A double-blind, randomized, placebo-controlled multicenter clinical trial to evaluate the effects of the angiotensin II receptor blocker candesartan cilexetil on intimal hyperplasia after coronary stent implantation.
BACKGROUND
Preclinical data suggest beneficial effects of angiotensin II receptor blockers (ARBs) on neointima formation after vascular injury. Preliminary clinical data, however, revealed conflicting results. The AACHEN trial was a double-blind, randomized, placebo-controlled clinical multicenter trial to evaluate the effects of candesartan cilexetil on intimal hyperplasia after coronary stent implantation.


METHODS
A total of 120 patients (61 +/- 9 years, 83% male) were randomized to receive either 32 mg candesartan cilexetil (active) or placebo starting 7 to 14 days before elective coronary stent implantation. A follow-up angiography including intravascular ultrasound assessment of the target lesion was performed 24 +/- 2 weeks after stent implantation. The primary end point was defined as the difference in neointimal area between groups as assessed by intravascular ultrasound. Secondary end points included differences in angiographic parameters (ie, restenosis rate) and incidence of major cardiac events.


RESULTS
The mean stent length measured 15.0 +/- 4.9 mm in the active and 14.6 +/- 5.7 mm in the placebo group (P = .81). There was no significant difference in neointimal area between groups (2.1 +/- 1.0 vs 2.1 +/- 1.5 mm2, P = 1.00), nor were there differences in angiographic end point parameters. Major cardiac event rates were not significantly different between treatment groups (8% vs 11%, P = .75).


CONCLUSIONS
High-dose candesartan cilexetil therapy in patients with symptomatic coronary artery disease undergoing coronary stent implantation does not reduce clinical event rates, restenosis rates, or neointimal proliferation after elective stent implantation.
Radke
Peter W
PW
Medical Clinic I, RWTH University Hospital Aachen, Aachen, Germany. radke@innere2.uni-luebeck.de
Figulla
Hans R
HR
Drexler
Helmut
H
Klues
Heinrich G
HG
Mügge
Andreas
A
Silber
Sigmund
S
Daniel
Werner
W
Schmeisser
Alexander
A
Reifart
Nicolaus
N
Motz
Wolfgang
W
Büttner
Hans-Joachim
HJ
Fischer
Dieter
D
Ortlepp
Jan R
JR
Schaefers
Kerstin
K
Hoffmann
Rainer
R
Hanrath
Peter
P
D000368:Aged; D047228:Angiotensin II Type 1 Receptor Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D001713:Biphenyl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D017023:Coronary Angiography; D003327:Coronary Disease / Q000175:diagnosis / Q000473:pathology* / Q000628:therapy*; D023903:Coronary Restenosis / Q000517:prevention & control; D003331:Coronary Vessels / Q000473:pathology*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006965:Hyperplasia; D008297:Male; D008875:Middle Aged; D015607:Stents / Q000009:adverse effects; D013777:Tetrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D017539:Tunica Intima / Q000473:pathology*; D018084:Ultrasonography, Interventional
D047228:Angiotensin II Type 1 Receptor Blockers; D001562:Benzimidazoles; D001713:Biphenyl Compounds; D013777:Tetrazoles; C077793:candesartan cilexetil