背景　過往研究主要使用隨機對照試驗探討經皮冠狀動脈介入治療的效果，僅少數研究使用真實世界的數據分析，並且這些研究大多使用心導管侵入性檢查收錄患者。本觀察性研究目的為探討使用非侵入性檢查納入的慢性冠狀動脈心臟病（Chronic coronary syndrome, CCS）患者，比較兩種不同治療模式，即只需藥物治療而未有支架置入，與放置支架相比，在長期追蹤下之臨床不良結果的差異。本研究對象為經由非侵入性方式診斷的CCS患者，並提出以下假設：支架置入與否對於CCS患者在發生全因死亡、非致死性心肌梗塞、重複血管重建及主要心血管事件風險沒有差異。
方法　本研究採用回溯型世代追蹤研究，資料來源使用2012-2018年成大醫院心血管疾病資料庫，串連2009-2022年心導管紀錄、2009-2022年成醫資訊室之患者藥物紀錄以及2013-2022衛生福利部資料科學中心全國全因死亡紀錄。研究設計使用landmark design，將landmark time設為檢查後一年，期間接受支架置入者為支架組，其餘為藥物組。研究樣本總共納入6584名CCS患者，透過傾向分數1:4配對方式對干擾因子進行控制，形成具可比性之兩個分析樣本。使用Kaplan-Meier方法及累積發生函數（Cumulative Incidence Function, CIF）估計兩組在四個追蹤終點各自的累積發生率，接著使用Cox比例風險模型檢定四個追蹤終點的發生風險，並以抗血栓或他汀類藥物依從度達80%與否進行分組、支架的傾向分數以及樣本特質進行分層分析，同時檢定支架與分層變項的交互作用。
結果　支架治療組相比藥物治療組，在死亡風險（aHR=1.10，P=0.25）和心肌梗塞風險（aHR=1.06，P=0.71）皆無顯著差異，但在重複血管重建風險（aHR=1.73，P<.0001）和主要心血管事件風險（aHR=1.41，P<.0001）顯著較高。藥物依從度分層分析顯示，死亡風險隨藥物依從度降低而增加（≧80%，aHR=1.06；<80%，aHR=1.66），支架與藥物依從度的交互作用項在統計上達顯著（P=0.04）；心肌梗塞風險不隨藥物依從度分層而有變化；在重複血管重建方面，風險顯著隨藥物依從度降低而顯著增加（≧80%，aHR=1.51；<80%，aHR=2.94），交互作用檢定顯著（P ＝0.0023）；在主要心血管事件方面，風險同樣隨藥物依從度降低而顯著增加（≧80%，aHR=1.30；<80%，aHR=2.09），交互作用檢定顯著（P＝0.0024）。傾向分數分層分析顯示，當傾向分數越低時，支架組相比藥物組的重複血管重建及主要心血管事件風險越高，且支架與傾向分數分層的交互作用有顯著差異。次族群分析顯示，在不同樣本特質分層的次族群當中，支架治療相比於藥物治療皆在主要心血管事件的風險較高，但支架與次族群的交互作用，僅在女性顯著。本研究另外執行三項敏感度分析，包含使用傾向分數加權、更改研究族群定義，結果皆與主分析一致，顯示使用支架治療在發生死亡及心肌梗塞與藥物治療無差異，低藥物依從度患者放置支架，會比沒放支架增加死亡及重複血管重建風險。
討論　本研究是使用非侵入性檢查收錄陽性患者之觀察性研究，與過去隨機試驗研究大多使用侵入性檢查收錄患者不同，但更符合實際臨床狀況。根據結果顯示，支架治療相比於單純藥物治療，發生死亡及心肌梗塞的風險並無顯著差異，且患者接受支架置入後藥物依從度較差的，發生術後不良臨床結果的風險更高，建議臨床醫師與CCS患者共同討論使用心臟支架的必要性，以減少無效的支架置入。本研究具有多項優勢，包括填補國內過去缺少比較慢性冠心症患者支架置入與藥物治療成效的文獻缺口。本研究採用非侵入性檢查方法，更貼近日常臨床狀況，使結果更具實用價值。此外，將抗血栓與他汀類等藥物視為控制變項，並將藥物依從度納入分層分析，可更精確地評估支架治療的獨立效果。本研究使用臨床資料，相比行政申報數據，獲得更詳細的生理指標數據。然而，本研究也有幾項限制: 首先，僅使用單間醫院的資料，代表性及外推性較低。其次，無法取得部分重要臨床數據，例如血管阻塞程度及心絞痛分級，可能導致治療效果的不確定性，亦無法得知患者在生活習慣上的改善情況，使用非侵入性檢查也存在診斷偽陰性、偽陽性的問題。儘管使用配對及加權方法減少干擾因子影響，但在觀察性研究中難以完全避免其他因素干擾，需謹慎解讀結果。建議未來研究使用全國性或多間醫院的臨床資料庫進行分析，以增加研究之外推性。

This study used non-invasive examinations to select patients in an observational study. The aims were to investigate long-term outcomes in chronic coronary syndrome (CCS) patients with or without stent placement, hypothesizing no difference in all-cause mortality, non-fatal myocardial infarction, revascularization, or major adverse cardiac events (MACE) between treatments. Using a retrospective cohort design, data from the Cardiovascular Disease Databank at National Cheng Kung University Hospital (2012-2018) were linked with catheterization records (2009-2022), medication records (2009-2022), and national mortality records (2013-2022). A total of 6,584 CCS patients were included, with two groups of the stent vs. the medication only group created using 1:4 propensity score matching on the likelihood of receiving stents. Kaplan-Meier methods and Cox proportional hazards models were used to assess risks, with analyses based on medication adherence, stent propensity score, and patient characteristics. Results showed the stent group had no significant difference in the hazards of death (aHR=1.10, P=0.25) and the hazards of myocardial infarction (aHR=1.06, P=0.71) between stent and medication groups, but higher hazards revascularization (aHR=1.73, P<.0001) and MACE (aHR=1.41, P<.0001) than the medication only group. Poor medication adherence increased the hazards of death and revascularization. Subgroup analysis indicated that stent treatment increased the hazards of MACE across all subgroups, particularly among women. Sensitivity analyses confirmed the results of the main findings. The recommendation is for clinicians to discuss with CCS patients the necessity of using stents to reduce ineffective placements.

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