DCB-BIF Trial: Randomized Study of Side Branch Drug-Coated Balloon Angioplasty Following Provisional Stenting

Coronary bifurcations present technical challenges that should be addressed for adequate coronary geometry. The first treatment option for complex coronary bifurcations (according to the DEFINITION study), especially in the left main, is the two stent technique (generally DK-Crush).

Simpler bifurcations, where side-branch length is less than 10 mm, are often treated with provisional stenting, which consists of placing only one stent in the main vessel. Side-branch systematic predilation is not recommended in this technique, to minimize the need for a second stent. However, there could be plaque and carina shift, which would severely compromise the side-branch ostium. 

Treating side-branch ostium with no compliant balloons (NCB) might lead to vessel dissection or occlusion, which would call for a second stent. This area, in the long term, is prone to restenosis. This is why the concept of “leave nothing behind” using drug-coated balloons (DCB) is appealing. 

Gao et al. designed the DCB-BIF, a randomized study to assed the efficacy of DCBs vs NCBs for side-branch treatment following main vessel provisional stenting in true coronary bifurcations. The study included patients from 22 centers (mainly in China) with silent ischemia, stable or unstable angina, or acute MI (AMI). The main requirement was side-branch ostium compromise after provisional stenting, with ≥70% stenosis, and patients were randomized 1:1.

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In the DCB group, predilation was performed with a NCB at 1:1 ratio with reference vessel, considering it adequate if residual stenosis was <50%. Subsequently, a DCB was deployed at nominal pressure for 60 seconds (ratio 0.8-1:1). After DCB angioplasty, kissing balloon inflation (KBI) was performed with two NCBs and re-POT. In cases of type C dissection or TIMI flow compromise, a bailout stent was used.

The primary outcome was major adverse cardiovascular event rate (MACE) at 12 months after procedure, including cardiac death, target vessel MI or clinically driven revascularization. Secondary end points included all-cause mortality, spontaneous and periprocedural AMI, target vessel revascularization and crossover to two-stent technique. 

784 patients treated with provisional stenting were included (pinched side-branch), mean age 65, 76.7% were men and 36.6% presented diabetes. Most patients presented unstable angina (61.1%) or non-ST elevation MI (24.5%). 76.1% had Medina 1,1,1, lesions and the treated vessels were mostly the anterior descending (67.9%) and left main (15.2%). IVUS was used in 22.6% of patients and OCT in 4.7%. Crossover to two-sent technique happened in 3.3% of NCB patients and in 3.8% of DCB patients.

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At 12 months, 14.2% of NCB patients and 16.4% of DCB patients required a new angiography (P = 0.41). The primary outcome was seen in 12.5% of NCB patients and 7.2% of DCB patients (HR: 0.56; CI 95%: 0.35-0.88; P = 0.013). The risk of spontaneous AMI was higher among NCB patients (3.6% vs. 1.0%; HR: 0.27; CI 95%: 0.09-0.81; P = 0.029), as was target vessel MI (HR: 0.50; IC 95%: 0.30-0.84; P = 0.009).

There were no differences in secondary outcomes. Of the 18 spontaneous MI, only two were caused by stent thrombosis. 

Conclusions

The DCB-BIF showed that, in a specific population, treating the main vessel with a drug eluting stent followed by a drug coated balloon to the compromised side branch, vs non-compliant balloons, significantly reduced cardiovascular events at one year (HR: 0.56) 

Original Title: Drug-Coated Balloon Angioplasty of the Side Branch During Provisional Stenting. The Multicenter Randomized DCB-BIF Trial.

Reference: Gao X, Tian N, Kan J, Li P, Wang M, Sheiban I, Figini F, Deng J, Chen X, Santoso T, Shin ES, Munawar M, Wen S, Wang Z, Nie S, Li Y, Xu T, Wang B, Ye F, Zhang J, Shou X, Chen SL. Drug-Coated Balloon Angioplasty of the Side Branch During Provisional Stenting: The Multicenter Randomized DCB-BIF Trial. J Am Coll Cardiol. 2025 Jan 7;85(1):1-15. doi: 10.1016/j.jacc.2024.08.067. Epub 2024 Oct 28. PMID: 39480378.