A New Strategy for Discontinuation of Dual Antiplatelet Therapy

Kim, Byeong Keuk; Hong, Myeong‐Ki; Shin, Dong Ho; Nam, Chung Mo; Kim, Jung-Sun; Ko, Young Guk; Choi, Donghoon; Kang, Tae-Soo; Park, Byoung-Eun; Kang, Woong-Chol; Lee, Seung Hwan; Yoon, Junghan; Hong, Bum–Kee; Kwon, Hyuck Moon; Jang, Yangsoo; Investigators, Reset

doi:10.1016/j.jacc.2012.06.043

Cited by 587 publications

(150 citation statements)

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“…Figure 1 shows the study population (the study flow diagram is shown in fig A in the appendix). Six trials were included in the final analysis, comprising PROD-IGY, 25 OPTIMIZE, 26 EXCELLENT, 27 RESET, 28 SECU-RITY, 29 and ITALIC 30 (tables A-C in appendix). Among these randomised controlled trials, two studies compared 3 month with 12 month DAPT (RESET and OPTI-MIZE), two studies compared 6 month with 12 month DAPT (EXCELLENT and SECURITY), and two studies compared 6 month with 24 month DAPT (PRODIGY and ITALIC) (fig 1).…”

Section: Discussionmentioning

confidence: 99%

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Short term versus long term dual antiplatelet therapy after implantation of drug eluting stent in patients with or without diabetes: systematic review and meta-analysis of individual participant data from randomised trials

Gargiulo

Windecker

Costa

et al. 2016

BMJ

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Objective To compare clinical outcomes between short term (up to 6 months) and long term (12 months) dual antiplatelet therapy (DAPT) after placement of a drug eluting stent in patients with and without diabetes.Design Individual participant data meta-analysis. Cox proportional regression models stratified by trial were used to assess the impact of diabetes on outcomes.Data source Medline, Embase, and Cochrane databases and proceedings of international meetings searched for randomised controlled trials comparing durations of DAPT after placement of a drug eluting stent. Individual patient data pooled from six DAPT trials.Primary outcome Primary study outcome was one year risk of major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction, or definite/probable stent thrombosis. All analyses were conducted by intention to treat.Results Six trials including 11 473 randomised patients were pooled. Of these patients, 3681 (32.1%) had diabetes and 7708 (67.2%) did not (mean age 63.7 (SD 9.9) and 62.8 (SD 10.1), respectively), and in 84 (0.7%) the information was missing. Diabetes was an independent predictor of MACE (hazard ratio 2.30, 95% confidence interval 1.01 to 5.27; P=0.048 At one year follow-up, long term DAPT was not associated with a decreased risk of MACE compared with short term DAPT in patients with (1.05, 0.62 to 1.76; P=0.86) or without (0.97, 0.67 to 1.39; P=0.85) diabetes (P=0.33 for interaction). The risk of myocardial infarction did not differ between the two DAPT regimens (0.95, 0.58 to 1.54; P=0.82; for those with diabetes and 1.15, 0.68 to 1.94; P=0.60; for those without diabetes (P=0.84 for interaction). There was a lower risk of definite/probable stent thrombosis with long term DAPT among patients with (0.26, 0.09 to 0.80; P=0.02) than without (1.42, 0.68 to 2.98; P=0.35) diabetes, with positive interaction testing (P=0.04 for interaction), although the landmark analysis showed a trend towards benefit in both groups. Long term DAPT was associated with higher rates of major or minor bleeding, irrespective of diabetes (P=0.37 for interaction).Conclusions Although the presence of diabetes emerged as an independent predictor of MACE after implantation of a drug eluting stent, compared with short term DAPT, long term DAPT did not reduce the risk of MACE but increased the risk of bleeding among patients with stents with and without diabetes.

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Section: Discussionmentioning

confidence: 99%

“…In addition to the four previously included randomised controlled trials, [24][25][26][27][28] we included the SECURITY 29 and the ITALIC 30 trials (fig 1 ; tables A-D in appendix). The intention to treat population was used for these analyses, including all patients according to randomised treatment arm regardless of actual treatment.…”

Section: Methodsmentioning

confidence: 99%

Short term versus long term dual antiplatelet therapy after implantation of drug eluting stent in patients with or without diabetes: systematic review and meta-analysis of individual participant data from randomised trials

Gargiulo

Windecker

Costa

et al. 2016

BMJ

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“…However, the greatest absolute reductions in cardiovascular events with dual antiplatelet therapy are seen in the first 3 months (table 1) and since these studies, advances in drug-eluting stent technology have led to a substantially reduced incidence of late (>30 days) and very late (>1 year) stent thrombosis. 16 In recent trials of patients treated with newer generation drug-eluting stents, shorter durations of dual antiplatelet therapy (3 months to 6 months) were non-inferior to 12 [17][18][19][20][21][22] months or 24 23 months of treatment with regard to etiher a composite of cardiovascular events or cardiovascular events plus major bleeding. Moreover, all of these trials included patients with an acute coronary syndrome (range 23% to 74% of study population) and in those who undertook prespecified subgroup analyses, no heterogeneity in treatment effect between stable and unstable coronary artery disease was observed (figure 3).…”

Section: Duration Of Dual Antiplatelet Therapy: Clinical Trialsmentioning

confidence: 99%

Duration of dual antiplatelet therapy in acute coronary syndrome

Wilson

Newby

Dawson

et al. 2017

Heart

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Despite a large volume of evidence supporting the use of dual antiplatelet therapy in patients with acute coronary syndrome, there remains major uncertainty regarding the optimal duration of therapy. Clinical trials have varied markedly in the duration of therapy, both across and within trials. Recent systematic reviews and meta-analyses suggest that shorter durations of dual antiplatelet therapy are superior because the avoidance of atherothrombotic events is counterbalanced by the greater risks of excess major bleeding with apparent increases in all-cause mortality with longer durations. These findings did not show significant heterogeneity according to whether patients had stable or unstable coronary heart disease. Moreover, the potential hazards and benefits may differ when applied to the general broad population of patients encountered in everyday clinical practice who have markedly higher bleeding and atherothrombotic event rates. Clinicians lack definitive information regarding the duration of therapy in patients with acute coronary syndrome and risk scores do not appear to be sufficiently robust to address these concerns. We believe that there is a pressing need to undertake a broad inclusive safety trial of shorter durations of therapy in real world populations of patients with acute coronary syndrome. The clinical evidence would further inform future research into strategies for personalised medicine.

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“…However some patient-related factors and device-related criteria that determine safety and allow early dual antiplatelet therapy withdrawal, or interruption e.g. for urgent surgery, still have to be determined [64,65]. It remains unclear whether there is a "safe" time threshold with the 2 nd generation DES, for clopidogrel discontinuation, after which event rates are negligible.…”

Section: ) Second Generation Des (Ees and Zes)mentioning

confidence: 99%

Coronary artery stents and surgery; the basis of sound perioperative management

Bolsin¹,

Hiew²,

Birdsey³

et al. 2013

Health

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The introduction of drug-eluting stents (DES) to interventional cardiology heralded a limited time of increased anaesthetic and surgical complications in patients implanted with these devices. The horns of the dilemma, in the anaesthetic and surgical management of patients in the first 3 -6 months after the 1 st generation DES insertion, were between the risk of bleeding from continued clopidogrel treatment and the risk of instent thrombosis and myocardial infarction following discontinuation of dual antiplatelet therapy, clopidogrel and aspirin. Initial accounts of early catastrophic cardiac and haemorrhagic complications, at the time of elective or emergency surgery, following DES insertion, were followed by equally worrying reports of in-stent thrombosis many months after DES insertion. Initial recommendations for the conduct of safe operations were propagated in the literature before formal guidelines were produced. This article summarises the issues identified in the development of interventional cardiology particularly DES and the requirement for ongoing antiplatelet therapy. The article reviews the treatment protocols that are still applicable for the different devices that have been deployed in clinical practice.

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A New Strategy for Discontinuation of Dual Antiplatelet Therapy

Abstract: E-ZES+3-month DAPT was noninferior to the standard therapy with respect to the occurrence of the primary endpoint. (REal Safety and Efficacy of a 3-month dual antiplatelet Therapy following E-ZES implantation [RESET]; NCT01145079).

Cited by 587 publications

References 19 publications

Short term versus long term dual antiplatelet therapy after implantation of drug eluting stent in patients with or without diabetes: systematic review and meta-analysis of individual participant data from randomised trials

Short term versus long term dual antiplatelet therapy after implantation of drug eluting stent in patients with or without diabetes: systematic review and meta-analysis of individual participant data from randomised trials

Duration of dual antiplatelet therapy in acute coronary syndrome

Coronary artery stents and surgery; the basis of sound perioperative management

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