Thrombus Aspiration during Percutaneous coronary intervention in Acute XXXX Study (TAPAS)--study design.

@entity1 @entity296 @entity2948 @entity1188 @entity432 @entity583 @entity715
BACKGROUND AND OBJECTIVE: Embolization of atherothrombotic material is common during percutaneous coronary intervention (PCI) in acute @entity583 ( @entity583 ). This may lead to @entity432 resulting in @entity296 , 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 @entity715 material before stent implantation of the infarct-related coronary artery results in improved myocardial perfusion compared with conventional primary PCI. STUDY DESIGN: TAPAS is a single-center, prospective, randomized trial with a planned inclusion of 1080 @entity1 with @entity583 . @entity1 are assigned to treatment with @entity715 aspiration with the 6F Export Aspiration Catheter (Medtronic Corporation, Santa Rosa, @entity2948 ) or to balloon angioplasty before stent implantation in the @entity1188 . All @entity1 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. IMPLICATIONS: If @entity715 aspiration significantly improves myocardial perfusion, it will lend support to the use of this treatment as part of the standard approach in @entity1 with @entity583 .
