In patients with coronary bifurcation lesions undergoing provisional stenting, main vessel stenting with a drug-coated balloon (DCB) for a compromised side branch resulted in lower rates of major cardiovascular events at one year compared with use of a noncompliant balloon (NCB) for the side branch, according to findings from the DCB-BIF trial presented at TCT 2024 and simultaneously published in JACC.

Researchers randomly assigned 784 patients from 22 centers in China, Indonesia, Italy and Korea who had true coronary bifurcation lesions and a severely compromised side branch after undergoing main vessel stenting to either DCB (n=391) or NCB (n=393). The primary endpoint was a composite of cardiac death, target vessel myocardial infarction, or clinically driven target-lesion revascularization at one-year follow-up.

According to Xiaofei Gao, MD, et al., the primary endpoint occurred in 28 patients (7.2%) in the DCB group and 49 patients (12.5%) in the NCB group, largely driven by a reduction in myocardial infarction. The researchers noted no significant differences between groups in procedural success, crossover to a 2-stent approach, all-cause death, revascularization or stent thrombosis.

"DCB-BIF, to our knowledge, is the first powered, multicenter, and randomized trial to demonstrate that stenting the main vessel with a drug-eluting stent combined with a DCB for the side branch resulted in a lower incidence of major adverse cardiac events … compared to the provisional approach with an NCB for the side branch in patients with simple true coronary bifurcation lesions," write Gao and colleagues.

In a related editorial comment, Ziad Ali, MD, DPhil, and Celina M. Yong, MD, MBA, MSc, FACC, note that the DCB-BIF findings appear to affirmatively answer the question of whether DCBs should become the standard for treating side-branch stenosis in patients with simple bifurcations. However, they caution that "clinical benefit is not the only factor that determines therapy" and highlight that "access to therapy also plays a crucial role." They compare Canada, where the cost of a DCB is only marginally higher than that of a drug-eluting stent, with the U.S., where DCBs are currently more than 10 times more expensive than DES. The also suggest that "further research is needed to explore the potential benefits of DCBs in more complex bifurcation lesions."