Prospective multi-center registry to evaluate efficacy and safety of the newly developed diamond-like carbon-coated cobalt-chromium coronary stent system.
Prospective multi-center registry to evaluate efficacy and safety of the newly developed diamond-like carbon-coated cobalt-chromium coronary stent system.
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DOI：
10.1007/s12928-016-0407-z
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发表时间：
2017-07
影响因子：
3.2
通讯作者：
Kimura T
中科院分区：
文献类型：
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作者：
Ando K;Ishii K;Tada E;Kataoka K;Hirohata A;Goto K;Kobayashi K;Tsutsui H;Nakahama M;Nakashima H;Uchikawa S;Kanda J;Yasuda S;Yajima J;Kitabayashi H;Sakurai S;Nakanishi K;Inoue N;Noike H;Hasebe T;Sato T;Yamasaki M;Kimura T
这项多中心、非随机和开放标签临床试验的目的是确定类金刚石(DLC)涂层钴铬冠状动脉支架(MOMO DLC冠状动脉支架)相对于商用裸金属支架(MULTI-LINK VISION®)的非劣性。日本有19个中心参加。研究队列包括来自19个日本中心的99名符合研究资格标准的患者，这些患者患有单支或双支本土冠状动脉疾病，并伴有新生病变和再狭窄病变。这群人组成了安全分析集。疗效分析集由98名患者组成(排除1例违反资格标准的患者)。主要终点是支架置入后9个月的靶血管衰竭(TVF)发生率。在98例疗效分析集患者中，11例患者在指数型支架置入后9个月发生TVF(11.2%，95%可信区间5.7-19.2%)。研究支架的TVF的上限95%可信区间低于之前报道的商用多链接VISION®的可信区间(19.6%)，表明研究支架与多链接VISION®相比并不逊色。所有TVF病例均与靶血管重建有关。无一例发生支架内血栓或心肌梗死。术后6个月的平均支架内晚期损失率为0.69 mm，二次再狭窄率为10.5%，均低于商品化裸金属支架的报道。总之，目前评估新的MOMO DLC涂层冠状动脉支架的关键临床研究表明，尽管考虑到样本量小和单臂研究设计，这些数据是初步考虑的，但它的TVF和血管造影双重再狭窄率较低，支架内晚期损失较小。
The purpose of this multi-center, non-randomized, and open-label clinical trial was to determine the non-inferiority of diamond-like carbon (DLC)-coated cobalt–chromium coronary stent, the MOMO DLC coronary stent, relative to commercially available bare-metal stents (MULTI-LINK VISION®). Nineteen centers in Japan participated. The study cohort consisted of 99 patients from 19 Japanese centers with single or double native coronary vessel disease with de novo and restenosis lesions who met the study eligibility criteria. This cohort formed the safety analysis set. The efficacy analysis set consisted of 98 patients (one case was excluded for violating the eligibility criteria). The primary endpoint was target vessel failure (TVF) rate at 9 months after stent placement. Of the 98 efficacy analysis set patients, TVF occurred in 11 patients (11.2 %, 95 % confidence interval 5.7–19.2 %) at 9 months after the index stent implantation. The upper 95 % confidence interval for TVF of the study stent was lower than that previously reported for the commercially available MULTI-LINK VISION® (19.6 %), demonstrating non-inferiority of the study stent to MULTI-LINK VISION®. All the TVF cases were related to target vascular revascularization. None of the cases developed in-stent thrombosis or myocardial infarction. The average in-stent late loss and binary restenosis rate at the 6-month follow-up angiography were 0.69 mm and 10.5 %, respectively, which are lower than the reported values for commercially available bare-metal stents. In conclusion, the current pivotal clinical study evaluating the new MOMO DLC-coated coronary stent suggested its low rates of TVF and angiographic binary restenosis, and small in-stent late loss, although the data were considered preliminary considering the small sample size and single arm study design.