Optimal Duration of Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention: A Meta-Analysis_Chinese Journal of Evidence-Based Medicine

Authors：

BA Bayinsilema ,  MA Yitong , YU Zixiang , YANG Yining , MA Xiang , LI Xiaomei , XIE Xiang

Department of Cardiology, the First Affiliated Hospital, Xinjiang Medical University, Urumqi 830054, China;

Corresponding author：

MA Yitong, Email: myt-xj@sina.com

Keywords：

Percutaneous coronary intervention; Antiplatelet therapy; Meta-analysis; Systematic review; Randomized controlled trial; Cohort study

DOI：

10.7507/1672-2531.20120093

Video：

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Objective 　To assess the effectiveness and safety of different dual antiplatelet therapies in patients undergoing percutaneous coronary intervention.
Methods 　Such databases as The Cochrane Library, MEDLINE, EMbase, CBM, CNKI and WanFang Data were searched to collect the randomized controlled trials (RCTs) and observational studies on the effectiveness and safety of dual antiplatelet therapies both short-duration (≤6 months) and long-duration ( gt;6 months) after percutaneous coronary intervention. The literature was screened according to the inclusive and exclusive criteria by two reviewers independently, the quality was evaluated, the data were extracted, and meta-analyses were performed by using RevMan 5.1 software.
Results 　Eight trials were included, of which 3 were RCTs involving 7 475 patients, and 5 were observational studies involving 12 744 patients. Meta-analyses on RCTs showed that the incidence of death or myocardial infarction in the long-duration treatment group was lower than that of the short-duration treatment group (OR=0.74, 95%CI 0.56 to 0.98, P lt;0.000 1), while meta-analyses on observation studies showed the similar result (OR=0.7, 95%CI 0.45 to 1.08, P=0.11). With the variables of published year and follow-up time, the heterogeneity of cohort studies was discussed through meta-regression (Z=3.61, P=0.000) which indicated that both published year and follow-up time might be the source of heterogeneity due to their contribution. For RCTs, the incidence of severe bleeding events in the short-duration treatment group was lower than that in the long-duration treatment group (OR=1.29, 95%CI 0.99 to 1.69, P=0.06). For observational studies, the incidence of late stent thrombosis in the long-duration treatment group was lower than that in the short-duration treatment group (OR=0.40, 95%CI 0.15 to 1.07, P=0.07).
Conclusion 　The long duration ( gt;6months) of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention can reduce the incidence of death or myocardial infarction and decrease the tendency of late stent thrombosis, but cannot obviously increase the incidence rate of severe bleeding events. The current evidence shows no marked superiority in longer duration ( gt;12months) of dual antiplatelet therapy.

Citation： BA Bayinsilema,MA Yitong,YU Zixiang,YANG Yining,MA Xiang,LI Xiaomei,XIE Xiang. Optimal Duration of Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention: A Meta-Analysis. Chinese Journal of Evidence-Based Medicine, 2012, 12(5): 577-582. doi: 10.7507/1672-2531.20120093 Copy

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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.

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.

Chinese Journal of Evidence-Based Medicine

Optimal Duration of Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention: A Meta-Analysis

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