Long Term Clinical Efficacy of Thrombectomy Devices in Acute ST Elevation Myocardial Infarction (ATTEMPT)

October 3, 2008 updated by: Catholic University of the Sacred Heart

Individual-Patient-Data Pooled-Analysis Comparing Long Term Clinical Outcome in Patients With ST-Elevation Myocardial Infarction Treated With Percutaneous Coronary Intervention With or Without Prior Thrombectomy

Available data from randomized trials on thrombectomy in patients with ST-elevation myocardial infarction have shown favourable trends on myocardial reperfusion. Better myocardial reperfusion may translate in better late clinical outcome. However, only few data are available on the impact of thrombectomy on long term clinical outcome.

Thus, the investigators designed a collaborative individual patient-data pooled-analysis aimed to assess the long-term clinical outcome in STEMI patients randomized to percutaneous coronary intervention with or without thrombectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Available data from randomized trials on thrombectomy in patients with ST-elevation myocardial infarction have shown favourable trends on myocardial reperfusion. However, only few data are available on the impact of thrombectomy on long term clinical outcome.The first trials on thrombectomy had a too small sample size and a too short follow-up to reliably assess the presence of a clinical benefit.

Only one, recently published, monocentric, randomized trial conducted on 1071 patients with STEMI, the TAPAS study, showed an advantage of thrombus-aspiration use in terms of mortality at one year follow-up.

To extend the investigation on this issue to a larger population, we have designed 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 long term clinical outcome.

Methods: After a thorough database search, all 15 principal investigators of 17 randomized trials comparing thrombectomy with standard PCI in patients with STEMI were contacted. All 10 principal investigators authoring 11 randomized trials who agreed to participate the study have been asked to complete a structured database including a series of key baseline clinical and angiographic data (sex, age, diabetes, rescue PCI, usage of IIb/IIIa-inhibitors, infarct related artery (LAD or LCX or RCA), multivessel disease, base-line TIMI flow 0 or 1 (yes or no), time from symptoms to balloon/cath-lab, thrombectomy device used (name of the device, for example Export catheter),device efficacy (device able to reach and treat the culprit lesion)) and also to update the clinical follow-up of each patient enrolled in the corresponding trial at one year or more.

Actually we have closed the data collection and we have the requested data with the updated clinical follow-up data of 11 randomized studies (REMEDIA trial, PIHRATE trial, X-AMINE ST trial, De Luca et al. trial, Noel et al. trial, EXPIRA trial, VAMPIRE trial, TAPAS trial, Kaltoft et al. trial, DEAR-MI trial, Antoniucci et al. trial).

The primary end point of this pooled analysis is the comparison of survival between patients randomized to PCI with thrombectomy or PCI without thrombectomy. The secondary end-points are survival free from myocardial infarction (MI), target lesion revascularization (TLR), major adverse coronary events (MACE: death + MI + TLR) and death + MI between patients randomized to PCI with thrombectomy or PCI without thrombectomy.

A pre-defined subgroup analysis is planned considering the following variables: diabetes, rescue PCI, IIb/IIIa-inhibitors use, time-to-reperfusion, infarct related artery, pre-PCI TIMI flow and type of thrombectomy device used.

Implications: This study will be able to provide useful data about the impact of the reported improved myocardial perfusion associated with thrombectomy on the long-term clinical outcome in patients with STEMI.

Study Type

Interventional

Enrollment (Actual)

2686

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Catholic University Of Sacred Heart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria for selected studies who entered this pooled analysis were:

  • Comparison of PCI with Thrombectomy with Standard PCI in patients with STEMI
  • Randomized treatment allocation

Exclusion criteria was:

  • Equivocal treatment allocation process

About the clinical and angiographic inclusion and exclusion criteria they were different for each single randomized trial that entered this pooled analysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
thrombectomy
Device: thrombectomy devices
mechanical or manual devices able to remove thrombus from the coronary arteries.
Other Names:
  • DIVER CE
  • PRONTO
  • EXPORT
  • X-SIZER
  • TVAC
  • RESCUE
  • ANGIO-JET
Active Comparator: 2
Standard PCI
Device: angioplasty
percutaneous coronary angioplasty with use of balloon catheters and bare metal stents or drug eluting stents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Major adverse coronary events (MACE: death + MI (myocardial infarction) + TLR (target lesion revascularization)
Time Frame: one year
one year
Myocardial infarction
Time Frame: one year
one year
Death + myocardial infarction
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Investigators

  • Principal Investigator: Francesco Burzotta, MD, PhD, Catholic University Of Sacred Heart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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(9628):1915-20. 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 2004,93:1033-35. 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;61:523-33. 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(2):371-6. 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;46:246-52. Noel B, Morice MC, Lefevre T et al. Thrombus aspiration in acute ST-elevation myocardial infarction: a randomized controlled trial. Circulation 2005; 112 (Suppl. II): 519. 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 17;48:1552-9. Ikari Y, Kawano S, Sakurada M, et al. Thrombus aspiration prior to coronary intervention improves myocardial microcirculation in patients with ST elevation acute myocardial infarction, the VAMPIRE Study. Circulation 2005;112 [Suppl., abstr]. 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;114:40-7. 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;92:951-7. Svilaas T, Vlaar PJ, van der Horst IC et al. Thrombus Aspiration during Primary Percutaneous Coronary Intervention. N Engl J Med 2008;358: 557-67. Dudek D et al. Polish-Italian-Hungarian Randomized ThrombEctomy Trial. PHIRATE trial; Expert slide presentation from Late Breaking Clinical Trials, TCT 2007. Sardella G et al. Impact of thrombectomy with EXPort catheter in Infarct Related Artery on procedural and clinical outcome in patients with AMI. (EXPIRA Trial); Expert slide presentation from Late Breaking Clinical Trials, TCT 2007. Chevalier B. Export Study; Expert slide presentation from Late Breaking Clinical Trials, TCT 2007.
  • Burzotta F, De Vita M, Gu YL, Isshiki T, Lefevre T, Kaltoft A, Dudek D, Sardella G, Orrego PS, Antoniucci D, De Luca L, Biondi-Zoccai GG, Crea F, Zijlstra F. Clinical impact of thrombectomy in acute ST-elevation myocardial infarction: an individual patient-data pooled analysis of 11 trials. Eur Heart J. 2009 Sep;30(18):2193-203. doi: 10.1093/eurheartj/ehp348. Epub 2009 Sep 2.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

October 3, 2008

First Submitted That Met QC Criteria

October 3, 2008

First Posted (Estimate)

October 6, 2008

Study Record Updates

Last Update Posted (Estimate)

October 6, 2008

Last Update Submitted That Met QC Criteria

October 3, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCSC-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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