Department of Cardiovascular Diseases, Scripps Clinic, La Jolla, California.
Shonan Kamakura General Hospital, Kamakura, Japan.
JACC Cardiovasc Interv. 2017 Jul 24;10(14):1381-1388. doi: 10.1016/j.jcin.2017.05.004.
The aim of this study was to explore the safety and efficacy of a dedicated drug-eluting stent for the treatment of coronary lesions with very small reference vessel diameter (RVD).
Smaller RVD is associated with increased risk for restenosis and target lesion failure (TLF) after stent implantation.
This was a prospective, single-arm, multicenter trial of the Resolute Onyx 2.0-mm zotarolimus-eluting stent. The primary endpoint was 12-month TLF, which was compared with a pre-specified performance goal. Subjects with stable or unstable angina or ischemia, target lesions ≤27 mm in length, and RVD ≥2.0 and <2.25 mm were eligible for enrollment. A subset of subjects underwent follow-up angiography at 13 months post-procedure.
A total of 101 subjects with 104 lesions were enrolled. The mean age was 67.3 ± 9.6 years, 47% of subjects had diabetes, the mean lesion length was 12.6 ± 6.3 mm, and the mean RVD was 1.91 ± 0.26 mm. The rate of TLF at 12 months was 5.0%, fulfilling the pre-specified performance goal of 19% (p < 0.001). The rates of target lesion revascularization and target vessel myocardial infarction were 2.0% and 3.0%, respectively. There were no episodes of stent thrombosis. In-stent late lumen loss was 0.26 ± 0.48 mm, and the rate of binary restenosis was 12.0%.
In this first report of a drug-eluting stent with a dedicated size to treat lesions with RVD <2.25 mm, the Resolute Onyx 2.0-mm zotarolimus-eluting stent was associated with a low rate of TLF and late lumen loss, without a signal for stent thrombosis. This novel-sized drug-eluting stent appears to be a feasible option for the treatment of coronary lesions in extremely small vessels. (Medtronic Resolute Onyx 2.0 mm Clinical Study; NCT02412501).
本研究旨在探讨专门用于治疗参考血管直径（RVD）非常小的冠状动脉病变的药物洗脱支架的安全性和疗效。
RVD 越小，支架植入后再狭窄和靶病变失败（TLF）的风险越高。
这是一项前瞻性、单臂、多中心的 Resolute Onyx 2.0mm 佐他莫司洗脱支架试验。主要终点是 12 个月时的 TLF，并与预先设定的性能目标进行比较。符合条件的患者为稳定性或不稳定性心绞痛或缺血，靶病变长度≤27mm，RVD≥2.0 且<2.25mm。部分患者在术后 13 个月进行了随访血管造影。
共纳入 101 例患者的 104 处病变。患者平均年龄为 67.3±9.6 岁，47%的患者患有糖尿病，平均病变长度为 12.6±6.3mm，平均 RVD 为 1.91±0.26mm。12 个月时的 TLF 发生率为 5.0%，达到了预先设定的 19%的性能目标（p<0.001）。靶病变血运重建和靶血管心肌梗死的发生率分别为 2.0%和 3.0%。无支架血栓形成事件。支架内晚期管腔丢失为 0.26±0.48mm，二元再狭窄率为 12.0%。
在首例报道的专门用于治疗 RVD<2.25mm 的病变的药物洗脱支架中，Resolute Onyx 2.0mm 佐他莫司洗脱支架与低 TLF 和晚期管腔丢失发生率相关，没有支架血栓形成的信号。这种新型尺寸的药物洗脱支架似乎是治疗极细血管病变的可行选择。（美敦力 Resolute Onyx 2.0mm 临床研究；NCT02412501）。
