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Drug-Coated Balloon Angioplasty of the Side Branch During Provisional Stenting: The Multicenter Randomized DCB-BIF
Xiaofei Gao1, Nailiang Tian1, Jing Kan1
1Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
Insights
Drug-coated balloons (DCB) significantly reduced major adverse cardiac events in patients with coronary bifurcations compared to noncompliant balloons (NCB). This study highlights DCB as a promising strategy for side branch intervention in provisional stenting.
Area of Science:
- Interventional Cardiology
- Cardiovascular Medicine
- Biomedical Engineering
Background:
- Side branch stenting during provisional stenting can lead to suboptimal outcomes.
- Drug-coated balloons (DCB) offer a potential solution for compromised side branches.
- The efficacy of DCB in coronary bifurcations requires further investigation.
Purpose of the Study:
- To compare the effectiveness of DCB versus noncompliant balloons (NCB) for side branch treatment.
- To evaluate outcomes in patients with simple, true coronary bifurcations undergoing provisional stenting.
- To determine if DCB improves results in pinched side branches post-main vessel stenting.
Main Methods:
- A multicenter randomized controlled trial involving 784 patients with true coronary bifurcations.
- Patients received either DCB or NCB intervention for a compromised side branch after main vessel stenting.
- The primary endpoint was major adverse cardiac events at 1-year follow-up.
Main Results:
- The DCB group showed a significantly lower rate of major adverse cardiac events (7.2% vs. 12.5%) compared to the NCB group.
- The reduction in events was primarily driven by a decrease in myocardial infarction.
- No significant differences were observed in procedural success, death, revascularization, or stent thrombosis.
Conclusions:
- DCB intervention for compromised side branches in simple, true coronary bifurcations resulted in better 1-year outcomes than NCB.
- The clinical significance of early periprocedural myocardial infarctions in the DCB group warrants further study.
- DCB is a viable strategy to improve outcomes in complex coronary bifurcation interventions.
Background:
Side branch stenting is often required during provisional stenting, leading to suboptimal results. Drug-coated balloons (DCB) for the compromised side branch have emerged as an attractive strategy. However, the benefit of DCB for coronary bifurcations remains unclear.
Objectives:
This study aimed to investigate whether DCB, compared with a noncompliant balloon (NCB), for the pinched side branch improves the outcomes of provisional stenting in patients with simple, true coronary bifurcations.
Methods:
In this multicenter, randomized controlled trial, patients with true coronary bifurcations who had side branch diameter stenosis of ≥70% after main vessel stenting at 22 centers in China, Indonesia, Italy, and Korea were randomly assigned to either DCB or NCB intervention. The primary endpoint was major adverse cardiac events, a composite of cardiac death, target vessel myocardial infarction, or clinically driven target-lesion revascularization at the 1-year follow-up.
Results:
Between September 8, 2020, and June 2, 2023, 784 patients with true coronary bifurcation lesions undergoing main vessel stenting and having a severely compromised side branch were randomly assigned to the DCB (n = 391) or NCB (n = 393) group. One-year follow-up was completed in all patients. The primary endpoint occurred in 28 patients in the DCB group and 49 patients in the NCB group (Kaplan-Meier rate: 7.2% vs 12.5%; HR: 0.56; 95% CI: 0.35-0.88; P = 0.013), driven by a reduction in myocardial infarction. There were no significant differences between groups in procedural success, crossover to a 2-stent approach, all-cause death, revascularization, or stent thrombosis.
Conclusions:
In patients with simple and true coronary bifurcation lesions undergoing provisional stenting, main vessel stenting with a DCB for the compromised side branch resulted in a lower 1-year rate of the composite outcome compared with an NCB intervention for the side branch. The high rates of periprocedural myocardial infarction, which occurred early and did not lead to revascularization, are of unclear clinical significance.
