PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-Elevation-combined embolic protection and thrombectomy during percutaneous coronary intervention in acute ST-segment elevation myocardial infarction: a randomised comparison using the PROXIS™ device

Conditions

Myocardial infarction Circulatory System Ischaemic heart diseases

van der Weg K, Kuijt WJ, Tijssen JG, Bekkers SC, Haeck JD, Green CL, Lemmert ME, de Winter RJ, Gorgels AP, Krucoff MW.

2015-05-206 citations

10.1016/j.ijcard.2015.05.106

Infarct size and left ventricular function in the PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-segment Elevation (PREPARE) trial: ancillary cardiovascular magnetic resonance study.

Haeck JD, Kuijt WJ, Koch KT, Bilodeau L, Henriques JP, Rohling WJ, Baan J, Vis MM, Nijveldt R, van Geloven N, Groenink M, Piek JJ, Tijssen JG, Krucoff MW, De Winter RJ.

2009-10-2615 citations

10.1136/hrt.2009.180448

Randomized comparison of primary percutaneous coronary intervention with combined proximal embolic protection and thrombus aspiration versus primary percutaneous coronary intervention alone in ST-segment elevation myocardial infarction: the PREPARE (PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-Elevation) study.

Haeck JD, Koch KT, Bilodeau L, Van der Schaaf RJ, Henriques JP, Vis MM, Baan J, Van der Wal AC, Piek JJ, Tijssen JG, Krucoff MW, De Winter RJ.

2009-10-0136 citations

10.1016/j.jcin.2009.07.013

Interventions

Patients with symptoms of acute MI within the previous six hours, persistent ST-elevation and a coronary anatomy suitable for PROXIS™ are randomly assigned to combined embolic protection and thrombect

Eligibility

Inclusion criteria

Inclusion criteria: Consecutive patients with an acute ST-segment elevation MI undergoing primary PCI: 1. Primary PCI within six hours after onset of symptoms of myocardial infarction 2. Electrocardiographic evidence of persistent ST-segment elevation of at least 0.1 mV in two or more contiguous leads at the time of randomisation 3. Proximal obstruction of infarct related coronary artery with TIMI zero to two flow with minimal diameter of 2.5 mm or more 4. The obstruction is amenable to the use of the PROXIS™ as judged by an experienced operator

Exclusion criteria

Exclusion criteria: 1. Younger than 18 years of age 2. Use of a thrombolytic agent within the previous 48 hours 3. Prior coronary artery bypass graft (CABG) 4. Contraindications to the use of a glycoprotein (GP) IIb/IIIa inhibitor 5. Co-existent condition associated with a limited life expectancy

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is a more than 70% resolution of ST-segment elevation at one hour after PCI, compared to ST-segment elevation immediately prior to PCI.	—

Secondary

Measure	Time frame
The secondary endpoints are: 1. ECG: the time course of the percentage of ST-segment elevation resolution (as a quantitative parameter) 2. Angiographic: the incidence of angiographic evidence distal embolisation based on TIMI-graded coronary flow, myocardial blush grade and distal branch occlusion 3. Laboratory: the myocardial infarct-size as assessed by serial CK-MB mass, troponin-T, a-HBDH, and NT proBNP, according to standard clinical practice 4. MRI: the difference of infarct size measured by left ventricular ejection fraction (LVEF) and by contrast enhanced MRI-infarct size between six and nine months after PCI, between patients treated by standard PCI and patients treated by PCI combined embolic protection and thrombectomy using the PROXIS™ 5. Clinical: the incidence of death, MI or rehospitalisation for non-ST-segment elevation acute coronary syndrome (nSTE-ACS), repeat PCI of the infarct related artery, CABG and stroke at one, six and 12 months. ECG-evaluation for ST-elevation resolution is performed blinded to the randomisation. The TIMI flow rate, the myocardial blush grade and the presence of distal embolisation is assessed on the final angiograms, made immediately following the primary coronary angioplasty, by two experienced investigators who are blinded to all other data.	—

Measure

Time frame

The secondary endpoints are: 1. ECG: the time course of the percentage of ST-segment elevation resolution (as a quantitative parameter) 2. Angiographic: the incidence of angiographic evidence distal embolisation based on TIMI-graded coronary flow, myocardial blush grade and distal branch occlusion 3. Laboratory: the myocardial infarct-size as assessed by serial CK-MB mass, troponin-T, a-HBDH, and NT proBNP, according to standard clinical practice 4. MRI: the difference of infarct size measured by left ventricular ejection fraction (LVEF) and by contrast enhanced MRI-infarct size between six and nine months after PCI, between patients treated by standard PCI and patients treated by PCI combined embolic protection and thrombectomy using the PROXIS™ 5. Clinical: the incidence of death, MI or rehospitalisation for non-ST-segment elevation acute coronary syndrome (nSTE-ACS), repeat PCI of the infarct related artery, CABG and stroke at one, six and 12 months. ECG-evaluation for ST-elevation resolution is performed blinded to the randomisation. The TIMI flow rate, the myocardial blush grade and the presence of distal embolisation is assessed on the final angiograms, made immediately following the primary coronary angioplasty, by two experienced investigators who are blinded to all other data.

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Countries

Canada, Netherlands

Outcome results

None listed