- 學位論文
塗藥支架與繞道手術在冠狀血管疾病的臨床療效與醫療耗用的比較：以末期腎臟疾病接受透析治療患者為例
Medical Outcome and Utilization in Dialysis-Dependent End-Stage-Renal Disease Patients with Coronary Artery Disease：DES v.s. Coronary Artery Bypass Graft Surgery
摘要
研究背景 末期腎臟疾病（end stage renal disease，ESRD）在台灣的發生率及盛行率節節上升。高達45%的ESRD者，最終死於心血管疾病，包括冠狀動脈疾病。冠狀動脈疾病嚴重阻塞時，須接受侵入性治療如經皮冠狀血管介入術（Percutaneous coronary intervention，PCI）或是冠狀動脈繞道手術 (coronary artery bypass surgery; CABG)。這兩者介入性治療方式，在此類患者的選擇仍未有定論。本研究針對接受透析的末期腎臟疾病患者，以塗藥支架（DES）與繞道手術（CABG）兩種術式應用在冠狀血管疾病，比較臨床預後與醫療資源的耗用。 研究方法 本研究2005年版的世代百萬抽樣檔，以回溯性方式擷取2007至2013年間，末期腎病接受透析且罹患冠狀血管疾病患者，比較接受DES（134人）與CABG（88人）後的一至七年的臨床療效，包括冠狀血管相關再住院率、血管再疏通率、死亡率、中風率、心肌梗塞率及重要不良心臟及腦血管事件發生率（MACCE，major adverse cardiac and cerebrovascular event）；醫療耗用部份討論住院天數與當次住院費用；最後分析影響MACCE的因素。 研究結果 在冠狀血管相關再住院風險，第一年CABG比上DES的OR = 0.91（p = 0.4），其後亦無差異。血管再疏通率（revascularization）追蹤七年的無事件率（event-free rate）都是CABG遠高於DES（log-rank p < 0.0001）。心肌梗塞率與中風率短或長期皆無顯著差異。死亡率則不然，七年的無事件率DES組皆高於CABG組（log-rank p = 0.003），尤其是住院中的死亡率，CABG組遠高於DES組（15.9% vs 2.2%）。總MACCE在短或長期的術後追蹤，兩組無差異。 住院天數在CABG組，平均住院天數36.1 39.9天；DES10.7 20.8天（p < 0.01），T值5.5（p < 0.001）。住院費用方面，因本研究病患人數不高，加上住院費用之間有極大的變異，為採Log10取對數後，再進行兩術式間住院費用T檢定結果。CABG術式平均費用指數5.6 ± 0.5仍顯著大於DES平均費用指數5.2 ± 0.3（t = 6.43，p < 0.001）。相較於CABG在標的手術當次住院，DES置入術的費用低廉許多。 MACCE為血管再疏通、心肌梗塞、死亡、中風等心血管負面事件的發生事件總和，影響因子包括：女性、單條血管介入、標的手術為急性心肌梗塞狀態，且最後者為關鍵因素。 結論 這類高風險的冠狀血管疾病患者，應優先考慮以塗藥支架為主的介入性手術。
並列摘要
Background： In Taiwan，the incidence and prevalence rate of end stage renal disease（ESRD）increase gradually year by year。Data from prospective studies support that cardiovascular diseases，including coronary artery disease（CAD），remains the most common cause of death（45%）in patient with ESRD。Percutaneous coronary intervention（PCI）or coronary artery bypass surgery （CABG）should be performed in patients with severe stenotic lesions of coronary artery。However，the efficiency and safety of such a strategy has not been studied so far in hemodialysis-dependence patients。In my study，I assessed the optimal strategy and compared drug-eluting stent（DES）and CABG for treating coronary artery disease in clinical effect and medical utilities。 Methods： This cross-sectional cohort study obtained from national health insurance research database and restricted the period between 2007 and 2013。The goal in this analysis was to investigate in patients with dialysis-dependence whether the favorable outcome in DES（134 patients）and CABG（88 patients）persisted over 7 years of follow-up included CAD associated re-admission、revascularization、mortality rate、stroke、myocardial infarction，which were composition of major adverse cardiac and cerebrovascular event（MACCE）。Medical utility analyzed the length of stays（LOS）and hospital expenses in the index intervention。Binary logistic regression analysis was used for prognostic analysis of MACCE。 Results： The risk of CAD associated re-admission during first year after procedure of CABG and DES implantation was no difference（OR = 0.91，p = 0.4），the following 6 years with same result。The event-free rate of any coronary revascularization after CABG was marked higher after DES implantation persisted over 7 years of follow-up（log-rank p < 0.0001）。When compared with CABG, there was increased all-cause mortality-free rate（log-rank p = 0.003）in patients who underwent PCI with DES in long-term follow up；in-hospital mortality rate was significant higher after CABG（15.9% vs 2.2%）。In patients underwent CABG or PCI，cumulative 7-year overall myocardial infarction，stroke and composite MACCE had similar risk。 Data from my study of DES compared with CABG has showed significant reduction in length of stay（CABG 36.1 39.9 vs DES 10.7 20.8 day，p < 0.01），T ＝ 5.5（p < 0.001）。Log transformation（Log10）was used in total hospital expenses which existed great variation between each group and small sample size。Compared with DES，average total cost in CABG was significantly higher on discharge（5.6 ± 0.5 v.s. DES 5.2 ± 0.3，t = 6.43，p < 0.001）。PCI with DES implantation was showed to be cost-saving procedure compared with CABG in index procedure admission。 MACCE，composite of revascularization、myocardial infarction、death and stroke，means whole adverse events associated with coronary artery disease。In our study the correlation factors included：female，single-vessel-disease and the most important - myocardial infraction status in index procedure。 Conclusion： PCI with DES implantation is clinical and economically attractive revascularization strategy compared with CABG in this high-risky group