Guo Zelin, Guo Julong, Wu Sensen, Zhang Fan, Gao Xixiang, Guo Lianrui
Department of Vascular Surgery, Xuanwu Hospital Capital Medical University, Beijing, China.
J Endovasc Ther. 2024 Nov 23:15266028241292954. doi: 10.1177/15266028241292954.
The optimal endovascular method to treat infrapopliteal chronic limb-threatening ischemia (CLTI) remains to be determined, given the limitations of stent use in infrapopliteal artery disease. We performed a network meta-analysis (NWM) of randomized controlled trials (RCTs) to simultaneously compare the outcomes of different balloon angioplasty procedures for infrapopliteal artery lesions in CLTI patients.
We searched the Cochrane Central Register of Controlled Trials, Embase, and PubMed. 8 eligible RCTs involving 3 endovascular modalities or combinations (plain old balloon angioplasty [POBA], drug-coated balloon [DCB], orbital atherectomy plus plain old balloon angioplasty [OA+POBA]) were included. Primary outcomes were efficacy (12-month clinically driven target lesion revascularization [CDTLR]) and safety (12-month major amputation and all-cause mortality). We used random-effects models based on the frequentist framework.
Plain old balloon angioplasty had a higher 12-month CDTLR rate than DCB (relative risk [RR]: 2.11, confidence interval [CI]: 1.33, 3.34) in the NWM and this result was still statistically significant (RR: 0.47, CI: 0.30, 0.75) in subgroup analyses. According to the SUCRA value, in terms of 12-month CDTLR, OA+POBA was considered the best treatment (SUCRA=72.2), while POBA was considered the worst treatment (SUCRA=8.9). In terms of 12-month all-cause mortality, OA+POBA was considered the best treatment (SUCRA=95.0), while DCB was considered the worst treatment (SUCRA=12.8). In terms of 12-month major amputation, POBA was considered the best treatment (SUCRA=72.0), while DCB was considered the worst treatment (SUCRA=23.0).
In infrapopliteal CLTI disease, DCB showed a significantly lower 12-month CDTLR in comparison to POBA. There is no statistically significant evidence to suggest that DCB raises safety concerns. The SUCRA values of OA+POBA indicate that it might offer a superior treatment option compared to DCB or POBA in terms of CDTLR and mortality. This advantage, however, was not sustained when major-amputation rates were analyzed. Consequently, further RCTs are required to examine the potential benefits of OA and other forms of atherectomy for managing infrapopliteal CLTI disease.
The findings of this study provide further evidence for the safety of DCB in the application of infrapopliteal CLTI disease and suggest preliminary benefits of atherectomy. These results are likely to encourage further research and application of these treatment modalities in managing infrapopliteal CLTI.POBA has been a traditional approach for treating infrapopliteal artery disease. The current evidence supports clinicians in exploring and utilizing DCB and atherectomy as better treatments.We focused on the performance of different balloon angioplasty procedures in infrapopliteal CLTI, considering the characteristics of infrapopliteal CLTI.
鉴于支架在腘下动脉疾病应用中的局限性，治疗腘下慢性肢体威胁性缺血（CLTI）的最佳血管内治疗方法仍有待确定。我们对随机对照试验（RCT）进行了网状Meta分析（NWM），以同时比较CLTI患者腘下动脉病变不同球囊血管成形术的疗效。
我们检索了Cochrane对照试验中央注册库、Embase和PubMed。纳入了8项符合条件的RCT，涉及3种血管内治疗方式或联合治疗（普通球囊血管成形术[POBA]、药物涂层球囊[DCB]、轨道斑块旋切术联合普通球囊血管成形术[OA+POBA]）。主要结局为疗效（12个月临床驱动的靶病变血运重建[CDTLR]）和安全性（12个月大截肢和全因死亡率）。我们使用基于频率论框架的随机效应模型。
在网状Meta分析中，普通球囊血管成形术的12个月CDTLR率高于药物涂层球囊（相对风险[RR]：2.11，置信区间[CI]：1.33，3.34），该结果在亚组分析中仍具有统计学意义（RR：0.47，CI：0.30，）。根据累积排序曲线下面积（SUCRA）值，就12个月CDTLR而言，OA+POBA被认为是最佳治疗方法（SUCRA=72.2），而POBA被认为是最差治疗方法（SUCRA=8.9）。就12个月全因死亡率而言，OA+POBA被认为是最佳治疗方法（SUCRA=95.0），而DCB被认为是最差治疗方法（SUCRA=12.8）。就12个月大截肢而言，POBA被认为是最佳治疗方法（SUCRA=72.0），而DCB被认为是最差治疗方法（SUCRA=23.0）。
在腘下CLTI疾病中，与POBA相比，DCB的12个月CDTLR显著更低。没有统计学显著证据表明DCB存在安全问题。OA+POBA的SUCRA值表明，就CDTLR和死亡率而言，与DCB或POBA相比，它可能提供更好的治疗选择。然而，在分析大截肢率时，这种优势并未持续。因此，需要进一步的RCT来研究OA和其他形式的斑块旋切术在治疗腘下CLTI疾病中的潜在益处。
本研究结果为DCB在腘下CLTI疾病应用中的安全性提供了进一步证据，并表明了斑块旋切术的初步益处。这些结果可能会鼓励在治疗腘下CLTI时进一步研究和应用这些治疗方式。POBA一直是治疗腘下动脉疾病的传统方法。目前的证据支持临床医生探索和使用DCB和斑块旋切术作为更好的治疗方法。我们考虑腘下CLTI的特点，重点研究了不同球囊血管成形术在腘下CLTI中的表现。
