Drug-eluting balloons: don’t get stuck in small branches

In spite that drug-eluting stents (DES), particularly newer generations,  are the gold standard in treating significant coronary artery lesions, there is at least 2-4% risk of target lesion failure (TLF) per year, in the form of in-stent restenosis (ISR).

The risk of In-stent restenosis (ISR) is invariably higher when you are obliged to use smaller stents (2.5 mm diameter and lower) in small arteries and distal segments of bigger arteries. Drug-eluting balloons (DEB) may provide us with the solution in such conditions when we have to treat such lesions.

In the SELFIE registry published in 2020, which included 74 patients, 62 of them were presenting with acute coronary syndrome, Drug-eluting balloons (DEB) achieved a good safety and efficacy profile for the treatment of coronary lesions, especially in de-novo small vessels lesions, with a 100% procedural success rate. During follow-up period of about 1-1.5 yrs, only 4.8% MACEs occurred, with only 2 patients suffering from myocardial infarction and TLF.

FURTHERMORE, In the Chinese BEYOND study published in 2020, over 9-month follow-up, Drug-elution balloons used to treat side branches in de novo non-left main coronary artery bifurcations treated with provisional  stenting, showed better angiographic results than treatment with regular balloon dilatation regarding target lesion failure.

Additionally, In the coming years we are waiting for the outcome of the remarkable SELUTION DeNovo Trial that is designed to compare sirolimus-eluting balloon treatment to drug-eluting stent implantation in de novo coronary lesions regarding target lesion failure (TLF) in one year and five year follow-up.

It is noted that the best results of Drug-eluting balloons (DEB in recent studies, were achieved mainly using the newer Sirolimus-eluting balloons. An example of Sirolimus-eluting balloons available in the Egyptian cath labs is the Magic touch balloon. On the other hand, the widely available brand in Egypt, the iVascular essential pro is Paclitaxel-eluting.

Paclitaxel-eluting balloons are a bit older, and their long-term follow-up is somewhat disappointing. In a meta-analysis published in 2019, which included about 600 patients, the 3-year follow up mortality rates were comparable in both Paclitael-eluting balloons and uncovered PTCA. However, older evidences for them were promising.

A recent Egyptian study published in 2020, on 50 patients, Paclitaxel-eluting balloons showed satisfactory short-term results in patients with de-novo lesions in small  coronary vessels less than 2.8 mm in diameter.

Practical application: 

• As long as rational, try to avoid stening of small branches, to avoid higher risks of ISR.
• DEB is  a good option in treating small branches lesions, preferably, using sirolimus-eluting ones.
• If only paclitaxel-eluting balloons are available on-shelf, they may be used as indicated in treating small branches, or you may resort to only PTCA if you think plausible.