CYPHER药物涂层冠状动脉支架的临床应用

Early and short-term clinical evaluation of CYPHER drug-eluting coronary stenting

目的 评估CYPHER药物涂层冠状动脉内支架术的即刻和近期临床效果。方法 30例接受CYPHER雷帕霉素药物涂层冠状动脉内支架治疗 (4 2枚 )的冠心病患者为药物支架组 ,同期 30例行普通冠状动脉支架术治疗的患者为普通支架组 ,比较两组的临床应用情况。结果 药物支架组的高血脂患者占 5 0 % ,明显高于普通支架组的 2 3% (P <0 .0 5 )。药物支架治疗冠状动脉中左前降支占 5 9% ,复杂病变 (B2或C型 )占6 4 % ;90 %的药物涂层支架植入前进行球囊预扩张 ,支架术成功率达 10 0 %。药物支架的平均内径较小 ,为 (2 .8± 0 .2 )mm ,与普通支架的 (3.1± 0 .4 )mm比较 ,差异有显著性 (P =0 .0 0 4 ) ;药物支架的释放压力较高 ,为(170 2 .2 6± 10 1.32 )kPa ,与普通支架的 (130 7.0 9± 10 1.32 )kPa比较 ,差异亦有显著性 (P <0 .0 0 1)。两组平均随访 (74± 2 1)d ,药物支架组 1例和普通支架组 2例未完全血运重建者复发胸痛 ,均无严重不良心脏事件发生。结论 CYPHER冠状动脉药物涂层支架术治疗冠心病安全、有效 ,即刻和近期临床疗效较好 。

Objective To evaluate the feasibility, safety and efficacy of CYPHER coronary drug eluting stent(DES) in patients with coronary artery disease(CAD). Methods From September to December 2002, 42 CYPHER stents were implanted in 30 patients with de novo lesions. For each patient the demographic, interventional and short term follow up informations were recorded, and compared with that in 30 sex matched patients undergone plain coronary stenting contemporarily(control group). Results In DES group, 50% patients had hyperlipidemia, and 64% target lesions had unfavorable morphological characteristics (type B2 or C). The mean diameter of CYPHER stents was less than that of the plain stents, (2.8±0.2) mm vs (3.1±0.4) mm( P =0.004), and the mean stent deploy pressure was significantly higher than that of the plain stents, (1 702.26±101.32) kPa vs (1 307.09±101.32) kPa ( P <0.001). No stent deployment failure and branch was compromising occurred in 3 DES cases. With a mean of 3 months follow up, no MACE occurred except 1 incomplete revascularization patient with recurrence of chest pain. Conclusion The CYPHER drug eluting stent is safe and effective in treating coronary artery disease.