Siablis Dimitris, Karnabatidis Dimitris, Katsanos Konstantinos, Kagadis George C, Kraniotis Pantelis, Diamantopoulos Athanassios, Tsolakis John
Department of Radiology (Angiography Suite), University Hospital of Patras, Rion, Greece.
J Endovasc Ther. 2007 Apr;14(2):241-50. doi: 10.1177/152660280701400217.
To report the 1-year angiographic and clinical outcome from a prospective single-center study investigating the infrapopliteal application of sirolimus-eluting versus bare metal stents in patients with critical limb ischemia (CLI) who underwent below-the-knee endovascular revascularization.
Stenting was performed as a bailout procedure for suboptimal angioplasty results (flow-limiting dissection, elastic recoil, or postangioplasty residual stenosis >30%). In the first 29 patients, infrapopliteal stenting was performed with bare metal stents (group B) and with sirolimus-eluting stents in the other 29 patients (group S).
Below-the-knee angioplasty and stenting involved 65 lesions in 40 infrapopliteal arteries of 29 limbs in group B and 66 lesions in 41 infrapopliteal arteries of 29 limbs in group S. Baseline comorbidities (hyperlipidemia and symptomatic cardiac and carotid disease) were more pronounced in group S (p<0.05). At 6 months, sirolimus-eluting stents demonstrated significantly higher primary patency (OR 5.625, 95% CI 1.711 to 18.493, p = 0.004) and decreased in-stent binary restenosis (OR 0.067, 95% CI 0.021 to 0.017, p<0.001) and in-segment binary restenosis (OR 0.229, 95% CI 0.099 to 0.533, p = 0.001). After 1 year, sirolimus-eluting stents were steadily associated with increased primary patency (OR 10.401, 95% CI 3.425 to 31.589, p<0.001) and significantly less in-stent (OR 0.156, 95% CI 0.060 to 0.407, p<0.001) and in-segment (OR 0.089, 95% CI 0.023 to 0.349, p = 0.001) binary restenosis. In addition, sirolimus-eluting stents were associated with significantly fewer cumulative target lesion reinterventions at 6 months (OR 0.057, 95% CI 0.008 to 0.426, p = 0.005) and 1 year (OR 0.238, 95% CI 0.067 to 0.841, p = 0.026). No significant differences between groups B and S were noted at 1 year with respect to mortality (10.3% versus 13.8%, respectively), minor amputation (17.2% versus 10.3%), or limb salvage (100% versus 96%).
The application of sirolimus-eluting stents reduces the restenosis rate in the infrapopliteal arteries and the rate of repeat endovascular procedures the first year after treatment.
报告一项前瞻性单中心研究的1年血管造影和临床结果，该研究调查了西罗莫司洗脱支架与裸金属支架在接受膝下血管腔内血运重建的严重肢体缺血（CLI）患者中的腘下应用情况。
支架置入作为对球囊血管成形术效果欠佳（限流性夹层、弹性回缩或球囊血管成形术后残余狭窄>30%）的补救措施。前29例患者行腘下裸金属支架置入术（B组），另外29例患者行西罗莫司洗脱支架置入术（S组）。
B组29条肢体的40条腘下动脉中有65处病变接受了膝下血管成形术和支架置入术，S组29条肢体的41条腘下动脉中有66处病变接受了同样治疗。S组的基线合并症（高脂血症以及有症状的心脏和颈动脉疾病）更为明显（p<0.05）。6个月时，西罗莫司洗脱支架的主要通畅率显著更高（比值比5.625，95%置信区间1.711至18.493，p = 0.004），支架内二元再狭窄（比值比0.067，95%置信区间0.021至0.017，p<0.001）和节段内二元再狭窄（比值比0.229，95%置信区间0.099至0.533，p = 0.001）降低。1年后，西罗莫司洗脱支架与主要通畅率持续增加（比值比10.401，95%置信区间3.425至31.589，p<0.001）以及显著更少的支架内（比值比0.156，95%置信区间0.060至0.407，p<0.001）和节段内（比值比0.089，95%置信区间0.023至0.349，p = 0.001）二元再狭窄相关。此外，西罗莫司洗脱支架与6个月时（比值比0.057，95%置信区间0.008至0.426，p = 0.005）和1年时（比值比0.238，95%置信区间0.067至0.841，p = 0.026）显著更少的累积靶病变再次干预相关。1年时，B组和S组在死亡率（分别为10.3%和13.8%）、小截肢率（17.2%和10.3%）或肢体挽救率（100%和96%）方面未观察到显著差异。
西罗莫司洗脱支架的应用降低了腘下动脉的再狭窄率以及治疗后第一年重复血管腔内手术的发生率。
