Iliac and Femoral Stent Trials are a Waste

Iliac and Femoral Stent Trials are a Waste of Time and Taxpayer Money Con: The Answer is You Don’t Know David H. Deaton, MD Chief, Endovascular Surgery Georgetown University Hospital

DISCLOSURES David H. Deaton, MD Consulting Fees – Aptus Endosystems, Inc. , ROX Medical Honoraria – m 2 s, Inc. Grants/Contracted Research – Boston Scientific Corporation, Terumo Medical Corporation I intend to reference unlabeled/ unapproved uses of drugs or devices in my presentation. I intend to reference the published data from FDA sanctioned trials of devices that have not been approved yet. I will describe these devices and how they are physically different from current devices.

Pre Test Are bile ducts different than blood vessels? A) no, they’re both tubes B) no, they both accept a guidewire and a balloon C) no, they both carry liquids D) A, B, and C are correct E) Yes Georgetown University Hospital

They’re all the same: Boats Georgetown University Hospital

Are different vascular beds really all that different? YES Carotid – high flow, focal disease, sensitive end organ Iliac – Intracavitary, often calcified, short Femoral – Extracavitary, enveloped by muscle / fascia, long Tibial – Extracavitary, small vessels, diffuse disease Georgetown University Hospital

Do we need to test devices in different environments? Journal of Vascular Surgery, Volume 48, Issue 2, Pages 435 -440, August 2008 Georgetown University Hospital

The SFA Environment 0° flexion 90° flexion

The SFA Environment Georgetown University Hospital

Can small changes make big differences in outcome? YOU BETCHA! The de. Havilland Comet 1 Window. Shape Georgetown University Hospital

Stent Patterns SENTINOL ABSOLUTE PRO ABSOLUTE XCEED LIFESTENT FLEXSTAR XL PROTEGE EVERFLEX E·LUMINEXX SMART CONTROL Georgetown University Hospital

Clinical Rates of Stent Fracture in the SFA Duda SH, et al. Circ. 2002; 106: 1505 -1509. Schillinger M, et al. New Engl. J. Med. 2006; 354: 1879 -1888. Schlager O, et al. J. Endovasc. Ther. 2005; 12: 676 -684. Krankenberg H, et al. Circ. 2007; 116: 285 -292. Katzen BT. Transcatheter Cardiovascular Therapeutics, Washington, 2007. Scheinert D. Leipzig Interventional Course, Leipzig, 2008. Ferreira M, et al. Eur. J. Vasc. Endovasc. Surg. 2007; 34: 702 -708. Schroë H, et al. CIRSE, 2006; Duda S. Leipzig Interventional Course. Leipzig, Germany, 2009.

S. M. A. R. T. Stent Fracture in SIROCCO Lansky AJ. Angiographic analysis of strut fractures in the SIROCCO trial and relationship to adverse clinical events. Transcatheter Cardiovascular Therapeutics, Washington, D. C. , 2004.

Instent Restenosis Georgetown University Hospital

The Devil is in the details…. . Modern Stent Manufacturing Raw Tubing Laser Cut Stent Descaled Stent Finished Stent START Laser Cutting Descaling Electropolishing Georgetown University Hospital

Caveats Trials for indication should be limited to applications that are clinically and physiologically different Trials should be limited to applications that are likely to see significant clinical usage Georgetown University Hospital

Considerations Clinical need Unmet clinical need, or…. Yet another stent without demonstrated additional benefit Do trials inhibit clinical practice… No, but unregulated use with bad long-term outcomes will threaten all endovascular Who’s being regulated ? Industry not Physicians Georgetown University Hospital

despair. com Georgetown University Hospital

Thank you Georgetown University Hospital