Thrombus Aspiration during Percutaneous coronary intervention in Acute non-ST-elevation myocardial infarction Study (TAPAS II)-Study design.

Background and Objective. The Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) has shown that thrombus aspiration improves myocardial perfusion and clinical outcome compared with conventional primary percutaneous coronary intervention (PCI) in patients with ST-segment-elevation myocardial infarction. Impaired myocardial perfusion due to spontaneous or angioplasty-induced embolisation of atherothrombotic material also occurs in patients with non-ST-elevation myocardial infarction (NSTEMI). The aim of this study is to determine whether thrombus aspiration before stent implantation will result in improved myocardial perfusion in patients with NSTEMI compared with conventional PCI.Study design. The study is a single-centre, prospective, randomised trial with blinded evaluation of endpoints. The planned inclusion is 540 patients with acute NSTEMI who are candidates for urgent PCI. Patients are randomised to treatment with manual thrombus aspiration or to conventional PCI. The primary endpoint is the incidence of myocardial blush grade 3 after PCI. Secondary endpoints are coronary angiographic, histopathological, enzymatic, electrocardiographic and clinical outcomes including major adverse events at 30 days and one year.Implications. If thrombus aspiration leads to significant improvement of myocardial perfusion in patients with acute NSTEMI it may become part of the standard interventional approach. (Neth Heart J 2009;17:409-13.).

RCT Entities:   Population Interventions Outcomes