We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00766740
Recruitment Status : Completed
First Posted : October 6, 2008
Last Update Posted : October 6, 2008
Information provided by:
Catholic University of the Sacred Heart

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Device: thrombectomy devices Device: angioplasty Phase 4

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  (Clinical Trial)
Actual Enrollment : 2686 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2007
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Device: thrombectomy devices
mechanical or manual devices able to remove thrombus from the coronary arteries.
Other Names:
  • TVAC
Active Comparator: 2
Standard PCI
Device: angioplasty
percutaneous coronary angioplasty with use of balloon catheters and bare metal stents or drug eluting stents.

Primary Outcome Measures :
  1. All cause mortality [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Major adverse coronary events (MACE: death + MI (myocardial infarction) + TLR (target lesion revascularization) [ Time Frame: one year ]
  2. Myocardial infarction [ Time Frame: one year ]
  3. Death + myocardial infarction [ Time Frame: one year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766740

Catholic University of Sacred Heart
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Principal Investigator: Francesco Burzotta, MD, PhD Catholic University of Sacred Heart

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francesco Burzotta, MD, PhD, Catholic University of Sacred Heart
ClinicalTrials.gov Identifier: NCT00766740     History of Changes
Other Study ID Numbers: UCSC-001
First Posted: October 6, 2008    Key Record Dates
Last Update Posted: October 6, 2008
Last Verified: October 2008

Keywords provided by Catholic University of the Sacred Heart:
ST elevation myocardial infarction
primary PCI

Additional relevant MeSH terms:
Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases