直接支架術與預擴張支架術治療冠心病的Meta分析_《中國循證醫學雜志》

作者：

劉蕾 ^1,2 , 馬彬 ¹ , 楊克虎 ¹ ,  姚亞麗 ²

1. 蘭州大學循證醫學中心（蘭州 730000）；2. 蘭州大學第一臨床醫院（蘭州 730000）;

關鍵詞：

接支架術預擴張支架術 Meta分析隨機對照試驗

DOI：

10.7507/1672-2531.20120136

視頻：

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目的　系統評價冠脈內直接支架術和需球囊的預擴張支架術兩種介入方法的安全及有效性。
方法　采用Cochrane系統評價方法，計算機檢索PubMed、EMbase、Cochrane Library（2011年第3期）、CBMdisc、VIP、CNKI，檢索時間從建庫截至 2011年4月，納入中外文關于冠脈內直接支架術和球囊預擴張后支架術的RCT。由兩名評價者獨立評價納入研究質量、提取資料并交叉核對后，采用 RevMan 5.0軟件進行Meta分析。
結果　共納入24個RCT，6 666例患者。結果顯示：與預擴張支架術相比，直接支架術手術時間短［MD=–3.36，95%CI（–4.41，–2.30），P lt;0.000 01］，但在手術過程中急性管腔獲得［MD=–0.01，95%CI（–0.04，0.02），P=0.64］、隨訪6個月時的主要心臟不良事件率［OR=0.89，95%CI（0.69，1.14），P=0.35］、再狹窄率［OR=1.02，95%CI（0.82，1.26），P=0.88］方面，兩組差異無統計學意義。
結論　當前證據表明，直接支架術并不優于預擴張支架術。今后的臨床研究仍需開展大規模設計良好的隨機對照試驗和盡可延長隨訪時間。

引用本文： 劉蕾,馬彬,楊克虎,姚亞麗. 直接支架術與預擴張支架術治療冠心病的Meta分析. 中國循證醫學雜志, 2012, 12(7): 764-769. doi: 10.7507/1672-2531.20120136 復制

1.	陸再英, 鐘南山, 等. 內科學(第7版). 人民衛生出版社, 2008: 272.
2.	顏紅兵, 朱小玲, 高海. 冠心病介入治療臨床隨機試驗. 中國環境科學出版社, 2005: 簡介.
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6.	Kovar LI, Monrad ES, Sherman W, et al. A randomized trial of stenting with or without balloon predilatation for the treatment of coronary artery disease. Am Heart J, 2001, 142(5): E9.
7.	Carrie D, Khalife K, Citron B, et al. for the BET Study Group. Comparison of direct coronary stenting with and without balloon predilatation in patients with stable angina pectoris. Am J Cardiol, 2001, 87(6): 693-698.
8.	Baim DS, Flatley M, Caputo R, et al. Comparison of PRE-dilatation vs Direct stenting In Coronary Treatment using the Medtronic AVE S670 coronary stent system (the PREDICT Trial). Am J Cardiol, 2001, 88(12): 1364-1369.
9.	Le Breton H, Boschat J, Commeau P, et al. for the Stent Without Balloon Predilatation (SWIBAP) Study Group.Randomised comparison of coronary stenting with and without balloon predilatation in selected patients. Heart, 2001, 86(3): 302-308.
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11.	Loubeyre C, Morice MC, Lefe ´vre T, et al. A randomized comparison of direct stenting with conventional stent implantation in selected patients with acute myocardial infarction. J Am Coll Cardiol, 2002, 39(1): 15-21.
12.	Martinez-Elbal L, Ruiz-Nodar JM, Zueco J, et al, for the DISCO Investigators. Direct coronary stenting versus stenting with balloon pre-dilation: immediate and follow-up results of a multicentre, prospective,randomized study. The DISCO trial. DIrect Stenting of COronary Arteries. Eur Heart J, 2002, 23(8): 633-640.
13.	Sabatier R, Hamon M, Zhao QM, et al. Could direct stenting reduce no-reflow in acute coronary syndromes? A randomized pilot study. Am Heart J, 2002, 143(6): 1027-1032.
14.	Brueck M, Scheinert D, Wortmann A, et al. Direct Coronary Stenting Versus Predilatation Followed by Stent Placement. Am J Cardiol, 2002, 90(11): 1187-1192.
15.	Ballarino MA, Moreyra E, Damonte A, et al. Multicenter Randomized Comparison of Direct vs.Conventional Stenting: The DIRECTO Trial. Cathet Cardiovasc Intervent, 2003, 58(4): 434-440.
16.	Airoldi F, Mario CD, Gimelli G, et al. A Randomized Comparison of Direct Stenting Versus Stenting With Predilatation in Native Coronary Artery Disease: Results from the Multicenter CROSSCUT Study. J Invas Cardiol, 2003, 15(1): 1-5.
17.	Ijsselmuiden AJJ, Serruys PW, Scholte A, et al. Direct coronary stent implantation does not reduce the incidence of in-stent restenosis or major adverse cardiac events. Eur Heart J, 2003, 24(): 421-429.
18.	Hoffmann R, Takimoglu-Boerekci M, Langenberg R, et al. Randomized comparison of direct stenting with predilatation followed by stenting on vessel trauma and restenosis. Am Heart J, 2004, 147(4): E13.
19.	López-Palop R, Pinar E, Lozano Í, et al. Comparison of Intracoronary Ultrasound Expansion Parameters in Coronary Stents Implanted With or Without Balloon Predilatation. A Randomized Intravascular Ultrasound Study. Rev Esp Cardiol, 2004, 57(5): 403-411.
20.	Mehilli J, Kastrati A, Dirschinger J, et al. Intracoronary Stenting and Angiographic Results: Restenosis After Direct Stenting Versus Stenting With Predilation in Patients With Symptomatic Coronary Artery Disease (ISAR-DIRECT Trial). Cathet Cardiovasc Intervent, 2004, 61(2): 190-195.
21.	Balachandran KP, Singh B, Sandilands A, et al. Functional result following direct coronary artery stenting with drug eluting stents in chronic stable angina is similar to stenting after balloon predilatation. International Journal of Cardiology, 2008, 128(3): 374-377.
22.	Wijns W, Verheye S, Manoharan G, et al. Angiographic, intravascular ultrasound, and fractional flow reserve evaluation of direct stenting vs. conventional stenting using BeStent2 in a multicentre randomized trial. Eur Heart J, 2005, 26(18): 1852-1859.
23.	Dawkins KD, Chevalier B, Suttorp MJ, et al. Effectiveness of “Direct” Stenting Without Balloon Predilatation (from the Multilink Tetra Randomised European Direct Stent Study [TRENDS]). Am J Cardiol, 2006, 97(3): 316-321.
24.	Ozdemir R, Sezgin AT, Barutcu I, et al. Comparison of Direct Stenting Versus Conventional Stent Implantation on Blood Flow in Patients With ST-Segment Elevation Myocardial Infarction. Angiology, 2006, 57(4): 453-458.
25.	Gasior M, Gierlotka M, Lekston A, et al. Comparison of Outcomes of Direct Stenting Versus Stenting After Balloon Predilation in Patients With Acute Myocardial Infarction (DIRAMI). Am J Cardiol, 2007, 100(5): 798-805.
26.	Cuisset THamilos M, Melikian N, et al. Direct Stenting for Stable Angina Pectoris Is Associated With Reduced Periprocedural Microcirculatory Injury Compared With Stenting After Pre-Dilation. J Am Coll Cardiol, 2008, 51(11): 1060-1065.
27.	劉曉堃, 傅向華. 直接冠狀動脈內支架術與球囊預擴張后支架術的對比研究. 中國綜合臨床, 2002, 18(10): 890.
28.	中國衛生部. 2008年我國公共衛生事業發展公報. 2009.
29.	周玉杰. 支架血栓2009: 現狀與展望. Available at: http://med.haoyisheng.com/09/1028/310046724.html.
30.	Rogers C, Parikh S, Seifert P, et al. Endogenous cell seeding: remnant endothelium after stenting enhances vascular repair. Circulation, 1996, 94(11): 2909-2914.

1. 陸再英, 鐘南山, 等. 內科學(第7版). 人民衛生出版社, 2008: 272.
2. 顏紅兵, 朱小玲, 高海. 冠心病介入治療臨床隨機試驗. 中國環境科學出版社, 2005: 簡介.
3. Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions: version 5.0.1 Cochrane Collaboration, 2008.
4. Danzi GB, Capuano C, Fiocca L, et al. Stent implantation in patients with a single, noncalcified coronary artery lesion. Am J Cardiol, 1999, 84(10): 1250-1253.
5. Ormiston JA, Webster MWI, Ruygrok PN, et al. A randomized study of direct coronary stent delivery compared with stenting after predilatation: the NIR Future Trial. Cathet Cardiovasc Intervent, 2000, 50(4): 377-381.
6. Kovar LI, Monrad ES, Sherman W, et al. A randomized trial of stenting with or without balloon predilatation for the treatment of coronary artery disease. Am Heart J, 2001, 142(5): E9.
7. Carrie D, Khalife K, Citron B, et al. for the BET Study Group. Comparison of direct coronary stenting with and without balloon predilatation in patients with stable angina pectoris. Am J Cardiol, 2001, 87(6): 693-698.
8. Baim DS, Flatley M, Caputo R, et al. Comparison of PRE-dilatation vs Direct stenting In Coronary Treatment using the Medtronic AVE S670 coronary stent system (the PREDICT Trial). Am J Cardiol, 2001, 88(12): 1364-1369.
9. Le Breton H, Boschat J, Commeau P, et al. for the Stent Without Balloon Predilatation (SWIBAP) Study Group.Randomised comparison of coronary stenting with and without balloon predilatation in selected patients. Heart, 2001, 86(3): 302-308.
10. Brito FS, Caixeta AM, Perin MA, et al, on behalf of the DIRECT Study Investigators. Comparison of direct stenting versus stenting with predilation for the treatment of selected coronary narrowings. Am J Cardiol, 2002, 89(2): 115-120.
11. Loubeyre C, Morice MC, Lefe ´vre T, et al. A randomized comparison of direct stenting with conventional stent implantation in selected patients with acute myocardial infarction. J Am Coll Cardiol, 2002, 39(1): 15-21.
12. Martinez-Elbal L, Ruiz-Nodar JM, Zueco J, et al, for the DISCO Investigators. Direct coronary stenting versus stenting with balloon pre-dilation: immediate and follow-up results of a multicentre, prospective,randomized study. The DISCO trial. DIrect Stenting of COronary Arteries. Eur Heart J, 2002, 23(8): 633-640.
13. Sabatier R, Hamon M, Zhao QM, et al. Could direct stenting reduce no-reflow in acute coronary syndromes? A randomized pilot study. Am Heart J, 2002, 143(6): 1027-1032.
14. Brueck M, Scheinert D, Wortmann A, et al. Direct Coronary Stenting Versus Predilatation Followed by Stent Placement. Am J Cardiol, 2002, 90(11): 1187-1192.
15. Ballarino MA, Moreyra E, Damonte A, et al. Multicenter Randomized Comparison of Direct vs.Conventional Stenting: The DIRECTO Trial. Cathet Cardiovasc Intervent, 2003, 58(4): 434-440.
16. Airoldi F, Mario CD, Gimelli G, et al. A Randomized Comparison of Direct Stenting Versus Stenting With Predilatation in Native Coronary Artery Disease: Results from the Multicenter CROSSCUT Study. J Invas Cardiol, 2003, 15(1): 1-5.
17. Ijsselmuiden AJJ, Serruys PW, Scholte A, et al. Direct coronary stent implantation does not reduce the incidence of in-stent restenosis or major adverse cardiac events. Eur Heart J, 2003, 24(): 421-429.
18. Hoffmann R, Takimoglu-Boerekci M, Langenberg R, et al. Randomized comparison of direct stenting with predilatation followed by stenting on vessel trauma and restenosis. Am Heart J, 2004, 147(4): E13.
19. López-Palop R, Pinar E, Lozano Í, et al. Comparison of Intracoronary Ultrasound Expansion Parameters in Coronary Stents Implanted With or Without Balloon Predilatation. A Randomized Intravascular Ultrasound Study. Rev Esp Cardiol, 2004, 57(5): 403-411.
20. Mehilli J, Kastrati A, Dirschinger J, et al. Intracoronary Stenting and Angiographic Results: Restenosis After Direct Stenting Versus Stenting With Predilation in Patients With Symptomatic Coronary Artery Disease (ISAR-DIRECT Trial). Cathet Cardiovasc Intervent, 2004, 61(2): 190-195.
21. Balachandran KP, Singh B, Sandilands A, et al. Functional result following direct coronary artery stenting with drug eluting stents in chronic stable angina is similar to stenting after balloon predilatation. International Journal of Cardiology, 2008, 128(3): 374-377.
22. Wijns W, Verheye S, Manoharan G, et al. Angiographic, intravascular ultrasound, and fractional flow reserve evaluation of direct stenting vs. conventional stenting using BeStent2 in a multicentre randomized trial. Eur Heart J, 2005, 26(18): 1852-1859.
23. Dawkins KD, Chevalier B, Suttorp MJ, et al. Effectiveness of “Direct” Stenting Without Balloon Predilatation (from the Multilink Tetra Randomised European Direct Stent Study [TRENDS]). Am J Cardiol, 2006, 97(3): 316-321.
24. Ozdemir R, Sezgin AT, Barutcu I, et al. Comparison of Direct Stenting Versus Conventional Stent Implantation on Blood Flow in Patients With ST-Segment Elevation Myocardial Infarction. Angiology, 2006, 57(4): 453-458.
25. Gasior M, Gierlotka M, Lekston A, et al. Comparison of Outcomes of Direct Stenting Versus Stenting After Balloon Predilation in Patients With Acute Myocardial Infarction (DIRAMI). Am J Cardiol, 2007, 100(5): 798-805.
26. Cuisset THamilos M, Melikian N, et al. Direct Stenting for Stable Angina Pectoris Is Associated With Reduced Periprocedural Microcirculatory Injury Compared With Stenting After Pre-Dilation. J Am Coll Cardiol, 2008, 51(11): 1060-1065.
27. 劉曉堃, 傅向華. 直接冠狀動脈內支架術與球囊預擴張后支架術的對比研究. 中國綜合臨床, 2002, 18(10): 890.
28. 中國衛生部. 2008年我國公共衛生事業發展公報. 2009.
29. 周玉杰. 支架血栓2009: 現狀與展望. Available at: http://med.haoyisheng.com/09/1028/310046724.html.
30. Rogers C, Parikh S, Seifert P, et al. Endogenous cell seeding: remnant endothelium after stenting enhances vascular repair. Circulation, 1996, 94(11): 2909-2914.

《中國循證醫學雜志》

直接支架術與預擴張支架術治療冠心病的Meta分析

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《中國循證醫學雜志》

直接支架術與預擴張支架術治療冠心病的Meta分析

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