冠状动脉长病变时应用进口及国产雷帕霉素涂层支架的比较:冠状动脉造影随访评估心血管管腔内的变化

Curative effect of foreign versus domestic Rapamycin-eluting stents on long coronary lesions:Evaluations of intraluminal changes in cardiac vessels by coronary arteriongraphy

目的:比较国产雷帕霉素洗脱支架和进口雷帕霉素洗脱支架在冠状动脉长病变中应用的生物相容性及其安全性。方法:选择2004-07/2006-12就诊于唐山工人医院心内科,冠状动脉造影提示冠状动脉为长病变的患者144例,经患者及家属知情同意后进行临床观察,治疗过程经医院医学伦理委员会批准。裸支架组45例,Cypher支架组51例和Firebird支架组48例。随访6～9个月,复查冠状动脉造影,计算支架内最小管腔内径、病变节段内最小管腔内径、支架内晚期管腔丢失及节段内晚期管腔丢失,并观察患者的主要心脏不良事件。结果:①124例患者随访6～9个月,其中裸支架组40例,Cypher支架组43例和Firebird支架组41例,随访时间各组比较差异无显著性。②Firebird支架组、Cypher支架组随访中支架内最小管腔内径、病变节段内最小管腔内径、支架内晚期管腔丢失、节段内晚期管腔丢失、靶血管再狭窄率、血运重建率及再发心绞痛率均低于裸支架组(P<0.05),Cypher支架组及Firebird支架组比较差异无显著性意义。结论:雷帕霉素药物涂层支架在冠状动脉长病变中应用是安全的,长期随访未发现管腔内出现血液及组织细胞的变化,无特殊生物相容性和安全性问题,且进口及国产雷帕霉素药物涂层支架各项指标差异不明显。

AIM：To evaluate the biocompatibility and safety of foreign and domestic Rapamycin-eluting stents on long coronary lesions. METHODS： From July 2004 to December 2006, 144 patients with long coronary lesions were enrolled from the Department of Cardiology in Tangshan Worker＇s Hospital. With the informed consents of patients and relatives as well as the approvals of the hospital ethical committee, the patients were treated with bare metal stent （n =45）, Cypher stent （n =51） and Firebird （n =48）, respectively. Patients were followed-up for 6-9 months, and examined by using coronary arteriongraphy to record the major adverse cardiac events, in-stent minimal lumen diameter （MLD）, in-segment MLD, in-stent late lumen loss （LLL） and in-segment （LLL）. RESULTS： ①Totally 124 patients were followed up for 6-9 months, including 40 cases in bare metal stent group, 43 cases in Cypher stent group and 41 cases in Firebird group. No significant differences were found in the follow-up time among three groups.②The ratios of target restenosis, blood flow reconstruction and recurrence of angina pectoris, in-stent MLD, in-segment MLD, in-stent LLL, in-segment LLL of Cypher stent group and Firebird stent group were no statistical differences, but rare than bare metal stent group （P 〈 0.05）. There were no significant differences between Cypher stent group and Firebird stent group. CONCLUSION： Rapamycin-eluting stents are safe and efficient on long coronary lesions, without special biocompatibility and safety. No changes are found in the cells of intraluminal blood and tissues during the long-term follow-ups. Foreign and domestic Rapamycin-eluting stents are of no evident differences in terms of indexes.