DCBs Perform Better in De Novo Compared With Restenotic Femoropopliteal Lesions

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Drug-coated balloons (DCBs) are more effective at 12 months in treating de novo disease compared with restenosis in patients with femoropopliteal artery disease, according to a single-center study published online October 10, 2014, ahead of print in the Journal of Vascular Surgery.

The findings, previously presented at the 2014 Vascular Annual Meeting of the Society for Vascular Surgery in Boston, MA, were published the same day that the US Food and Drug Administration issued its first approval of a DCB—the Lutonix 035 (Bard; Murray Hill, NJ), which is indicated for femoropopliteal disease.

Monika Herten, PhD, of University Hospital (Münster, Germany), and colleagues prospectively studied 100 consecutive patients receiving paclitaxel-coated balloons for femoropopliteal disease, either de novo (n = 46 lesions) or restenotic (n = 65 lesions), at a single center between October 2009 and February 2013. The restenotic group included a mix of stented and unstented lesions, and of 105 limbs treated, 78% had intermittent claudication and 22% had critical limb ischemia.
The IN.PACT Admiral balloon (Medtronic; Minneapolis, MN) was used in 85.6% of lesions and the Freeway (Eurocor; Bonn, Germany) in 14.4%.
Baseline characteristics, including Rutherford classification (median, 3), were largely similar between the 2 groups, though patients with de novo disease were more likely to be smokers and had a higher mean ankle-brachial index (ABI). Restenotic lesions also were longer than de novo lesions at 99 ± 76 mm vs 77 ± 68 mm (P = .050).


Primary patency (freedom from restenosis > 50% in the target lesion by duplex ultrasound) was 86% at 6 months and 74% at 12 months (primary endpoint). A trend toward improved patency for de novo compared with restenotic lesions seen at 6 months became significant by 12 months; when excluding bailout stenting, de novo lesions fared better at both time points (table 1). There also was a lower 12-month rate of TLR in the de novo lesions (15% vs 32%; P = .021)

Table 1. Primary Patency


De Novo


P Value

With Bailout Stenting

    6 Months

    12 Monthsa










Without Bailout Stenting

    6 Months

    12 Months










aPrimary endpoint.

ABI increased over follow-up in both the restenotic group (from 0.57 ± 0.29 to 0.85 ± 0.20) and the de novo group (from 0.68 ± 0.25 to 0.90 ± 0.12). Each group also showed sustained improvement in at least 1 Rutherford classification through 1 year (P < .001 for all vs baseline).

No MACE or cerebrovascular events occurred during hospitalization, and no patients required amputation in the year after treatment. In total, 7 deaths occurred, all unrelated to DCB treatment, with similar survival for both groups on Kaplan-Meier analysis (P = .965).

Debulking May Enhance DCB Efficacy in Restenotic Lesions

While the results for de novo lesions match those of earlier randomized controlled trials of paclitaxel-coated vs uncoated balloons—including FemPac, THUNDER, PACIFIER, LEVANT I, and BIOLUX P-I—those for restenotic lesions “appear to be less favorable compared with what has previously been reported for in-stent [restenosis],” the researchers note.

Few data are available on the effectiveness of DCBs in femoropopliteal restenosis, they say, despite the fact that such lesions are often seen in clinical practice. Yet the results for DCBs in this context “are better or similar to technically more demanding strategies such as cryoplasty and stenting, rotational atherectomy, directed atherectomy, and laser atherectomy,” Dr. Herten and colleagues write.

“The problem of recurrent in-stent [restenosis in the peripheral arteries] might not be solved with stenting, debulking technology, or [drug-coated balloons] alone,” they stress, citing the need for adequately powered trials. According to the researchers, better results may be obtained in combination with debulking. “Here,” they say, “the endovascular approach should ideally combine mechanical and biological effects without additional metal in the artery.”


Herten M, Torsello GB, Schönefeld E, et al. Drug-eluting balloons for femoropopliteal lesions show better performance in de novo stenosis or occlusion than in restenosis. J Vasc Surg. 2014;Epub ahead of print.




Dr. Herten reports no relevant conflicts of interest.


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