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CLINICAL RESEARCH: CLINICAL TRIALS: VIEWPOINT

Actinomycin-eluting stent for coronary revascularization

A randomized feasibility and safety study: The ACTION trial

Patrick W. Serruys, MD, PhD, FACC^*,*, John A. Ormiston, MD, Georgios Sianos, MD, PhD^*, J. Eduardo Sousa, MD, Eberhard Grube, MD, Peter den Heijer, MD^||, Pim de Feyter, MD^*, Pawel Buszman, MD^¶, Albert Schömig, MD^#, Jean Marco, MD^**, Lech Polonski, MD^¶, Leif Thuesen, MD, Andreas M. Zeiher, MD, J.H. Nicholas Bett, MD, Maarten J. Suttorp, MD^||||, Helmut D. Glogar, MD^¶¶, Mark Pitney, MD^##, Gerard T. Wilkins, MD^***, Robert Whitbourn, MD, Susan Veldhof, RN, Karine Miquel, PhD, Rachel Johnson, BA, Leslie Coleman, DVM, Renu Virmani, PhD ACTION Investigators

^* Erasmus Medical Center, Rotterdam, The Netherlands
Green Lane Hospital, Auckland, Australia
Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil
Krankenhaus Siegburg, Siegburg, Germany
^|| Amphia Ziekenhuis, Breda, The Netherlands
^¶ Silesian Heart Disease Center, Katowice, Poland
^# Deutsches Herzzentrum München, Munich, Germany
^** Clinique Pasteur, Toulouse, France
Skejby Syghus, Aarhus, Denmark
Klinikum de J. W. Goethe Universität, Frankfurt, Germany
Prince Charles Hospital, Chermside, Australia
^|||| Sint Antonius Ziekenhuis, Nieuwegein, The Netherlands
^¶¶ Allgemeines Krankenhaus de Stadt Wien, Vienna, Austria
^## Prince of Wales Hospital, Sydney, Australia
^*** Dunedin Hospital, Dunedin, New Zealand
St. Vincent's Hospital, Melbourne, Australia
Guidant Corporation, Diegim, Belgium
Armed Forces Institute of Pathology, Washington, DC

Manuscript received November 20, 2003; revised manuscript received March 8, 2004, accepted March 17, 2004.

^* Reprint requests and correspondence: Dr. Patrick W. Serruys, Professor of Interventional Cardiology, Erasmus Medical Center, Thoraxcentre Bd 408, Dr. Molewaterplein 40, 3015 GD Rotterdam, the Netherlands (Email: p.w.j.c.serruys{at}erasmusmc.nl).

OBJECTIVES: We sought to demonstrate the safety and performance of the actinomycin D-coated Multilink-Tetra stent(Guidant Corp., Santa Clara, California) in the treatment of patients with single de novonative coronary esions.

BACKGROUND: Drug-eluting stents (DES) releasing sirolimus or paclitaxel dramatically reduce restenosis. The anti-proliferative drug, actinomycin D, which is highly effective in reducing neointimal proliferation in preclinical studies, was selected for clinical evaluation.

METHODS: The multi-center, single-blind, three-arm ACTinomycin-eluting stent Improves Outcomes by reducing Neointimal hyperplasia (ACTION) trial randomized 360 patients to receive a DES (2.5 or 10 µg/cm² of actinomycin D) or metallic stent (MS). The primary end points were major adverse cardiac events (MACE) at 30 days, diameter stenosis by angiography, tissue effects, and neointimal volume by intravascular ultrasound (IVUS) at six months. When early monitoring revealed an increased rate of repeat revascularization, the protocol was amended to allow for additional follow-up for DES patients. Angiographic control of MS patients was no longer mandatory.

RESULTS: The biased selection of DES patients undergoing IVUS follow-up invalidated the interpretation of the IVUS findings. The in-stent late lumen loss and that at the proximal and distal edges were higher in both DES groups than in the MS group and resulted in higher six-month and one-year MACE (34.8% and 43.1% vs. 13.5%), driven exclusively by target vessel revascularization without excess death or myocardial infarction.

CONCLUSIONS: The results of the ACTION trial indicate that all anti-proliferative drugs will not uniformly show a drug class effect in the prevention of restenosis.

Abbreviations and Acronyms   DES = drug-eluting stent   IVUS = intravascular ultrasound   MACE = major adverse cardiac events   MI = myocardial infarction   MS = metallic stent   QCA = quantitative coronary angiography   TSR = target site revascularization   TVF = target vessel failure

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