Simvastatin does not inhibit intimal hyperplasia and restenosis but promotes plaque regression in normocholesterolemic patients undergoing coronary stenting: a randomized study with intravascular ultrasound.
BACKGROUND
Restenosis after coronary stenting is mainly caused by intimal hyperplasia. Both experimental and clinical studies suggest that statins may be able to inhibit intimal hyperplasia and, therefore, in-stent restenosis (ISR), by mechanisms beyond lipid lowering.


METHODS
In a 12-month study, we randomized 71 normocholesterolemic patients to 20 mg simvastatin or no treatment, 2 weeks before elective coronary stenting. Patients were evaluated by quantitative coronary angiography and intravascular ultrasound, immediately after the index procedure and at the 12-month catheterization.


RESULTS
Binary ISR was present in 15% and in 18% of simvastatin-treated patients and controls, respectively (P = NS). Intimal hyperplasia did not differ significantly between the 2 groups (3.6 +/- 1.8 vs 3.8 +/- 2.3 mm3/mm, 34% +/- 15% vs 35% +/- 23% for simvastatin vs controls, P = NS). However, persistent plaque decreased with simvastatin but increased in controls (-4.0 +/- 4.0 vs +1.6 +/- 3.8 mm3/mm, -14% +/- 10% vs +6% +/- 12%, P < .05). The same behavior was shown by intermediate plaques at nonstented sites (-2.5 +/- 3.0 vs +1.0 +/- 3.0 mm3/mm, -10% +/- 8% vs +9% +/- 9%, P < .05). Major adverse events at 12 months were present in 11% and 24% of simvastatin-treated patients and controls, respectively (P = .20).


CONCLUSIONS
In normocholesterolemic patients undergoing coronary stenting, simvastatin does not prevent intimal hyperplasia or ISR, but it promotes atherosclerotic regression both at stented and at nonstented sites.
Petronio
Anna Sonia
AS
Cardiothoracic Department, Pisa, Italy.
Amoroso
Giovanni
G
Limbruno
Ugo
U
Papini
Barbara
B
De Carlo
Marco
M
Micheli
Andrea
A
Ciabatti
Nicola
N
Mariani
Mario
M
D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D023903:Coronary Restenosis / Q000175:diagnosis / Q000517:prevention & control*; D003331:Coronary Vessels / Q000000981:diagnostic imaging*; D004730:Endothelium, Vascular / Q000000981:diagnostic imaging / Q000187:drug effects / Q000473:pathology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000494:pharmacology / Q000627:therapeutic use; D006965:Hyperplasia / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D011292:Premedication; D019821:Simvastatin / Q000494:pharmacology* / Q000627:therapeutic use; D015607:Stents; D018084:Ultrasonography, Interventional
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D019821:Simvastatin