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目的:前瞻性、非随机探索性研究,用定量冠状动脉(冠脉)造影方法(QCA),评价无聚合物微孔紫杉醇洗脱支架(YINYITMDES)置入冠脉原发(denovo)病变的近期、远期有效性和安全性。方法:2005-03至2005-09月大连医科大学附属第一医院和北京同仁医院的冠心病患者69例,年龄30～70岁,其中男性49例(71.0%),女性20例(29.0%),经冠脉造影(CAG)证实至少一支冠脉狭窄(冠脉原发病变,直径狭窄≥70%),靶病变长度≤26mm,靶血管直径2.5～3.5mm,按照常规方法行冠脉造影并置入YINYITMDES。结果:69例患者共放置79个支架。支架平均直径为(3.21±0.45)mm,置入支架长度平均为(18.29±6.09)mm。69例患者临床平均随访(11±2)个月,随访率100%。其中对45例患者(放置53个支架)在支架置入后9～13个月进行了冠脉造影随访,随访率65.2%。与术前相比,术后即刻最小内腔直径(MLD)明显改善,术前为(0.45±0.27)mm,支架术后为(3.21±0.45)mm,术后9～13个月与术后即刻相比,支架内再狭窄程度为(10.59±12.45)%,最小内腔直径(2.87±0.41)mm,支架内晚期管腔丢失(0.34±0.11)mm;支架内再狭窄率5.7%。结论:无聚合物微孔紫杉醇载药YINYITM对冠脉原发病变有较好的近期和远期治疗作用。
PURPOSE: A prospective, nonrandom, exploratory study was performed to assess the recent adverse effects of implantation of a polymer-free micropyridaxel-eluting stent (YINYITMDES) into denovo lesions using a quantitative coronary angiography (QCA) , Long-term effectiveness and safety. Methods: From March 2005 to September 2005, 69 patients with coronary heart disease were admitted to the First Affiliated Hospital of Dalian Medical University and Beijing Tongren Hospital, aged from 30 to 70 years, including 49 males (71.0%) and 20 females (29.0%), , Coronary artery stenosis (CAG) confirmed at least one coronary artery stenosis (primary coronary lesions, diameter stenosis ≥ 70%), the target lesion length ≤ 26mm, target vessel diameter 2.5 ~ 3.5mm, according to the conventional method of coronary angiography And put YINYITMDES. Results: A total of 79 stents were placed in 69 patients. The mean diameter of the stent was (3.21 ± 0.45) mm, and the average stent length was (18.29 ± 6.09) mm. The average clinical follow-up of 69 patients (11 ± 2) months, follow-up rate was 100%. 45 patients (53 stents placed) were followed up for coronary angiography 9 to 13 months after stenting, with a follow-up rate of 65.2%. Compared with the preoperative, the minimal postoperative lumen diameter (MLD) was significantly improved, preoperatively (0.45 ± 0.27) mm, postoperative stent was (3.21 ± 0.45) mm, postoperative 9 to 13 months and postoperative Immediate restenosis was (10.59 ± 12.45)% in the stent, with a minimum lumen diameter (2.87 ± 0.41) mm and a late stent loss of 0.34 ± 0.11 mm in the stent. The rate of in-stent restenosis was 5.7%. CONCLUSION: Polymeric paclitaxel-loaded YINYITM has good short-term and long-term therapeutic effects on primary coronary lesions.