[德国西罗莫司洗脱冠状动脉支架“实际使用”中的安全性及当前适应证。德国前瞻性多中心西罗莫司洗脱支架注册研究结果]

[Safety and current indications during "real life" use of sirolimus-eluting coronary stents in Germany. Results from the prospective multicenter German Cypher Registry].

作者信息

Zahn Ralf, Hamm Christian W, Zeymer Uwe, Schneider Steffen, Nienaber Christoph A, Richardt Gert, Kelm Malte, Levenson Benny, Bonzel Tassilo, Tebbe Ulrich, Schöbel Wolfgang A, Sabin Georg, Senges Jochen

机构信息

Herzzentrum, Kardiologie, Ludwigshafen,

出版信息

Herz. 2004 Mar;29(2):181-6. doi: 10.1007/s00059-004-2560-x.

DOI:10.1007/s00059-004-2560-x

PMID:15057439

Abstract

BACKGROUND

Although randomized, controlled clinical trials (RCTs) showed a reduced target vessel revascularization rate and a good safety profile for the sirolimus-eluting coronary Cypher stent, at least the safety data need to be confirmed by larger data in clinical practice. Under the circumstances of frozen medical budgets in Germany, there may also be a shift toward implantation of a drug-eluting stent (DES) for indications not yet evaluated by RCTs.

METHODS

The authors analyzed the data of the German Cypher Registry a nationwide registry which was initiated in parallel to the launch of the first DES, the Cypher stent, in April 2002.

RESULTS

From April 2002 until December 2003, 3,579 interventions using a Cypher stent at 102 centers were included in the German Cypher Registry. This reflects a proportion of this DES compared to all stents implanted at the participating centers of < 10%. Patients' median age was 63.4 years (quartiles: 55-70 years) with 75% men. Renal insufficiency was seen in 10.1%, previous myocardial infarction in 37%, prior percutaneous coronary intervention (PCI) in 54.6%, and prior coronary artery bypass grafting (CABG) in 18.7%. In a large proportion of interventions, Cypher stents were implanted in lesions or in clinical situations not yet evaluated by RCTs: 10.1% ST elevation myocardial infarction, 1.8% cardiogenic shock, 2.1% left main stenoses, 5.5% CABG lesions, 23.2% in-stent stenosis, and 6% chronic total occlusions. PCI before DES implantation was performed in 65.5% of cases, a mean of 1.02 +/- 0.43 Cypher stents per lesion were implanted with a median sum length of all Cypher stents per lesion of 18 mm (quartiles: 13-21 mm). Maximum median balloon diameter during stent implantation was 3.00 mm (quartiles: 2.75-3.00 mm). Acute complication rate was low, with 0.2% deaths, 0.3% subacute stent thromboses, 1.3% myocardial infarctions, 2.1% urgent PCIs, and 0.2% CABGs.

CONCLUSION

In about one half of the patients included into the German Cypher Registry, the DES were implanted in lesions that were excluded from RCTs. The use of this sirolimus-eluting coronary stent in "real life" conditions was found to be safe concerning acute complications.

摘要

背景

尽管随机对照临床试验（RCT）显示西罗莫司洗脱冠状动脉Cypher支架的靶血管再血管化率降低且安全性良好，但至少安全性数据需要在临床实践中通过更大规模的数据来证实。在德国医疗预算冻结的情况下，对于RCT尚未评估的适应症，可能也会转向植入药物洗脱支架（DES）。

方法

作者分析了德国Cypher注册研究的数据，该注册研究是在2002年4月首个DES即Cypher支架推出时同时启动的一项全国性注册研究。

结果

从2002年4月至2003年12月，德国Cypher注册研究纳入了102个中心使用Cypher支架进行的3579例干预。这反映了该DES在参与中心植入的所有支架中所占比例不到10%。患者的中位年龄为63.4岁（四分位数间距：55 - 70岁），男性占75%。10.1%的患者存在肾功能不全，37%有既往心肌梗死史，54.6%有既往经皮冠状动脉介入治疗（PCI）史，18.7%有既往冠状动脉旁路移植术（CABG）史。在很大一部分干预中，Cypher支架被植入到RCT尚未评估的病变或临床情况中：10.1%为ST段抬高型心肌梗死，1.8%为心源性休克，2.1%为左主干狭窄，5.5%为CABG病变，23.2%为支架内狭窄，6%为慢性完全闭塞。65.5%的病例在植入DES前进行了PCI，每个病变平均植入1.02±0.43个Cypher支架，每个病变所有Cypher支架的中位总长度为18 mm（四分位数间距：13 - 21 mm）。支架植入期间的最大中位球囊直径为3.00 mm（四分位数间距：2.75 - 3.00 mm）。急性并发症发生率较低，死亡率为0.2%，亚急性支架血栓形成率为0.3%，心肌梗死率为1.3%，紧急PCI率为2.1%，CABG率为0.2%。