Seung-Yul Lee1, Jung-Sun Kim2, Hyuck-Jun Yoon3, Seung-Ho Hur3, Sang-Gon Lee4, Jin Won Kim5, Young Joon Hong6, Ki-Seok Kim7, So-Yeon Choi8, Dong-Ho Shin2, Chung-Mo Nam9, Byeong-Keuk Kim2, Young-Guk Ko2, Donghoon Choi2, Yangsoo Jang10, Myeong-Ki Hong11. 1. Sanbon Hospital, Wonkwang University College of Medicine, Gunpo, Republic of Korea. 2. Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Republic of Korea; Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea. 3. Dongsan Medical Center, Keimyung University College of Medicine, Daegu, Republic of Korea. 4. Ulsan University Hospital, Ulsan, Republic of Korea. 5. Korea University Guro Hospital, Seoul, Republic of Korea. 6. Chonnam National University Hospital, Gwangju, Republic of Korea. 7. Jeju National University Hospital, Jeju, Republic of Korea. 8. Ajou University Hospital, Suwon, Republic of Korea. 9. Department of Preventive Medicine and Biostatistics, Yonsei University College of Medicine, Seoul, Republic of Korea. 10. Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Republic of Korea; Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea; Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, Republic of Korea. 11. Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Republic of Korea; Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea; Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: mkhong61@yuhs.ac.
Abstract
OBJECTIVES: This study sought to measure early strut coverage in patients receiving drug-eluting stents (DESs) and to explore the feasibility of short-term dual antiplatelet therapy (DAPT) based on the degree of early strut coverage. BACKGROUND: Data for early strut coverage in patients receiving new-generation DESs, and its implications for DAPT continuation were limited. METHODS: A randomized, multicenter trial was conducted in 894 patients treated with DESs. Patients were randomly assigned to everolimus-eluting stent (EES) (n = 444) or biolimus-eluting stent (BES) (n = 450) groups and optical coherence tomography (OCT)-guided (n = 445) or angiography-guided (n = 449) implantation groups using a 2-by-2 factorial design. Early strut coverage was measured as the percentage of uncovered struts on 3-month follow-up OCT examination. The primary outcome was the difference in early strut coverage between EES and BES groups and between OCT- and angiography-guided implantation groups. The secondary outcome was a composite of cardiac death, myocardial infarction, stent thrombosis, and major bleeding during the first 12 months post-procedure in patients receiving 3-month DAPT based on the presence of early strut coverage (≤6% uncovered) on 3-month follow-up OCT. RESULTS: Three-month follow-up OCT data were acquired for 779 patients (87.1%). The median percentage of uncovered struts at 3 months was 8.9% and 8.2% in the EES and BES groups, respectively (p = 0.69) and was lower in the OCT-guided group (7.5%) than in the angiography-guided group (9.9%; p = 0.009). Favorable early strut coverage (≤6% uncovered strut) was observed in 320 of 779 patients (41.1%). At 12 months, the composite event rarely occurred in the 3-month (0.3%) or 12-month (0.2%) DAPT groups (p = 0.80). CONCLUSIONS:OCT-guided DES implantation improved early strut coverage compared with angiography-guided DES implantation, with no difference in strut coverage between EES and BES groups. Short-term DAPT may be feasible in selected patients with favorable early strut coverage (Determination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents Versus Biolimus A9-eluting Stents [DETECT-OCT]; NCT01752894).
RCT Entities:
OBJECTIVES: This study sought to measure early strut coverage in patients receiving drug-eluting stents (DESs) and to explore the feasibility of short-term dual antiplatelet therapy (DAPT) based on the degree of early strut coverage. BACKGROUND: Data for early strut coverage in patients receiving new-generation DESs, and its implications for DAPT continuation were limited. METHODS: A randomized, multicenter trial was conducted in 894 patients treated with DESs. Patients were randomly assigned to everolimus-eluting stent (EES) (n = 444) or biolimus-eluting stent (BES) (n = 450) groups and optical coherence tomography (OCT)-guided (n = 445) or angiography-guided (n = 449) implantation groups using a 2-by-2 factorial design. Early strut coverage was measured as the percentage of uncovered struts on 3-month follow-up OCT examination. The primary outcome was the difference in early strut coverage between EES and BES groups and between OCT- and angiography-guided implantation groups. The secondary outcome was a composite of cardiac death, myocardial infarction, stent thrombosis, and major bleeding during the first 12 months post-procedure in patients receiving 3-month DAPT based on the presence of early strut coverage (≤6% uncovered) on 3-month follow-up OCT. RESULTS: Three-month follow-up OCT data were acquired for 779 patients (87.1%). The median percentage of uncovered struts at 3 months was 8.9% and 8.2% in the EES and BES groups, respectively (p = 0.69) and was lower in the OCT-guided group (7.5%) than in the angiography-guided group (9.9%; p = 0.009). Favorable early strut coverage (≤6% uncovered strut) was observed in 320 of 779 patients (41.1%). At 12 months, the composite event rarely occurred in the 3-month (0.3%) or 12-month (0.2%) DAPT groups (p = 0.80). CONCLUSIONS: OCT-guided DES implantation improved early strut coverage compared with angiography-guided DES implantation, with no difference in strut coverage between EES and BES groups. Short-term DAPT may be feasible in selected patients with favorable early strut coverage (Determination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents Versus Biolimus A9-eluting Stents [DETECT-OCT]; NCT01752894).
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