Thrombus Aspiration Benefits NSTEMI Patients in TAPAS-II

March 28, 2009—Medtronic, Inc. (Minneapolis, MN) announced that findings from TAPAS-II suggest that thrombus aspiration with the company's Export aspiration catheter is feasible and safe and has potential benefits for most patients with non-ST-segment-elevation myocardial infarction (NSTEMI). The study concluded that "thrombus aspiration in most NSTEMI patients is feasible and safe, is associated with a high rate of retrieval of thrombotic material, and results in excellent clinical outcomes." Pieter J. Vlaar, MD, presented the abstract on TAPAS-II, "1-Year Follow-up of Thrombus Aspiration during Primary Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study."

TAPAS-II studied 70 patients undergoing percutaneous coronary intervention (PCI) for NSTEMI. All patients were prospectively enrolled in the study and received thrombus aspiration with the Export aspiration catheter. Aspiration was effective at removing thrombus in 83% of the patients. The successful reduction in thrombotic load was also associated with a marked improvement in coronary flow, the researchers reported.

According to the company, results from TAPAS and TAPAS-II are consistent with those from Medtronic's EXPORT study, a randomized controlled trial of 250 patients at 24 sites in Europe and India comparing the use of the Export aspiration catheter with conventional PCI. As reported in October 2007, the EXPORT study demonstrated that primary aspiration with the Export aspiration catheter followed by stenting improved myocardial reperfusion in acute myocardial infarction patients. The TAPAS results were originally published in February 2008 in The New England Journal of Medicine (2008;358:557-567). They were subsequently presented at the 2008 ACC meeting as a late breaking clinical trial and at the EuroPCR meeting in May 2008. As a result of this and other research, thrombus aspiration is now included in the European Society of Cardiology's international guidelines on STEMI, recommending it as a Class IIb Level B treatment to prevent "no reflow in STEMI," the company stated.

Medtronic noted that the original TAPAS trial suggests that STEMI patients who received thrombus aspiration prior to stenting had significantly improved blood flow and survival rates compared to those who received conventional treatment with stents alone. Both studies, TAPAS and TAPAS-II, were conducted at University Medical Center Groningen in the Netherlands. TAPAS and TAPAS-II are single-center studies that are suggestive of excellent patient outcomes with thrombus aspiration. Further clinical data are now necessary to confirm the potential of the Export system in a wider acute myocardial infarction patient population.