Cath Lab Digest - September 2007 - (Page 8)

8 ON THE HORIZON SEPTEMBER 2007 continued from page 1 The Genous Bio-engineered R Stent endothelialization and there was chronic inflammation, both as a reaction to the drug and as a reaction to the polymer that was coating the stent. If you look at the healing response to a BMS, there is an inflammatory reaction, but it is temporary. Endothelialization is complete after a few months and the inflammatory cells disappear after some time. If you look at the animal data from the Genous stent studies, you can see that endothelialization after Genous stent implantation is enhanced, so the process is much quicker. Even after 48 hours in the pig coronary artery, the endothelialization is rapidly occurring both on the stent struts and in the areas between the struts. The inflammatory reaction is also there, but it is not as serious as the inflammatory reaction after drug-eluting stent implantation. This concept of vessel treated with a Genous stent. Of course, one of the requirements is for the patients to enroll them in eHEALING is that they were on statin treatment prior to Genous stent implantation. The primary endpoint in e-HEALING is a clinical outcome of 6 to12 months. We showed preliminary clinical results from the e-HEALING Registry during the EuroPCR symposium in Barcelona this past May, and we now have a cohort of over 2000 patients with a 30-day outcome and a cohort of over a 1000 patients with a 6-month outcome. Both of these outcome data, 30-day and 6month, look quite good, with MACE rates comparable to the Cypher and Taxus registries and a low stent thrombosis. We are now enrolling a little over 200 patients a month in the e-HEALING Registry, and I About the Genous Stent Genous is a “bioengineered” stent. What does that mean? The definition of bio-engineering: The application of engineering principles to the fields of biology and medicine, as in the development of aids or replacements for defective or missing body organs, also called biomedical engineering. What are endothelial progenitor cells (EPCs) and how are they utilized by the Genous stent? In the case of Genous, we are capturing endothelial progenitor cells on the surface of the stent, which are cells that originate from the bone marrow and are precursors to endothelial cells, to quickly re-establish a healthy endothelium in a diseased segment of a coronary artery. Endothelium is the largest organ of the human body and is essential to vascular health. What has the HEALING clinical trial program shown thus far? The HEALING clinical trial series has shown that Genous appears to be as effective as drug-eluting stents (DES) but have a much broader safety profile. Patients that receive a DES are often prescribed lifetime dual anti-platelet therapy because of the dangers of late thrombosis associated with DES, whereas patients treated with Genous only have to take dual antiplatelet therapy for one month. What can you tell us about the R stent platform? The design of the coronary R stent is unique. Its patented dual helix configuration provides omni-directional flexibility (and conformability to the coronary anatomy) and extremely high radial strength. Each individual cell of the R stent can be expanded up to 4.5mm in diameter to enable excellent side branch access for bifurcation stenting. How is the stent stored in the lab? What is its shelf life? The Genous stent has a 24-month shelf life and is stored at room temperature. The shelf life is twice as long compared to DES, as the antibody coating is very stable. This concept of vessel healing and enhanced endothelialization is likely to translate into a lower incidence of restenosis and a lower risk of stent thrombosis after placement of a Genous stent in patients. healing and enhanced endothelialization is likely to translate into a lower incidence of restenosis and a lower risk of stent thrombosis after placement of a Genous stent in patients. Clinical experience from the First-InMan and the HEALING-II study, of which the principal investigator was Prof. Patrick Serruys, provided the first indication of clinical effectiveness and safety. e-HEALING is a multi-center, worldwide prospective registry of patients treated with the Genous Bio-engineered R stent. What has this registry shown so far? CE mark was obtained and the Genous stent was marketed in Europe and Asia Pacific. At that time, it was then possible to start a registry. The aim of the e-HEALING Registry is to enroll 5,000 patients think at this time, 3800 patients are enrolled. We expect to finish enrollment before the end of 2007. Is there a particular patient subset that would benefit most from the Genous stent? That’s a very important question. One reason we required two weeks of statin therapy is because it is likely to increase the number of endothelial progenitor cells and also increase their functionality. Therefore, we expect patients who are on statin treatment will benefit from Genous stent implantation. It was agreed from the beginning, however, that if patients are added into the registry but have not been on statin therapy for 2 weeks, we will still look at these patients. So we will have a subset of patients that have been on statin therapy for a shorter period of time than the required two weeks. It will be very interesting to look at these patients and see if two weeks or maybe one week of statin therapy will be sufficient. In addition to statin therapy starting two weeks prior to stent placement, what type of pharmacological regimen is required? There is no requirement for any accompanying drug treatment at the time of stent implantation. After Genous stent implantation, the recommendation is for 4 weeks of dual

Table of Contents Feed for the Digital Edition of Cath Lab Digest - September 2007

St. Dominic Hospital The Genous Bio-engineered R Stent Percutaneous Treatment of Peripheral Arterial Chronic Total Occlusions: Device Options and Clinical Outcomes Contents Clinical Editor’s Corner Percutaneous Revascularization of Peripheral Chronic Total Occlusion — Which Patients, Why, and How? Myocardial Infarction and Syncope: A Manifestation of the “Raynaud-Prinzmetal Syndrome”? Essential Technical Components of the Transradial Approach If You Build It, Will They Come? Evidence-Based Medicine with Drug-Eluting Stents Back to School: The Value of Education in Cardiovascular Services The ACVP Standards and Competencies: Are You Using Them Effectively? What Do You Think? My Experience with Fibromuscular Dysplasia and Stroke A Brief Review of Fibromuscular Dysplasia Letter to the Editor A Look at On-the-Job Training: Perceptions, Reality and Our Profession Doing the Wave: Inventory Management with RFID The Ten-Minute Interview with… Paul Pinsker, RCIS CLD’s Annual Salary Survey Harrisburg Area Community College Volunteer Survey CEU Education Center SICP* Section Ask the Clinical Instructor: A Q&A Column for Those New to the Cath Lab Clinical & Industry News

Cath Lab Digest - September 2007

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