Meta-analysis of outcomes from drug-eluting stent implantation in infrapopliteal arteries

BACKGROUND Percutaneous drug-eluting stent implantation(DESI)is an emerging and promising treatment modality for infrapopliteal artery diseases(IPADs).This systematic review and meta-analysis summarizes and quantitatively analyzes the outcomes of DESI in IPADs considering the hazard ratio(HR),which is a more accurate and appropriate outcome measure than the more commonly used relative risk and odds ratio.AIM To explore the superiority of drug-eluting stents(DESs)vs traditional treatment modalities for IPADs.METHODS The following postoperative indicators were the outcomes of interest:All-cause death(ACD)-free survival,major amputation(MA)-free survival,target lesion revascularization(TLR)-free survival,adverse event(AE)-free survival,and primary patency(PP)survival.The outcome measures were then compared according to their respective HRs with 95%confidence intervals(CIs).The participants were human IPAD patients who underwent treatments for infrapopliteal lesions.DESI was set as the intervention arm,and traditional percutaneous transluminal angioplasty(PTA)with or without bare metal stent implantation(BMSI)was set as the control arm.A systematic search in the Excerpta Medica Database(Embase),PubMed,Web of Science,and Cochrane Library was performed on November 29,2022.All controlled studies published in English with sufficient data on outcomes of interest for extraction or conversion were included.When studies did not directly report the HRs but gave a corresponding survival curve,we utilized Engauge Digitizer software and standard formulas to convert the information and derive HRs.Then,meta-analyses were conducted using a random-effects model.RESULTS Five randomized controlled trials and three cohort studies involving 2639 participants were included.The ACDfree and MA-free survival HR values for DESI were not statistically significant from those of the control treatment(P>0.05);however,the HR values for TLR-free,AE-free,and PP-survival differed significantly[2.65(95%CI:1.56-4.50),1.57(95%CI:1.23-2.01),and 5.67(95%CI:3.56-9.03),respectively].CONCLUSION Compared with traditional treatment modalities(i.e.,PTA with or without BMSI),DESI for IPADs is superior in avoiding TLR and AEs and maintaining PP but shows no superiority or inferiority in avoiding ACD and MA.

Evaluation of angiosome-targeted infrapopliteal endovascular revascularization in critical diabetic limb ischemia

Objective To evaluate the rates of wound healing and limb preservation following angiosome-targeted infrapopliteal endovascular revascularization in the treatment of diabetic limb ischemia. Methods We performed a retrospective analysis of data gathered from 102 infrapopliteal angioplasty cases(60 males and 42 females; mean age, 72 ± 11 years) with Fontaine IV ischemia(ankle-brachial index, ABI: 0.16 ± 0.06). Forty-seven angioplasties were performed based on the angiosome concept(direct revascularization, DR), while 55 did not incorporate the angiosome concept(indirect revascularization, IR). The curative effects of angioplasty were assessed by postoperative determinations of ABI performed every 3 months during clinical follow-up visits conducted to assess healing of the ischemic wound. Amputation and death events were recorded throughout the study. Results All 102 patients were successfully revascularized without complications, and during a mean follow-up period of 18 ± 11 months, the mean postoperative ABI improved to 0.84 ± 0.10. The postoperative 6 and 12 month healing rates in the DR group were 85.1% and 93.5%, respectively, while the limb-salvage rates were 100% and 93.5%, respectively. The postoperative 6 and 12 month healing rates in the IR group were 60% and 76.4%, respectively, while the limb-salvage rates were 90.1%, and 85.5%, respectively. Conclusion Angiosome-based Infrapopliteal angioplasty was associated with better wound healing and higher rates of limb salvage in cases of critical diabetic foot ischemia. Revascularization should be provided to patients who have undergone indirect perfusion of the ischemic angiosome, as acceptable rates of limb salvage are obtained.

Current evidence of drug-elution therapy for infrapopliteal arterial disease

New and sophisticated endovascular devices, such as drug-eluting stents(DES)and drug-coated balloons(DCB), provide targeted drug delivery to affected vessels. The invention of these devices has made it possible to address the reparative cascade of arterial wall injury following balloon angioplasty that results in restenosis. DESs were first used for the treatment of infrapopliteal lesions almost 20 years ago. More recently, however, DCB technology is being investigated to improve outcomes of endovascular below-the-knee arterial procedures, avoiding the need for a metallic scaffold. Today, level IA evidence supports the use of infrapopliteal DES for short to medium length lesions,although robust evidence that justifies the use of DCBs in this anatomical area is missing. This review summarizes and discusses all available data on infrapopliteal drug-elution devices and highlights the most promising future perspectives.

Revisiting endovascular treatment in below-the-knee disease. Are drug-eluting stents the best option？

Patients with below-the-knee arterial disease are primarily individuals suffering from critical limb ischemia(CLI), while a large percentage of these patients are also suffering from diabetes or chronic renal failure or both. Available data from randomized controlled trials and their meta-analysis demonstrated that the use of infrapopliteal drug-eluting stents(DES), in short-to medium-length lesions, obtains significantly better results compared to plain balloon angioplasty and bare metal stenting with regards to vascular restenosis, target lesion revascularization, wound healing and amputations. Nonetheless, the use of this technology in every-day clinical practice remains limited mainly due to concerns regarding the deployment of a permanent metallic scaffold and the possibility of valid future therapeutic perspectives. However, in the majority of the cases, these concerns are not scientifically justified. Large-scale, multicenter randomized controlled trials, investigating a significantly larger number of patients than those already published, would provide more solid evidence and consolidate the use of infrapopliteal DES in CLI patients. Moreover, there is still little evidence on whether this technology can be as effective for longer below-the-knee lesions, where a considerable number of DES is required. The development and investigation of new, longer balloon-expanding or perhaps selfexpanding DES could be the answer to this problem.