The 12-months results of the BASKET-SMALL 2 study, which were presented at the 2018 European Society of Cardiology (ESC) Congress (25–29 August, Munich, Germany), indicate that use of a drug-coated balloon (SeQuent Please, B Braun) to treat de novo lesions in small vessels is associated with a similar rate of major adverse cardiac events (MACE) as contemporary drug-eluting stents.
In the study, 758 patients with de novo lesions in small vessels (≤3mm) were randomised to undergo percutaneous coronary intervention (PCI) with a drug-coated balloon or a second-generation drug-eluting stent. The primary endpoint was the rate of MACE at one year; the rate of the primary endpoint was 7.6% for the drug-coated balloon group vs. 7.5% for the drug-eluting stent group (a non-significant difference).
Simultaneous to its ESC presentation, BASKET-SMALL 2 was published in the Lancet. Study author Bruno Scheller (Clinical and Experimental Interventional Cardiology, University of Saarland, Homburg/Saar, Germany) comments: “There was no acute and subacute vessel occlusions in the drug-coated balloon group, proving the safety of the standalone drug-coated balloon procedure, provided the lesion is carefully prepared. After one year, ‘drug-coated balloon’ only has the same event rate as modern drug-eluting stents, which so far has been regarded as the standard of care for this indication. Additionally, the absence of a permanent implant may provide a long-term benefit of drug-coated balloon therapy compared with stent implantation, which will be investigated in the long-term observation of the study.”
Gerd Wacker, senior vice president of B Braun Vascular Systems, comments: “With the new clinical evidence, SeQuent Please can be considered as a reasonable ‘implant free’ alternative to drug-eluting stents for a good number of patients with coronary artery disease.”
