Drug‐coated balloon treatment of coronary artery disease: A position paper of the Italian Society of Interventional Cardiology

Abstract

Drug-coated balloons are a new tool for the treatment of patients with coronary artery disease. The main feature of this technology is a rapid and homogenous transfer of an antiproliferative drug (paclitaxel) to the vessel wall just at the time of balloon inflation, when neointimal proliferation, in response to angioplasty, is the highest. Moreover, drug-coated balloons share adjuntive advantages over stents: the absence of permanent scaffold and polymer, the respect of the original coronary anatomy, and limited inflammatory stimuli, thereby allowing for short-term dual antiplatelet therapy. To this day, a lot of devices are available in the market, with limited scientific data for the vast majority of them. Thus, the Italian scientific society of interventional cardiologists GISE decided to coordinate the efforts of a group of reknown experts on the field, in order to obtain a Position Paper on the correct use of drug-coated balloons in all the settings of coronary artery disease, giving a class of indication to each one, based on the clinical evidence. This Position Paper represents a quick reference for operators, investigators, and manufactures to promote the understanding and the correct use of the drug-coated balloon technology in everyday clinical practice.

New Sirolimus-Coated Ballon for Complex Unprotected Left Main Distal Bifurcation

“…DCB are widely used for ISR management1 and are also variably used in other settings (small vessels, bifurcation) (3)(4)(5). Limited data are currently available on the optimal management of LM ISR, and the few available seem to suggest a good outcome of second generation DES (6,7).…”

Drug-Eluting Balloon Technology for Native Non-Small Coronary Artery Disease: Another Crusade against Skepticism!

“…Here, I would like to again underline how optimal preparation of lesions is mandatory for a good DEB angioplasty result, suggested in the Italian Society of Interventional Cardiology consensus paper [1] and proved by the PICCOLETO study experience [10]. In light of this, the employment of a CB could be a useful help.…”

“…There is a shorter duration of dual antiplatelet therapy; this is useful for high-risk patients [1,2]. There is no “onion-skin” phenomenon with further metal layers.…”

“…Moreover, the geographical mismatch was an issue when a BMS bail-out implantation was necessary. To learn from the PICCOLETO study, when a DEB angioplasty is planned, a good predilatation is mandatory to help drug penetration on the vessel wall as well to as avoid geographical mismatch [1,2,10]. …”

“…Experts suggest that the balloon should be kept inflated for 30-60 s to allow sufficient transfer of the antiproliferative drug after adequate predilatation [1,2]. …”