This angiographic substudy supports the safety of drug-coated balloons in small vessels. Despite better angiographic outcomes, there were eight cases of stent thrombosis among drug-eluting stent (DES) patients, while there was none with drug-coated balloons.
In patients with small vessels, using a drug-coated balloon appears safe and comparable to DES, with favorable angiographic outcomes at 1 year.
The main BASKET-SMALL 2 trial was conducted at 14 sites in Germany, Switzerland, and Austria. This trial had an open-label, noninferiority design, and it included 758 patients with de novo lesions in small vessels (at least 2 mm but less than 3 mm in diameter). All lesions were predilated, and absence of flow-limiting dissections and residual stenosis <30% were requirements for randomization.
Read also: EuroPCR 2019 | Intravascular Imaging Almost Indispensable for Planning an Angioplasty.
Patients were randomized to undergo angioplasty with the SeQuent Please paclitaxel-coated balloon (B. Braun Melsungen) or first- or second-generation DES. As regards DES, researchers initially used TAXUS and then Xience.
Patients in the drug-coated balloon group received dual antiplatelet therapy for 4 weeks, whereas the DES group received it for 6 weeks (yes, only 6) if they were stable or 1 year if they had acute coronary syndrome.
At 1 year, the rate of major adverse cardiac events (MACE) was 7.33% for the balloon group and 7.45% for the DES group. Such difference met criteria for noninferiority.
This protocol could be criticized regarding the short duration of dual antiplatelet therapy for the DES group and stable chronic angina patients, particularly if we consider the initial use of a first-generation DES, TAXUS, with verified higher rates of thrombosis than new DES.
Original Title: Drug-coated balloons vs drug-eluting stents for the treatment of small coronary artery lesions: angiographic analysis from the randomized BASKET-SMALL 2 trial.
Presenter: Jeger R et al.
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