BASKET-SMALL2 Trial Compares DCB and DES in De Novo Lesions of Small Arteries
August 28, 2018—The European Society of Cardiology (ESC) announced that results from the BASKET-SMALL2 trial were presented at the ESC Congress 2018 held August 25–29 in Munich, Germany. The results were simultaneously published online ahead of print by Prof. Raban V. Jeger, MD, et al in The Lancet.
According to ESC, the large, randomized BASKET-SMALL2 trial compared the effectiveness of drug-coated balloons (DCBs) versus drug-eluting stents (DESs) to treat de novo lesions in small arteries in terms of the rate of major adverse cardiac events (MACE) at 12 months.
Between 2012 and 2017, the trial enrolled 758 patients with a de novo lesion in an artery < 3 mm in diameter. In the study, the average age of patients was 68 years, 72% had stable coronary artery disease, and 28% had an acute coronary syndrome (heart attack or unstable angina).
Patients were randomized to receive DCB angioplasty (382 patients) or second-generation DES implantation (376 patients). Balloons were coated with iopromide and paclitaxel. Stents were covered with everolimus or paclitaxel.
Patients were followed for 12 months for the occurrence of MACE (death from cardiac causes, nonfatal heart attack, and target vessel revascularization [TVR]). Secondary endpoints included the individual components of MACE at 12 months, as well as major bleeding at 12 months.
The investigators found that there was no difference in the 12-month MACE rates for the DCB and DES groups (7.6% vs 7.5%; P = .918). Additionally, there were no statistical differences between groups in the rates of the individual components of the primary endpoint at 12 months: cardiac death (3.1% vs 1.3%; P = .113), nonfatal heart attack (1.6% vs 3.5%; P = .112), and TVR (3.4% vs 4.5%; P = .438). The 12-month rate of major bleeding was similar in the DCB and DES groups (1.1% vs 2.4%; P = .183).
Prof. Jeger, who is from the University Hospital of Basel, in Switzerland, and serves as principal investigator of the study, commented in the ESC announcement, "The BASKET-SMALL2 trial met its primary endpoint of noninferiority for MACE at 12 months. This is a long-awaited milestone in clinical evidence for the DCB technique, which so far has primarily been used for the treatment of in-stent restenosis."
Prof. Jeger added, "The potential benefits of a stent-free option to treat small blocked arteries are numerous. With no permanent implant left after the procedure, the problem of tissue growth and clot formation within the stent is eliminated. In addition, there may be no need for prolonged treatment with anticlotting medicines, which has been controversial because it increases the risk of bleeding."
He concluded, "DCB angioplasty has the possibility to become the standard treatment for small blocked arteries. We will continue to monitor patients in the trial for a further 2 years for MACE, stent thrombosis, and bleeding."