eComment. Drug-eluting stents versus angioplasty with or without bare metal stents in infra-inguinal arterial diseas

I read with great interest the position paper by Antoniou and colleagues [1] reviewing the data on endovascular treatment of infra-inguinal arterial disease comparing drug-eluting stents (DES) versus percutaneous transluminal angioplasty (PTA) with or without adjunctive bare metal stents (BMS). Over a 14-year period from January 2000 to October 2013, their literature search of specific query terms yielded 136 papers of which 5 provided the best evidence to answer the question posed. Related articles and references were also screened for suitable articles. As necessary, the data is separated into femoral-popliteal disease and infra-popliteal disease. The two major randomized controlled trials usually referenced for femoral-popliteal disease include the SIROCCO trial (with sirolimus as the active drug) and the Zilver PTX trial (using paclitaxel). Although the former failed to demonstrate a statistically significant difference between DES using sirolimus and BMS [2], the latter showed a primary patency of 75% in patients with the Zilver PTX (Cook Medical, Bloomington IN, USA) as compared to 27% with PTA, and a provisional 2-year primary patency of 83% with DES compared to 64% with BMS which was statistically significant concluding that DES treatment with the Zilver PTX provided superior outcomes with regard to the outcomes of event-free survival and primary patency compared to PTA or BMS [3]. In the infra-popliteal segment, data has demonstrated that at 1 year, patients with DES had a significantly higher primary patency, freedom from target lesion revascularization and clinical improvement than those with BMS, however, the ultimate outcome of limb salvage was not different between these groups. The three multicentre randomized controlled trials included in a recent qualitative analysis and quantitative data synthesis are the YUKON-BTX (using sirolimus), DESTINY (using everolimus), and ACHILLES (using sirolimus) trials [4,5]. These trials had several differences among them, namely the inclusion of only patients with critical limb ischaemia in the DESTINY trial as compared to both claudicants and patients with critical limb ischaemia in YUKON-BTX and ACHILLES; furthermore, ACHILLES included a greater proportion of patients with tibial chronic total occlusions compared with the other two. The pooled estimates have shown that primary DES placement for focal infra-popliteal lesions significantly improved primary patency, increased overall event-free survival and decreased the need for repeat procedures [4,5]. The ultimate outcome of patient survival and limb salvage, however, demonstrated no significant differences. It should also be noted that these trials were not powered for these outcome measures. Translating these data for both femoral-popliteal and infra-popliteal lesions into the clinical environment must be exercised with caution. Although Antoniou and colleagues present a case with a TASC II B lesion, the above trials evaluate short segment focal lesions that are not the majority of patients seen in everyday practice; more commonly seen patients usually involve complex, multiple and sequential lesions. Although multiple and tandem stenoses or occlusions may be treated percutaenously, Katsanos and colleagues in their meta-analysis of infra-popliteal DES should be commended on their foresight that "in the absence of randomized data about longer infra-popliteal lesions, it may be frivolous and unwise to extrapolate the reported results [of their meta-analysis] to the setting of long tibial obstructions that require multiple DES placement with still unproven clinical- and cost-effectiveness" [5]. The option and durability of primary open infra-inguinal bypass must be considered in the treatment algorithm of multi-segmental lower extremity arterial disease. And in an era of increasing health care economics, cost-containment, and clinical outcomes, quality-of-life metrics and cost-utility parameters must be critically evaluated. Conflict of interest: none declared.

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