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  • Drug-Coated Balloons: Where Is the Benefit? Superiority to regular balloons, stents not yet apparent

    For the percutaneous revascularization of infrapopliteal arteries, drug-coated balloons improve angiographic outcomes but not clinical endpoints, according to a meta-analysis published in JACC: Cardiovascular Interventions.

    Lesions treated with drug-coated balloons showed lower late lumen loss (LLL) than those getting uncoated balloons or drug-eluting stents (DES, P=0.04).

    Yet for a variety of patient-centered measures over a median of 12 months’ follow-up, patients treated with drug-coated balloons fared no better (or worse) than their control counterparts:

    • Target lesion revascularization (18.3% versus 29.1%, P=0.12)
    • Amputation (13.3% versus 14.9%, P=0.86)
    • Death (11.4% versus 10.6%, P=0.59)
    • Major adverse events (29.9% versus 38.5%, P=0.70)
    • Rutherford Class 5-6 (66.0% versus 55.6%, P=0.65)

    “In comparison to uncoated balloon or DES, the treatment of infrapopliteal arteries with drug-coated balloon is associated with similar clinical outcomes and favorable angiographic efficacy at 1-year follow-up,” Salvatore Cassese, MD, PhD, of German Heart Centre, and colleagues reported in the online publication.

    “The favorable angiographic outcome associated with drug-coated balloons seems due to inhibition of neointimal proliferation and positive vessel remodeling,” they added. “However, in patients suffering from advanced stages atherosclerotic disease of infrapopliteal vessels a positive angiographic result does not improve per se clinical outcomes (e.g., lower amputations, complete ulcer healing, etc.) unless aggressive wound care management is adopted.”

    Meanwhile, writers of an accompanying editorial Thomas Zeller, MD, of Germany’s Universitaets-Herzzentrum, and Michael R. Jaff, DO, of Massachusetts General Hospital in Boston — questioned the validity of the LLL findings.

    They asked: “First of all, are the angiographic findings correct? Are drug-coated balloons really superior in terms of LLL over uncoated percutaneous transluminal angioplasty and DES?

    “Interestingly, only the three uncontrolled studies using the IN.PACT Amphirion drug-coated balloons resulted in superior LLL outcomes,” they continued, “whereas both independently core laboratory adjudicated and fully industry funded studies found identical LLL outcomes for the drug-coated balloon and percutaneous transluminal angioplasty cohorts.

    “The potentially incorrect interpretation of a favorable angiographic outcome without a clinical benefit in this meta-analysis might result in problematic conclusions such as the one suggesting that patency does not matter in infrapopliteal interventions in general,” Zeller and Jaff wrote.

    “The Yukon BTK study comparing DES with bare metal stents resulted not only in a significantly reduced restenosis rate favoring the DES at 2 years of follow-up,” they added, “but as a result of the improved patency also resulted in a reduced target vessel revascularization and amputation rate underlining the relevance of a patent vessel in the long run.”

    To date, the ability to maintain lasting effects from the endovascular treatment of longer infrapopliteal lesions “remains one of the last significant challenges,” according to the editorialists.

    The meta-analysis included five randomized trials and a total of 641 patients.

    Cassese’s group acknowledged that it had been limited by the flaws of the original trials. In addition, “the limited numbers of patients, and the lack of a standardized wound care management in the majority of trials included preclude definitive assumption regarding the comparative clinical efficacy of these revascularization strategies,” the authors admitted.

    Owing to the scant data in favor of treating infrapopliteal lesions with drug-coated balloons, Zeller and Jaff noted, “this technology is not reimbursed even in countries where dedicated reimbursement is established for drug-coated balloon treatment of femoro-popliteal lesions, such as Germany.”

    “The conclusion drawn by the authors of this meta-analysis that drug-coated balloons result in favorable angiographic outcome compared to percutaneous transluminal angioplasty or DES must be interpreted with caution,” the editorialists declared.

    And, they added, “the results of this meta-analysis cannot be generalized to other commercially available drug-coated balloons without published clinical study data or to those drug-coated balloons still under clinical evaluation.”


    Cassese declared no relevant conflicts of interest.

    Zeller reported consulting for Boston Scientific, Cook, Medtronic, W. L. Gore, Veryan, Spectranetics, Trireme, and Terumo.


    JACC: Cardiovascular Interventions

    Cassese S, et al “Drug-coated balloons for revascularization of infrapopliteal arteries: a meta-analysis of randomized trials” JACC Cardiovasc Interv 2016; DOI: 10.1016/j.jcin.2016.02.011.


    JACC: Cardiovascular Interventions

    Zeller T, et al “Favorable angiographic outcome after treatment of infrapopliteal lesions with drug coated balloons without clinical benefit: what we learn from a meta-analysis” JACC Cardiovasc Interv 2016; DOI: 10.1016/j.jcin.2016.03.005.

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