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Early Strut Coverage in Patients Receiving Drug-Eluting Stents and its Implications for Dual Antiplatelet Therapy A Randomized Trial
JACC: Cardiovascular Imaging ( IF 14.0 ) Pub Date : 2018-12-01 , DOI: 10.1016/j.jcmg.2017.12.014
Seung-Yul Lee , Jung-Sun Kim , Hyuck-Jun Yoon , Seung-Ho Hur , Sang-Gon Lee , Jin Won Kim , Young Joon Hong , Ki-Seok Kim , So-Yeon Choi , Dong-Ho Shin , Chung-Mo Nam , Byeong-Keuk Kim , Young-Guk Ko , Donghoon Choi , Yangsoo Jang , Myeong-Ki Hong

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)



中文翻译:

接受药物洗脱支架的患者的早期支撑覆盖及其对双重抗血小板治疗的意义
随机试验


目的本研究旨在测量接受药物洗脱支架(DES)的患者的早期支撑物覆盖率,并根据早期支撑物覆盖率探讨短期双重抗血小板治疗(DAPT)的可行性。

接受新一代DES的患者早期撑杆覆盖的背景数据及其对DAPT持续治疗的意义是有限的。

方法在894名接受DES治疗的患者中进行了一项随机,多中心试验。将患者随机分为依维莫司洗脱支架(EES)(444例)或生物lim洗脱支架(BES)(n = 450)组,以光学相干断层扫描(OCT)引导(n = 445)或以血管造影术引导( n = 449)使用2乘2因子设计的植入组。在3个月的后续OCT检查中,测得的早期支撑物覆盖率为未覆盖支撑物的百分比。主要结果是EES和BES组之间以及OCT和血管造影术引导的植入组之间早期支撑物覆盖率的差异。次要结果是心脏死亡,心肌梗死,支架血栓形成,

结果获得了779例患者的8个月的随访OCT数据(占87.1%)。EES和BES组在3个月时未发现支杆的中位百分比分别为8.9%和8.2%(p = 0.69),而OCT指导组(7.5%)低于血管造影术指导组(9.9) %; p = 0.009)。779例患者中有320例(41.1%)的早期支气管覆盖率良好(未覆盖支气管≤6%)。在12个月时,在3个月(0.3%)或12个月(0.2%)的DAPT组中很少发生复合事件(p = 0.80)。

结论与血管造影术引导DES植入相比,OCT引导的DES植入改善了早期支撑覆盖,EES和BES组之间的支撑覆盖没有差异。短期DAPT在早期支架覆盖率良好的特定患者中是可行的(根据依维莫司洗脱支架与Biolimus A9之间的随机比较,通过光学相干断层扫描的支架覆盖度确定双重抗血小板治疗的持续时间洗脱支架[DETECT-OCT]; NCT01752894)

更新日期:2018-12-04
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