Removing thrombus from coronary arteries with the Export Aspiration Catheter from Medtronic, Inc., before implanting a stent in patients suffering a specific kind of heart attack, “results in excellent clinical outcomes,” at one year, according to new data released today at the American College of Cardiology (ACC) meeting.
Findings from TAPAS-II suggest that thrombus aspiration is feasible and safe and has potential benefits for most patients with non-ST-segment-elevation myocardial infarction (NSTEMI) – heart attacks not distinguished by particular electrocardiogram (ECG) features. For treatment purposes, heart attacks are categorized as ST-segment-elevation myocardial infarction (STEMI) or NSTEMI.
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 which 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 AMI patient population.
Presented by Dr. Pieter J. Vlaar, the abstract on TAPAS-II – “One Year Follow-up of Thrombus Aspiration during Primary Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study” (i.2 poster 2514-721) – concludes 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.”
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 percent of the patients. The successful reduction in thrombotic load was also associated with a marked improvement in coronary flow, the researchers reported.
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 (AMI) patients.
Results from TAPAS were originally published last year in The New England Journal of Medicine (Feb. 7, 2008). 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.”
Since its introduction in 2001, the Export Aspiration Catheter product line has been used to remove embolic debris in more than 250,000 patients worldwide. Medtronic’s latest generation technology, the Export AP Aspiration Catheter, was cleared by the FDA in June 2008.
The Export AP Aspiration Catheter was designed for improved deliverability. The full-wall variable braiding enables a seamless transition of shaft stiffness from one end of the catheter to the other. The device also features a soft tip material with a short, beveled design for minimal vessel trauma and improved debris capture, plus a hydrophilic coating for greater lubricity.