Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS)--study design.
OBJECTIVE
Embolization of atherothrombotic material is common during percutaneous coronary intervention (PCI) in acute myocardial infarction (MI). This may lead to distal vessel occlusion resulting in impaired myocardial perfusion, which is associated with larger infarct size and increased mortality. Adjunctive devices for PCI to protect the microcirculation have been developed. We intend to determine whether aspiration of thrombotic material before stent implantation of the infarct-related coronary artery results in improved myocardial perfusion compared with conventional primary PCI.


METHODS
TAPAS is a single-center, prospective, randomized trial with a planned inclusion of 1080 patients with ST-elevation MI. Patients are assigned to treatment with thrombus aspiration with the 6F Export Aspiration Catheter (Medtronic Corporation, Santa Rosa, Calif) or to balloon angioplasty before stent implantation in the infarct-related artery. All patients will be treated medically according to current international guidelines including glycoprotein IIb/IIIa inhibitors before PCI. Randomization will be performed before coronary angiography. The primary end point is angiographic myocardial blush grade of <2. Secondary end points are enzymatic infarct size, ST-segment elevation resolution and persistent ST-segment elevation, postprocedural distal embolization, and Major Adverse Cardiac Events at 30 days and 1 year.


CONCLUSIONS
If thrombus aspiration significantly improves myocardial perfusion, it will lend support to the use of this treatment as part of the standard approach in patients with acute MI.
Svilaas
Tone
T
Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands. t.svilaas@thorax.umcg.nl
van der Horst
Iwan C C
IC
Zijlstra
Felix
F
D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D003328:Coronary Thrombosis / Q000150:complications / Q000517:prevention & control / Q000628:therapy*; D004562:Electrocardiography; D006801:Humans; D008833:Microcirculation; D009203:Myocardial Infarction / Q000628:therapy*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D011446:Prospective Studies; D019736:Prostheses and Implants; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D015607:Stents; D013396:Suction
D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex