Comparison of angiojet rheolytic thrombectomy before direct infarct artery stenting with direct stenting alone in patients with acute myocardial infarction: The jetstent trial

Angela Migliorini, Amerigo Stabile, Alfredo E. Rodriguez, Caterina Gandolfo, Alfredo M. Rodriguez Granillo, Renato Valenti, Guido Parodi, Franz Josef Neumann, Antonio Colombo, David Antoniucci

Research output: Contribution to journalArticle

Abstract

Objectives: The aim of this study was to determine whether rheolytic thrombectomy (RT) before direct infarct artery stenting as compared with direct stenting (DS) alone results in improved myocardial reperfusion and clinical outcome in patients with acute myocardial infarction. Background: The routine removal of thrombus before infarct artery stenting is still a matter of debate. Methods: This is a multicenter, international, randomized, 2-arm, prospective study. Eligible patients were patients with acute myocardial infarction, angiographic evidence of thrombus grade 3 to 5, and a reference vessel diameter 99mTc-sestamibi infarct size. An α value = 0.05 achieved by both coprimary surrogate end points or an α value = 0.025 for a single primary surrogate end point would be considered evidence of statistical significance. Other surrogate end points were Thrombolysis In Myocardial Infarction (TIMI) flow grade 3, corrected TIMI frame count, and TIMI grade 3 blush. Clinical end points were a composite of major adverse cardiovascular events at 1, 6, and 12 months. Results: From December 2005 to September 2009, 501 patients were randomly allocated to RT before DS or to DS alone. The ST-segment resolution was more frequent in the RT arm as compared with the DS alone arm: 85.8% and 78.8%, respectively (p = 0.043), while no difference between groups were revealed in the other surrogate end points. The 6-month major adverse cardiovascular events rate was 11.2% in the thrombectomy arm and 19.4% in the DS alone arm (p = 0.011). The 1-year event-free survival rates were 85.2 ± 2.3% for the RT arm, and 75.0 ± 3.1% for the DS alone arm (p = 0.009). Conclusions: Although the primary efficacy end points were not met, the results of this study support the use of RT before infarct artery stenting in patients with acute myocardial infarction and evidence of coronary thrombus. (AngioJet Rheolytic Thrombectomy Before Direct Infarct Artery Stenting in Patients Undergoing Primary PCI for Acute Myocardial Infarction [JETSTENT]; NCT00275990)

Original languageEnglish
Pages (from-to)1298-1306
Number of pages9
JournalJournal of the American College of Cardiology
Volume56
Issue number16
DOIs
Publication statusPublished - Oct 12 2010

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Thrombectomy
Arteries
Myocardial Infarction
Biomarkers
Thrombosis
Technetium Tc 99m Sestamibi
Myocardial Reperfusion
Disease-Free Survival
Survival Rate
Prospective Studies

Keywords

  • Coronary stenting
  • Infarct artery
  • Thrombectomy

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Comparison of angiojet rheolytic thrombectomy before direct infarct artery stenting with direct stenting alone in patients with acute myocardial infarction : The jetstent trial. / Migliorini, Angela; Stabile, Amerigo; Rodriguez, Alfredo E.; Gandolfo, Caterina; Rodriguez Granillo, Alfredo M.; Valenti, Renato; Parodi, Guido; Neumann, Franz Josef; Colombo, Antonio; Antoniucci, David.

In: Journal of the American College of Cardiology, Vol. 56, No. 16, 12.10.2010, p. 1298-1306.

Research output: Contribution to journalArticle

Migliorini, Angela ; Stabile, Amerigo ; Rodriguez, Alfredo E. ; Gandolfo, Caterina ; Rodriguez Granillo, Alfredo M. ; Valenti, Renato ; Parodi, Guido ; Neumann, Franz Josef ; Colombo, Antonio ; Antoniucci, David. / Comparison of angiojet rheolytic thrombectomy before direct infarct artery stenting with direct stenting alone in patients with acute myocardial infarction : The jetstent trial. In: Journal of the American College of Cardiology. 2010 ; Vol. 56, No. 16. pp. 1298-1306.
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abstract = "Objectives: The aim of this study was to determine whether rheolytic thrombectomy (RT) before direct infarct artery stenting as compared with direct stenting (DS) alone results in improved myocardial reperfusion and clinical outcome in patients with acute myocardial infarction. Background: The routine removal of thrombus before infarct artery stenting is still a matter of debate. Methods: This is a multicenter, international, randomized, 2-arm, prospective study. Eligible patients were patients with acute myocardial infarction, angiographic evidence of thrombus grade 3 to 5, and a reference vessel diameter 99mTc-sestamibi infarct size. An α value = 0.05 achieved by both coprimary surrogate end points or an α value = 0.025 for a single primary surrogate end point would be considered evidence of statistical significance. Other surrogate end points were Thrombolysis In Myocardial Infarction (TIMI) flow grade 3, corrected TIMI frame count, and TIMI grade 3 blush. Clinical end points were a composite of major adverse cardiovascular events at 1, 6, and 12 months. Results: From December 2005 to September 2009, 501 patients were randomly allocated to RT before DS or to DS alone. The ST-segment resolution was more frequent in the RT arm as compared with the DS alone arm: 85.8{\%} and 78.8{\%}, respectively (p = 0.043), while no difference between groups were revealed in the other surrogate end points. The 6-month major adverse cardiovascular events rate was 11.2{\%} in the thrombectomy arm and 19.4{\%} in the DS alone arm (p = 0.011). The 1-year event-free survival rates were 85.2 ± 2.3{\%} for the RT arm, and 75.0 ± 3.1{\%} for the DS alone arm (p = 0.009). Conclusions: Although the primary efficacy end points were not met, the results of this study support the use of RT before infarct artery stenting in patients with acute myocardial infarction and evidence of coronary thrombus. (AngioJet Rheolytic Thrombectomy Before Direct Infarct Artery Stenting in Patients Undergoing Primary PCI for Acute Myocardial Infarction [JETSTENT]; NCT00275990)",
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T1 - Comparison of angiojet rheolytic thrombectomy before direct infarct artery stenting with direct stenting alone in patients with acute myocardial infarction

T2 - The jetstent trial

AU - Migliorini, Angela

AU - Stabile, Amerigo

AU - Rodriguez, Alfredo E.

AU - Gandolfo, Caterina

AU - Rodriguez Granillo, Alfredo M.

AU - Valenti, Renato

AU - Parodi, Guido

AU - Neumann, Franz Josef

AU - Colombo, Antonio

AU - Antoniucci, David

PY - 2010/10/12

Y1 - 2010/10/12

N2 - Objectives: The aim of this study was to determine whether rheolytic thrombectomy (RT) before direct infarct artery stenting as compared with direct stenting (DS) alone results in improved myocardial reperfusion and clinical outcome in patients with acute myocardial infarction. Background: The routine removal of thrombus before infarct artery stenting is still a matter of debate. Methods: This is a multicenter, international, randomized, 2-arm, prospective study. Eligible patients were patients with acute myocardial infarction, angiographic evidence of thrombus grade 3 to 5, and a reference vessel diameter 99mTc-sestamibi infarct size. An α value = 0.05 achieved by both coprimary surrogate end points or an α value = 0.025 for a single primary surrogate end point would be considered evidence of statistical significance. Other surrogate end points were Thrombolysis In Myocardial Infarction (TIMI) flow grade 3, corrected TIMI frame count, and TIMI grade 3 blush. Clinical end points were a composite of major adverse cardiovascular events at 1, 6, and 12 months. Results: From December 2005 to September 2009, 501 patients were randomly allocated to RT before DS or to DS alone. The ST-segment resolution was more frequent in the RT arm as compared with the DS alone arm: 85.8% and 78.8%, respectively (p = 0.043), while no difference between groups were revealed in the other surrogate end points. The 6-month major adverse cardiovascular events rate was 11.2% in the thrombectomy arm and 19.4% in the DS alone arm (p = 0.011). The 1-year event-free survival rates were 85.2 ± 2.3% for the RT arm, and 75.0 ± 3.1% for the DS alone arm (p = 0.009). Conclusions: Although the primary efficacy end points were not met, the results of this study support the use of RT before infarct artery stenting in patients with acute myocardial infarction and evidence of coronary thrombus. (AngioJet Rheolytic Thrombectomy Before Direct Infarct Artery Stenting in Patients Undergoing Primary PCI for Acute Myocardial Infarction [JETSTENT]; NCT00275990)

AB - Objectives: The aim of this study was to determine whether rheolytic thrombectomy (RT) before direct infarct artery stenting as compared with direct stenting (DS) alone results in improved myocardial reperfusion and clinical outcome in patients with acute myocardial infarction. Background: The routine removal of thrombus before infarct artery stenting is still a matter of debate. Methods: This is a multicenter, international, randomized, 2-arm, prospective study. Eligible patients were patients with acute myocardial infarction, angiographic evidence of thrombus grade 3 to 5, and a reference vessel diameter 99mTc-sestamibi infarct size. An α value = 0.05 achieved by both coprimary surrogate end points or an α value = 0.025 for a single primary surrogate end point would be considered evidence of statistical significance. Other surrogate end points were Thrombolysis In Myocardial Infarction (TIMI) flow grade 3, corrected TIMI frame count, and TIMI grade 3 blush. Clinical end points were a composite of major adverse cardiovascular events at 1, 6, and 12 months. Results: From December 2005 to September 2009, 501 patients were randomly allocated to RT before DS or to DS alone. The ST-segment resolution was more frequent in the RT arm as compared with the DS alone arm: 85.8% and 78.8%, respectively (p = 0.043), while no difference between groups were revealed in the other surrogate end points. The 6-month major adverse cardiovascular events rate was 11.2% in the thrombectomy arm and 19.4% in the DS alone arm (p = 0.011). The 1-year event-free survival rates were 85.2 ± 2.3% for the RT arm, and 75.0 ± 3.1% for the DS alone arm (p = 0.009). Conclusions: Although the primary efficacy end points were not met, the results of this study support the use of RT before infarct artery stenting in patients with acute myocardial infarction and evidence of coronary thrombus. (AngioJet Rheolytic Thrombectomy Before Direct Infarct Artery Stenting in Patients Undergoing Primary PCI for Acute Myocardial Infarction [JETSTENT]; NCT00275990)

KW - Coronary stenting

KW - Infarct artery

KW - Thrombectomy

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