March 30, 2008 - Using the Export Aspiration Catheter from Medtronic, before stenting, in patients suffering acute myocardial infarction (AMI) can significantly improve blood flow and survival rates compared to conventional treatment with percutaneous coronary intervention (PCI) alone, according to results of a Dutch study presented today at the American College of Cardiology meeting.
Presented by Professor Felix Zijlstra of the University Medical Center Groningen in the Netherlands during a special late-breaking clinical trial session, the study, dubbed TAPAS, found that most AMI patients with ST-segment elevation achieved better reperfusion and clinical outcomes when receiving thrombus aspiration before standard PCI, regardless of their clinical and angiographic characteristics at baseline. It was supported by a grant from Medtronic for angiographic analyses by the core laboratory; all other costs were covered by the Thorax Center of the University Medical Center Groningen.
"We are on the brink of a new development," Dr. Zijlstra said in an interview about the study when it was published in The New England Journal of Medicine, Feb. 7, 2008. "Instead of fragmenting clot material with a balloon and potentially sending it downstream, where it could cause further damage to the heart muscle, it makes sense to get rid of the debris to start with."
Dr. Zijlstra's presentation "Thrombus Aspiration during Coronary Angioplasty for Acute Myocardial Infarction? (2404-5) " summarized the design and findings of the study. Researchers at his center randomly assigned 1,071 AMI patients with ST-segment elevation to thrombus aspiration using the Export Aspiration Catheter or to conventional PCI prior to coronary angiography. The Export group had 35 percent fewer patients than the conventional PCI group exhibiting angiographic signs of poor blood flow to the heart muscle. In addition, 28 percent more patients in the Export group had resolution of ST-segment elevation compared to the conventional PCI group. Importantly, the study showed a reduction in death and major adverse cardiac events in patients that exhibited angiographic signs of improved blood flow to the heart muscle and resolution of ST-segment elevation. There also was a positive trend in favor of the Export Aspiration Catheter in reducing death.
Results from TAPAS 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. Reported at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in October 2007, the EXPORT study demonstrated that primary aspiration with the Export Aspiration Catheter followed by stenting improved myocardial reperfusion in AMI patients.
For more information: www.medtronic.com