Cath Lab Digest - October 2007 - (Page 24)

24 CLINICAL UPDATE OCTOBER 2007 Carotid Stenting: An update Cath Lab Digest talks with Rajesh M. Dave, MD, FACC, FSCAI, Chairman, Endovascular Medicine, Pinnacle Health Heart and Vascular Institute Harrisburg Hospital, Harrisburg, Pennsylvania about his thoughts on the challenges and research behind this procedure. I believe CAS is at least equivalent to the 54-year-old “gold standard” practice of CEA, based on published results of multiple CAS versus CEA clinical trials, and industry-sponsored registries and post market surveillance studies. EXACT, CAPTURE 2) will eventually establish the safety and efficacy of CAS relative to the CEA in patients with symptomatic or asymptomatic carotid artery disease. These trials will take considerable time and financial resources to complete; however, the results, in my opinion, will support the use of CAS as a safe and durable alternative to CEA. Patient demographics and clinical history, proximal and distal arterial anatomy, lesion characteristics, and physician CAS or CEA volume and experience, combined with appropriate pre-, peri-, and postprocedural management are common denominators for the shortand long-term success of either procedure. Results of the EVA 3S trial published late last year in the New England Journal of Medicine 1 unfortunately added controversy to the CAS versus CEA debate. The study was conducted in France over a five-year period and was sponsored by the National Ministry of Health. Careful review and analysis of the study design, results and published conclusions generated consensus by all experienced CAS physicians that the study results were extremely flawed. EVA-S3 study investigator experience with CAS was significantly less than their experience with CEA; in fact, physicians having no CAS experience performed procedures under the supervision of a physician proctor. The requirement for nonsupervised CAS was 5–12 lifetime CAS procedures with or without the use of an embolic protection device. Five different stent systems and seven different embolic protection systems were represented in the catalog of CAS devices and embolic protection was not included in the study until 2.25 years after study enrollment began. Five percent of the CAS procedures required crossover to CEA, with two strokes occurring within this population assigned to the CAS data set — this scenario did not occur in SAPPHIRE or any of the CAS registries. Predilation, routinely performed in the U.S. in preparation for stent deployment, was performed in only 20% of the EVA-S3 CAS procedures. Conversely, surgeons were required to have performed at least 25 CEA procedures within the past year. At the start of the trial, symptomatic patients with a > 70% carotid stenosis were screened for enrollment and randomization to either CEA or CAS. Three years into the trial, the stenosis requirement for enrollment was reduced to 60% because pooled data from other CEA trials indicated that CEA was beneficial to patients with stenosis > 50%. The primary study endpoint was stroke or death within 30 days; myocardial infarction (MI) was excluded. Five hundred twentyseven patients were enrolled from the start of the study in November 2000 to the time the study was halted in September 2005 “for reasons of both safety and futility.”1 Taking into account the number of participating centers (30), the mid-trial modification of enrollment criteria, delayed introduction of protection devices, and the duration of the study (5 years), the “futility” of the study was most likely related to slow patient recruitment (average enrollment of 3–4 cases/year/site). One final significant observation related to EVA 3S is that CAS has never been recognized by the French Ministry of Health as an acceptable treatment for carotid artery disease. The existence of this trial, similar to the current situation in the U.S., allowed physicians to perform CAS under the auspices of a governmentsanctioned clinical trial. I believe the What are the latest developments in carotid stenting trials and research? In July of this year, Kensey Nash Corporation announced a Board of Directors decision to cease all activities involving the marketing and regulatory approval process of the flow occlusion and aspiration TriActiv® System platforms. The system had received CE Mark approval in Europe for use as an embolic protection device (EPD) during coronary saphenous vein bypass graft (SVG) and carotid artery stenting (CAS) procedures and in the United States for SVG percutaneous coronary intervention (PCI). A Phase I clinical trial using the next generation device, TriActiv ProGuard™ for CAS, had been completed and enrollment was underway for a pivotal Phase II study for the same indication. Results of the pilot study were excellent, with a reported 30day minor/major stroke and death adverse event rate of 8%. At issue for Kensey Nash was the recent CMS decision to limit reimbursement coverage for carotid artery stenting in the United States and the dominance of filter-based EPDs for CAS. The anticipated cost of commercializing the TriActiv ProGuard in the U.S. carotid market and uncertainty as to when (or if) CAS would become an accepted alternative to carotid endarterectomy (CEA) for patients with asymptomatic carotid disease contributed to this cost-related corporate decision. I was disappointed to learn of this decision; the TriActiv System was very successful during CAS. I believe the ProGuard device would have provided excellent alternative protection during CAS, especially in patients with tortuous anatomy distal to a proximal lesion in the internal carotid artery (ICA) or in symptomatic patients with high grade ICA stenosis that might require predilation to allow a larger profile filter-based EPD to be deployed distally. I hope this decision is not repeated by other companies working on next-generation protection devices, especially the proximal flow-reversal systems, and low-profile filter systems currently under development and testing in Europe as well as the U.S. Several recent brief articles in practice tabloids highlighted misleading data to suggest inappropriate conclusions regarding the overall superiority of carotid endarterectomy (CEA) over CAS for the treatment of extracranial carotid artery disease. CAS, complimented with a distal or proximal embolic protection device, has been demonstrated through properly designed and wellmanaged evidence-based clinical investigations to be at least equivalent to CEA in terms of safety and efficacy. Ongoing CAS clinical trials (http://www.clinicaltrials.gov/ct) funded through the National Institutes of Health (CREST) and industry (ACT I, CHOICE, PROTECT, SAPPHIRE Worldwide, http://www.clinicaltrials.gov/ct

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

Saints Medical Center Fibromuscular Dysplasia in Children and Adolescents Cerebral Vascular Accident Following a Pulmonary Embolism: Search for the Hidden Patent Foramen Ovale Contents Clinical Editor’s Corner Meetings Calendar CEU Education Center Radiation Tracking in the Cardiac Catheterization Lab Letter to the Editor Carotid Stenting: An update Release from Stent-jail: Beneficial Snow-Plowing? Patient Management Guidelines Searching for a Cardiovascular Position? Tips for Creating a ‘Stand-Out’ Resume Long-Term Implications of Short-Term Closure Decisions – The Evolution to Vascular Access Management and the Boomerang Catalyst System The Ten-Minute Interview with… Angie Bowles, RN, CCRN CMS Issues Final FY 2008 IPPS Rule ACVP• Membership Page Experience with a New Workhorse Guidewire Ask the Clinical Instructor: Q&A for Those New to Cath Lab A Glimpse of the Future of Clinical Education: Boston Scientific’s SimSuite Bus Visits Carnegie Institute 2007 Educational Fair Held at the Washington Hospital Center Research Update: Original Contribution Abstracts from The Journal of Invasive Cardiology What Do You Think? A Virtual Cath Lab Viewer (VCL): The Development of an Online 3D C-arm Simulator and Coronary Anatomy Viewer Clinical & Industry News Cost-Effectiveness of the Radial versus Femoral Artery Approach to Diagnostic Cardiac Catheterization

Cath Lab Digest - October 2007

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