经皮冠脉介入术后双联抗血小板治疗时限的系统评价_《中国循证医学杂志》

作者：

巴巴音斯勒玛 ,  马依彤 , 于子翔 , 杨毅宁 , 马翔 , 李晓梅 , 谢翔

新疆医科大学第一附属医院心脏中心冠心病一科（乌鲁木齐 830054）;

关键词：

经皮冠脉介入术抗血小板治疗 Meta分析系统评价随机对照试验队列研究

DOI：

10.7507/1672-2531.20120093

视频：

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摘要 全文 图表 视频 参考文献 施引文献 补充材料

目的　系统评价经皮冠状动脉介入术后双联抗血小板治疗的病程、疗效及安全性的关系。
方法　计算机检索Cochrane Library、MEDLINE、EMbase、CBM、CNKI和WanFang Data，纳入所有比较经皮冠脉介入术后双联抗血小板短疗程（≤6个月）与长疗程（ gt;6个月）疗效及安全性比较的随机对照试验（RCT）和观察性研究，由两名评价员按照纳入与排除标准选择文献、提取资料和评价质量后，采用RevMan 5.1软件进行Meta分析。
结果　共纳入8篇文献，其中3个为RCT（共计7 475例患者），5个为队列研究（共计12 744例患者）。对RCT的Meta分析结果显示：长疗程双联抗血小板治疗组的死亡或心肌梗死事件发生率较短疗程组低［OR=0.74，95%CI（0.56，0.98），P lt;0.000 1］；短疗程组出现严重出血事件的发生率较长疗程组低，但两组差异无统计学意义［OR=1.29，95%CI（0.99，1.69），P=0.06］。对观察性研究的Meta分析结果显示：长疗程组的死亡或心梗发生率较短疗程组低［OR=0.7，95%CI（0.45，1.08），P=0.11］，应用Meta回归探讨队列研究间的异质性，结果提示研究年限、随访时间对异质性有贡献（Z=3.61，P=0.000）；而且长疗程组的晚期支架内血栓也较短疗程组发生率低［OR=0.40，95%CI（0.15，1.07），P=0.07］。
结论　经皮冠状动脉介入术后长疗程（ gt;6个月）双联抗血小板治疗能降低患者死亡或心肌梗死的发生率，而不会明显增加严重出血事件发生率；同时，长疗程组还有降低晚期支架内血栓发生的趋势。但更长疗程双联抗血小板治疗（ gt;12月）则未见明显优势。

引用本文： 巴巴音斯勒玛,马依彤,于子翔,杨毅宁,马翔,李晓梅,谢翔. 经皮冠脉介入术后双联抗血小板治疗时限的系统评价. 中国循证医学杂志, 2012, 12(5): 577-582. doi: 10.7507/1672-2531.20120093 复制

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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.
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13.	刘建平. 非随机研究的系统评价. 中国循证医学, 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.
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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.

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. 吴泰相, 刘关键. 隐蔽分组(分配隐藏)和盲法的概念、实施与报告. 中国循证医学杂志, 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. 刘建平. 非随机研究的系统评价. 中国循证医学, 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.

《中国循证医学杂志》

经皮冠脉介入术后双联抗血小板治疗时限的系统评价

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《中国循证医学杂志》

经皮冠脉介入术后双联抗血小板治疗时限的系统评价

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