Infrapopliteal drug‐eluting stents for chronic limb ischemia

Abstract

Objective: We report our experience with the elective placement of below-knee, drugeluting stents in patients with chronic limb ischemia. Background: Infrapopliteal percutaneous transluminal angioplasty has been associated with a lower rate of procedural success and high rate of restenosis because of the small size of the tibial vessels and the prevalence of calcified and diffuse atherosclerotic disease. Prior published data reports 3-year patency rates below 25%. Bare metal stents have been reported in bailout situations. Drug-eluting stents have markedly reduced restenosis compared to bare metal stents in the coronary vasculature, but there is little data supporting the use of these devices below the knee. Methods: Elective placement of drug-eluting stents in infrapopliteal lesions was performed on 10 patients with severe (≥Fontaine Stage IIb) claudication (n 5 1) or limb-threatening ischemia (n 5 9) (rest pain, nonhealing ulcers and gangrene). Results: A total of 17 drug-eluting stents were electively placed in 12 below-knee arteries in 10 patients, resulting in an average of 1.7 6 0.7 stents per patient. The mean lesion length was 24.8 6 10.9 mm, the mean total stent length was 38.3 6 19.1 mm, and the mean nominal stent diameter was 2.8 6 0.3 mm. One patient required target vessel revascularization (TVR) at 3 weeks because of stent thrombosis. TVR was 10% at 12.4 6 6.5 months of follow-up. Clinically driven angiography in three different patients was performed at 4, 15, and 16 months and confirmed drug-eluting stent patency in each case. Conclusions: The use of below-knee drug-eluting stents is feasible and appears to be safe in our small series of complex infrapopliteal lesions causing chronic limb ischemia. The occurrence of a single case of stent thrombosis warrants continued observation in this cohort. Prospective clinical trials will be necessary to confirm the benefits and justify the costs of this strategy for treating patients with infrapopliteal culprit lesions and chronic limb ischemia. '

Drug eluting stents for below the knee lesions in patients with critical limb ischemia

“…The findings of our study are consistent with and echo the positive findings in a recently published trial involving infrapopliteal DES for CLI [17]. In this smaller series of patients, the authors also quote a high procedural success rate, achieving such in 100% of their 10 patients [17].…”

“…In this smaller series of patients, the authors also quote a high procedural success rate, achieving such in 100% of their 10 patients [17]. The authors were also able to document DES patency in all patients who had angiographic follow‐up, which was up to 16 months [17].…”

Predictors of adverse clinical outcomes after successful infrapopliteal intervention

“…Also, with increasing experience of CLI in clinical practice, there could be a changing practice pattern during the study period. Finally, although there is a current trend for increased attention to drug‐eluting stents [33–37], we used a bare‐metal stent only in a case of failed balloon angioplasty because a drug‐eluting stent is not approved for infrapopliteal use in Japan. As already reported [38, 39], a drug‐eluting stent can reduce the need for clinically‐driven repeat intervention as well as in‐stent restenosis compared to a bare‐metal stent, even though there is no significant difference in the limb salvage rate between these stents.…”

Endovascular Therapies for Peripheral Arterial Disease

“…80 The largest series, a nonrandomized comparison of tibioperoneal bailout stenting in 58 patients (29 bare-metal stents and 29 sirolimus-eluting stents [Cypher, Cordis]) demonstrated a marked reduction in restenosis at 6 months from 55% in bare-metal stents to 4% (PϽ0.001) in the drug-eluting stents. 81 Although these results are encouraging and very "coronary-like," more rigorous comparisons and longer follow-up are required, especially concerning late thrombosis risk as seen in the coronary application of drug-eluting stents.…”