新发股腘动脉病变各种腔内治疗方法疗效与安全性的Meta分析

Meta-analysis of the efficacy and safety of endovascular treatment modalities for newly developed femoropopliteal arterial lesions

摘要:

背景与目的 腔内治疗目前被认为是大多数症状性外周动脉疾病患者的一线治疗方法，近期相关研究主要关注在短期或中期（≤2年）的随访期间，腔内方法治疗新发股腘动脉病变的疗效差异。然而，长期随访下新发股腘动脉病变的最佳腔内治疗方法仍未明确。因此，本研究通过随机对照试验（RCT）的网络Meta分析，比较普通球囊血管成形术（BA）、裸镍钛合金支架（BNS）、药物涂层球囊（DCB）和药物洗脱支架（DES）植入术在短期和长期随访中治疗新发股腘动脉病变的疗效。方法 检索多个医学数据库后，共纳入26项RCT（共4 480例患者），对各种方法的疗效与安全性进行网络Meta分析。结局指标包括1、2和（或）3年随访期间的一期通畅率、靶病变血运重建（TLR）率、大截肢率和全因病死率。结果 在1、2、3年随访的一期通畅率方面，DES均显示为最有效的治疗方法，并且其2年的一期通畅率明显均高于BA（OR=11.11，95% CI=3.06~40.28）、BNS（OR=2.82，95% CI=1.06~7.53）和DCB（OR=4.19，95% CI=1.06~16.51）。在1、2、3年随访的TLR率方面，DES均显示为最有效的治疗方法，并且其2年的TLR率明显均低于BA（OR=0.08，95% CI=0.03~0.25）、BNS（OR=0.43，95% CI=0.19~0.97）和DCB（OR=0.29，95% CI=0.09~0.88）。在1、2、3年随访的大截肢率方面，各治疗方法之间均无明显差异，但1、2、3年的累积排序曲线下面积值显示，DCB是免于大截肢最有效的方法。在1、2、3年的全因病死率方面，各治疗方法之间均无明显差异。结论 对于新发股腘动脉病变的治疗，DES有较高的一期通畅率和较低的TLR率，而DCB可能是免于大截肢最有效的方法。因此，DES与DCB应优先被考虑用于此类疾病的治疗。

Abstract:

Background and aims Endovascular therapy is currently considered the first-line treatment for most patients with symptomatic peripheral artery disease. Recent research has primarily focused on short- or mid-term (≤2 years) follow-up periods, investigating the efficacy differences in endovascular methods for treating newly developed femoropopliteal arterial lesions. However, the optimal endovascular treatment method for newly developed femoropopliteal arterial lesions during long-term follow-up remains unclear. Therefore, this study conducted a network Meta-analysis of randomized controlled trials (RCTs) to compare the efficacy of common balloon angioplasty (BA), bare nitinol stent (BNS), drug-coated balloon (DCB), and drug-eluting stent (DES) implantation during short-term and long-term follow-up in the treatment of newly developed femoropopliteal arterial lesions.Methods After searching multiple medical databases, a total of 26 RCTs (with a total of 4 480 patients) were included, and a network Meta-analysis was conducted to assess the efficacy and safety of various methods. Outcome measures included primary patency rates at of follow-up, target lesion revascularization (TLR) rates, major amputation rates, and all-cause mortality rates during 1, 2, and/or 3 years of follow-up.Results In terms of primary patency rates at 1, 2, and 3 years of follow-up, DES consistently showed to be the most effective treatment method, with its 2-year primary patency rate significantly higher than BA (OR=11.11, 95% CI=3.06-40.28), BNS (OR=2.82, 95% CI=1.06-7.53), and DCB (OR=4.19, 95% CI=1.06-16.51). Regarding TLR rates at 1, 2, and 3 years of follow-up, DES again proved to be the most effective treatment method, with its 2-year TLR rate significantly lower than BA (OR=0.08, 95% CI=0.03-0.25), BNS (OR=0.43, 95% CI=0.19-0.97), and DCB (OR=0.29, 95% CI=0.09-0.88). There were no significant differences in major amputation rates among the treatment methods, but the surface under the values of cumulative ranking curve at 1, 2, and 3 years indicated that DCB was the most effective method in preventing major amputation. No significant differences were observed in all-cause mortality rates at 1, 2, and 3 years among the treatment methods.Conclusions For the treatment of newly developed femoropopliteal arterial lesions, DES demonstrated higher primary patency rates and lower TLR rates, while DCB may be the most effective method in preventing major amputations. Therefore, DES and DCB should be prioritized in the consideration for treatment.