摘要
目的比较生物可降解雷帕霉素洗脱支架（Excel，山东吉威医疗制品有限公司）和非可降解雷帕霉素洗脱支架（Cypher，美国Cordis公司）的临床效果。方法回顾性分析从2006年5月至2006年11月在阜外心血管病医院连续置人Excel支架[E组：n=350，（58．1±10．9）岁]和Cypher支架[C组：n=241，（56．4±10．7）岁]的591例患者。结果临床基线上E组既往心肌梗死（MI）比率大于C组，左主干病变比率少于C组，而3支病变比率大于C组。基线病变特点上E组参照血管直径、支架直径、后扩张比率和支架内最小直径均小于C组。两组介入成功率均为100％。主要不良心血管事件发生率E组与C组比较差异无统计学意义（8．3％比7．1％，P=0．641），其中心原性死亡、非致死性MI和靶血管血运重建率两组差异无统计学意义（分别为0．9％比0．0％，P=0．274；2．0％比1．2％，P=0．747；5．4％比5．8％，P=0．857）。支架内血栓形成发生率E组和C组差异无统计学意义（0．9％比0．4％，P=0．649），早期、晚期支架内血栓形成发生率两组差异亦无统计学意义（分别为0．6％比0．0％，P=0．516；0．3％比0．4％，P=1．000）。7个月造影随访支架内和血管段再狭窄率E组和C组差异无统计学意义（分别为4．7％比3．2％，P=0．725；5．6％比3．2％，P=0．505），但支架内和血管段的管腔晚期丢失E组均明显小于C组[分别为（0．18±0．07）mm比（0．21±0．08）mm，P〈0．001；（0．21±0．09）mm比（0．23±0．11）mm，P=0．003]。结论Excel和Cypher支架在真实世界应用具有相似的良好效果。
Objective To compare the outcome of patients with coronary artery disease implanted with bioabsorbable polymer sirolimus-eluting stent （Excel） and the durable polymer sirolimus-eluting stent （Cypher）. Methods One year clinical and 7 months angiographic follow-up data were analyzed in 591 consecutive patients implanted with Excel （E group： n = 350, 58. 1± 10. 9 years old） or Cypher （C group： n =241, 56. 4 ± 10. 7 years old） during May 2006 to November 2006 in our center. Results There were more patients with old myocardial infarction and triple vessel diseases while there were less left main stem disease in E group compared to those of C group at baseline. Reference vessel diameter[ （2. 76±0. 45）mm vs. （2.87±0.38）mm,P=0.043], stent diameter [（3.11 ±0.48）mm vs. （3.25 ±0.34）mm, P= 0. 045 ] and minimal stent diameter [ （ 2. 67 ± 0.43 ） mm vs. （ 2. 78 ± 0. 35 ） mm, P = 0. 046 ] and rate of post-dilation （ 15.9% vs. 46. 7% ,P 〈0. 001 ）were all significantly smaller in E group compared to those in C group. Procedure was successful in all patients. One year clinical follow-up results showed similar results on major adverse cardiac events （MACE） rate （8.3% vs. 7. 1%, P = 0. 641 ）, rate of cardiac death （0. 9% vs. 0.0% , P =0. 274） ,non-fatal myocardial infarction （2. 0% vs. 1.2% , P =0. 747） and target vessel revascularization （5.4% vs. 5.8% , P =0. 857） between E and C groups. Total （0. 9% vs. 0.4% , P=0.649）, early （0.6% vs. 0.0%, P =0.516） and late （0.3% vs. 0.4%, P = 1.000） stent thrombosis rates according to Academic Research Consortium （ARC） standard definitions （definite ＋ probable） were also similar between the E and C groups. Seven months angiographic follow-up results indicated that there were no differences of in-stent and in-segment restenosis rate between E and C groups （4. 7% vs. 3.2%, P=0. 725; 5.6% vs. 3.2% , P =0. 505） but in-stent and in-segment late loss were significantly smaller in E group than those in C group [ （0. 18 ± 0. 07 ）mm vs. （0. 21± 0. 08 ）mm, P 〈 0.001; （0.21±0.09）mm vs. （0.23 ±0. 11）mm, P =0.003]. Conclusion One year clinical and 7 months angiographic outcome were comparable in patients implanted with Excel and Cypher sirolimus-eluting stents.
出处
《中华心血管病杂志》
CAS
CSCD
北大核心
2008年第12期1074-1077,共4页
Chinese Journal of Cardiology
关键词
血管成形术
经腔
经皮冠状动脉
支架
对比研究
Angioplasty,transluminal, percutaneous coronary
Stents
Comparative study
