Phosphorylcholine-coated Dexamethasone Eluting Stent in the Prevention of Restenosis: A Randomized Trial in a Single Hospital

用phosphorylcholine塗覆dexamethasone釋放支架預防再狹窄：某醫學中心隨機研究

李愛先(Ai-Hsien Li) ； 廖朝崧(Chiau-Suong Liau) ； 莊文博(Wen-Po Chuang) ； 葉東峰(Dong-Feng Yeih) ； 朱樹勳(Shu-Hsun Chu)

《Acta Cardiologica Sinica》 23卷1期 (2007/03) Pp. 35-42

摘要

目的　大約有五分之一的病人在接受冠狀動脈支架放置手術之後可能會出現支架內再狹窄的現象。造成這種現象的主要病理機轉之一可能是血管在支架放置後出現了發炎反應，繼而出現內皮增生和平滑肌細胞位移的情形。我們嘗試研究以dexamethasone處理已塗有phosphorylcholine的支架對於預防支架內再狹窄的效果。
方法　我們的研究共納入了十二個病人，其中包含了十七個直徑狹窄程度大於70%的冠狀動脈病兆。參照血管的直徑介於2.7mm到3.7mm之間（平約值為3.18+/-0.31mm）。在開放標籤的隨機化後，有9個病灶被分配到對照組，也就是以未塗藥支架來處理這些病灶；其餘的病灶則以用dexamethasone處理已塗有phosphorylcholine的支架來治療。所有的病人都接受了臨床追蹤，部分則加上血管攝影的追蹤。
結果　有一個病人在接受手術後的一個星期，因為非手術相關的原因死亡。而有四個病人（包含dexamethasone組和對照組各二個）拒絕接受血管攝影追蹤。但這四個病人中有三個人（（包括對照組的兩位及dexamethasone組的其中一位）的thallium灌流攝影有心肌灌流不足的現象。剩下的七個病人（共12個病灶）中，dexamethasone組直徑的狹窄程度比對照組較少，雖然沒有達到統計學上的意義（0.33+/-0.22比0.22+/-0.06mm, P=0.352）。而對照組的再狹窄率也有較高的傾向（33%比0，p=0.202）。當我們同時考應血管攝影和臨床上的再狹窄率後，我們發現對照組的再狹窄率比dexamethasone組要高(44% vs. 0%, p=0.042)。在全部的病人中，只有一個對照組的病人針對目標病灶再進行處理。
結論　從我們的初步結果可以得知對於要放置冠狀動脈支架的病人而言，塗有dexamethasone的支架可能對於預防支架內再狹窄扮演潛在的角色。

關鍵字

支架內再狹窄 ； 藥物釋放型支架 ； 類固醇

並列摘要

Background/Purpose: In-stent restenosis (ISR) occurs in approximately 20% of the patients undergoing coronary stenting. Post-stenting inflammation may be among the major pathogenetic mechanisms in which vascular reactions produce intimal hyperplasia and smooth muscle cell migration. The objective of this open-label randomized controlled study was to evaluate the effect of phosphorylcholine-coated stents treated with dexamethasone to prevent TSR.
Method: We evaluated 17 discrete coronary lesions with a stenosis diameter＞ 70% from 13 patients. The diameter of the reference vessels ranged from 2.7mm to 3.7 mm (mean 3.18 ± 0.31 mm). Using open-label randomization, 9 lesions were assigned to the control group and implanted with un-coated bare-metal stents. The remaining lesions were treated with dexamethasone-treated phosphorylcholine-coated stents. All patients were followed clinically and/or angiographically.
Result: One patient died from a nontreatment-related event one week after the procedure. Four patients, two each in the dexamethasone group and the control group, refused to have a follow-up coronary angiography (CAG), however, three of those patients refusing CAG had a thallium myocardial perfusion study. Of these patients, 2 in control group showed myocardial perfusion impairment. In the remaining 12 lesions in 7 patients, the diameter of the stenosis was smaller in the dexamethasone group versus the control group, although the difference was not significant statistically (0.33 ± 0.22 versus 0.22 ± 0.06 mm, p = 0.352). There was a tendency toward a higher binary restenosis rate in the control group versus the dexamethasone group (33% vs. 0%, p = 0.202). When the angiographic and clinical restenosis rates were combined, the control group had a significantly higher restenosis rate than the dexamethasone group (44.4% vs. 0% p = 0.042). One patient from the control group underwent target lesion revascularization.
Conclusion: Results of this study suggest that dexamethasone-eluting stents may have a potential role in the prevention of TSR in patients with coronary artery stents implanted.

並列關鍵字

In-stent restenosis ； Drug eluting stents ； Dexamethasone