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Utilization of DES for the Treatment of Infrapopliteal Arterial Disease
The definitive treatment of patients with infrapopliteal arterial disease has been a vexing problem for physicians engaged in tackling this issue on a daily basis. Infrapopliteal arterial disease can potentially lead to critical limb ischemia, resulting in eventual limb loss or even death in untreated cases. Comorbidities such as diabetes, age and smoking have also hastened the detrimental effects of this vascular entity.
Given the technical demands of surgical bypass techniques for patients with critical limb ischemia (CLI), it is of no surprise that minimally invasive endovascular techniques have emerged as the primary treatment for this specific population. Although traditionally infrapopliteal interventions were limited to only patients with CLI, increasing evidence is growing for the use of these techniques in patients with intermittent claudication (IC) as well. The use of percutaneous transluminal angioplasty (PTA) has been the traditional first-line therapy for patients with CLI and has shown to have favorable results. However, issues relating to complications from PTA (ie, vessel recoil and dissection), as well as questionable long-term patency rates, are a reality that often necessitates further interventions with PTA and/or potentially bail-out stenting.
Srinivas Iyengar
Given the aforementioned issues, the utilization of bare-metal stents has emerged as an additional option for the treatment of infrapopliteal arterial disease after failed PTA — especially in cases of dissection/small residual lumen area — although limitations with this method (namely restenosis) are also present. With the known robust data from numerous trials examining the superior patency rates of drug-eluting stents vs. BMS in the coronary arterial circulation, increasing interest to see if DES technology can be applied in the infrapopliteal arterial vasculature has been mounting.
To this end, there has been a flurry of activity over the last 10 years on a worldwide scale examining the use of DES technology for patients with infrapopliteal arterial disease, mainly initially in the CLI population. Studies performed in single centers, either prospective or retrospective in design, have largely shown the positive short- and long-term effects of DES in this patient cohort when compared with PTA/BMS. These encouraging initial results have spurned the formation of multicenter, randomized trials comparing DES vs. PTA and/or BMS, results of which have been reported. Presented here and in the Table are the results of three of the randomized trials.
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DESTINY
The Drug Eluting Stents in the Critically Ischemic Lower Leg (DESTINY) trial was a multicenter, randomized trial that evaluated the use/patency rates of everolimus-eluting stents (EES; Xience V, Abbott Vascular) vs. BMS (Multi-Link Vision, Abbott Vascular) in the treatment of patients with infrapopliteal arterial disease/CLI. The primary endpoint for this trial was arterial patency at 1 year, as defined by the absence of >50% restenosis based on quantitative analysis of contrast angiography. In total, 74 patients were treated with EES and 66 patients were treated with BMS. After 12 months, statistically significant differences were observed in the primary patency rates: 85% with EES treatment compared with 54% after treatment with BMS (P=.0001). Additionally, utilization of EES significantly reduced mean in-stent diameter stenosis (21 ± 21% vs. 47 ± 27%; P<.0001) and mean in-stent late lumen loss (0.78 ± 0.63 mm vs. 1.41 ± 0.89 mm; P=.001). Also, patients in the EES arm had significantly fewer repeat procedures for target lesion revascularization (66% vs. 91%; P=.001). There were no major differences in respect to changes in Rutherford classification or major extremity amputations between the two groups.
Yukon-BTK
Rastan and colleagues reported results on a prospective, randomized, multicenter, double blind trial comparing a polymer-free sirolimus-eluting stent (SES) with a placebo-coated (ethanol) BMS in patients with either IC or CLI who also had a de novo lesion in an infrapopliteal artery. A total of 161 patients were included in this trial with the main study endpoint being the 1-year primary patency rate, defined as freedom from in-stent restenosis (>50% luminal narrowing) as per duplex ultrasound or angiography. A number of secondary endpoints were also examined, including secondary patency rates and changes in Rutherford classification.
At 1 year, a majority of patients (n=125) reached their annual evaluation, and results revealed that the 1-year primary patency rate was significantly higher in the SES vs. BMS group (80.6% vs. 55.6%; P=.004). Additionally, the 1-year secondary patency rates were 91.9% for the SES arm and 71.4% for the BMS arm (P=.005), and significant improvements were also seen regarding Rutherford class, favoring the SES-treated patients (P=.004). No significant differences between the two arms regarding mortality or amputations rates were observed in this initial report at 1 year. However, the researchers published long-term follow-up data from this initial trial, which not only confirmed the durability of SES vs. BMS utilization in this patient population, but also SES superiority in endpoints such as event-free survival and amputation rates.
ACHILLES
In 2012, Scheinert and colleagues reported the results of a trial investigating the efficacy and safety of SES vs. PTA in patients with symptomatic infrapopliteal arterial disease. In total, 200 patients were randomly assigned to SES (n=99) or PTA (n=101; with eight patients crossing over to bailout SES), with the primary endpoint of 1-year in-segment binary restenosis by quantitative angiography. At 1 year, the researchers found that there were significantly lower angiographic restenosis rates (22.4% vs. 41.9%; P=.019) and greater vessel patency (75% vs. 57.1%; P=.025) for SES vs. PTA. Additionally, similar rates in repeat revascularization, mortality and amputations were observed in both groups.
Conclusion
The current treatment paradigm for patients who have CLI or IC from infrapopliteal arterial disease is rapidly evolving. Future data in this arena will include not only follow-up studies to the previously discussed trials (eg, DESTINY 2; Identifier: NCT01442636), but also with anticipated alternate DES variations. Recently published data from a meta-analysis by Fusaro and colleagues have further supported the use of DES technology in this patient cohort. In addition, other trials examining self-expanding stents and drug-eluting balloons for this population cohort have also added to the clinician’s knowledge base in tackling this issue. Although the initial randomized trial results are very encouraging for DES in CLI, whether this technology becomes the veritable “gold standard” for patients with occlusive infrapopliteal arterial disease is a question that will no doubt be increasingly asked in the near future.