Drug-eluting balloons in coronary interventions: the quiet revolution?

ABSTRACT

Introduction: Drug-eluting balloons (DEB) may be considered as a ‘quiet revolution’ in percutaneous coronary interventions. Early-generation DEB eluting paclitaxel proved to be very effective in animal models to reduce neointimal hyperplasia.

Areas covered: Review of DEB efficacy in patients with coronary de novo lesions and in-stent restenosis (ISR).

Expert opinion: Many randomized clinical trials and meta-analyses have demonstrated the value of DEB in patients with ISR. In this setting, DEB are safe and effective with clinical and angiographic results superior to plain balloon angioplasty and at least equivalent to first generation drug-eluting stents (DES). In selected ‘de novo’ lesions (bifurcation lesions, small vessels, diffuse disease, myocardial infarction) DEB represent an attractive alternative although additional evidence in these ‘niche’ indications is still required before a widespread clinical utilization can be recommended. Recently, new generation DEB have become available, offering interesting new possibilities (paclitaxel and also sirolimus) for coronary interventions. Further studies are required to compare the results of novel generation DEB with those of second-generation DES.

KEYWORDS:

• In-stent restenosis
• drug-coated balloon
• stents
• optical coherence tomography

Article highlights

• Drug-eluting balloon (DEB) have demonstrated significant efficacy to reduce neointimal proliferation in several animal models

• First generation DEB used paclitaxel and provided very satisfactory clinical and angiographic results in patients with coronary in-stent restenosis (ISR) and de novo lesions

• DEB are recommended in patients with ISR (evidence/level of recommendation IA)

• DEB appear to be of value in selected patients with de novo coronary lesions (small vessels, bifurcations, diffuse disease, acute myocardial infarction) but the available evidence is rather limited

• The challenge in the clinical setting is to identify clinical and anatomic scenarios where the results of DEB are non-inferior to those of new-generation drug-eluting stents

• Novel DEB include attractive technical characteristics and are able to elute potent drugs (limus-type) but clinical trials are eagerly warranted to confirm the expectations generated by these new devices.

This box summarizes key points contained in the article.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

This paper was not funded.