Safety of six-month dual antiplatelet therapy after second-generation drug-eluting stent implantation: OPTIMA-C Randomised Clinical Trial and OCT Substudy

Lee, Byoung Kwon; Kim, Jung Sun; Lee, Oh Hyun; Min, Pil‐Ki; Yoon, Young Won; Hong, Bum Kee; Shin, Dong Ho; Kang, Tae Soo; Kim, Byung Ok; Cho, Deok Kyu; Jeon, Dong Woon; Woo, Sung Ill; Choi, Seonghoon; Kim, Yong Hoon; Kang, Woong Chol; Kim, Seunghwan; Kim, Byeong Keuk; Hong, Myeong Ki; Jang, Yangsoo; Kwon, Hyuck Moon

doi:10.4244/eij-d-17-00792

Cited by 42 publications

(40 citation statements)

References 21 publications

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“…All available studies from trial registries were included in the database search, resulting in 17 studies of 18 parallel randomised controlled trials from 2010 to 2018 and including 46 864 participants (range 1259-9961 in each study). 5 6 7 8 9 34 35 36 37 38 39 40 41 42 43 44 45 The shortest duration of DAPT was three months and the longest duration was 48 months. Overall, 13 234 participants were randomly assigned to short term DAPT, 18 473 to standard term DAPT, and 15 157 to long term DAPT.…”

Section: Resultsmentioning

confidence: 99%

“…Randomised controlled trials have always concluded that short term DAPT was non-inferior to standard term DAPT. 5 6 7 8 35 37 40 42 44 62 Piccolo’s analysis of 38 919 patients reported that long term DAPT exposure showed increased major adverse cardiac and cerebrovascular events (MACCE) through 90 days after DAPT continuation which was not observed in <12 months of DAPT. 63 However, several studies showed that long term DAPT was associated with similar major adverse cardiac events and a higher risk of bleeding after PCI with DES compared with short term DAPT, regardless of diabetes diagnosis or sex.…”

Section: Discussionmentioning

confidence: 99%

“…The recommendation for ≥12 months of DAPT after PCI with DES has received scrutiny by several randomised controlled trials, which proved non-superiority compared with three to six months of DAPT. 5 6 7 8 9 Furthermore, shorter durations, as opposed to longer durations of DAPT, were associated with lower rates of all cause mortality as a result of lower rates of bleeding-related deaths. 10 Nevertheless, the wide non-inferiority margins of up to six months of DAPT from single randomised controlled trials have prevented researchers from concluding that short term DAPT could replace the conventional standard duration.…”

Section: Introductionmentioning

confidence: 99%

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Duration of dual antiplatelet therapy after percutaneous coronary intervention with drug-eluting stent: systematic review and network meta-analysis

Yin

Wang

et al. 2019

BMJ

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Objective To evaluate the efficacy and safety of standard term (12 months) or long term (>12 months) dual antiplatelet therapy (DAPT) versus short term (<6 months) DAPT after percutaneous coronary intervention (PCI) with drug-eluting stent (DES). Design Systematic review and network meta-analysis. Data sources Relevant studies published between June 1983 and April 2018 from Medline, Embase, Cochrane Library for clinical trials, PubMed, Web of Science, ClinicalTrials.gov, and Clinicaltrialsregister.eu. Review methods Randomised controlled trials comparing two of the three durations of DAPT (short term, standard term, and long term) after PCI with DES were included. The primary study outcomes were cardiac or non-cardiac death, all cause mortality, myocardial infarction, stent thrombosis, and all bleeding events. Results 17 studies (n=46 864) were included. Compared with short term DAPT, network meta-analysis showed that long term DAPT resulted in higher rates of major bleeding (odds ratio 1.78, 95% confidence interval 1.27 to 2.49) and non-cardiac death (1.63, 1.03 to 2.59); standard term DAPT was associated with higher rates of any bleeding (1.39, 1.01 to 1.92). No noticeable difference was observed in other primary endpoints. The sensitivity analysis revealed that the risks of non-cardiac death and bleeding were further increased for ≥18 months of DAPT compared with short term or standard term DAPT. In the subgroup analysis, long term DAPT led to higher all cause mortality than short term DAPT in patients implanted with newer-generation DES (1.99, 1.04 to 3.81); short term DAPT presented similar efficacy and safety to standard term DAPT with acute coronary syndrome (ACS) presentation and newer-generation DES placement. The heterogeneity of pooled trials was low, providing more confidence in the interpretation of results. Conclusions In patients with all clinical presentations, compared with short term DAPT (clopidogrel), long term DAPT led to higher rates of major bleeding and non-cardiac death, and standard term DAPT was associated with an increased risk of any bleeding. For patients with ACS, short term DAPT presented similar efficacy and safety with standard term DAPT. For patients implanted with newer-generation DES, long term DAPT resulted in more all cause mortality than short term DAPT. Although the optimal duration of DAPT should take personal ischaemic and bleeding risks into account, this study suggested short term DAPT could be considered for most patients after PCI with DES, combining evidence from both direct and indirect comparisons. Systematic review registration PROSPERO CRD42018099519.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Duration of dual antiplatelet therapy after percutaneous coronary intervention with drug-eluting stent: systematic review and network meta-analysis

Yin

Wang

et al. 2019

BMJ

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“…In the present network meta-analysis of 16 RCTs to evaluate the safety and efficacy of various DAPT durations in DES-treated PCI patients, we had several notable findings [12][13][14][15][20][21][22][23][24][25][26][27][28][29][30][31]. First, long-duration DAPT (≥24 mo) reduces the composite ischemic vascular events significantly when compared with short-duration DAPT (3-6 mo).…”

Section: Discussionmentioning

confidence: 99%

Best duration of dual antiplatelet therapy after drug-eluting stent implantation: an updated network meta-analysis of randomized controlled trials

Barbarawi

Kheiri

Zayed

et al. 2019

Journal of Community Hospital Internal Medicine Perspectives

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Background: Drug-eluting stent(DES) implantation is the main interventional treatment for coronary artery disease, and dual antiplatelet therapy(DAPT) remains the gold standard strategy to prevent ischemic events. However, the optimal duration of DAPT after DES implantation remains controversial. Therefore, we aimed to evaluate the best duration of DAPT following DES implantation.Method: We searched PubMed, Embase, Cochrane Library, and clinicaltrials.gov for all randomized clinical trials(RCTs) that compared different durations of DAPT after DES implantation. Major adverse cardiac events(MACE) and major bleeding were the primary and secondary outcomes, respectively.Results: We included 16 RCTs (n = 42,993). The mean age of included patients was 63.1 ± 10.1. The primary outcome was statistically significant for lower MACE in patients who received DAPT for 24–48 months (mo) following DES when compared with those who received 3–6 mo of DAPT (odds ratio [OR] 0.75; 95% credible interval [CI] 0.58–0.97). There was nonstatistically significant difference in MACE when comparing those who received 12 mo of DAPT to those taking either 3–6 mo of DAPT (OR 0.86; 95% CI 0.69–1.08) or 24–48 mo of DAPT (OR 0.87; 95% CI 0.72–1.05). In contrast, major bleeding was significantly lower in those who received 3–6 mo of DAPT (OR 0.32; 95% CI 0.17–0.54) and 12 mo of DAPT (OR 0.43; 95% CI 0.27–0.63) than in those who received 24–48 mo of DAPT.Conclusion: In patients who undergo DES implantation, a longer duration of DAPT is associated with lower MACE, despite the increased risk of major bleeding events. Therefore, individualizing the duration of DAPT after DES according to the patient’s risk of bleeding and recurrent ischemia is recommended.

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“…7 The OPTIMA-C trial enrolled 1,367 patients with at least 1 de novo lesion treated with a biolimus or zotarolimus DES randomly assigned to DAPT for 6 or 12 months. 8 The EXCELLENT trial enrolled 1,443 patients with at least 1 de novo lesion treated with an everolimus or 1st-generation sirolimus DES. 9 From a total of 6,327 patients, 1,045 treated with a 1stgeneration DES were excluded, leaving a study population of 5,282 patients treated with a 2nd-generation DES.…”

Section: Methodsmentioning

confidence: 99%

Efficacy and Safety of Guideline-Recommended Risk Score-Directed Dual Antiplatelet Therapy After 2nd-Generation Drug-Eluting Stents

Jang

Lee

Kim

et al. 2020

Circ J

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DES. Importantly, results have consistently shown that during longer DAPT, there is a trade-off between fewer ischemic events and increased bleeding events. 4 Alternatively, studies evaluating the clinical compatibility of short-term DAPT showed non-inferior clinical outcomes for patients with low thrombotic risk. 5-9 However, similar D ual antiplatelet therapy (DAPT) effectively treats ischemic heart disease by preventing thrombotic complications, especially after stent implantation. 1 With 1st-generation drug-eluting stents (DES), DAPT therapy was recommended for 12 months to prevent late or very late stent thrombosis (ST). 2 However, the clinical benefits of longer DAPT have been attenuated following the introduction of improved stent technology that has reduced thrombotic events, including the 2nd-generation Editorial p 153

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Safety of six-month dual antiplatelet therapy after second-generation drug-eluting stent implantation: OPTIMA-C Randomised Clinical Trial and OCT Substudy

Abstract: After second-generation DES implantation, six-month DAPT was not inferior to 12-month DAPT in terms of MACE occurrence over the 12-month follow-up period. OCT examination revealed favourable stent strut coverage at six months after stent implantation.

Cited by 42 publications

References 21 publications

Duration of dual antiplatelet therapy after percutaneous coronary intervention with drug-eluting stent: systematic review and network meta-analysis

Duration of dual antiplatelet therapy after percutaneous coronary intervention with drug-eluting stent: systematic review and network meta-analysis

Best duration of dual antiplatelet therapy after drug-eluting stent implantation: an updated network meta-analysis of randomized controlled trials

Efficacy and Safety of Guideline-Recommended Risk Score-Directed Dual Antiplatelet Therapy After 2nd-Generation Drug-Eluting Stents

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