Results from the BELLO (Balloon elution and late loss optimization) study, published in the Journal of the American College of Cardiology, indicate that the use of a paclitaxel-eluting balloon for the treatment of de novo small vessel disease is associated with less angiographic late loss and similar rates of restenosis and revascularisation compared with a paclitaxel-eluting stent.
Azeem Latib, Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy, and others wrote that drug-eluting balloons are “emerging as an effective treatment for in-stent restenosis in both bare-mental stents and drug-eluting stents.” However, they added that the efficacy of drug-eluting balloons in de novo lesions has not been established and, furthermore—as drug-eluting stents are associated with a high rate of restenosis in small vessel disease drug-eluting balloons may represent an alternative treatment in this setting. Latib et al reported: “Because limited and inconsistent data are available for drug-eluting balloons in small-vessel disease, we performed a randomised study to evaluate the efficacy and safety of a drug-eluting balloon as compared with paclitaxel-eluting stent implantation for the reduction of restenosis in patients with coronary artery disease in small vessels.”
Patients were eligible for inclusion in the BELLO study if they had stable or unstable angina or documented silent ischaemia, and a maximum of two angiographically significant de novo target lesions <25mm in length in native coronary arteries with a visually estimated reference vessel diameter of <2.8mm. Of 182 patients in the study, after randomisation, 90 (in 94 lesions) received treatment with a drug-eluting balloon (IN.PACT Falcon, Medtronic) dilation and provisional bare metal stent and 92 (in 98 lesions) received treatment with a drug-eluting stent (Taxus Liberte, Boston Scientific). In the group that received the drug-eluting balloon, 20.2% of lesions required a bailout bare metal stent.
Latib et al reported: “The primary endpoint of in-stent (in-balloon) late loss was significantly less in lesions treated with drug-eluting balloon[s] compared with paclitaxel-eluting stent[s] (0.08±0.38mm vs. 0.29±0.44mm; p=0.0001 for non-inferiority and p=0.001 for superiority). In-segment late loss was also less in the drug-eluting balloon group (0.05±0.37 vs. 0.17±0.45mm; p<0.0001 for non-inferiority and p=0.06 for superiority).” They added that there were no significant differences between the groups in terms of the rate of death, myocardial infarction, target lesion revascularisation and target vessel revascularisation.
According to the authors, drug-eluting balloons may offer some advantages compared with drug-eluting stents for the treatment of small vessel disease, including: providing an immediate and homogenous drug uptake, avoiding an inflammatory retraction to stent struts or polymers, and respecting the normal vessel anatomy. They also said: “Drug-eluting balloons also provide a therapeutic option in very small vessels (<2.25mm), which comprised more than half of the lesions treated in this study, for which drug-eluting stents sizes are not available.”
However, in their conclusion, Latib et al claimed that the results of the BELLO study should not be “interpreted in the context of drug-eluting balloons as a generic substitute to drug-eluting stents but rather as an adjunctive tool.” They explained that their data supported the use of drug-eluting balloons when an operator “may not be confident to deploy a drug-eluting stent (eg, small vessel size, long lesions, excessive number of drug-eluting stents required) because the results of drug-eluting stents are not as optimal and in attempt to limit the amount of metal implanted.”
