Abteilung Angiologie, Herz-Zentrum Bad Krozingen, Südring 15, Bad Krozingen, Germany.
Eur Heart J. 2011 Sep;32(18):2274-81. doi: 10.1093/eurheartj/ehr144. Epub 2011 May 26.
Preliminary reports indicate that sirolimus-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. We conducted a prospective, randomized, multi-centre, double-blind trial comparing a polymer-free sirolimus-eluting stent with a placebo-coated bare-metal stent in patients with either intermittent claudication or critical limb ischaemia who had a de-novo lesion in an infrapopliteal artery.
161 patients were included in this trial. The mean target lesion length was 31 ± 9 mm. The main study endpoint was the 1-year primary patency rate, defined as freedom from in-stent-restenosis (luminal narrowing of ≥50%) detected with duplex ultrasound if not appropriate with angiography. Secondary endpoints included the 6-month primary patency rate, secondary patency rate, and changes in Rutherford-Becker classification after 1 year. Twenty-five (15.5%) patients died during the follow-up period. One hundred and twenty-five patients reached the 1-year examinations. The 1-year primary patency rate was significantly higher in the sirolimus-eluting stent group (80.6%) than in the bare-metal stent group (55.6%, P= 0.004), and the 1-year secondary patency rates were 91.9 and 71.4% (P= 0.005), respectively. The median (interquartile range) change in Rutherford-Becker classification after 1 year was -2 (-3 to -1) in the sirolimus-eluting stent group and -1 (-2 to 0) in the bare-metal stent group, respectively (P= 0.004).
Mid-term patency rates of focal infrapopliteal lesions are substantially improved with sirolimus-eluting stent compared with bare-metal stent. Corresponding to the technical results, the changes in Rutherford-Becker classification reveal a significant advantage for the sirolimus-eluting stent.
初步报告表明，雷帕霉素洗脱支架可降低经皮下肢动脉再血管化后再狭窄的风险。我们进行了一项前瞻性、随机、多中心、双盲试验，比较了在下肢动脉有新发病变的间歇性跛行或严重肢体缺血患者中，一种无聚合物雷帕霉素洗脱支架与一种安慰剂涂层裸金属支架的效果。
本试验纳入 161 例患者。平均靶病变长度为 31 ± 9 mm。主要研究终点为 1 年通畅率，定义为无支架内再狭窄（双功能超声检测到管腔狭窄≥50%，必要时行血管造影）。次要终点包括 6 个月通畅率、次级通畅率和 1 年后 Rutherford-Becker 分级的变化。在随访期间，有 25 例（15.5%）患者死亡。125 例患者完成 1 年检查。雷帕霉素洗脱支架组 1 年通畅率显著高于裸金属支架组（80.6%比 55.6%，P=0.004），1 年次级通畅率分别为 91.9%和 71.4%（P=0.005）。雷帕霉素洗脱支架组 1 年后 Rutherford-Becker 分级的中位数（四分位距）变化为-2（-3 至-1），裸金属支架组为-1（-2 至 0），差异有统计学意义（P=0.004）。
与裸金属支架相比，雷帕霉素洗脱支架可显著改善下肢动脉局灶性病变的中期通畅率。与技术结果相对应，Rutherford-Becker 分级的变化显示雷帕霉素洗脱支架具有显著优势。
