臺灣博碩士論文加值系統

傳統平面氣球擴張術(Plain Old Balloon Angioplasyt, POBA)用於治療冠狀動脈分叉病灶效果並不理想，新的手術方法如：冠狀動脈內粥狀硬塊切除術 (Directional Coronary Atherectomy, DCA)、非塗藥物支架(Bare Metal Stent, BMS)置放術、塗藥物支架(drug eluting stent, DES)置放術、和帶刀片氣球擴張術(cutting balloon angioplasty, CBA )，治療效果雖然較好，但沒有相關研究比較新的手術方法和傳統平面氣球擴張術用於治療冠狀動脈分叉病灶的成本差異。
自彰化基督教醫院接受冠狀動脈氣球擴張術患者中，收集法國巴黎心臟協會(Institute Cardiovascular Paris Sud, ICPS)定義之冠狀動脈分叉病灶分類中的第1型患者，以1：1隨機分派接受帶刀片氣球擴張術和傳統平面氣球擴張術，每組各15人。紀錄第一次手術和追蹤六個月以後心導管的手術時間、輻射線劑量、顯影劑使用量、氣球使用量、放支架個數、保栓通(Plavix)和手術直接成本。分析比較兩種手術的成本結構。。
接受帶刀片氣球擴張術這組第一次手術之手術時間、輻射線劑量、顯影劑用量、和手術直接成本都明顯較傳統平面氣球擴張術這組來得高(p<0.003)，氣球使用量也有較多趨勢(1.9±0.5 V.S 2.3±0.7, p＝0.056)。6個月追蹤時，接受帶刀片氣球擴張術這組患者的手術直接成本也明顯高於傳統平面氣球擴張術這組(19386±25387 vs 29588±26744, P=0.03)。但在手術時間、輻射線劑量，顯影劑用量、和氣球使用量方面並無統計上差異(p=0.1)。若將兩次手術的手術直接成本合併計算，則帶刀片氣球擴張術這組明顯高於傳統平面氣球擴張術(72380±49350 vs 136201±51524, P＝0.002)。由本研究的結果顯示影響手術時間的因素包括：使用帶刀片氣球擴張術和血管鈣化嚴重(P＝0.004)。會增加手術直接成本的因素則有：使用帶刀片氣球(P＝0.002)、血管鈣化厲害(P＝0.004)、和左前降支阻塞(P＝0.007)。若以皮爾森相關係數 r進一步分析手術時間和手術直接成本之關連性則r值為0.64屬低度正相關。若將血管鈣化扭曲和歪角的分數加起來，則所得分數和手術直接成本的r值為0.53屬低度正相關。
針對真正冠狀動脈分叉病灶合併有中度以下鈣化的病灶，帶刀片氣球擴張術可能會減少手術時間和成本，但減少的程度有限，不足以抵銷帶刀片氣球本身增加的成本，因此對真正冠狀動脈分叉病灶合併有中度以上鈣化的病灶，基於成本考量不建議使用帶刀片氣球擴張術。

In the plain old balloon angioplasty era, the risk of side branch occlusion was high after percutaneous coronary intervention(PCI). The cutting balloon angioplasty is theoretically able to prevent uncontrolled damage to the vessel wall and pressure injury and plaque shift. This prospective study compared the procedural costs of cutting balloon angioplasty with plain old balloon angioplasty for treatment of coronary bifurcation lesion.
From May 2007 to Oct 2008, a total of 30 patients with Institute Cardiovasculaire Paris(ICPS) classification type 1 lesions were randomized to either plain old balloon angioplasty or cutting balloon angioplasty. There was no significant differences in baseline characteristics, vessel size, minimal lumen diameter and severe of stenosis between the two groups. There was a significantly longer procedure time and fluoroscopy time, a higher procedural cost , and a greater volume of contrast used in cutting balloon angioplasty group (NTD$ 136201±51524 vs 72380±49350 p=0.002). The angiographic lesion calcification (p=0.004) and elected procedure (p=0.003) were independent predictors of procedure time. The predictors of procedural costs were elected procedure (p=0.002), angiographic lesion calcification (p=0.004), and left anterior descending artery lesion (p=0.007).
In conclusion, for patients with ICPS classification type I and moderately calcified lesion, cutting balloon angioplasty is not the first choice of intervention.

摘要 II
ABSTRACT III
圖目錄 VI
表目錄 VII
第一章 緒論 1
1.1 研究動機和目的 1
第二章 文獻探討 4
2.1 傳統平面氣球治療冠狀動脈分叉病灶的相關文獻 4
2.2 冠狀動脈內粥狀硬塊切除術 5
2.3 非塗藥物支架時期 6
2.4 塗藥物支架時期 6
2.5 帶刀片氣球時期 8
2.6 適當醫療決策的成本效益評估－以心絞痛為例 8
第三章 研究方法 10
3.1 問題定義 10
3.1.1 名詞定義 10
3.2 研究設計與步驟 12
3.2.1 樣本來源 12
3.2.2 研究設計與步驟 13
3.2.3 手術方法 13
3.2.4 手術總花費的計算 15
3.2.5 統計分析 15
第四章 案例分析討論 16
4.1 患者基本資料和罹患冠狀動脈疾病之危險因子 16
4.2 冠狀動脈定量分析 16
4.3 手術成本分析 19
第五章 討論與建議 25
5.1 討論 25
5.2 建議 27
5.3 研究限制 28
參考文獻 29


圖目錄
圖1.1 Yves Louvard對冠狀動分支的分類 2
圖1.2. 各種不同手術方法. 3
圖4.1 各種使用氣球情境 24


表目錄
表4.1 患者基本資料和罹患冠狀動脈疾病之危險因子 17
表4.2 手術前、後、和六個月後追蹤之管徑 18
表4.3 第一次手術和六個月後的花費成本 20
表4.4 影響手術時間的因素分析： 21
表4.5影響總花費的因素分析： 22
表4.6總花費和手術時間與病灶之間的關係： 23

1.Al Suwaidi J, Berger PB, Rihal CS, Garratt KN, Bell MR, Ting HH, et al. Immediate and long-term outcome of intracoronary stent implantation for true bifurcation lesions. J Am Coll Cardiol.2000;35:929-936
2.Bourassa MG, Lesperance J, Eastwood C, et al: Clinical, physiologic, anatomic and procedural factors predictive of restenosis after percutaneous transluminal coronary angioplasty. J Am Coll Cardiol. 1991;18:368-376.
3.Collins N, Seidelin PH, Daly P, Ivanor J, Barolet A, Mackie K, et al. Long-term outcomes after percutaneous coronary intervention of bifurcation narrowings. Am J Cardiol. 2008;102:404-410.
4.Colombo A, Moses JW, Morice MC, Ludwig J, Holmes Jr DR, Spanos V, et al. Randomized study of evaluate Sirolimus-eluting stents implanted at coronary bifurcation lesion. Circulation. 2004;109:1244-1249.
5.Dahm JB, Dorr M, Scholz E, Ruppert J, Hummel A, Staudt A, et al. Cutting-balloon angioplasty effectively facilitates the interventional procedure and leads to a low rate of recurrent stenosis in ostial bifurcation coronary lesions: a subgroup analysis of the NICECUT multicenter registry. Int J Cardiol. 2007:1-6.
6.Dauerman HL, Higgins PJ, Sparano AM, Gibson CM, Garber GR, Carrozza JP, et al. Mechanical debulking versus balloon angioplasty for the treatment of true bifurcation lesions. J Am Coll Cardiol. 1998;32:1845-1852.
7.Freed M, Grines C, Safian DS. The New Manual of Interventional Cardiology. Birmingham, Michigan: Division of Cardiology William Beaumont Hospital Royal Dak. 1998;243-261.
8.George BS, Myler RK, Stertzer SH, Clark DA, Cote G, Shaw RE, et al. Balloon angioplasty of coronary bifurcation lesions: the kissing balloon technique. Cathet Cardiovasc Diagn. 1986;12:124-138.
9.Griffin SC, Barber JA, Manca A, Sculpher MJ, Thompson SG, Buxton MJ, et al. Cost effectiveness of clinically appropriate decisions on alternative treatments for angina pectoris: prospective observational study. BMJ 2007;334:624-631.
10.Lee MS, Singh V, Nero TJ, Wilentz JR. Review: cutting balloon angioplasty. J Invas Cardiol.2002;14(9):552-556.
11.Lewis BE, Leya FS, Johnson SA. Assessment of outcome of bifurcation lesions and non-bifurcation lesions treated in the CAVEAT trial. CAVEAT investigatory group. J Invas Cardiol. 1995;7:251-258.
12.Louvard Y, Lefevre T, Morice MC. Percutaneous coronary Intervention for bifurcation coronary disease. Heart. 2004;90:713-722.
13.Meier B, Gruentzig AR, King III SB, Douglas Jr JS, Hollman J, Ischinger T, et al. Risk of side branch occlusion during coronary angioplasty. Am J Cardiol. 1984;53:10-14.
14.Movahed MR, Kern K, Thai H, Ebrahimi R, Friedman M, Slepian M, et al. Coronary artery bifurcation lesions: a review and update on classification and interventional techniques. Cardiovasc Rev Med. 2008;9:263-268.
15.Pan M, Suarez de Lezo J, Medina A, Romero M, Segura J, Pavlovic D, et al. Rapamycin-eluting stents for the treatment of bifurcated coronary lesions: a randomized comparison of a simple versus complex strategy. Am Heart J. 2004;148:857-864.
16.Rupprecht HJ, Brennecke R, Bernhard G, et al: Analysis of risk factors for restenosis after percutaneous transluminal coronary angioplasty. Cathet Cardiovasc Diagn 1990;19:151-159.
17.Ryan TJ, Faxon DP, Gunnar RM, et al: Guidelines for percutaneous transluminal coronary angioplasty: A report of the American college of Cardiology/American Heart association Task force on assessment of diagnostic and therapeutic cardiovascular procedures (subcommittee of percutaneous transluminal coronary angioplasty). J Am Coll Cardiol. 1998;12:519..
18.Sheehan FH, Braunwald E, Canner P, Dodge HT, Gore J, Van Natta P, et al. The effect of intravenous thrombolytic therapy on left ventricular function: a report on tissue-type plasminogen activator and streptokinase from the Thrombolysis in Myocardial Infarction(TIMI) phase I Trial. Circulation.1987;72:817-829.
19.Siber S, Albertsson P, Fernandez-Aviles F, Camici P.G., Colombo A, Hamm C, et al. Guidelines for percutaneous coronary intervention. The Task for percutaneous coronary interventions of the European society of cardiology. European Heart Journal. 2005;36:804-847.
20.Steigen TK, Maeng M, Wiseth R, Erglis A, Kumsars I, Inga N, et al. Randomized study on simple versus complex stenting of coronary artery bifurcation lesions: the Nordic bifurcation study. Circulation. 2006;114:1955-1961.
21.Takebayashi H, Haruta S, Kohno H, Ichinose H, Taniguchi M, Shimakura T, et al. Immediate and 3-month follow-up outcome after cutting balloon angioplasty for bifurcation lesions. J Interven Cardiol. 2004;17:1-7.
22.Weinstein JS, Baim DS, Sipperly ME, McCabe CH, Lorell BH. Salvage of branch vessels during bifurcation lesion angioplasty: acute and long-term follow-up. Cathet Cardiovasc Diagn. 1991;22:1-6.
23.Yamashita T, Nishida T, Adamian MG., Briguori C, Vaghetti M, Corvaja N, et al. Bifurcation lesions: two stents versus one stent -immediate and follow-up results. J Am Coll Cardiol.2000;35:1145-1151.