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  • 學位論文

冠狀動脈疾病治療-塗藥支架與傳統支架之臨床結果與醫療費用分析

Coronary artery disease therapy -Drug-Eluting stent & Bare Metal Stent on Clinical Outcomes and Resources Utilization Analysis

指導教授 : 林能白

摘要


動機與目的:冠狀動脈疾病簡稱為冠心症,目前仍然是全世界最主要的健康問題之一。根據2005年衛生署統計資料顯示,心血管疾病高居國人十大死因的第3位,其中冠狀動脈疾病(Coronary artery disease, CAD)是心血管疾病的主要殺手。冠狀動脈疾病的治療,一直不斷在發展,從藥物治療、氣球擴張術到血管支架的置放都有相當的成效。由於傳統支架置放很容易產生再狹窄(restenosis)的現象,導致半年內病患血管再度狹窄機率高達25%至30%,其中糖尿病患者的再狹窄率更是高達40%。冠狀動脈疾病的治療常常受到很大的限制。而不斷的住院與進行手術對病患及現行醫療資源更是一大負擔。因此,本研究的目的在於瞭解兩種不同血管支架(塗藥支架與傳統支架)處置後追蹤二年對於臨床治療結果與醫療資源耗用之間的影響,並進一步探討其成本效益。 方法:以回溯性研究法分析從個案醫院自2003年9月至2004年11月進行冠狀動脈介入性治療並置放支架之病患之全部病患的臨床的數據和費用。排除急性冠心症,處置前經加護病房(CCU)觀察之病患、當次處置同時置放塗藥支架與傳統支架的病患、當次處置僅進行氣球擴張術(PTCA)者以及已開過冠狀動脈繞道手術之患者。 結果發現:在226位塗藥支架與250位傳統支架中,臨床治療結果方面:置放塗藥支架組有較低的血管再阻塞率(目標病灶再阻塞相差:8%目標血管再阻塞相差10)及較低的重大心臟血管事件 (8.4%);醫療費用方面:在總醫療費用上相比較,塗藥支架仍比傳統支架為高(NT$363K:19K) ;但在增加成本效益比率上(ICER) 為花費NT$ 517K 可以避免一次的目標血管再阻塞. 同時也發現兩組塗藥支架在成本上是相近的。另在不同病患特性方面上顯示以ICER分析有糖尿病病患及三條血管阻塞特性以及置放一支以上支架之病患族群更具成本效益。 結論:塗藥支架的選擇確實能在2年中降低目標血管再阻塞率是有利,雖然我們的研究過程中它並沒有那麼節省成本。但如果選擇某些病患族群上使用塗藥支架如糖尿病病患、三條血管阻塞或者使用不止一支支架處置上將更為有利。

並列摘要


Purpose and Aim:Coronary artery disease (CAD) remains one of the most important health problems in the world. According to the statistical record from National Health Institute in Taiwan in 2005, the cardiovascular disease was the third leading cause of death; among them, the CAD was the major killer(event). The treatment of CAD has been proceeding since medical treatment, balloon angioplasty to coronary stents and resulted in major achievement. There are around ten thousand patients with CAD undergoing the implantation of coronary stents to keep adequate coronary blood flow every year. The phenomenon of restenosis develops frequently after the implantation of traditional bare metal stents (BMS), and results in clinically-driven revascularization around 25-30%, and even up to 40% in diabetes patients. The repeated hospitalizations for percutaneous coronary intervention place great burden on patients as well as on the health care system. The object of our study is to elucidate the difference in clinical outcome and to demonstrate the cost-benefit between the two different types of stents (drug eluting stent (DES) and BMS). Method:We retrospectively analyzed the clinical data and cost from patients undergoing coronary stenting from Sep. 2003 to Nov. 2004 in one tertiary-referring center. Patients presented with acute coronary syndrome initially and received BMS and DES at the same procedure were excluded. Result: There were 226 patients enrolled in the DES group and 250 patients in the BMS group. The rate of target lesion revascularization (14.6% vs 24.4%, p=0.008), target vessel revascularizationwas (20.4% vs 28.4%, p=0.044) and major adverse cardiac events (20.8% vs 29.2%, p=0.044) were much lower in the DES group compared with that in the BMS group. DES group had a higher overall cost compared with BMS group (NT$363K ± 154K vs NT$319K ± 147K, p=0.002). The incremental cost-effectiveness ratio (ICER) to avoid a target vessel revascularization was NT$ 517K. In the subgroup analysis, the ICER showed better result in patient with diabetes or patient with triple vessel disease. Conclusion: The use of DES resulted in lower rate of target vessel revascularization at two years. The cost-effectiveness did not favor BMS group. it will be more beneficial to use DES in selective patient groups such as patients with diabetes or triple vessel disease.

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