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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Endothelial Progenitor Cell Capture by Stents Coated With Antibody Against CD34

The HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man) Registry

Jiro Aoki, MD^_*, Patrick W. Serruys, MD, PhD, FACC^_*,_*, Heleen van Beusekom, MD, PhD^_*, Andrew T.L. Ong, MBBS, FRACP^_*, Eugene P. McFadden, MBChB, MD, FRCPI, FACC^_*, Georgios Sianos, MD, PhD^_*, Willem J. van der Giessen, MD, PhD^_*, Evelyn Regar, MD, PhD^_*, Pim J. de Feyter, MD, PhD, FACC^_*, H. Richard Davis, MSc, Stephen Rowland, PhD and Michael J.B. Kutryk, MD, PhD

^_* Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
OrbusNeich, Fort Lauderdale, Florida
Terrence Donnelly Heart Centre, St. Michael’s Hospital, University of Toronto, Toronto, Canada

Manuscript received December 9, 2004; revised manuscript received January 22, 2005, accepted January 25, 2005.

^_* Reprint requests and correspondence: Dr. Patrick W. Serruys, Thoraxcenter, Bd 406, Erasmus Medical Center, Dr. Molewaterplein 40, 3015 GD Rotterdam, the Netherlands (Email: p.w.j.c.serruys{at}erasmusmc.nl).

OBJECTIVES: This study was designed to evaluate whether rapid endothelialization of stainless steel stents with a functional endothelium prevents stent thrombosis and reduces the restenotic process.

BACKGROUND: A "pro-healing" approach for prevention of post-stenting restenosis is theoretically favored over the use of cytotoxic or cytostatic local pharmacologic therapies. It is believed that the central role of the vascular endothelium is to maintain quiescence of the underlying media and adventitia.

METHODS: Sixteen patients with de novo coronary artery disease were successfully treated with implantation of endothelial progenitor cell (EPC) capture stents.

RESULTS: Complete procedural and angiographic success was achieved in all 16 patients. The nine-month composite major adverse cardiac and cerebrovascular events (MACCE) rate was 6.3% as a result of a symptom-driven target vessel revascularization in a single patient. There were no other MACCE despite only one month of clopidogrel treatment. At six-month follow-up, mean angiographic late luminal loss was 0.63 ± 0.52 mm, and percent stent volume obstruction by intravascular ultrasound analysis was 27.2 ± 20.9%.

CONCLUSIONS: This first human clinical investigation of this technology demonstrates that the EPC capture coronary stent is safe and feasible for the treatment of de novo coronary artery disease. Further developments in this technology are warranted to evaluate the efficacy of this device for the treatment of coronary artery disease.

Abbreviations and Acronyms   EPC = endothelial progenitor cell   HAMA = human antimurine antibody   HEALING-FIM = Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man   IVUS = intravascular ultrasound   MACCE = major adverse cardiac and cerebrovascular events   MI = myocardial infarction   SMC = smooth muscle cell   TIMI = Thrombolysis In Myocardial Infarction

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