Safety of six-month dual antiplatelet therapy after secondgeneration drug-eluting stent implantation: OPTIMA-C randomised clinical trial and OCT substudy

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

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Abstract

Aims: There are few randomised studies concerning the optimal duration of dual antiplatelet therapy (DAPT) for patients who receive a second-generation drug-eluting stent (DES). This trial aimed to investigate the safety of six-month compared with 12-month DAPT maintenance after second-generation DES implantation. Methods and results: A prospective, randomised, multicentre trial was performed at 10 medical centres. The 1,368 patients included in the study received a biolimus-eluting stent (BES) or a zotarolimus-eluting stent (ZES). The primary outcome measured was the composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), or ischaemia-driven target lesion revascularisation at the 12-month follow-up. The secondary outcome was the percentage of uncovered struts at six months in 60 patients (30 ZES, 30 BES) using optical coherence tomography (OCT) assessment. Each patient was randomly assigned to six-month (n=684) or 12-month DAPT (n=684). Major adverse cardiac events at 12 months occurred in eight patients (1.2%) in the six-month DAPT group and in four patients (0.6%) in the 12-month DAPT group (risk difference 0.6%; 95% confidence interval [CI]: -0.4-1.6%; p=0.24). The upper 95% CI limit was lower than the pre-specified limit of 4% non-inferiority (p for non-inferiority <0.05). The percentage of uncovered struts was 3.16±4.30% at six months in 60 stents of 60 patients. Conclusions: 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. The current trial is registered under ClinicalTrials.gov Identifier: NCT03056118.

Original languageEnglish
Pages (from-to)1923-1930
Number of pages8
JournalEuroIntervention
Volume13
Issue number16
DOIs
Publication statusPublished - 2018 Mar

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

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    Lee, B. K., Kim, J. S., Lee, O. H., Min, P. K., Yoon, Y. W., Hong, B. K., Shin, D. H., Kang, T. S., Kim, B. O., Cho, D. K., Jeon, D. W., Woo, S. I., Choi, S., Kim, Y. H., Kang, W. C., Kim, S., Kim, B. K., Hong, M. K., Jang, Y., & Kwon, H. M. (2018). Safety of six-month dual antiplatelet therapy after secondgeneration drug-eluting stent implantation: OPTIMA-C randomised clinical trial and OCT substudy. EuroIntervention, 13(16), 1923-1930. https://doi.org/10.4244/EIJ-D-17-00792