriction was applied.

Inclusion criteria for selected studies were: (i) comparison of thrombectomy with standard PCI in patients with STEMI; (ii) randomized treatment allocation. Exclusion criteria were: (i) equivocal treatment allocation processes.

Fifteen studies were published as full papers16–30 and two additional studies31–32 were reported as abstract31 or expert slides presentation.32

The 15 principal investigators of these 17 identified studies were contacted by mail or by fax to participate into the ATTEMPT study (pooled Analysis of Trials on ThrombEctomy in acute Myocardial infarction based on individual PatienT data). The study flowchart is depicted in Figure 1. Each principal investigator who agreed to participate into the study was asked to complete a structured patient-level database including a series of key baseline clinical and angiographic data as well as the longest available clinical outcome data of each patient previously enrolled in the corresponding trial. The modality of follow-up update was not defined in the study protocol.


Figure 1
View larger version (22K):
[in this window]
[in a new window]
[Download PowerPoint slide]
  		Figure 1 Flow-chart of the systematic search process (RCT, randomized controlled trials; PI, principal investigator).

 
The requested dataset included: sex (male or female), age (years), diabetes (yes or no), rescue PCI (yes or no), usage of IIb/IIIa-inhibitors (yes or no), infarct-related artery [left anterior descending artery (LAD), left circumflex artery (LCX), or right coronary artery (RCA)], multivessel disease (yes or no), baseline TIMI flow 0 or 1 (yes or no), time from symptoms to balloon/cath-lab (minutes), thrombectomy device used (name of the device), device efficacy (device able to reach and treat the culprit lesion), and long-term clinical follow-up [death for any cause, time to death, myocardial infarction (MI), time to MI, target lesion/vessel revascularization (TLR/TVR), time to TLR/TVR]. Such individual patient data have been sent to the study coordinator (M.D.V.) who was responsible for data consistency checking (matching against previous publication of the trials as well as coherence controls) and for final pooling in a single database. A statistical expert in the field of meta-analysis (G.B.Z.) was responsible for statistical analyses.

Sample size calculation
A meta-analysis of randomized trials comparing thrombectomy with standard PCI in patients with STEMI6 showed a rate of post-procedural MBG 3 significantly higher in the thrombectomy group with an OR estimate of 2.3. Moreover, van't Hof et al. demonstrated that post-PCI MBG is a strong predictor of long-term mortality in patients with STEMI treated with primary PCI. In particular, they reported a long-term total mortality rate of 3% in patients with post-PCI MBG 3 and of 29% in patients with post-PCI MBG<3.3 Considering these results, we anticipated a sample size of 1350 patients (675 for each randomization arm) to demonstrate, with an alpha risk of 5% and a beta risk of 20%, a survival advantage at 1 year using thrombectomy compared with standard PCI.

Primary endpoint
The primary endpoint of the study was the comparison of all-cause mortality between patients randomized to thrombectomy or standard PCI.

Secondary endpoints
Secondary endpoints of the study were survival free from MI, TLR or TVR, major adverse coronary events (MACE: death + MI + TLR/TVR) and death + MI between patients randomized to thrombectomy or standard PCI.

Pre-defined subgroup analyses
The comparison of all-cause mortality between patients randomized to thrombectomy and standard PCI was performed according to the following pre-defined subgroups:14

  1. treated by manual thrombectomy devices or non-manual thrombectomy devices
  2. with or without diabetes mellitus
  3. undergoing primary PCI or rescue PCI (after failed thrombolysis)
  4. treated or not treated with IIb/IIIa-inhibitors
  5. different ischaemic time (pre-defined time intervals: ≤3, >3 ≤ 6, >6 h)
  6. infarct-related artery (LAD, LCX, or RCA)
  7. pre-PCI TIMI flow (TIMI 0–1 or TIMI 2–3)

Statistical analysis
Continuous variables are reported as mean ± standard deviation or median (first to third quartiles) and categorical variables as n (%), unless otherwise stated. Statistical pooling has been performed with the Peto fixed effect method for patient-level analysis (according to event counts reported at the longest available follow-up) as well as with a random effect method with generic inverse variance weighting (according to risk estimates obtained with Cox proportional hazard analysis). Thus, we have been able to compute pooled odds ratios (OR) with their corresponding 95% confidence intervals. Kaplan–Meier curves have been computed for survival and event-free survival analyses, both crude and stratified by study, with statistical testing based on log-rank test. A two-tailed P-value of 0.05 was chosen as cut-off for statistical significance at hypothesis testing, whereas statistical inconsistency was appraised by means of I2, with values more than 50% identifying subsets with at least moderate heterogeneity. The internal validity and quality of the individual studies entering the pooled analysis have been performed according to the Cochrane collaboration's tool for risk of bias assessment.33 Publication bias has been appraised by means of funnel plot inspection and Egger test.34


   Results
Top
 Abstract
 Introduction
 Methods
 Results
Discussion
 Study limitations
 Conclusions
 References
 
Study population
Ten principal investigators who authored 11 of 17 eligible randomized studies agreed to participate into the study and provided the requested data for each patient enrolled in the corresponding trial.

A total of 2686 patients entered the present pooled analysis: 1347 (50.1%) subjects randomized to PCI with thrombectomy device use and 1339 (49.9%) randomized to standard PCI.

The key protocol characteristics of the 11 randomized studies are summarized in Table 1. As shown in Table 1, the updated clinical follow-up available for the present analysis was significantly extended compared with that previously published for the majority of the studies. As a result, from a total of 2686 patients clinical follow-up was available in 2674 (99.6%) patients at a median of 365 days (first to third quartiles 232–365; mean 380 ± 272 days; follow-up time interval: 6–1594 days). In particular, clinical follow-up was available in 2470 patients at 6 months, in 1896 patients at 9 months, in 1685 patients at 12 months, in 374 patients at 18 months, in 296 patients at 24 months, and in 281 patients at more than 24 months.


View this table:
[in this window]
[in a new window]

  		Table 1 Key characteristics of the trials entered the ATTEMPT study and ATTEMPT FU length

 
The clinical and angiographic data collected in the pooled ATTEMPT population were similar between patients randomized to thrombectomy or standard PCI (Table 2).


View this table:
[in this window]
[in a new window]

  		Table 2 Baseline key clinical and angiographic characteristics of the ATTEMPT study population

 
The assessment of internal validity and quality for each study included in the analysis is reported in Table 3.


View this table:
[in this window]
[in a new window]

  		Table 3 Appraisal of internal validity and quality of included studies

 
Primary endpoint
Kaplan–Meier analysis at the longest available follow-up, either crude (Figure 2) or stratified by study (which provided similar results for direction and magnitude of statistical significance), showed that allocation to thrombectomy was associated with reduced all-cause mortality (log-rank P = 0.049). A similar result was provided by Peto fixed effect analysis, showing that thrombectomy was associated with significantly fewer deaths (OR = 0.71, 95% CI 0.49–1.00; P = 0.05) when compared with standard PCI. Notably, no evidence of heterogeneity (P for heterogeneity >0.10), statistical inconsistency (I2 < 50%), or small study bias (Egger test >0.05) was evident (Figure 3). The result was similar in the analysis performed excluding the two studies not yet published as full paper.


Figure 2
View larger version (14K):
[in this window]
[in a new window]
[Download PowerPoint slide]
  		Figure 2 Kaplan–Meier curves for cumulative survival; log-rank P = 0.049.

 

Figure 3
View larger version (10K):
[in this window]
[in a new window]
[Download PowerPoint slide]
  		Figure 3 Funnel plot graph for mortality.

 
Secondary endpoints
Kaplan–Meier analyses at the longest follow-up available, either crude or stratified by study (which provided similar results for direction and magnitude of statistical significance), showed that allocation to thrombectomy was associated with significantly fewer MACE (log-rank P = 0.011) (Figure 4) and death + MI (log-rank P = 0.015), but non-significant differences in MI (log-rank P = 0.126) or in TLR/TVR (log-rank P = 0.126). Similar results were provided by Peto fixed effect analysis, showing that thrombectomy was associated with significantly fewer MACE (OR = 0.80, 95% CI 0.65–0.98; P = 0.03) and death + MI (OR = 0.70, 95% CI 0.52–0.93; P = 0.02) when compared with standard PCI, whereas there were non-significant differences in MI (OR = 0.72, 95% CI 0.47–1.10; P = 0.13) or TLR/TVR (OR = 0.87, 95% CI 0.67–1.12; P = 0.27). No evidence of heterogeneity (all P for heterogeneity >0.10), statistical inconsistency (all I2 < 50%), or small study bias (all P at Egger test >0.05) was evident in any of the analyses.


Figure 4
View larger version (15K):
[in this window]
[in a new window]
[Download PowerPoint slide]
  		Figure 4 Kaplan–Meier curves for MACE-free survival; log-rank P = 0.011.

 
Subgroups analysis
Type of thrombectomy device
The ATTEMPT study population was divided into two groups considering the type of thrombectomy device used: manual thrombectomy group (1815 patients enrolled in trials with use of Diver CE, Pronto, and Export catheters) and non-manual thrombectomy group (871 patients enrolled in trials with use of X-Sizer, Angiojet, Rescue, and TVAC devices).

In the manual thrombectomy group, Kaplan–Meier analyses at the longest follow-up available showed that allocation to thrombectomy was associated with significantly fewer deaths (log-rank P = 0.011) (Figure 5A), whereas in the non-manual thrombectomy group, the allocation to thrombectomy was associated to similar mortality compared with standard PCI (log-rank P = 0.481) (Figure 5B).


Figure 5
View larger version (14K):
[in this window]
[in a new window]
[Download PowerPoint slide]
  		Figure 5 (A) Kaplan–Meier curves for cumulative survival in the manual thrombectomy group and corresponding control group; log-rank P = 0.011. (B) Kaplan–Meier curves for cumulative survival in the non-manual thrombectomy group and corresponding control group; log-rank P = 0.481.

 
Clinical and angiographic subgroups
There was no qualitative difference in mortality when splitting the study population according to the presence or absence of diabetes, to shorter, intermediate or longer time-to-reperfusion, to type of culprit artery (left anterior descending or circumflex artery or RCA) and to pre-PCI TIMI flow (0–1 or 2–3).

Conversely, subgroup analysis according to administration of IIb/IIIa-inhibitors showed that randomization to thrombectomy was associated to a survival benefit in the subgroup of patients treated with IIb/IIIa-inhibitors (1787 patients; log-rank P = 0.045; HR 0.61, 95% CI 0.38–0.90) and not in those not receiving this drugs (899 patients; log-rank P = 0.843; HR 0.93, 95% CI 0.48–1.80).


   Discussion
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
Study limitations
 Conclusions
 References
 
The failure to achieve myocardial tissue reperfusion is known to be the main complication limiting the early and long-term clinical benefit of mechanical reperfusion in patients with STEMI. Among the different strategies to limit the ‘no reflow phenomenon’, reducing distal embolization by thrombectomy devices use is a promising one.13 The present pooled analysis on 2686 individual patients data (from 11 randomized trials) shows that the adjunct of thrombectomy during mechanical reperfusion is associated to a detectable improvement of survival at follow-up with an estimated number needed to treat to prevent one death at 1 year of 62. Moreover, we found that the survival advantage of thrombectomy is confined to patients treated by simple manual thrombectomy catheters with an estimated number needed to treat to prevent one death at 1 year of 34.

Such findings extend the recently published single-centre TAPAS trial results11 which showed a significantly lower cardiac mortality at 12 months in the group of patients treated with manual thrombectomy. However, the TAPAS trial was not specifically designed and powered to assess the difference between thrombectomy and standard PCI at the long-term clinical follow-up.35 In the absence of large, multicentre trials adequately powered to assess long-term outcome in patients with STEMI treated with PCI and thrombectomy, the best way to evaluate the role of this treatment is pooling individual patient data collected by different investigators in different randomized studies of standard PCI vs. PCI with thrombectomy. Indeed, pooled analyses of randomized trials using individual patient data are known to provide more accurate results compared with simple meta-analyses,36 so that they have been used to answer the key questions in the field of cardiovascular medicine like the benefit of prolonged anti-platelet therapy,37 the benefit of beta-blockade after MI,38 the impact of mechanical over pharmacological reperfusion in STEMI39 and the safety of drug-eluting stents in selected patients with coronary artery disease.40 Thus, we designed and carried out this collaborative study, which allowed not only to collect a large number of patients, pooling the majority of available randomized trials, but also to significantly extend the clinical follow-up of some of the studies previously published with a short clinical follow-up. As a consequence, the number of patients with at least 1 year follow-up (i.e. 1685) was larger than the calculated sample size for a reliable assessment of the primary endpoint. Moreover, as the very late outcome of patients treated by thrombectomy was not previously investigated, the present study provides novel information on a subgroup of patients with follow-up extended beyond 1 year. In keeping with the hypothesis of a long-lasting thrombectomy-induced benefit, the survival curves of thrombectomy-treated patients continued to differ from that of control patients throughout the study period.

Large studies are also needed to assess if subgroups of patients have more to gain from the application of this novel treatment. Thus, we planned to collect data allowing a series of pre-defined clinical and angiographic subgroup analyses. Interestingly, the benefit of thrombectomy was more evident in patients who received IIb/IIIa-inhibitors thus suggesting a possible additive benefit of thrombectomy in patients treated with IIb/IIIa-inhibitors. It might be speculated that pharmacological and mechanical thrombus remodelling are synergic to obtain the best myocardial reperfusion and, consequently, the best clinical outcome. Indeed, in the ATTEMPT study, patients treated by both thrombectomy and IIb/IIIa-inhibitors had the lower mortality rate, those who had none of these treatments had the higher mortality rate, patients receiving only one of these therapies exhibiting intermediate outcome (Figure 6). Accordingly, such observations seem to support the last release of the ESC guidelines on the management of patients with STEMI which recommends the use of both IIb/IIIa-inhibitors and thrombus-aspiration to prevent no-reflow.41


Figure 6
View larger version (15K):
[in this window]
[in a new window]
[Download PowerPoint slide]
  		Figure 6 Mortality rates observed in the ATTEMPT database according to thrombectomy and to administration of IIb/IIIa-inhibitors. Comparison between four treatment subgroups performed by Fisher test.

 
Finally, once the use of thrombectomy to reduce distal embolization is accepted, the issue of device selection emerges. More complex (non-manual) devices are probably more effective than manual thrombus-aspiration catheters in extracting athero-thrombotic particles from the coronary arteries. Yet, they are bulky, require longer learning curves and selected coronary anatomies. Conversely, manual thrombus-aspirating catheters are user-friendly, not associated with specific complications, and suitable for most coronary anatomies. In the absence of large studies comparing the simple manual thrombectomy catheters with the more complex non-manual thrombectomy devices, the present study does not support the routine use of non-manual thrombectomy. Possible benefits of complex non-manual thrombectomy devices might be confined to selected subgroups of patients with larger thrombus burden and device-favourable coronary anatomy and need to be tested in ad hoc prospective studies.


   Study limitations
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Study limitations
Conclusions
 References
 
The results obtained in the present study may have been influenced by the quality of each original trial. In particular, no further quality control has been performed nor any restriction in trial size, publication status, and updated clinical follow-up length or modality of assessment have been applied. All these limitations were anticipated14 and have been accepted in the effort to achieve the goal to collect in a single database the largest number of patients randomized in thrombectomy trials. Moreover, the validated statistical analyses applied allowed to show no evidence of heterogeneity, statistical inconsistency, or small study bias in any of the analyses.

Another limitation of the present study is the exclusion of six eligible trials (accounting for 1019 patients) due to lack of agreement by the principal investigators to participate the study. As a consequence, the participation was unbalanced in favour of manual thrombectomy trials (indeed 88% of studies testing manual thrombectomy were included when compared with 44% of studies testing non-manual thrombectomy). Thus, the hypothesis that the overall positive result may have been driven by manual thrombectomy studies cannot be discarded.

The subgroup analysis generated small subgroups of patients so that the survival analyses were underpowered. Yet, as no large assessment of clinical benefit of thrombectomy according to the key angiographic and clinical parameters has previously been conducted, the present results should be considered as hypothesis-generating and deserve further evaluations.

Finally, the different endpoint definitions for MI, TVR, or TLR adopted in the trials included may have limited the strength of the secondary endpoints analysis. However, the presence of such possible heterogeneity cannot have influenced the primary endpoint which was the unequivocal all-cause mortality.


   Conclusions
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Study limitations
 Conclusions
References
 
The pooled analysis of patients with STEMI enrolled in 11 randomized trials showed that the adjunct of thrombectomy (in particular manual thrombectomy) during mechanical reperfusion improves late clinical outcome and that this benefit is evident in patients receiving IIb/IIIa-inhibitors.

Conflict of interest: none declared.


   Footnotes
 
{dagger} The first two authors contributed equally to the study. Back


   References
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Study limitations
 Conclusions
 References
 

  1. Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet (2003) 361:13–20.[CrossRef][Web of Science][Medline]
  2. Rezkalla SH, Kloner RA. No-reflow phenomenon. Circulation (2002) 105:656–662.[Free Full Text]
  3. van ‘t Hof AW, Liem A, Suryapranata H, Hoorntje JC, de Boer MJ, Zijlstra F. 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) 97:2302–2306.[Abstract/Free Full Text]
  4. Niccoli G, Burzotta F, Galiuto L, Crea F. Coronary no-reflow in humans. J Am Coll Cardiol (2009) 54:281–292.[Abstract/Free Full Text]
  5. Gu YL, Fokkema ML, Zijlstra F. The emerging role of thrombus aspiration in the management of acute myocardial infarction. Circulation (2008) 118:1780–1782.[Free Full Text]
  6. Burzotta F, Testa L, Giannico F, Biondi-Zoccai GG, Trani C, Romagnoli E, Mazzari M, Mongiardo R, Siviglia M, Niccoli G, De Vita M, Porto I, Schiavoni G, Crea F. Adjunctive devices in primary or rescue PCI: a meta-analysis of randomized trials. Int J Cardiol (2008) 123:313–321.[CrossRef][Web of Science][Medline]
  7. Henriques JP, Zijlstra F, Ottervanger JP, de Boer MJ, van ‘t Hof AW, Hoorntje JC, Suryapranata H. Incidence and clinical significance of distal embolization during primary angioplasty for acute myocardial infarction. Eur Heart J (2002) 23:1112–1117.[Abstract/Free Full Text]
  8. Gibson CM, Cannon CP, Murphy SA, Ryan KA, Mesley R, Marble SJ, McCabe CH, Van De Werf F, Braunwald E. Relationship of TIMI myocardial perfusion grade to mortality after administration of thrombolytic drugs. Circulation (2000) 101:125–130.[Abstract/Free Full Text]
  9. Schröder K, Wegscheider K, Zeymer U, Tebbe U, Schroder R. Extent of ST-segment deviation in a single electrocardiogram lead 90 min after thrombolysis as a predictor of medium-term mortality in acute myocardial infarction. Lancet (2001) 358:1479–1486.[CrossRef][Web of Science][Medline]
  10. Reffelmann T, Kloner RA. The ‘no-reflow’ phenomenon: basic science and clinical correlates. Heart (2002) 87:162–168.[Free Full Text]
  11. Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. 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.[CrossRef][Web of Science][Medline]
  12. De Luca G, Dudek D, Sardella G, Marino P, Chevalier B, Zijlstra F. Adjunctive manual thrombectomy improves myocardial perfusion and mortality in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction: a meta-analysis of randomized trials. Eur Heart J (2008) 24:3002–3010.
  13. Burzotta F, Crea F. Thrombus-aspiration: a victory in the war against no reflow. Lancet (2008) 37:1889–1890.
  14. De Vita M, Burzotta F, Biondi-Zoccai GGL, Lefevre T, Dudek D, Antoniucci D, Silva Orrego P, De Luca L, Kaltoft A, Sardella G, Zijlstra F, Isshiki T, Crea F. Individual patient data meta-analysis comparing long term clinical outcome in patients with ST elevation myocardial infarction treated with percutaneous coronary intervention with or without prior thrombectomy. ATTEMPT study: a pooled Analysis of Trials on ThrombEctomy in acute Myocardial infarction based on individual PatienT data. Vasc Health Risk Manag (2009) 5:243–247.[Medline]
  15. Biondi Zoccai GG, Agostoni P, Abbate A, Testa L, Burzotta F. A simple hint to improve Robinson and Dickersin's highly sensitive PubMed search strategy for controlled clinical trials. Int J Epidemiol (2005) 34:224–225.[Free Full Text]
  16. Beran G, Lang I, Schreiber W, Denk S. Intracoronary thrombectomy with the X-Sizer catheter system improves epicardial flow and accelerates ST-segment resolution in patients with acute coronary syndrome. Circulation (2002) 105:2355–2360.[Abstract/Free Full Text]
  17. Napodano M, Pasquetto G, Sacca S, Cernetti C, Scarabeo V, Pascotto P, Reimers B. Intracoronary thrombectomy improves myocardial reperfusion in patients undergoing direct angioplasty for acute myocardial infarction. J Am Coll Cardiol (2003) 42:1395–1402.[Abstract/Free Full Text]
  18. Antoniucci D, Valenti R, Migliorini A, Parodi G, Memisha G, Santoro GM, Sciagra R. Comparison of rheolitic thrombectomy before direct infarct artery stenting versus direct stenting alone in patients undergoing percutaneous coronary intervention of acute myocardial infarction. Am J Cardiol (2004) 93:1033–1035.[CrossRef][Web of Science][Medline]
  19. Dudek D, Mielecki W, Legutko J, Chyrchel M, Sorysz D, Bartus S, Rzeszutko L, Dubiel JS. Percutaneous thrombectomy with the RESCUE system in acute myocardial infartion. Kardiol Pol (2004) 61:523–533.[Medline]
  20. Burzotta F, Trani C, Romagnoli E, Mazzari MA, Rebuzzi AG, De Vita M, Garramone B, Giannico F, Niccoli G, Biondi-Zoccai GG, Schiavoni G, Mongiardo R, Crea F. 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) 46:371–376.[Abstract/Free Full Text]
  21. Lefevre T, Garcia E, Reimers B, Lang I, di Mario C, Colombo A, Neumann FJ, Chavarri MV, Brunel P, Grube E, Thomas M, Glatt B, Ludwig J, X AMINE ST Investigators. X-sizer for thrombectomy in acute myocardial infarction improves ST-segment resolution: results of the X-sizer in AMI for negligible embolization and optimal ST resolution (X AMINE ST) trial. J Am Coll Cardiol (2005) 46:246–252.[Abstract/Free Full Text]
  22. Silva-Orrego P, Colombo P, Bigi R, Gregori D, Delgado A, Salvade P, Oreglia J, Orrico P, de Biase A, Piccalò G, Bossi I, Klugmann S. 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) 48:1552–1559.[Abstract/Free Full Text]
  23. Kaltoft A, Bottcher M, Nielsen SS, Hansen HH, Terkelsen C, Maeng M, Kristensen J, Thuesen L, Krusell LR, Kristensen SD, Andersen HR, Lassen JF, Rasmussen K, Rehling M, Nielsen TT, Botker HE. Routine thrombectomy in percutaneous coronary intervention for acute ST-segment-elevation myocardial infarction: a randomized, controlled trial. Circulation (2006) 114:40–47.[Abstract/Free Full Text]
  24. De Luca L, Sardella G, Davidson CJ, De Persio G, Beraldi M, Tommasone T, Mancone M, Nguyen BL, Agati L, Gheorghiade M, Fedele F. Impact of intracoronary aspiration thrombectomy during primary angioplasty on left ventricular remodelling in patients with anterior ST elevation myocardial infarction. Heart (2006) 92:951–957.[Abstract/Free Full Text]
  25. Ali A, Cox D, Dib N, Brodie B, Berman D, Gupta N, Browne K, Iwaoka R, Azrin M, Stapleton D, Setum C, Popma J, AIMI Investigators. Rheolytic thrombectomy with percutaneous coronary intervention for infarct size reduction in acute myocardial infarction: 30-day results from a multicenter randomized study. J Am Coll Cardiol (2006) 48:244–252.[Abstract/Free Full Text]
  26. Ozaki Y, Nomura M, Nakayama T, Ogata T, Nakayasu K, Nakaya Y, Ito S. Effects of thrombus suction therapy on myocardial blood flow disorders in males with acute inferior myocardial infarction. J Med Invest (2006) 53:167–173.[CrossRef][Medline]
  27. Svilaas T, Vlaar PJ, van der Horst IC, Diercks GF, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Thrombus Aspiration during Primary Percutaneous Coronary Intervention. N Engl J Med (2008) 358:557–567.[Abstract/Free Full Text]
  28. Ikari Y, Sakurada M, Kozuma K, Kawano S, Katsuki T, Kimura K, Suzuki T, Yamashita T, Takizawa A, Misuni K, Hashimoto H, Isshiki T, VAMPIRE Investigators. Upfront thrombus aspiration in primary coronary intervention for patients with ST-segment elevation acute myocardial infarction. Report of the VAMPIRE (VAcuuM asPIration thrombus REmoval) Trial. J Am Coll Cardiol Intv (2008) 1:424–431.[Abstract/Free Full Text]
  29. Chevalier B, Gilard M, Lang I, Commeau P, Roosen J, Hanssen M, Lefevre T, Carrié D, Bartorelli A, Montalescot G, Parikh K. Systematic primary aspiration in acute myocardial percutaneous intervention: a multicentre randomised controlled trial of the export aspiration catheter. EuroIntervention (2008) 4:222–228.[Medline]
  30. Sardella G, Mancone M, Bucciarelli-Ducci C, Agati L, Scardala R, Carbone I, Francone M, Di Roma A, Benedetti G, Conti G, Fedele F. Thrombus aspiration during primary percutaneous coronary intervention improves myocardial reperfusion and reduces infarct size: the EXPIRA (thrombectomy with export catheter in infarct-related artery during primary percutaneous coronary intervention) prospective, randomized trial. J Am Coll Cardiol (2009) 53:309–315.[Abstract/Free Full Text]
  31. Noel B, Morice MC, Lefevre T, Garot P, Tavolaro O, Louvard Y, Dumas P. Thrombus aspiration in acute ST-elevation myocardial infarction: a randomized controlled trial. Circulation (2005) 112(Suppl. II):519.
  32. Dudek D. Polish-Italian-Hungarian Randomized ThrombEctomy Trial. PHIRATE trial; Expert slide presentation from Late Breaking Clinical Trials, TCT. (2007).
  33. Higgins JPT, Green S. Cochrane Reviewers’ Handbook 5.0.0. Available at http://www.cochrane-handbook.org.
  34. Egger M, Smith GD, Schneider M, Minder C. Bias in meta-analysis detected by a simple graphical test. BMJ (1997) 315:629–634.[Abstract/Free Full Text]
  35. Svilaas T, van der Horst IC, Zijlstra F. Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) study design. Am Heart J (2006) 151:597.e1–597.e7.[CrossRef][Medline]
  36. Jeng GT, Scott JR, Burmeister LF. A comparison of meta-analytic results using literature vs individual patient data. Paternal cell immunization for recurrent miscarriage. J Am Med Assoc (1995) 274:830–836.[Abstract/Free Full Text]
  37. Antiplatelet Trialists’ Collaboration. Collaborative overview of randomised trials of antiplatelet therapy-I: prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. BMJ (1994) 308:81–106.[Abstract/Free Full Text]
  38. Olsson G, Wikstrand J, Warnold I, Manger Cats V, McBoyle D, Herlitz J, Hjalmarson A, Sonneblick EH. Metoprolol-induced reduction in postinfarction mortality: pooled results from five double-blind randomized trials. Eur Heart J (1992) 13:28–32.[Abstract/Free Full Text]
  39. Grines C, Patel A, Zijlstra F, Weaver WD, Granger C, Simes RJ, PCAT Collaborators. Primary coronary angioplasty compared with intravenous thrombolytic therapy for acute myocardial infarction: six-month follow up and analysis of individual patient data from randomized trials. Am Heart J (2003) 145:47–57.[CrossRef][Web of Science][Medline]
  40. Spaulding C, Daemen J, Boersma E, Cutlip DE, Serruys PW. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med (2007) 356:989–997.[Abstract/Free Full Text]
  41. Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M, Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Silber S, Aguirre FV, Al-Attar N, Alegria E, Andreotti F, Benzer W, Breithardt O, Danchin N, Di Mario C, Dudek D, Gulba D, Halvorsen S, Kaufmann P, Kornowski R, Lip GY, Rutten F, ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J (2008) 29:2909–2945.[Free Full Text]

Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?

Related articles in EHJ:

Thrombectomy in acute ST-elevation myocardial infarction: keep it simple
Eric Eeckhout
EHJ 2009 30: 2180-2181. [Extract] [FREE Full Text]  



This article has been cited by other articles:


Home page
 J Am Coll Cardiol IntvHome page
J. C. George and G. D. Dangas
European Society of Cardiology Congress 2009: Update in Interventional Cardiology
J. Am. Coll. Cardiol. Intv., November 1, 2009; 2(11): 1160 - 1162.
[Full Text] [PDF]

Home page
 Eur Heart JHome page
E. Eeckhout
Thrombectomy in acute ST-elevation myocardial infarction: keep it simple
Eur. Heart J., September 2, 2009; (2009) ehp349v1.
[Full Text] [PDF]

E-letters:

Read all E-letters

Before complete acceptance, keep an eye on safety:
Anthony A Bavry, et al.
European Heart Journal, 22 Oct 2009 [Full text]
An Increase in Mortality Between 400-500 Days After Acute ST Elevation Myocardial Infarction
Hideaki Kaneda, et al.
European Heart Journal, 22 Oct 2009 [Full text]
The impact of inter-center variability on the study outcomes in the ATTEMPT study
Yoichi Inaba, et al.
European Heart Journal, 3 Nov 2009 [Full text]
Reply to doctor Bavry and doctor Bhatt comment letter to the ATTEMPT study
Maria De Vita, et al.
European Heart Journal, 26 Oct 2009 [Full text]
This Article
Right arrow Abstract Freely available
Right arrow FREE Full Text (PDF) Freely available
Right arrow All Versions of this Article:
30/18/2193    most recent
ehp348v1
Right arrow E-letters: Submit a response
Right arrow E-letters: View responses
Right arrow Alert me when this article is cited
Right arrow Alert me when E-letters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Related articles in EHJ
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrowRequest Permissions
Right arrow Disclaimer
Google Scholar
Right arrow Articles by Burzotta, F.
Right arrow Articles by Zijlstra, F.
PubMed
Right arrow PubMed Citation
Right arrow Articles by Burzotta, F.
Right arrow Articles by Zijlstra, F.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?