Sanbon Hospital, Wonkwang University College of Medicine, Gunpo, Republic of Korea.
Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Republic of Korea; Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
JACC Cardiovasc Imaging. 2018 Dec;11(12):1810-1819. doi: 10.1016/j.jcmg.2017.12.014. Epub 2018 Feb 14.
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.
Data for early strut coverage in patients receiving new-generation DESs, and its implications for DAPT continuation were limited.
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.
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).
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).
本研究旨在测量接受药物洗脱支架(DES)治疗的患者的早期支架覆盖率,并探讨基于早期支架覆盖率程度进行短期双联抗血小板治疗(DAPT)的可行性。
关于新一代 DES 治疗患者的早期支架覆盖率数据及其对 DAPT 持续时间的影响有限。
在 894 例接受 DES 治疗的患者中进行了一项随机、多中心试验。患者被随机分为依维莫司洗脱支架(EES)(n=444)或生物可吸收洗脱支架(BES)(n=450)组,并采用 2×2 析因设计分为光学相干断层扫描(OCT)指导(n=445)或血管造影指导(n=449)植入组。在 3 个月的 OCT 随访时,通过测量未覆盖支架的百分比来评估早期支架覆盖率。主要终点是 EES 和 BES 组之间以及 OCT 指导和血管造影指导植入组之间的早期支架覆盖率差异。次要终点是根据 3 个月 OCT 随访时(≤6%未覆盖)的早期支架覆盖率,在接受 3 个月 DAPT 的患者中(12 个月时)发生心脏死亡、心肌梗死、支架血栓形成和主要出血的复合终点。
779 例患者(87.1%)获得了 3 个月的 OCT 随访数据。EES 和 BES 组 3 个月时未覆盖支架的中位数百分比分别为 8.9%和 8.2%(p=0.69),OCT 指导组(7.5%)低于血管造影指导组(9.9%;p=0.009)。在 779 例患者中,有 320 例(41.1%)有良好的早期支架覆盖率(≤6%未覆盖的支架)。在 12 个月时,3 个月(0.3%)或 12 个月(0.2%)DAPT 组的复合事件很少发生(p=0.80)。
与血管造影指导的 DES 植入相比,OCT 指导的 DES 植入可改善早期支架覆盖率,EES 和 BES 组之间的支架覆盖率无差异。在具有良好早期支架覆盖率的患者中,短期 DAPT 可能是可行的(通过光学相干断层扫描确定支架覆盖率来确定双联抗血小板治疗的持续时间:依维莫司洗脱支架与生物可吸收洗脱支架的随机比较[DETECT-OCT];NCT01752894)。