塗藥型血管支架納入健保部份給付之成效評估

研究背景依據衛生署公佈的衛生統計資料，心臟疾病2007年為國人十大死因之第二名。健康保險局於2006年12月開始採取部分支付的方式，同意符合血管支架適應症的病人，可以以補付差額的方式使用塗藥型支架。中央健康保險局同意塗藥型支架部分支付以來，尚未有整合臨床療效與發生醫療費用的研究報告。故本研究的目的為探討病患使用塗藥型支架(Drug-eluting Stent；DES)與裸露型支架(Bare Metal Stent；BMS)之臨床療效、醫療資源利用、被保險人社經地位對支架類別選擇的差異，及此選擇差異對結果的影響。研究方法本研究使用健保局高屏分局之申報資料及承保資料之及死亡資料。包含DES組472位病患，BMS組1586位病患，我們追蹤15個月的醫療資源利用，醫療結果和臨床療效。醫療資源利用包含住院天數、醫療費用、追蹤門診次數、再住院等，臨床療效包含當次住院之療效及出院後追蹤之療效；醫療結果包含處置後死亡、執行冠狀動脈繞道手術及再介入手術、心肌梗塞等。整合收集的資料以複迴歸、存活分析分析探討不同PCI處置的醫療資源利用、醫療結果和臨床療效的影響因子。研究結果醫療資源利用部份，在平均住院日DES組為5.11日；BMS組6.63日(p<0.001)。在醫療費用DES組為242,034元； BMS組為185016元(p<0.001)。使用支架數DES 為1.41支； BMS組為1.32支(p <0.001)。追蹤15個月後，DES組總支出費用363,092元，BMS組總支出費用337,692元。BMS組之追蹤費用較高。在臨床結果中，當次住院死亡率DES組為1.48% ； BMS組3.91%( p =0.010)。執行血管繞道手術(CABG) BMS組5件(0.32%)，DES組為0(p =0.222)。住院中發生重大心臟血管不良事件(MACE)在 DES組6.99% ； BMS組15.38%(p <0.001)。出院後追蹤15個月，整體存活率94.8%，BMS存活率94.0%，DES組存活率97.4%；(p =0.010)。追蹤期間死亡，DES為12位(2.58%)；BMS組死亡人數為91位(5.97%) (p =0.004)。追蹤期間執行血管繞道手術(CABG) DES組為4位(0.86% ) ； BES組27件(1.77%)( p =0.367)。再執行氣球擴張術(PTCA) DES組為28位(6.02% )； BMS組129件(8.46%)( p =0.070)。再次植入支架 DES組為38位(8.17% )；BMS組139件(9.01%)(p=0.741)。出院累積重大心臟不良事件(MACE) DES組81人(17.42%) ； BMS組369人(23.93%)(p =0.005)。透過迴歸模式分析，研究主要影響追蹤死亡因子為併發症(風險3.43倍)、由急診入院者(風險1.31倍)；合併症(風險1.39~2.97倍)。醫師未經PCI認證(風險1.39倍)。年齡每增加一歲死亡風險增加5%。使用塗藥型血管支架的比例，在第五類低收入戶為9%，第一類為30%(p<0.001)。高收入組使用塗藥型血管支架的比例為39%、中等收入組為30%、較低收入組為23%。以上均達統計學之顯著差異。由入院至追蹤15個月之存活率: 第一類(93.76%)、低收入戶(90.91%)；高收入組(96%)、低收入組(94%)、中等收入組(93%)( p=0.015)。以上二種分類各自比較存活率，均未達達統計上顯著差異。結論對當次住院，或追蹤期間各項療效結果，最要的影響因素是病人的年齡，疾病嚴重度，包括併發症、由急診入院，和醫師有無PCI認證。使用支架類別的影響仍須更多的研究作進一步的探討。經濟收入差異會影響治療方式的選擇，但此選擇差異並未造成此處置治療結果的差別。

關鍵字

塗藥型支架；冠狀動脈疾病；臨床療效；醫療資源利用

並列摘要

Background According to report from Natinal Department of Health, coronary artery disease (CAD) was the 2nd in top of ten death causes during 2007 in Taiwan. The National Health Insurance Bureau started the co-payment method so that those patients indicated for percutaneous coronary intervention (PCI) could allow to use Drug-eluting Stent(DES) while paying the cost difference only. Since the co-payment method lunched, there was no any report for the connection of clinical results and resource utilization yet. So this study was designed for probing the clinical effectiveness and resource utilization of (DES) and Bare Metal (BMS), the stent type choosing according to social economic status and the consequences after the choice made. Method: We use the insurance payment and death data from National health Insurance Bureau data base. There were 472 patients in (DES) group and 1586 patient in (BMS) group. With the follow up period of 15months, we tracked the resource utilization, medical outcome and the clinical effectiveness of these cases. The resource utilization includes admission days, medical cost, follow up clinic visits, and if readmitted. The medical outcome included post procedure fatality, proceeded coronary artery bypass surgery, redid the procedure and AMI attack. The clinical effectiveness included results post admission and post follow up. With above data, we used logistic regression model and survival analysis for predict the influence factors of resource utilization, medical outcome and the clinical effectiveness in different type of stent used. Result: The average length of stay was 5.11 days in DES group and 6.63 days in BMS group (p<0.001). The Medical cost was 252,034 NTD in DES group and 185,016 NTD in BMS group (p<0.001). The number of stent used was 1.41 in DES group and 1.32 in BMS group (p<0.001). The total cost after 15months follow up was 363,092NTD in DES group and 337,692 in BMS group. The BMS group had higher follow up expenditure. In clinical outcome, the hospital mortality rate was 1.48% in DES group and 3.91% in BMS group. The case number for proceeded (CABG) was 5 in BMS group and 0 in DES group (p=0.222). Incident of major arterial-cardiac event (MACE) during admission was 6.99% in DES group and 15.38% in BMS group (p<0.001). After 15 month’s follow up, the survival rate was 94% in BMS group, 97.4% in DES group and totally 94.8% (p=0.010). Number of case death during follow up period was 12 (2.58%) in DES group and 91 in BMS group (5.97%) (p=0.004). Case number of Proceeded (CABG) during follow up period was 4(0.86%) in DES group and 27 (1.77%) (p=0.367). Case number for redid (PTCA) was 28 (6.02%) in DES group and 129 (8.46%) (p=0.70) in BMS group. Case number of replant stent was 38 (8.17%) in DES group and 139 (9.01%) (p=0.741). Total case number of (MACE) after discharge was 81 ( 17.42%) in DES group and 369 (23.93%) in BMS group. After logistic regression model analysis, the most significant risk factors were admitted from ER with risk of 1.31 times, co-morbidity with risk of 1.39-2.97 times, physician without PCI certification with risk of 1.39 times. Risk of death increased 5% as aging by one year. Those analysis data above were significant. The percentile of using (DES) in patients from type V( low income family) was 9%, while patients from type I was 30% (p<0.001). Patients from high income family had 39% rate of chooseing DES, and had 30% for median income；and 23% for low income family。 The above analysis were significant. From admission to the end of 15 months follow up, the survival rate was 93.76% in type I group, (90.91%) in low income family group, (96%) in high income group, (94%) in low income group, (93%) in median income group (p=0.015). The above 2 kind of grouping and comparing survival rate were not significant. Conclusion: The most important factors influence medical outcome during admission or follow up period were age, illness severity, complication, admitted from ER and the PCI certificate of the physician. The influences of different type of stent should be define with more further investigations. Personal income was a factor for patients to choose treating methods, but the choice didn’t change the medical outcome.