經皮冠脈介入術后雙聯抗血小板治療時限的系統評價_《中國循證醫學雜志》

作者：

巴巴音斯勒瑪 ,  馬依彤 , 于子翔 , 楊毅寧 , 馬翔 , 李曉梅 , 謝翔

新疆醫科大學第一附屬醫院心臟中心冠心病一科（烏魯木齊 830054）;

關鍵詞：

經皮冠脈介入術抗血小板治療 Meta分析系統評價隨機對照試驗隊列研究

DOI：

10.7507/1672-2531.20120093

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目的　系統評價經皮冠狀動脈介入術后雙聯抗血小板治療的病程、療效及安全性的關系。
方法　計算機檢索Cochrane Library、MEDLINE、EMbase、CBM、CNKI和WanFang Data，納入所有比較經皮冠脈介入術后雙聯抗血小板短療程（≤6個月）與長療程（ gt;6個月）療效及安全性比較的隨機對照試驗（RCT）和觀察性研究，由兩名評價員按照納入與排除標準選擇文獻、提取資料和評價質量后，采用RevMan 5.1軟件進行Meta分析。
結果　共納入8篇文獻，其中3個為RCT（共計7 475例患者），5個為隊列研究（共計12 744例患者）。對RCT的Meta分析結果顯示：長療程雙聯抗血小板治療組的死亡或心肌梗死事件發生率較短療程組低［OR=0.74，95%CI（0.56，0.98），P lt;0.000 1］；短療程組出現嚴重出血事件的發生率較長療程組低，但兩組差異無統計學意義［OR=1.29，95%CI（0.99，1.69），P=0.06］。對觀察性研究的Meta分析結果顯示：長療程組的死亡或心梗發生率較短療程組低［OR=0.7，95%CI（0.45，1.08），P=0.11］，應用Meta回歸探討隊列研究間的異質性，結果提示研究年限、隨訪時間對異質性有貢獻（Z=3.61，P=0.000）；而且長療程組的晚期支架內血栓也較短療程組發生率低［OR=0.40，95%CI（0.15，1.07），P=0.07］。
結論　經皮冠狀動脈介入術后長療程（ gt;6個月）雙聯抗血小板治療能降低患者死亡或心肌梗死的發生率，而不會明顯增加嚴重出血事件發生率；同時，長療程組還有降低晚期支架內血栓發生的趨勢。但更長療程雙聯抗血小板治療（ gt;12月）則未見明顯優勢。

引用本文： 巴巴音斯勒瑪,馬依彤,于子翔,楊毅寧,馬翔,李曉梅,謝翔. 經皮冠脈介入術后雙聯抗血小板治療時限的系統評價. 中國循證醫學雜志, 2012, 12(5): 577-582. doi: 10.7507/1672-2531.20120093 復制

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12.	Liu M, Zhang SH. Intention to treat analysis in clinical trials. BMJ (Chinese edition), 2001, 4(4): 223-224.
13.	劉建平. 非隨機研究的系統評價. 中國循證醫學, 2001, 1(3): 137-139.
14.	Stroup DF, Berlin JA, Morton SC, et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA, 2000, 283(15): 2008-2012.
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16.	Steven R, Steinhubl, Peter B. Early and Sustained Dual Oral Antiplatelet Therapy Following Percutaneous Coronary Intervention. JAMA, 2002, 288(19): 2411-2420.
17.	Park SJ, Park WD, Kim YH. Duration of Dual Antiplatelet Therapy after Implantation of Drug-Eluting Stents. N Engl J Med, 2010, 362: 1374-1382.
18.	Eisenstein EL, Anstrom KJ, Kong DF, et al. Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA, 2007, 297(2): 159-168.
19.	Brar SS, Kim J, Brar SK, et al. Long-Term Outcomes by Clopidogrel Duration and Stent Type in a Diabetic Population With De Novo Coronary Artery Lesions. J Am Coll Cardiol, 2006, 51(23): 2220-2227.
20.	Kimura T, Morimoto T, Nakagawa Y, et al. Implantation Antiplatelet Therapy and Stent Thrombosis After Sirolimus-Eluting Stent implantation. Circulation, 2009, 119(7): 987-995.
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25.	Byrne RA, Schulz S, Mehilli J, et al. Rationale and design of a randomized, double-blind, placebo-controlled trial of 6 versus 12 months clopidogrel therapy after implantation of a drug-eluting stent: The Intracoronary Stenting and Antithrombotic Regimen: Safety And EFficacy of 6 Months Dual Antiplatelet Therapy After Drug-Eluting Stenting (ISAR-SAFE) study. Am Heart J, 2009, 157(4): 620-624. e2.
26.	Valgimigli M, Campo G, Percoco G, et al. Randomized comparison of 6-versus 24-month clopidogrel therapy after balancing anti-intimal hyperplasia stent potency in all-comer patients undergoing percutaneous coronary intervention: Design and rationale for the PROlonging Dual-antiplatelet treatment after Grading stent-induced Intimal hyperplasia study (PRODIGY). Am Heart J, 2010, 160(5): 804-811.

1. Plosker GL, Lyseng-Williamson KA. Clopidogrel: a review of its use in the prevention of thrombosis. Drugs, 2007, 67(4): 613-646.
2. Stone GW, Aronow HD. Long-term care after percutaneous coronary intervention: focus on the role of antiplatelet therapy. Mayo Clin Proc, 2006, 81(5): 641-652.
3. Pfisterer M, Brunner-La Rocca HP, Buser PT, et al. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol, 2006, 48(12): 2584-2591.
4. Eisenstein EL, Anstrom KJ, Kong DF, et al. Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA, 2007, 297(2): 159-168.
5. Spertus JA, Kettelkamp R, Vance C, et al. Prevalence, predictors, and outcomes of premature discontinuation of thienopyridine therapy after drug-eluting stent placement: results from the PREMIER registry. Circulation, 2006, 113(24): 2803-2809.
6. Carlsson J, von Wagenheim B, Linder R, et al. Is late stent thrombosis in drug-eluting stents a real clinical issue?A single-center experience and review of the literature. Clin Res Cardiol, 2007, 96(2): 86-93.
7. Biondi-Zoccai GG, Lotrionte M, Agostoni P, et al. A systematic review and meta-analysis on the hazards of discontinuing or not adhering to aspirin among 50,279 patients at risk for coronary artery disease. Eur Heart J, 2006, 27(22): 2667-2674.
8. King SB 3rd, Smith SC Jr, Hirshfeld JW Jr, et al. 2007 Focused update of the ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice guidelines. J Am Coll Cardiol, 2008, 51(2): 172-2 09.
9. Higgins JPT, Green S, editors. Assessing risk of bias in included studies. Cochrane Handbook for Systematic Reviews of Interventions 5. 0. 0[updated February 2008, Part 2 Chapter 8. In: The Cochrane Library, Issue 3, 2008. Chichester, UK: John Wiley & Sons, Ltd.
10. The Cochrane Collaboration. Cochrane Handbook for Systematic Reviews of Interventions 4. 2. 6 Updated May 2006.
11. 吳泰相, 劉關鍵. 隱蔽分組(分配隱藏)和盲法的概念、實施與報告. 中國循證醫學雜志, 2007, 7(3): 222-225.
12. Liu M, Zhang SH. Intention to treat analysis in clinical trials. BMJ (Chinese edition), 2001, 4(4): 223-224.
13. 劉建平. 非隨機研究的系統評價. 中國循證醫學, 2001, 1(3): 137-139.
14. Stroup DF, Berlin JA, Morton SC, et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA, 2000, 283(15): 2008-2012.
15. Mehta SR, Yusuf S, Peters RJ, et al. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet, 2001, 358(9281): 527-533.
16. Steven R, Steinhubl, Peter B. Early and Sustained Dual Oral Antiplatelet Therapy Following Percutaneous Coronary Intervention. JAMA, 2002, 288(19): 2411-2420.
17. Park SJ, Park WD, Kim YH. Duration of Dual Antiplatelet Therapy after Implantation of Drug-Eluting Stents. N Engl J Med, 2010, 362: 1374-1382.
18. Eisenstein EL, Anstrom KJ, Kong DF, et al. Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA, 2007, 297(2): 159-168.
19. Brar SS, Kim J, Brar SK, et al. Long-Term Outcomes by Clopidogrel Duration and Stent Type in a Diabetic Population With De Novo Coronary Artery Lesions. J Am Coll Cardiol, 2006, 51(23): 2220-2227.
20. Kimura T, Morimoto T, Nakagawa Y, et al. Implantation Antiplatelet Therapy and Stent Thrombosis After Sirolimus-Eluting Stent implantation. Circulation, 2009, 119(7): 987-995.
21. Dean J, Yujie Z, Yingxin Z, et al. Prolonged Dual Antiplatelet Therapy Improves Clinical Outcomes in High-risk Patients Implanted with Sirolimus-eluting Stents. Clin Cardiol, 2009, 32(3): 164-168.
22. Butler MJ, Eccleston D, Clark DJ, et al. The effect of intended duration of clopidogrel use on early and late mortality and major adverse cardiac events in patients with drug-eluting stents. Am Heart J, 2009, 157(5): 899-907.
23. King SB III, Smith SC Jr, Hirshfeld JW Jr, et al. 2007 Focused update of the ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice guidelines. J Am Coll Cardiol, 2008, 51: 172-209.
24. Mauri L, Kereiakes DJ, Normand SL, et al. Rationale and design of the dual antiplatelet therapy study, a prospective, multicenter, randomized, double-blind trial to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy in subjects undergoing percutaneous coronary intervention with either drug-eluting stent or bare metal stent placement for the treatment of coronary artery lesions. Am Heart J, 2010, 160(6): 1035-1041. e1.
25. Byrne RA, Schulz S, Mehilli J, et al. Rationale and design of a randomized, double-blind, placebo-controlled trial of 6 versus 12 months clopidogrel therapy after implantation of a drug-eluting stent: The Intracoronary Stenting and Antithrombotic Regimen: Safety And EFficacy of 6 Months Dual Antiplatelet Therapy After Drug-Eluting Stenting (ISAR-SAFE) study. Am Heart J, 2009, 157(4): 620-624. e2.
26. Valgimigli M, Campo G, Percoco G, et al. Randomized comparison of 6-versus 24-month clopidogrel therapy after balancing anti-intimal hyperplasia stent potency in all-comer patients undergoing percutaneous coronary intervention: Design and rationale for the PROlonging Dual-antiplatelet treatment after Grading stent-induced Intimal hyperplasia study (PRODIGY). Am Heart J, 2010, 160(5): 804-811.

《中國循證醫學雜志》

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《中國循證醫學雜志》

經皮冠脈介入術后雙聯抗血小板治療時限的系統評價

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