Sirolimus-eluting versus bare stents for bailout after suboptimal infrapopliteal angioplasty for critical limb ischemia: 6-Month angiographic results from a nonrandomized prospective single-center study
Sirolimus-eluting versus bare stents for bailout after suboptimal infrapopliteal angioplasty for critical limb ischemia: 6-Month angiographic results from a nonrandomized prospective single-center study
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DOI：
10.1583/05-1620mr.1
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发表时间：
2005-12-01
影响因子：
2.6
通讯作者：
Tsolakis, J
中科院分区：
文献类型：
--
作者：
Siablis, D;Kraniotis, P;Tsolakis, J
目的：报告一项前瞻性单中心研究的6个月血管造影结果，研究西罗莫司洗脱支架用于严重肢体缺血（CLI）患者膝下血运重建后救助的疗效和结局。（21名男子;平均年龄68.7岁）接受膝下血管重建术，在65处病变中植入裸金属支架（B组）进行补救40支膝下动脉狭窄38支，闭塞27支。另外29名患者（21名男性;平均年龄68.8岁）在41条血管的66处病变（46处狭窄和20处闭塞）中接受了西罗莫司洗脱支架（S组）膝下挽救性支架植入术。结果：S组高血压和症状性心脏及颈动脉疾病较S组明显（p < 0.05）。B组的技术成功率为96.6%（28/29条肢体），S组为100.0%（p=0.16）。B组的6个月一期通畅率为68.1%，S组为92.0%（p < 0.002）。裸支架组的二元支架内和节段内再狭窄率分别为55.3%和66.0%，西罗莫司洗脱支架组分别为4.0%和32.0%（均为p < 0.001）。B组6个月时的靶病变再介入率为17.0%，S组为4.0%（p=0.02）。两组的保肢率均为100%。B组6个月死亡率和小截肢率分别为6.9%和17.2%，而S组分别为10.3%和3.4%（分别为p=0.32和p=0.04）。
Purpose: To report the 6-month angiographic results from a prospective sing le-center study investigating the efficacy and outcome of sirolimus-eluting stents used for bailout after infrapopliteal revascularization of patients with critical limb ischemia (CLI).Methods: Twenty-nine patients (21 men; mean age 68.7 years) underwent infrapopliteal revascularization with bare metal stents (group B) implanted for bailout in 65 lesions (38 stenoses and 27 occlusions) in 40 infrapopliteal arteries. Another 29 patients (21 men; mean age 68.8 years) underwent infrapopliteal bailout stenting with sirolimus-eluting stents (group S) in 66 lesions (46 stenoses and 20 occlusions) in 41 vessels. Preliminary 6-month angiographic and clinical results were analyzed.Results: Hyperlipidemia and symptomatic cardiac and carotid diseases were more pronounced in group S (p < 0.05). Technical success was 96.6% (28/29 limbs) in group B versus 100.0% in group S (p=0.16). Six-month primary patency was 68.1% in group B versus 92.0% in group S (p < 0.002). Binary in-stent and in-segment restenosis rates were 55.3% and 66.0%, respectively, in patients with bare stents versus 4.0% and 32.0%, respectively, in patients treated with the sirolimus-eluting stents (both p < 0.001). The target lesion re-intervention rate at 6 months was 17.0% in group B versus 4.0% in group S (p=0.02). Limb salvage was 100% in both groups. Six-month mortality and minor amputation rates were 6.9% and 17.2%, respectively, in group B versus 10.3% and 3.4%, respectively, in group S (p=0.32 and p=0.04, respectively).Conclusions: Sirolimus-eluting stents seem to restrict neointimal hyperplasia in the infrapopliteal vascular bed.