直接支架植入术治疗膝下动脉粥样硬化闭塞症的荟萃分析

Systematic review of primary stenting for arteriosclerotic occlusion in below-the-knee arteries

目的 通过比较直接膝下支架植入术与经皮腔内血管成形术（PTA）评价直接支架植入术在治疗膝下血管病中的临床价值.方法 通过检索PubMed,ScienceDirect,Embase数据库及中国生物文献数据库（CBM）检索相关文献.根据不同的支架类型,支架组分为金属裸支架（BMS）与药物涂层支架（DES）两个亚组进行分析.研究终点包括直接技术成功率、一期通畅率、保肢率及免于靶血管血运重建率（TVR）.结果 根据纳入标准最终确定并纳入14篇文献,总样本量为3 278例患者（3 699例肢体）.PTA组技术成功率为90.95％,95％可信区间（CI）为86.25％ ～ 94.15％.在直接支架组中仅1篇文献报道了技术失败率为4％（5/118）.1年一期通畅率及免于TVR率在PTA组及BSM组差异均无统计学意义（均P＞0.05）.而在DES组合并后的1年一期通畅率及免于TVR率明显高于PTA及BSM组,分别为85.05％ （95％ CI 79.95％ ～ 89.02％）及90.52％ （95％ CI 83.68％ ～94.67％）,均P＜0.01.PTA,BMS及DES组的1年保肢率分别为88.41％（95％ CI 84.53％～91.43％）,94.41％ （95％ CI 89.52％ ～97.1％）及96.81％ （95％ CI 94.04％ ～98.32％）.支架组在保肢率上明显优于PTA组（P＜0.01）.尽管敏感性分析显示了结果具有相对稳健性,但本文中的文献异质性较大且混杂因素未能校正.结论 在减少膝下动脉病变腔内治疗后再狭窄及再次血运重建BMS与PTA相比并无优势.而DES在治疗局限性膝下病变中表现出满意的疗效.

Objective To evaluate the clinical value of primary stenting for treating peripheral arterial diseases in below-the-knee arteries by comparing to pereutancous transluminal angioplasty （PTA）. Methods PubMed, ScicnceDirect, Embase, and CBM databases were searched for relevant articles. Based on the different types of stents, we divided the primary stent group into the bare metal stent（BMS） group and drug-eluting stent （DES） group. The outcome measures were immediate technical success, freedom from target vessel revascularization （TVR-free） rate and limb salvage. Results Finally, 14 studies （published between 2001 and 2012） satisfying the inclusion criteria were identified. A total of 3 278 patients and 3 699 limbs constituted our final study population. The technical success rate of PTA was 90. 95% （95% confidence interval （CI） 86. 25% -94. 15% ）. Only one study reported a technical failure of 4% （5/118） in the primary stent group. There were no significant differences in the 1-year primary patency and TVR-free rates between the PTA group and BMS groups （ P 〉 0. 05 and P 〉 0. 05 ）, respectively. The pooled estimates of 1-year primary patency and TVR-free rate in DES group were 85.05% （95% C179. 95% -89.02% ） and 90. 52% （95% CI 83.68% - 94.67% ） , respectively, which were better than those of the BMS （ P 〈 0. 001 ） and PTA groups （P 〈0. 001 ）. The pooled estimate of l-year limb salvage in the PTA, BMS, and DES groups was 88.41% （95%CI84.53% -91.43%）, 94.41% （95%C189.52% -97.1%）, and 96. 81% （95% CI 94. 04% - 98.32% ）, respectively. The BMS and DES groups had higher limb salvage rates than the PTA group （P 〈 0. 001 for both comparisons）. The rates of severe complications were low both in the PTA and primary stent groups. Although the influence analysis showed rather robust results, the heterogeneity was quite high and they were not adjusted for confounding variables. Conclusion Primary BMS implantation had no advantage over PTA in reducing restenosis or revascularization for infrapopliteal disease. Primary DES implantation seems to be a promising treatment for focal infrapopliteal lesions.