The favorable clinical and angiographic outcomes of a high-dose dexamethasone-eluting stent: randomized controlled prospective study.
BACKGROUND
Previous studies with dexamethasone-eluting stents could not elucidate the role of dexamethasone in the prevention of neointimal hyperplasia because they did not compare their results with a control group. We prospectively evaluated the clinical and angiographic outcomes of dexamethasone-eluting stents, comparing them with unloaded stents of an identical design.


METHODS
A total of 92 patients (98 lesions) were randomly assigned to the dexamethasone group (67 patients, 71 lesions) or control group (25 patients, 27 lesions). The inclusion criteria for a stent implantation were a de novo lesion with a diameter of 2.60 to 4.0 mm. BiodivYsio Drug Delivery phosphorylcholine-coated stents (Biocompatibles Ltd, Galway, Ireland) were immersed in a 20-mg/mL dexamethasone solution, yielding a total dexamethasone dose of 0.5 microg/mm2 per stent.


RESULTS
The total major adverse cardiac events rate at 12 months was significantly lower in the dexamethasone group, as compared with the control group (10.4% [7/67] vs 28.0% [7/25], P = .037). The binary restenosis rate at 6 months was 11.9% (7/59) in the dexamethasone group and 42.9% (9/21) in the control group (P = .002). The use of dexamethasone-eluting stents was the only independent predictor for the major adverse cardiac event at 12 months (relative risk 0.20, 95% CI 0.06-0.68, P = .009) and binary restenosis at 6 months (relative risk 0.17, 95% CI 0.05-0.60, P = .006) by multivariate analysis.


CONCLUSIONS
Dexamethasone-eluting stents exhibited an improvement in the clinical and angiographic outcomes, as compared with the control stents. These results suggest that dexamethasone may play an important role in the inhibition of the polymer-induced inflammation in the era of drug-eluting stents.
Han
Seung Hwan
SH
Cardiology, Gachon Medical School, Incheon, South Korea.
Ahn
Tae Hoon
TH
Kang
Woong Chol
WC
Oh
Kyu Jin
KJ
Chung
Wook-Jin
WJ
Shin
Mi-Seung
MS
Koh
Kwang Kon
KK
Choi
In Suck
IS
Shin
Eak Kyun
EK
D000368:Aged; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000188:drug therapy / Q000517:prevention & control; D023921:Coronary Stenosis / Q000188:drug therapy* / Q000628:therapy; D003907:Dexamethasone / Q000008:administration & dosage*; D016503:Drug Delivery Systems; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D006965:Hyperplasia; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome; D017539:Tunica Intima / Q000187:drug effects* / Q000473:pathology
D005938:Glucocorticoids; D003907:Dexamethasone