A randomized, double-blind, placebo-controlled trial on restenosis prevention by the receptor tyrosine kinase inhibitor imatinib.
OBJECTIVE
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 significant 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). Similarly, 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.
Zohlnhöfer
Dietlind
D
Deutsches Herzzentrum München, Munich, Germany. zohlnhoefer@dhm.mhn.de
Hausleiter
Jörg
J
Kastrati
Adnan
A
Mehilli
Julinda
J
Goos
Christoph
C
Schühlen
Helmut
H
Pache
Jürgen
J
Pogatsa-Murray
Gisela
G
Heemann
Uwe
U
Dirschinger
Josef
J
Schömig
Albert
A
D000368:Aged; D000787:Angina Pectoris / Q000628:therapy; D015906:Angioplasty, Balloon, Coronary; D001549:Benzamides; D017023:Coronary Angiography; D003327:Coronary Disease / Q000628:therapy; D023903:Coronary Restenosis / Q000517:prevention & control*; D003404:Creatinine / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000068877:Imatinib Mesylate; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage / Q000627:therapeutic use*; D011505:Protein-Tyrosine Kinases / Q000037:antagonists & inhibitors*; D011743:Pyrimidines / Q000008:administration & dosage / Q000627:therapeutic use*; D055502:Secondary Prevention; D015607:Stents
D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D000068877:Imatinib Mesylate; D003404:Creatinine; D011505:Protein-Tyrosine Kinases