DES Shows Superiority to BMS in Treatment of CLI

December 15, 2011—Marc Bosiers, MD, et al concluded that treatment of infrapopliteal occlusive lesions in critical limb ischemia (CLI) with everolimus-eluting stents results in a greater reduction of restenosis and the need for reintervention compared with bare-metal stents in the DESTINY study published online ahead of print in the Journal of Vascular Surgery.

According to the investigators, this prospective, randomized, controlled clinical trial tested the hypothesis that treatment of infrapopliteal arterial occlusive lesions with an everolimus-eluting stent (Xience V, Abbott Vascular, Santa Clara, CA) would provide superior patency compared to treatment with a bare-metal stent (Multi-Link Vision, Abbott Vascular).

The investigators noted that CLI is the most severe form of peripheral arterial disease and results in extremity amputation if left untreated. Endovascular recanalization of stenotic or occluded infrapopliteal arteries has recently emerged as an effective form of therapy, although the duration of patency is typically limited by restenosis.

According to the investigators, it has recently been suggested that drug-eluting stents that were originally developed for the coronary arteries might also be effective in preventing restenosis in the infrapopliteal arteries.

As detailed in the Journal of Vascular Surgery, the study was planned for a sample size of 140 patients to be enrolled at five European investigative sites. The primary endpoint was arterial patency at 12 months, which was defined as the absence of ≥ 50% restenosis based on quantitative analysis of contrast angiography.

Between March 2008 and September 2009, 74 patients were treated with Xience V, and 66 patients were treated with Multi-Link Vision. After 12 months, the primary patency rate after treatment with Xience V was 85% compared with 54% after treatment with Multi-Link Vision (P = .0001). Treatment with Xience V 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). There were no differences in the percentage of patients with Rutherford class 0 or 1 at the 12-month follow-up visit (56% for Multi-Link Vision vs 60% for Xience V; P = .68). Major extremity amputations were rare in both groups (two with Multi-Link Vision and one with Xience V). The use of the Xience V stent significantly reduced the need for repeat intervention: freedom from target lesion revascularization was 91% with Xience V versus 66% with Multi-Link Vision (P = .001), reported the investigators in the Journal of Vascular Surgery.