Why is this study important? 

• One of the main challenges of bifurcation stenting using a provisional approach is management of the side branch lesion.  
• With drug-coated balloons (DCB) more widely available, interventional cardiologists have one more tool to consider for the management of the compromised side branch. However, the clinical benefit of DCBs in bifurcation stenting is uncertain.  
• In this study, Gao et al aimed to evaluate the efficacy of DCB angioplasty vs. noncompliant balloon (NCB) angioplasty for management of the stenotic side branch after provisional stenting in patients with simple true coronary bifurcations. 

What question was this study supposed to answer? 

• While DCBs have been studied for the management of in-stent restenosis or small coronary artery lesions, the clinical benefit of DCBs in coronary artery bifurcations remains uncertain. 
• DCB-BIF is the first randomized trial that evaluated the efficacy of DCB angioplasty compared to NCB angioplasty for compromised side branch management during provisional stenting in simple true coronary bifurcation lesions (defined as SB lesion <10mm). 
• The primary endpoint looked at one-year major adverse cardiac events, which was a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. 
• Patients were randomized to DCB or NCB strategy after main vessel stenting if the side branch had an ostial stenosis >70%.
• Study sample: 
  • Patients included: >18 years of age, stable angina, acute coronary syndrome, silent ischemia, reference vessel diameter >2.5mm, baseline stenosis >50%, ostial side branch stenosis >70% after main vessel stenting. 
  • Patient excluded: allergy to study devices or medications, intolerant to dual antiplatelet therapy, life expectancy <12 months, pregnancy or nursing, restenosis lesion, severe calcification requiring rotational atherectomy, or hemodynamic instability. 

What did the study show? 

At one year, there was a lower incidence of major adverse cardiac events in the DCB vs. NCB group (7.2 % vs. 12.5%, p=0.013), mostly driven by reduction in target vessel myocardial infarction (MI). 

• DCB group had lower rates of target vessel MI compared to the NCB group (5.6% vs. 10.9% p=0.009). This was further broken down into periprocedural (within 48h of index procedure) and spontaneous MI (>48h from index procedure).  
• There was a lower incidence of spontaneous MI in the DCB group compared to the NCB group (1% vs. 3.6%, p=0.029), but no significant difference in periprocedural MI in the DCB vs. NCB group (4.6% vs. 7.4% p=0.13).  
• Despite the higher levels of MI, there was no increase in target vessel revascularization, which is of unclear significance. 
• No difference in secondary endpoints of death or major adverse cardiac events (excluding periprocedural MI, stent thrombosis, and clinical-driven target lesion revascularization). 

Key takeaway

Drug-coated balloon angioplasty is an attractive option for the management of compromised side branch lesions in provisional bifurcation stenting with improved clinical outcomes when compared to non-compliant balloon angioplasty.