两种药物洗脱支架在冠状动脉复杂弥漫病变中的疗效比较

The clinical efficacy of sirolimus-eluting stents versus paclitaxel-eluting stents in complex and diffuse coronary lesions

目的比较雷帕霉素洗脱支架(SES)和紫杉醇洗脱支架(PES)对长度≥25mm复杂病变的疗效。方法入选138例患者(男124例,女14例)冠状动脉(冠脉)病变长度≥25mm,接受SES和PES介入治疗,并且在支架术后6个月左右接受冠脉造影随访。结果共147处病变在6个月后随访。其中2型糖尿病患者43例(31·2%),C型病变129处(87·8%)。SES组的支架内再狭窄率(5·9%,17·7%,P=0·023)、支架段再狭窄率(9·4%,21·0%,P=0·048)和支架段晚期腔径丢失[(0·16±0·52)mm比(0·45±0·65)mm,P=0·003)]、支架内晚期腔径丢失[(0·26±0·46)mm比(0·60±0·66)mm,P=0·001)]明显低于PES组。两组之间在随访期间靶病变血管重建率(7·1%比12·9%,P=0·223)差异无统计学意义。结论对于复杂弥漫病变SES在再狭窄率和晚期腔径丢失要优于PES,对于远期预后的影响还需要进一步的观察。SES更适合用于复杂小血管病变。

Objective To compare the effect of sirolimus-eluting stents to paclitaxel-eluting stents in complex and diffuse coronary lesions. Methods 138 consecutive patients with complex and diffuse coronary lesions were enrolled from April 2004 to August 2005 ; they were implanted with more than 25 mm long sirolimus-eluting stents or paclitaxel-eluting stents. Unsuccessful cases were excluded. All patients received medical treatment according to guideline. Aspirin 300 mg and clopidogrel 75 mg once daily were continually administered for 6 months after the procedure. The patients were followed up after 6 months. Results The study population consisted of 138 patients, including 124 men and 14 women. There were 129 （87.8%） C ACC/AHA type lesions. The average reference vessel diameter was （2. 91 ± 0. 43 ） mm. The average lesion length was （36. 36 ± 12. 27）mm . The average stent length per lesion was （40. 25 ± 12. 79） mm. There was no difference of patient and lesion baseline characteristics between the groups of sirolimuseluting and paclitaxel-eluting stents. At the end of follow up, in-stent restenosis rate（5.9% vs 17.7%, P = 0. 023 ） and in-segment restenosis rate （9. 4% vs 21.0% , P = 0. 048 ） in the group of sirolimus-eluting stents were less than that in the group of paclitaxel-eluting stents. The difference was also seen in in-stent late luminal loss [ （ 0. 26 ± 0. 46 ） mm vs （ 0. 60 ± 0. 66 ） mm, P = 0. 001 ） ] and in-segment late lumens loss [ （0. 16 ±0. 52）mm vs（ 0. 45±0. 65）mm, P =0. 003） ]. There was no difference between the sirolimuseluting stents group and paclitaxel-eluting stents group in the incidence of target lesion revascularization （7. 1% vs 12. 9%, P = 0. 223）. Conclusions In patients with complex and diffuse coronary lesions, the use of the sirolimus-eluting stent was associated with a decrease in the extent of late luminal loss, as compared with use of paclitaxel-eluting stents, suggesting that sirolimus-eluting stent might be more suitable to be used in small vessel.