Cath Lab Digest - December 2007 - (Page 18) 18 SPOTLIGHT DECEMBER 2007 continued from previous page Dr. Khanna and Dixie Sargent, CVT, RCIS, doing a peripheral case. Figure 1. ASAN data presented by SJ Park, TCT 2007. GHOST data presented by Harjai, TCT 2007. MIDAS data presented by Vagonescu, TCT 2007. NY State data presented by Hannan, TCT 2007. Ontario data presented by Ko, TCT 2007. STENT data presented by Brodie, TCT 2007. Western Denmark data presented by Jensen, TCT 2007. Q You make a good point. Double-blind randomized trials have shown that on-label use of DES does not increase overall death and MI rates. What is the important take-away for interventional cardiologists based on these data? There are three important take-away messages. First, DES clearly lower rates of restenosis by a factor of 50 to 70 percent. Interventionalists must keep these numbers in mind when reviewing the utilization of these stents. Second, when you look at the death or MI endpoints, there is no difference between DES and BMS. There has been some suggestion that there might be an increase in both of these endpoints with DES. However, there is no signal that this is true, based on thousands of patients in clinical trials. Third, very-late stent thrombosis does occur at a slightly increased frequency with DES compared to BMS, but rates of this event with DES are beginning to plateau in the most recent data from the two earliest of the blinded, randomized trials, TAXUS IV and SIRIUS. Rates of very-late stent thrombosis are less the second year compared to the first, and there has been as yet no additional very-late stent thrombosis beyond four years. As you know, TCT 2007 featured updates on some of the registry studies that have been at the center of the stent thrombosis debate over the past year, including SCAAR. The four-year SCAAR data presented at TCT pointed to higher adverse-event rates in off-label vs. on-label DES use, but no overall increase in death or MI in DES compared to BMS-treated patients. What can be concluded from this data about stent thrombosis? The Swedish Coronary Angiography and Angioplasty Registry (SCAAR) points out the potential pitfalls of analyzing endpoints of relatively low frequency, particularly mortality and stent thrombosis. The four-year presentation at TCT suggests that rates have pretty much equalized between BMS and DES, and a signal is no longer seen. Again, people should realize that there is going to be some biological variation in this particular endpoint, particularly when it is occurring at a low frequency. To be accurate, it takes a patient population followed for an extended period of time. Is there anything else that these trials are telling us? DES have taught us many lessons, one of which is that the traditional sixmonth or one-year cut-off that we are used to following for stent registries and trials is no longer adequate. The most recent data from ARRIVE — which now includes almost 7,500 cases — shows that events are still occurring between years one and two. The slope of those events is considerably continued on next page Steve Jones, RT, Dr. Hackshaw, cardiologist, Maureen Lochridge, RT. A Q We use several different products and devices, including devices from FoxHollow Technology (Redwood City, CA) devices, AngioScore (Fremont, CA) balloons, the recently FDA-approved Orbital Arthrectomy System (Cardiovascular Systems, Inc., St. Paul, MN) and stenting. To achieve an optimal result, a patient site access is geared to the lesion location and degree of difficulty. Site access may be traditional and/or antegrade. Our interventional cardiologists are innovative and progressive in their treatment of peripheral vascular disease (PVD). Does your cath lab perform primary angioplasty with surgical backup? Primary angioplasty is performed without scheduled surgical backup. We do have open-heart surgical services available for the rare emergent surgical intervention. What procedures do you perform on an outpatient basis? Outpatient procedures include all diagnostics for cardiac and peripheral. A patient who has a diagnostic procedure that evolves to an intervention is admitted as an inpatient for overnight observation. There are Frank Zazueta, Ancillary Support A some exceptions. A small population of patients will be same-day discharged post recovery from interventional procedures. What percentage of your patients is female? Available data is for percutaneous coronary intervention (PCI) patients only. We track interventional coronary data for the American College of Cardiology National Cardiovascular Registry (ACC-NCDR™). Diagnostic Q A
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