Stent-free treatment with a drug-coated balloon (DCB) is noninferior to drug-eluting stents (DES) for de novo lesions in small coronary arteries, according to results from the BASKET-SMALL 2 trial presented at the 2018 ESC Congress. Second-generation DES are the standard treatment for percutaneous intervention in coronary artery disease, but use of DES in small coronary arteries is associated with a higher risk of restenosis and lesion failure than in larger vessels. “Given the known high rates of adverse events with DES in small-vessel coronary artery disease, the option of DCB treatment as an alternative to DES is very welcome,” remarks lead investigator Raban Jeger.

Credit: V. Summersby/Springer Nature Limited

At present, DCBs are an established therapeutic option for in-stent restenosis, but data from randomized, controlled trials on DCBs in small coronary arteries are limited. Therefore, Jeger and colleagues initiated an open-label, randomized, noninferiority trial to assess the safety and efficacy of DCBs for the treatment of small-vessel coronary artery disease. In total, 758 patients with de novo lesions in small coronary arteries (<3 mm in diameter) were randomly assigned to receive the SeQuent Please DCB (B. Braun Melsungen) or second-generation DES (everolimus-eluting Xience stent (Abbott Vascular) or paclitaxel-eluting Taxus Element stent (Boston Scientific)) after successful predilatation of the lesion with a standard balloon. All patients received dual antiplatelet therapy according to current guidelines.

The rate of major adverse cardiac events (MACE; cardiac-related death, nonfatal myocardial infarction, and target-vessel revascularization) after 1 year was similar in the DCB and DES groups (7.5% versus 7.3%; HR 0.97, 95% CI 0.58–1.64). Results in the per-protocol population were similar, with a difference between the two groups in the absolute risk of MACE of 0.0005 (95% CI −0.038 to 0.039), which met the noninferiority criteria (P = 0.0217). Rates of the individual components of the primary end point did not differ between the groups, and adverse events rates were low and similar in both groups.

Given the known high rates of adverse events with DES in small-vessel coronary artery disease, the option of DCB treatment … is very welcome

Larger studies with a longer follow-up are needed to confirm these findings. Looking to the future, Jeger comments that the investigators will try to expand the DCB technology to other patient populations, such as patients with lesions in larger coronary arteries.