DISCLOSURES Lawrence A Garcia MD Consulting Fees ev

DISCLOSURES Lawrence A. Garcia, MD Consulting Fees – ev 3, Inc. , Spectranetics, Pathway Medical Technologies, Inc. , Boston Scientific Corporation Ownership Interest (Stocks, Stock Options or Other Ownership Interest) – Scion Cardio-Vascular, Arsenal Medical, Tissue. Gen, Inc.

Rebuttal: The Gods Must Be Crazy! Lawrence A. Garcia, MD Chief, Section Interventional Cardiology Co-Director, Vascular Medicine Program Director, Interventional Cardiology Fellowship Program St. Elizabeth’s Medical Center Tuft’s University School of Medicine Boston, MA

Infra-inguinal Intervention

Forces Exerted on the SFA • Unfavorable anatomy – Two bifurcations/articulations 1. Extension / Contraction • Unique vessel forces • Diffuse disease – High incidence of occlusive disease – Extremly complex lesion morphologies – Competitive flow via PFA 2. 3. Torsion Compression Flexion 4.

Nitinol Self-expanding stenting 2009 at 12 months Here is the unmet need! Resilient Durability Fem-Pac Thunder Absolute Idev Vibrant

• So we have heard how these few studies mean we still lack an answer • How many times do we need to see the same re-hashed data in a meaningless fashion? • We need to re-think and save our money for new directions in infra-inguinal therapy.

ABSOLUTE 2 -year • Clinically no difference from PTA versus endoprosthesis • Although patency benefit still present • Walking test in favor of stenting • Clinically how did this help?

• What should we do: – First throw out the current thoughts that stenting with current technology in short lesions needs further review – Second we rethink the process we are trying to treat • No longer should these studies be “cherrypicked” for the best lesions to treat • When was an SFA lesion only 6 cm without calcification?

Enough already? ! • We need to rethink the trial designs • An OPC with non-scientific endpoint is unfortunate • Goals of 30% restenosis is shameful • Clinically PTA alone is equivalent to an endoprosthesis at 2 years suggests the stenting approach of revascularization with the current technology is NOT the answer • Let’s agree to challenge ourselves to study clinically and anatomically relevant patient groups we see everyday in our practices to glean real scientific answers!