Complications following paclitaxel-eluting stent implantation:6-month follow-up

Hongbin LIU; Luyue GAI; Tingshu YANG; Qinhua JIN; Lian CHEN; Yu WANG; Yihong REN; Zhijun SUN; Jun GU

ABSTRACT

BACKGROUND:

The safety and efficacy of paclitaxel-eluting stents (Taxus DES) has been proved by international researchers in clinic investigations.Based on further inclusion criteria,the incidence of in-stent restenosis is still lower than that of bare-metal stent.

OBJECTIVE:

TO observe restenosis of Taxus DES and the effect on local vessels through applying the follow up of coronary angiography and to investigate the biocompatibility of stent and host.

DESIGN:

Following-up observation.

SETTING:

Department of Cardiology,General Hospital of Chinese PLA.

PARTICIPANTS:

A total of 297 patients who had undergone coronary Taxus DES implantation for coronary artery disease were selected from Cardiovascular Department of General Hospital of Chinese PLA from May 2003 to May 2005.There were 265 males and 32 females and their ages ranged from 36 to 76 years.All patients provided informed consent,and the experiment had got confirmed consent from local ethic committee.

METHODS:

All patients were implanted Taxus DES and received the follow up within 6 and 12 months.In addition,at 6 months after operation,coronary angiography was used to measure the reference vessel diameter (RVD) and the minimal lumen diameter(MLD),calculate diameter restenosis rate and observe late loss.MAIN OUTCOME

MEASURES:

Coronary angiography at 6 months after Taxus DES implantation and biocompatibility of stent and host.

RESULTS:

①Quantitative angiographic analysis(QCA)Angiographic follow-up showed that the late loss of in-stent was significantly higher than that of pro-in-lesion and dis-in-lesion(P＜0.05).②Coronary angiography in-stent restenosisIn 134 angiographic follow-up patients,a total of 14 patients experienced restenosis,and the incidence was 10.4%(14/134).The patterns of restenosis were diffuse in-stent in 7 patients and the rate of revascularization was 6.7%.③Stent aneurysmAngiographic evidence of aneurysm was observed in one patient among follow-up cases,and the rate of which was 0.75% (1/134).④Clinic follow-up major adverse cardiac events(MACE)Among 297 patients,one patient was attracted sudden death 5 months after intervention (0.34%; 1/297),and one patient was suffered subacute thrombosis 5 days after stent implant (0.34%;1/297),and late thrombosis occurred in 2 patients.The general rate of MACE was 1.35%.

CONCLUSION:

①The late loss of Taxus DES mainly takes place in in-stent.The patterns of restenosis of Taxus DES are in majority of diffuse in-stent,and the incidence of MACE is low.②Taxus DES possibly results aneurysm in local vessels.The follow up indicates that Taxus DES has a good biocompatibility to patients.