Biolimus-eluting biodegradable polymer versus sirolimus-eluting permanent polymer stent performance in long lesions: results from the LEADERS multicentre trial substudy.
Biolimus-eluting biodegradable polymer versus sirolimus-eluting permanent polymer stent performance in long lesions: results from the LEADERS multicentre trial substudy.
复制标题
生物莫司洗脱可生物降解聚合物与西罗莫司洗脱永久性聚合物支架在长病变中的性能：来自 LEADERS 多中心试验子研究的结果。
DOI：
10.4244/v5i3a49
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发表时间：
2009
期刊：
影响因子：
--
通讯作者：
P. Serruys
中科院分区：
文献类型：
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作者：
J. Wykrzykowska;L. Räber;T. de Vries;Marco Bressers;P. Buszman;A. Linke;T. Ischinger;V. Klauss;F. Eberli;R. Corti;W. Wijns;M. Morice;C. Di Mario;E. Regar;P. Jüni;S. Windecker;P. Serruys
旨在
病变长度仍然是靶病变血运重建的预测因素，长病变支架植入术的结果仍然较差。西罗莫司洗脱支架在长病变中的表现优于紫杉醇洗脱支架。在LEADERS试验的这一子研究中，我们比较了Biolimus生物可降解聚合物（BES）和西罗莫司永久性聚合物支架（SES）在长病变中的性能。
方法和结果
共有1，707名“全科”患者被随机分配到BES和SES治疗组。对病变长度20 mm（通过定量血管造影测量）的血管分别进行了9个月和1年的血管造影和临床结局分层分析<20 mm versus >。在1，707例患者中，592例BES患者（831处病变）和619例SES患者（876处病变）仅治疗了短病变。153例BES患者（166处病变）和151例SES患者（162处病变）有长病变。除了两个支架组中出现急性心肌梗死的长病变患者数量较多外，基线临床特征无显著差异。与短病变相比，长病变在基线时的MLD更低，直径狭窄百分比更大。长病变的晚期丢失率高于短病变。BES和SES支架之间的晚期丢失无统计学显著差异（0.32+/-0.69 vs 0.24+/-0.57，p=0.59）。在BES和SES治疗的长病变中，分别有23.2%和13.1%存在二元节段内再狭窄（p=0.042）。在长病变患者中，BES和SES的总体MACE率相似（17% vs 14.6%; p=0.62）。BES（12.4% vs 6.0%; HR=2.06; p=0.07）和临床驱动TLR（10.5% vs 5.3%：HR 1.94; p=0.13）的总体TLR率有升高的趋势。长病变组和短病变组的明确支架内血栓形成率分别为3.3%和1.3- 1.7%。
结论
BES和SES在该“所有患者”人群中长病变的MACE方面相似。然而，BES治疗后长病变的二元节段内再狭窄和TLR发生率往往高于SES治疗。
AIMS
Lesion length remains a predictor of target lesion revascularisation and results of long lesion stenting remain poor. Sirolimus-eluting stents have been shown to perform better than paclitaxel eluting stents in long lesions. In this substudy of the LEADERS trial, we compared the performance of biolimus biodegradable polymer (BES) and sirolimus permanent polymer stents (SES) in long lesions.
METHODS AND RESULTS
A total of 1,707 'all-comer' patients were randomly allocated to treatment with BES and SES. A stratified analysis of angiographic and clinical outcomes at nine months and one year, respectively was performed for vessels with lesion length <20 mm versus >20 mm (as measured by quantitative angiography).Of 1,707 patients, 592 BES patients with 831 lesions and 619 SES patients with 876 lesions had only short lesions treated. One hundred and fifty-three BES patients with 166 lesions and 151 SES patients with 162 lesions had long lesions. There were no significant differences in baseline clinical characteristics, except for higher number of patients with long lesions presenting with acute myocardial infarction in both stent groups. Long lesions tended to have lower MLD and greater percent diameter stenosis at baseline than short lesions. Late loss was greater for long lesions than short lesions. There was no statistically significant difference in late loss between BES and SES stents (0.32+/-0.69 vs 0.24+/-0.57, p=0.59). Binary in-segment restenosis was present in 23.2% versus 13.1% of long lesions treated with BES and SES, respectively (p=0.042). In patients with long lesions, the overall MACE rate was similar for BES and SES (17% vs 14.6%; p=0.62). There was a trend towards higher overall TLR rate with BES (12.4 % vs 6.0%; HR=2.06; p=0.07) and clinically driven TLR (10.5% vs 5.3%: HR 1.94; p=0.13). Rates of definite stent thrombosis were 3.3% in the long lesion group and 1.3-1.7 % in the short lesion group.
CONCLUSIONS
BES and SES appear similar with respect to MACE in long lesions in this "all-comer" patient population. However, long lesions tended to have a higher rate of binary in-segment restenosis and TLR following BES than SES treatment.