Gaku Nakazawa, Kengo Tanabe, Aoki Jiro, Onuma Yoshinobu, Yamamoto Hirosada, Higashikuni Yasutomi, Nakajima Hiroyoshi, Hara Kazuhiro
Division of Cardiology, Mitsui Memorial Hospital, Tokyo 101-8643, Japan.
Circ J. 2006 Nov;70(11):1367-71. doi: 10.1253/circj.70.1367.
Studies in Western countries have shown that sirolimus-eluting stents (SES) are clinically effective in the real world, but the detailed serial angiographic analyses are limited to some complex lesions. In addition, the efficacy of SES has not been fully investigated in a Japanese population.
The study population consisted of 249 consecutive unselected patients who underwent percutaneous coronary intervention (PCI) with SES. Clinical and angiographic follow-up were evaluated at 8 months. Clinical follow-up was obtained in all patients and angiographic follow-up was obtained in 228 patients (91.6%) with 272 lesions (91.0%). Major adverse cardiac events were documented in 44 patients (17.7%). There were 2 stent thromboses within 24 h and 11 days after PCI (0.8%). Late lumen loss in the proximal edge, in-stent, and distal edge was 0.06+/-0.44 mm, 0.26+/-0.60 mm, and -0.05+/-0.30 mm, respectively. The rate of angiographic in-segment binary restenosis was 14.0% (proximal edge: 3.3%, in-stent: 10.7%, distal edge: 0.7%). By multivariate analysis, an increased risk of restenosis was significantly associated with hemodialysis, diabetes, lesion length, and impaired left ventricular ejection fraction.
In accordance with previous reports, SES is considered to be feasible, safe and effective based on the results in an unselected Japanese population. ).
西方国家的研究表明,西罗莫司洗脱支架(SES)在现实世界中具有临床疗效,但详细的系列血管造影分析仅限于某些复杂病变。此外,SES在日本人群中的疗效尚未得到充分研究。
研究人群包括249例连续入选的接受SES经皮冠状动脉介入治疗(PCI)的患者。在8个月时评估临床和血管造影随访情况。所有患者均获得临床随访,228例患者(91.6%)的272处病变(91.0%)获得血管造影随访。44例患者(17.7%)记录有主要不良心脏事件。PCI术后24小时内和11天内发生2例支架血栓形成(0.8%)。近端边缘、支架内和远端边缘的晚期管腔丢失分别为0.06±0.44mm、0.26±0.60mm和-0.05±0.30mm。血管造影节段内二元再狭窄率为14.0%(近端边缘:3.3%,支架内:10.7%,远端边缘:0.7%)。多因素分析显示,再狭窄风险增加与血液透析、糖尿病、病变长度和左心室射血分数受损显著相关。
根据先前的报告,基于未选择的日本人群的结果,SES被认为是可行、安全和有效的。