Comparison of short-term and long-term dual antiplatelet therapy after implantation of drug-eluting stents—Meta analysis

FEI Shuyang; ZHAO Li; SUN Lin; ZHANG Rong; LI Jing; GE Changjiang

doi:10.3969/j.issn.1006-0111.201907135

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Volume 38 Issue 1

Mar. 2020

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Article Navigation > Journal of Pharmaceutical Practice and Service > 2020 > 38(1): 81-87

FEI Shuyang, ZHAO Li, SUN Lin, ZHANG Rong, LI Jing, GE Changjiang. Comparison of short-term and long-term dual antiplatelet therapy after implantation of drug-eluting stents—Meta analysis[J]. Journal of Pharmaceutical Practice and Service, 2020, 38(1): 81-87. doi: 10.3969/j.issn.1006-0111.201907135

Citation:

FEI Shuyang, ZHAO Li, SUN Lin, ZHANG Rong, LI Jing, GE Changjiang. Comparison of short-term and long-term dual antiplatelet therapy after implantation of drug-eluting stents—Meta analysis[J]. Journal of Pharmaceutical Practice and Service, 2020, 38(1): 81-87. doi: 10.3969/j.issn.1006-0111.201907135

Comparison of short-term and long-term dual antiplatelet therapy after implantation of drug-eluting stents—Meta analysis

doi: 10.3969/j.issn.1006-0111.201907135

1.
Anzhen Hospital, Capital Medical University, Beijing 100048, China
2.
Sixth Medical Center of General Hospital of PLA, Beijing 100048, China

Received Date: 2019-07-29
Rev Recd Date: 2019-12-25

Abstract

Objective To evaluate the clinical effects of short-term (3-6 months) and long-term (12 months) dual antiplatelet therapy (DAPT) after the implantation of coronary drug-eluting stents (DES). Methods The eligibilities of the patients included stable angina, acute coronary syndrome and silent ischemia. The lesions were in a native coronary vessel. The clinical observation endpoints were all-cause death, cardiogenic death, myocardial infarction, stroke, stent thrombosis, target lesion revascularization, severe bleeding, and true adverse clinical events. The clinical observation endpoints were all-cause death, cardiogenic death, myocardial infarction, stroke, stent thrombosis, target lesion revascularization, severe bleeding, and true adverse clinical events. By searching Pubmed, Chinese biomedical literature and other Chinese and English databases and manual search, qualified randomized controlled studies were evaluated and data were extracted for meta-analysis. Results A total of 12 randomized controlled studies were conducted. Detsky scores were all greater than 5 points. There were a total of 25949 patients in the study with a follow-up rate of 97.9%. There were no significantly different in all cause death (OR=0.86,95%CI 0.71-1.05,P=0.14), cardiac death (OR=0.94,95% CI 0.70-1.25,P=0.67), stent thrombosis (OR=1.36,95%CI 0.94-1.98,P=0.11), stroke (OR=1.01,95%CI 0.71-1.42,P=0.98), target lesion revascularization (OR=0.121,95%CI 0.94-1.55,P=0.14),and true adverse clinical events (OR=0.98,95%CI 0.83-1.14,P=0.75). The incident rate of myocardial infarction during the follow-up period was higher in the short-term group than in the long-term group (OR=1.27, 95% CI 1.02-1.59, P=0.04). The proportion of severe bleeding in the long-term group increased significantly (OR=0.69, 95% CI 0.50-0.95, P=0.02). Asian population studies showed that all-cause mortality was higher in the long-term treatment group than in the short-term group (OR=0.72, 95% CI 0.53-0.97, P=0.03), and there was no significant difference in severe bleeding between the two groups. Conclusion According to the defined clinical observation endpoints, the short-term dual antiplatelet effect is not inferior to the long-term group. Seven asian group studies have shown that the long-term group has high all-cause mortality. It can not rule out the deviation and/or population caused by the small sample size or individual variation. The results need to be further verified. This result can be used as a clinical warning to adjust the dual antiplatelet cycle based on the individualized risk of bleeding and coronary lesions.
- dual antiplatelet therapy,
- drug eluting stents,
- acute coronary syndrome,
- stable angina,
- randomized controlled trial,
- Meta analysis

References

[1]	BYRNE R A, SARAFOFF N, KASTRATI A, et al. Drug-eluting stents in percutaneous coronary intervention: a benefit-risk assessment[J]. Drug Saf,2009,32(9):749-770
[2]	VALGIMIGLI M, BUENO H, BYRNE R A, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS[J]. Eur J Cardiothorac Surg,2018,53(1):34-78
[3]	LEVINE G N, BATES E R, BITTL J A, et al. 2016 ACC/AHA guideline focused update on duration of dual antiplatelet therapy in patients with coronary artery disease: A report of the American college of cardiology/ American heart association task force on clinical practice guidelines[J]. J Am Coll Cardiol,2016,68(10):1082-1115
[4]	BONACA M P, BHATT D L, COHEN M, et al. Long-term use of ticagrelor in patients with prior myocardial infarction[J]. N Engl J Med,2015,372(19):1791-1800
[5]	YEH R W, SECEMSKY E A, KEREIAKES D J, et al. Development and validation of a prediction rule for benefit and harm of dual antiplatelet therapy beyond 1 year after percutaneous coronary intervention[J]. JAMA,2016,315(16):1735-1749
[6]	BABER U, MEHRAN R, GIUSTINO G, et al. Coronary thrombosis and major bleeding after PCI with drug-eluting stents: risk scores from Paris[J]. J Am Coll Cardiol,2016,67(19):2224-2234
[7]	GRANGER C B, GOLDBERG R J, DABBOUS O, et al. Predictors of hospital mortality in the global registry of acute coronary events[J]. Arch Intern Med,2003,163(19):2345-2353
[8]	MEHRAN R, POCOCK S J, NIKOLSKY E, et al. A risk score to predict bleeding in patients with acute coronary syndromes[J]. J Am Coll Cardiol,2010,55(23):2556-2566
[9]	DETSKY A S, NAYLOR C D, O'ROURKE K, et al. Incorporating variations in the quality of individual randomized trials into meta-analysis[J]. J Clin Epidemiol,1992,45(3):255-265
[10]	GWON H C, HAHN J Y, PARK K W, et al. Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the efficacy of xience/promus versus cypher to reduce late loss after stenting (EXCELLENT) randomized, multicenter study[J]. Circulation,2012,125(3):505-513
[11]	KIM B K, HONG M K, SHIN D H, et al. A new strategy for discontinuation of dual antiplatelet therapy: the RESET Trial (Real safety and efficacy of 3-month dual antiplatelet therapy following endeavor zotarolimus-eluting stent implantation)[J]. J Am Coll Cardiol,2012,60(15):1340-1348
[12]	FERES F, COSTA R A, ABIZAID A, et al. Three vs twelve months of dual antiplatelet therapy after zotarolimus-eluting stents: the OPTIMIZE randomized trial[J]. JAMA,2013,310(23):2510-2522
[13]	COLOMBO A, CHIEFFO A, FRASHERI A, et al. Second-generation drug-eluting stent implantation followed by 6-versus 12-month dual antiplatelet therapy: the SECURITY randomized clinical trial[J]. J Am Coll Cardiol,2014,64(20):2086-2097
[14]	GILARD M, BARRAGAN P, NORYANI A A L, et al. 6-versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: the randomized, multicenter ITALIC trial[J]. J Am Coll Cardiol,2015,65(8):777-786
[15]	SCHULZ-SCHUPKE S, BYRNE R A, TEN BERG J M, et al. Intracoronary stenting and antithrombotic regimen: safety and efficacy of 6 months dual antiplatelet therapy after drug-eluting stenting (ISAR-SAFE) trial investigators. ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting[J]. Eur Heart J,2015,36:1252-1263
[16]	HONG S J, SHIN D H, KIM J S, et al. 6-month versus 12-month dual-antiplatelet therapy following long everolimus-eluting stent implantation: the IVUS-XPL randomized clinical trial[J]. JACC Cardiovasc Interv,2016,9(14):1438-1446
[17]	HAN Y L, XU B, XU K, et al. Six versus 12 months of dual antiplatelet therapy after implantation of biodegradable polymer sirolimus-eluting stent: randomized substudy of the I-LOVE-IT 2 trial[J]. Circ Cardiovasc Interv,2016,9(2):e003145
[18]	NAKAMURA M, ⅡJIMA R, AKO J, et al. Dual antiplatelet therapy for 6 versus 18 months after biodegradable polymer drug-eluting stent implantation[J]. JACC Cardiovasc Interv,2017,10(12):1189-1198
[19]	LEE B K, KIM J S, LEE O H, et al. Safety of six-month dual antiplatelet therapy after second-generation drug-eluting stent implantation: OPTIMA-C Randomised Clinical Trial and OCT Substudy[J]. EuroIntervention,2018,13(16):1923-1930
[20]	HAHN J Y, SONG Y B, OH J H, et al. 6-month versus 12-month or longer dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (SMART-DATE): a randomised, open-label, non-inferiority trial[J]. Lancet,2018,391(10127):1274-1284
[21]	KEDHI E, FABRIS E, VAN DER ENT M, et al. Six months versus 12 months dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction (DAPT-STEMI): randomised, multicentre, non-inferiority trial[J]. BMJ,2018:k3793
[22]	VALGIMIGLI M, CAMPO G, MONTI M, et al. Prolonging dual antiplatelet treatment after grading stent-induced intimal hyperplasia study (PRODIGY) investigators. Short-versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial[J]. Circulation,2012,125:2015-2026
[23]	MAURI L, KEREIAKES D J, YEH R W, et al. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents[J]. N Engl J Med,2014,371(23):2155-2166
[24]	COLLET J P, SILVAIN J, BARTHÉLÉMY O, et al. Dual-antiplatelet treatment beyond 1 year after drug-eluting stent implantation (ARCTIC-Interruption): a randomised trial[J]. Lancet,2014,384(9954):1577-1585
[25]	LEE C W, AHN J M, PARK D W, et al. Optimal duration of dual antiplatelet therapy after drug-eluting stent implantation: a randomized, controlled trial[J]. Circulation,2014,129(3):304-312
[26]	PARK S J, PARK D W, KIM Y H, et al. Duration of dual antiplatelet therapy after implantation of drug-eluting stents[J]. N Engl J Med,2010,362(15):1374-1382
[27]	GARRATT K N, WEAVER W D, JENKINS R G, et al. Prasugrel plus aspirin beyond 12 months is associated with improved outcomes after Taxus Liberté paclitaxel-eluting coronary stent placement[J]. Circulation,2015,131(1):62-73
[28]	COSTA F, VRANCKX P, LEONARDI S, et al. Impact of clinical presentation on ischaemic and bleeding outcomes in patients receiving 6- or 24-month duration of dual-antiplatelet therapy after stent implantation: a pre-specified analysis from the PRODIGY (Prolonging dual-antiplatelet treatment after grading stent-induced intimal hyperplasia) trial[J]. Eur Heart J,2015,36(20):1242-1251
[29]	SABATÉ M, RÄBER L, HEG D, et al. Comparison of newer-generation drug-eluting with bare-metal stents in patients with acute ST-segment elevation myocardial infarction: a pooled analysis of the EXAMINATION (clinical evaluation of the xience-V stent in acute myocardial infarction) and COMFORTABLE-AMI (comparison of biolimus eluted from an erodible stent coating with bare metal stents in acute ST-elevation myocardial infarction) trials[J]. JACC Cardiovasc Interv,2014,7(1):55-63
[30]	中华医学会心血管病学. 2013年抗血小板治疗中国专家共识[J]. 中华心血病杂志, 2013, 40(3):183-194

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通讯作者: 陈斌, bchen63@163.com

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沈阳化工大学材料科学与工程学院沈阳 110142

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Comparison of short-term and long-term dual antiplatelet therapy after implantation of drug-eluting stents—Meta analysis

1. Anzhen Hospital, Capital Medical University, Beijing 100048, China

2. Sixth Medical Center of General Hospital of PLA, Beijing 100048, China

Received Date: 2019-07-29

Rev Recd Date: 2019-12-25

Key words:

Abstract: Objective To evaluate the clinical effects of short-term (3-6 months) and long-term (12 months) dual antiplatelet therapy (DAPT) after the implantation of coronary drug-eluting stents (DES). Methods The eligibilities of the patients included stable angina, acute coronary syndrome and silent ischemia. The lesions were in a native coronary vessel. The clinical observation endpoints were all-cause death, cardiogenic death, myocardial infarction, stroke, stent thrombosis, target lesion revascularization, severe bleeding, and true adverse clinical events. The clinical observation endpoints were all-cause death, cardiogenic death, myocardial infarction, stroke, stent thrombosis, target lesion revascularization, severe bleeding, and true adverse clinical events. By searching Pubmed, Chinese biomedical literature and other Chinese and English databases and manual search, qualified randomized controlled studies were evaluated and data were extracted for meta-analysis. Results A total of 12 randomized controlled studies were conducted. Detsky scores were all greater than 5 points. There were a total of 25949 patients in the study with a follow-up rate of 97.9%. There were no significantly different in all cause death (OR=0.86,95%CI 0.71-1.05,P=0.14), cardiac death (OR=0.94,95% CI 0.70-1.25,P=0.67), stent thrombosis (OR=1.36,95%CI 0.94-1.98,P=0.11), stroke (OR=1.01,95%CI 0.71-1.42,P=0.98), target lesion revascularization (OR=0.121,95%CI 0.94-1.55,P=0.14),and true adverse clinical events (OR=0.98,95%CI 0.83-1.14,P=0.75). The incident rate of myocardial infarction during the follow-up period was higher in the short-term group than in the long-term group (OR=1.27, 95% CI 1.02-1.59, P=0.04). The proportion of severe bleeding in the long-term group increased significantly (OR=0.69, 95% CI 0.50-0.95, P=0.02). Asian population studies showed that all-cause mortality was higher in the long-term treatment group than in the short-term group (OR=0.72, 95% CI 0.53-0.97, P=0.03), and there was no significant difference in severe bleeding between the two groups. Conclusion According to the defined clinical observation endpoints, the short-term dual antiplatelet effect is not inferior to the long-term group. Seven asian group studies have shown that the long-term group has high all-cause mortality. It can not rule out the deviation and/or population caused by the small sample size or individual variation. The results need to be further verified. This result can be used as a clinical warning to adjust the dual antiplatelet cycle based on the individualized risk of bleeding and coronary lesions.

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Reference (30)

[1]	BYRNE R A, SARAFOFF N, KASTRATI A, et al. Drug-eluting stents in percutaneous coronary intervention: a benefit-risk assessment[J]. Drug Saf,2009,32(9):749-770
[2]	VALGIMIGLI M, BUENO H, BYRNE R A, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS[J]. Eur J Cardiothorac Surg,2018,53(1):34-78
[3]	LEVINE G N, BATES E R, BITTL J A, et al. 2016 ACC/AHA guideline focused update on duration of dual antiplatelet therapy in patients with coronary artery disease: A report of the American college of cardiology/ American heart association task force on clinical practice guidelines[J]. J Am Coll Cardiol,2016,68(10):1082-1115
[4]	BONACA M P, BHATT D L, COHEN M, et al. Long-term use of ticagrelor in patients with prior myocardial infarction[J]. N Engl J Med,2015,372(19):1791-1800
[5]	YEH R W, SECEMSKY E A, KEREIAKES D J, et al. Development and validation of a prediction rule for benefit and harm of dual antiplatelet therapy beyond 1 year after percutaneous coronary intervention[J]. JAMA,2016,315(16):1735-1749
[6]	BABER U, MEHRAN R, GIUSTINO G, et al. Coronary thrombosis and major bleeding after PCI with drug-eluting stents: risk scores from Paris[J]. J Am Coll Cardiol,2016,67(19):2224-2234
[7]	GRANGER C B, GOLDBERG R J, DABBOUS O, et al. Predictors of hospital mortality in the global registry of acute coronary events[J]. Arch Intern Med,2003,163(19):2345-2353
[8]	MEHRAN R, POCOCK S J, NIKOLSKY E, et al. A risk score to predict bleeding in patients with acute coronary syndromes[J]. J Am Coll Cardiol,2010,55(23):2556-2566
[9]	DETSKY A S, NAYLOR C D, O'ROURKE K, et al. Incorporating variations in the quality of individual randomized trials into meta-analysis[J]. J Clin Epidemiol,1992,45(3):255-265
[10]	GWON H C, HAHN J Y, PARK K W, et al. Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the efficacy of xience/promus versus cypher to reduce late loss after stenting (EXCELLENT) randomized, multicenter study[J]. Circulation,2012,125(3):505-513
[11]	KIM B K, HONG M K, SHIN D H, et al. A new strategy for discontinuation of dual antiplatelet therapy: the RESET Trial (Real safety and efficacy of 3-month dual antiplatelet therapy following endeavor zotarolimus-eluting stent implantation)[J]. J Am Coll Cardiol,2012,60(15):1340-1348
[12]	FERES F, COSTA R A, ABIZAID A, et al. Three vs twelve months of dual antiplatelet therapy after zotarolimus-eluting stents: the OPTIMIZE randomized trial[J]. JAMA,2013,310(23):2510-2522
[13]	COLOMBO A, CHIEFFO A, FRASHERI A, et al. Second-generation drug-eluting stent implantation followed by 6-versus 12-month dual antiplatelet therapy: the SECURITY randomized clinical trial[J]. J Am Coll Cardiol,2014,64(20):2086-2097
[14]	GILARD M, BARRAGAN P, NORYANI A A L, et al. 6-versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: the randomized, multicenter ITALIC trial[J]. J Am Coll Cardiol,2015,65(8):777-786
[15]	SCHULZ-SCHUPKE S, BYRNE R A, TEN BERG J M, et al. Intracoronary stenting and antithrombotic regimen: safety and efficacy of 6 months dual antiplatelet therapy after drug-eluting stenting (ISAR-SAFE) trial investigators. ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting[J]. Eur Heart J,2015,36:1252-1263
[16]	HONG S J, SHIN D H, KIM J S, et al. 6-month versus 12-month dual-antiplatelet therapy following long everolimus-eluting stent implantation: the IVUS-XPL randomized clinical trial[J]. JACC Cardiovasc Interv,2016,9(14):1438-1446
[17]	HAN Y L, XU B, XU K, et al. Six versus 12 months of dual antiplatelet therapy after implantation of biodegradable polymer sirolimus-eluting stent: randomized substudy of the I-LOVE-IT 2 trial[J]. Circ Cardiovasc Interv,2016,9(2):e003145
[18]	NAKAMURA M, ⅡJIMA R, AKO J, et al. Dual antiplatelet therapy for 6 versus 18 months after biodegradable polymer drug-eluting stent implantation[J]. JACC Cardiovasc Interv,2017,10(12):1189-1198
[19]	LEE B K, KIM J S, LEE O H, et al. Safety of six-month dual antiplatelet therapy after second-generation drug-eluting stent implantation: OPTIMA-C Randomised Clinical Trial and OCT Substudy[J]. EuroIntervention,2018,13(16):1923-1930
[20]	HAHN J Y, SONG Y B, OH J H, et al. 6-month versus 12-month or longer dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (SMART-DATE): a randomised, open-label, non-inferiority trial[J]. Lancet,2018,391(10127):1274-1284
[21]	KEDHI E, FABRIS E, VAN DER ENT M, et al. Six months versus 12 months dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction (DAPT-STEMI): randomised, multicentre, non-inferiority trial[J]. BMJ,2018:k3793
[22]	VALGIMIGLI M, CAMPO G, MONTI M, et al. Prolonging dual antiplatelet treatment after grading stent-induced intimal hyperplasia study (PRODIGY) investigators. Short-versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial[J]. Circulation,2012,125:2015-2026
[23]	MAURI L, KEREIAKES D J, YEH R W, et al. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents[J]. N Engl J Med,2014,371(23):2155-2166
[24]	COLLET J P, SILVAIN J, BARTHÉLÉMY O, et al. Dual-antiplatelet treatment beyond 1 year after drug-eluting stent implantation (ARCTIC-Interruption): a randomised trial[J]. Lancet,2014,384(9954):1577-1585
[25]	LEE C W, AHN J M, PARK D W, et al. Optimal duration of dual antiplatelet therapy after drug-eluting stent implantation: a randomized, controlled trial[J]. Circulation,2014,129(3):304-312
[26]	PARK S J, PARK D W, KIM Y H, et al. Duration of dual antiplatelet therapy after implantation of drug-eluting stents[J]. N Engl J Med,2010,362(15):1374-1382
[27]	GARRATT K N, WEAVER W D, JENKINS R G, et al. Prasugrel plus aspirin beyond 12 months is associated with improved outcomes after Taxus Liberté paclitaxel-eluting coronary stent placement[J]. Circulation,2015,131(1):62-73
[28]	COSTA F, VRANCKX P, LEONARDI S, et al. Impact of clinical presentation on ischaemic and bleeding outcomes in patients receiving 6- or 24-month duration of dual-antiplatelet therapy after stent implantation: a pre-specified analysis from the PRODIGY (Prolonging dual-antiplatelet treatment after grading stent-induced intimal hyperplasia) trial[J]. Eur Heart J,2015,36(20):1242-1251
[29]	SABATÉ M, RÄBER L, HEG D, et al. Comparison of newer-generation drug-eluting with bare-metal stents in patients with acute ST-segment elevation myocardial infarction: a pooled analysis of the EXAMINATION (clinical evaluation of the xience-V stent in acute myocardial infarction) and COMFORTABLE-AMI (comparison of biolimus eluted from an erodible stent coating with bare metal stents in acute ST-elevation myocardial infarction) trials[J]. JACC Cardiovasc Interv,2014,7(1):55-63
[30]	中华医学会心血管病学. 2013年抗血小板治疗中国专家共识[J]. 中华心血病杂志, 2013, 40(3):183-194

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Comparison of short-term and long-term dual antiplatelet therapy after implantation of drug-eluting stents—Meta analysis

doi: 10.3969/j.issn.1006-0111.201907135

Abstract

References

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通讯作者: 陈斌, bchen63@163.com

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