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The Favorable Long Term Clinical Outcomes of a High Dose Dexamethasone- Eluting Stent: Randomized Controlled Prospective Study.
가천의과학대학교 길병원 심장내과
박예민, 한승환, 강웅철, 고광곤, 신권철, 김명건, 안태훈, 최인석, 신익균
Background: The long term clinical efficacy of dexamethasone-eluting stents, comparing them with unloaded stents of an identical design, has not been evaluated. Methods: A total of 92 patients were randomly assigned to the dexamethasone group (67 patients, 71 lesions) or control group (unloaded stents of an identical stent design, 25 patients, 27 lesions). Ninety patients (60.7 ± 10.0 years, 53 men, 96 lesions) with available clinical data at five year were analyzed for the major adverse cardiac events. 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 µg/mm2 per stent. The MACE was composite of the cardiovascular death, nonfatal Q-wave or non–Q-wave myocardial infarction (MI), and ischemia driven target lesion revascularization (TLR). Results: Total MACE rate at 5 years was significantly lower in the dexamethasone group, as compared with the control group (13.8% [9 (1 MI, 8 TLR) / 65] vs 36.0% [8 (1 cardiovascular death, 8 TLR) / 25], P = 0.032). MI and cardiovascular death rate at five years were comparable between two groups, however the target lesion revascularization rate at five years was significantly lower in the dexamethasone group as compared with the control group (10.8 % [7 / 65] vs 32.0 % 8 / 25], P = .021). Conclusions: This is the first prospective analysis of the long term clinical outcome of Dexamethasone–eluting stents. Our results demonstrate sustained favorable beneficial clinical outcomes of dexamethasone-eluting stent over 5 years as compared with control group.


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