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The favorable clinical and angiographic outcomes of a high-dose dexamethasone-eluting stent: randomized controlled prospective study.

Abstract：

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.

journal_name

Am Heart J

journal_title

American heart journal

authors

Han SH,Ahn TH,Kang WC,Oh KJ,Chung WJ,Shin MS,Koh KK,Choi IS,Shin EK

doi

10.1016/j.ahj.2006.05.011

subject

Has Abstract

pub_date

2006-11-01 00:00:00

pages

887.e1-7

issue

eissn

0002-8703

issn

1097-6744

pii

S0002-8703(06)00457-1

journal_volume

152

pub_type

杂志文章,随机对照试验

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The favorable clinical and angiographic outcomes of a high-dose dexamethasone-eluting stent: randomized controlled prospective study.