Cath Lab Digest - February 2008 - (Page 10)

10 CLINICAL TRIAL UPDATE FEBRUARY 2008 follow up had a greater difference in target lesion revascularization between Endeavor and Taxus stents, than in the 80% of patients with only clinical follow up. In the clinical follow-up cohort, the 12-month target lesion revascularization rates were 3.6% for Endeavor stents versus 3.3% with Taxus stents, obviously no difference. Our group and others have shown that there is not a linear relationship between late loss and the probability of target lesion revascularization. This means that at late loss levels below or around 0.6 millimeters, we still see slowly rising target lesion revascularization rates in the mid-single digits, whereas when late loss climbs to 0.8 or 1.0 millimeters, usually observed with bare-metal stents, target lesion revascularization increases at a steeper slope, to several-fold higher values. If during all angiographic follow up in clinical trials we used a pressure wire (physiologic measurement to determine whether a lesion actually requires treatment), what effect might that have? That’s a great question. If you used a pressure wire and required that only lesions with documented physiologic obstruction be revascularized, the results would be much closer to the natural clinical state, where revascularization procedures are dictated by clinical symptoms or evidence of inducible ischemia on stress tests. In fact, in one of our earlier trial designs we proposed that an abnormal pressure wire response should be a requirement for repeat revascularization, but we couldn’t get most of the operators to apply the technique consistently. Why do you think that is? Well, it’s not a standard technique, it involves using a different guidewire, and the methodology, although fairly simple, is generally not used routinely in the U.S. You are right, however; if we had physiologic assessments of stenosis severity as opposed to only visual estimates of stenoses from the angiogram, I think the clinical trials would more accurately reflect the “real world” clinical scenario, wherein recurrent symptoms or documented ischemia tend to drive revascularization decisions. We don’t know if the increased late loss seen in angiographic follow up is due to “healthy re-endothelialization”? People like to use that term; I’m not sure what it means, but certainly there is more homogenous and more equally distributed neo-intima seen on intravascular ultrasound imaging over an Endeavor stent than with other drug-eluting stents. Also, animal studies have demonstrated rates of early re-endothelialization with Endeavor which are more similar to bare-metal stents and further animal studies indicate that this new endothelium has normal functional attributes. We think this probably contributes to the observation in patients that Endeavor stents are similar in safety profile to baremetal stents. What’s unique about the ENDEAVOR trial series? The ENDEAVOR series of clinical trials is very comprehensive. The suite of studies which were discussed with the FDA included ongoing trials and post-market surveillance trials totaling more than 25,000 patients. There has never been a drug-eluting stent subjected to this degree of clinical trial scrutiny in the immediate pre- and post-approval time-frame. We presented data from a blinded, randomized trial with Endeavor versus a bare-metal stent which showed similar efficacy to SIRIUS and TAXUS IV. We also presented two additional randomized studies which compared Endeavor to both commercially approved drug-eluting stents, Cypher and Taxus, including ENDEAVOR IV. This high density of data allowed us to pool studies with common definitions and perform appropriate statistical analyses to assess long-term safety of the Endeavor stent. We had 1,287 patients with long-term follow up at TLR: target lesion revascularization

Table of Contents Feed for the Digital Edition of Cath Lab Digest - February 2008

Cath Lab Digest - February 2008 Bay Regional Medical Center ENDEAVOR IV: A Zotarolimus-Eluting Stent Versus a Paclitaxel-Eluting Stent in a Randomized Clinical Trial A 3D CT Vessel “Roadmap” Over Live Fluoroscopy for Chronic Total Occlusions Contents Clinical Editor’s Corner An Evaluation of Cath Lab Turnaround Time Commentary: An Evaluation of Cath Lab Turnaround Time Excerpts from Chapter 19. STEMI Interventions – Future Perspectives The Potential Clinical Utility of Intravascular Ultrasound Guidance in Patients Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents The Ten-Minute Interview with…Debbie Charlton, RN The Society of Invasive Cardiovascular Professionals (SICP) at Transcatheter Cardiovascular Therapeutics (TCT) 2007 The Cath Lab is a Business: Do You Have the Knowledge to Stay Afloat? Incidence and Predictors of Vascular Complications after Invasive Coronary Procedures: A Prospective Analysis Ask the Clinical Instructor: A Q&A Column for those New to the Cath Lab Volunteer Survey SICP* Section Meetings Calendar What Do You Think? CEU Education Center Clinical & Industry News Classifieds Advertisers Index

Cath Lab Digest - February 2008

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