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CLINICAL RESEARCH: CLINICAL TRIAL

A Randomized, Double-Blind, Placebo-Controlled Trial on Restenosis Prevention by the Receptor Tyrosine Kinase Inhibitor Imatinib

Dietlind Zohlnhöfer, MD^_*,_*, Jörg Hausleiter, MD^_*, Adnan Kastrati, MD^_*, Julinda Mehilli, MD^_*, Christoph Goos^_*, Helmut Schühlen, MD^_*, Jürgen Pache, MD^_*, Gisela Pogatsa-Murray, MD^_*, Uwe Heemann, MD, Josef Dirschinger, MD and Albert Schömig, MD^_*

^_* Deutsches Herzzentrum München, Munich, Germany; Klinik an der Technische Universität München, Munich, Germany
2.Medizinische Klinik des Klinikum rechts der Isar, Technische Universität, Munich, Germany
1.Medizinische Klinik des Klinikums rechts der Isar, Technische Universität, Munich, Germany

Manuscript received May 10, 2005; revised manuscript received July 13, 2005, accepted July 18, 2005.

^_* Reprint requests and correspondence: Dr. Dietlind Zohlnhöfer, Deutsches Herzzentrum, Lazarettstrasse 36, 80636 München, Germany. (Email: zohlnhoefer{at}dhm.mhn.de).

OBJECTIVES: The aim of the present double-blind, placebo-controlled study was to evaluate the efficacy of a systemic imatinib treatment, a potent platelet-derived growth factor (PDGF) receptor kinase inhibitor, for the prevention of recurrent restenosis in patients with in-stent restenosis (ISR).

BACKGROUND: Neointima proliferation after stent placement has been associated with the effect of potent mitogenes such as PDGF, and their inhibition has resulted in reduction of neointima formation in experimental models.

METHODS: A total of 180 patients with either symptoms or a positive stress test in the presence of angiographically signficiant ISR were randomly assigned to two treatment arms: imatinib treatment or placebo. Patients received imatinib (600 mg/day) for 10 days starting 2 days before repeat intervention. Angiographic restenosis at follow-up angiography was the primary end point of the study.

RESULTS: Repeat angiography was performed in 160 of 180 patients (88.9%). The combined rate of death or MI at one year was 1.0% in patients randomized to either group (p = 0.67). Compared with the placebo group, imatinib treatment did not affect the angiographic restenosis rate (38.8% with imatinib vs. 41.3% with placebo; p = 0.75). Similarily, the need for target lesion revascularization did not differ between both groups (28.1% with imatinib vs. 28.6% with placebo; p = 0.94).

CONCLUSIONS: Systemic imatinib therapy does not affect the risk of recurrence in patients with ISR.

Abbreviations and Acronyms   CI = confidence interval   CML = chronic myeloid leukemia   GIST = gastrointestinal stromal tumor   ISR = in-stent restenosis   MI = myocardial infarction   MLD = minimum lumen diameter   PCI = percutaneous coronary intervention   PDGF = platelet-derived growth factor   SMC = smooth muscle cell   TLR = target lesion revascularization

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