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Feasibility, Safety, and Efficacy of a Novel Polymeric Pimecrolimus-Eluting Stent

Traditional Pre-Clinical Safety End Points Failed to Predict 6-Month Clinical Angiographic Results

John A. Ormiston, MBChB^_*,,,_*, Mark W.I. Webster, MBChB^_*,,, Robert S. Schwartz, MD, Patrick Gladding, MBChB, James T. Stewart, MD^_*,,, I. Patrick Kay, MBChB^_*, Peter N. Ruygrok, MD^_*,,, Robert Hatrick, MBBS

^_* Mercy Angiography, Auckland, New Zealand
Auckland Heart Group, Auckland, New Zealand
Auckland City Hospital, Auckland, New Zealand
Minneapolis Heart Institute and Foundation, Minneapolis, Minnesota

View larger version (58K): [in this window] [in a new window] [Download PPT slide]   Figure 1 Neointimal Growth and Injury Following a Pimecrolimus Stent Implantation (A) Low-power section showing neointimal growth and injury in a pimecrolimus stent. More neointima has formed across the top portion of this vessel, where injury is greater and media is absent due to vessel stretch. (B) Higher-power section showing a moderate neointimal growth at a region of higher vascular injury.

View larger version (104K): [in this window] [in a new window] [Download PPT slide]   Figure 2 Cine Frames From the 8 Patients Who Had Restenosis by 6 Months (A) Before stenting, (B) after stenting, and (C) at follow-up.