Comparison of Noncompliant Balloon With Drug-Coating Balloon Angioplasties for Side Branch After Provisional Stenting for Patients With True Coronary Bifurcation Lesions - DCB-BIF

Oct 28, 2024
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Author/Summarized by Author:
Amit Saha, MD
Summary Reviewer:
Anthony A. Bavry, MD,MPH,FACC
Trial Sponsor:
National Key Research and Development Plan, Chinese Society of Cardiology, National Natural Scientific Foundation of China, and Jiangsu Provincial and Nanjing Municipal Clinical Trial Project.
Date Presented:
10/28/2024
Date Published:
10/28/2024
Original Posted Date:
10/28/2024
References

Contribution To Literature:

The DCB-BIF trial showed that in patients with simple coronary bifurcation lesions undergoing provisional stenting, paclitaxel-coated DCB angioplasty of residual side branch stenosis reduced the incidence of target-vessel MI compared with noncompliant balloons alone.

Description:

The goal of the trial was to assess the efficacy of drug-coated balloon (DCB) angioplasty of residual side branch stenosis in coronary bifurcation lesions treated with a provisional stenting strategy.

Study Design

  • International multicenter
  • Randomized
  • Single-blinded

Patients undergoing provisional stenting of a coronary bifurcation lesion with residual side branch stenosis ≥70% were randomized in a 1:1 fashion to undergo side branch intervention with a paclitaxel DCB (n = 391) or a noncompliant balloon (NCB) (n = 393). Randomization was done after main vessel stenting and proximal optimization technique (POT) with residual side branch disease. NCB dilation was performed in all patients followed by DCB inflation at nominal pressure for 60 seconds in the DCB arm. Kissing balloon inflation and re-POT using NCB were performed after side branch intervention.

  • Total number of enrollees: 784
  • Duration of follow-up: 1 year
  • Median patient age: 65 years
  • Percentage female: 23%

Inclusion criteria:

  • Age ≥18 years
  • Silent ischemia, stable or unstable angina, or acute myocardial infarction (MI) >7 days from onset of chest pain to admission
  • Medina 0,1,1, Medina 1,0,1, or Medina 1,1,1 coronary bifurcation lesion
  • Main branch and side vessel angiographic diameter ≥2.5 mm
  • Target lesion angiographic stenosis ≥50%
  • Side branch lesion length <10 mm and angiographic stenosis ≥70% after POT of main vessel stent

Exclusion criteria:

  • Intolerance to dual antiplatelet therapy
  • Unsuccessfully recanalized chronic total occlusion in main vessel or side branch
  • Severe calcific disease requiring rotational atherectomy
  • Restenotic lesion
  • Cardiogenic shock

Other salient features/characteristics:

  • Unstable angina: 61%
  • Acute MI: 30%
  • Medina 1,1,1 lesion: 76%
  • Left anterior descending artery lesion: 68%
  • Distal left main lesion: 15%
  • Intravascular imaging guidance: 27%
  • Transition to two-stent strategy: 4%

Principal Findings:

The primary outcome of major adverse cardiac events (MACE), a composite of cardiac death, target-vessel MI, or clinically driven target lesion revascularization (TLR) at 1 year for DCB vs. NCB, was: 7.2% vs. 12.5%, hazard ratio (HR) 0.56 (95% confidence interval [CI] 0.35-0.88), p = 0.013.

Secondary outcomes for DCB vs. NCB at 1 year:

  • Cardiac death: 1.0% vs. 0.5%, HR 2.46 (95% CI 0.38-11.31), p = 0.45
  • All-cause death: 1.8% vs. 0.8%, HR 2.35 (95% CI 0.61-9.08), p = 0.22
  • Target-vessel MI: 5.6% vs. 10.9%, HR 0.50 (95% CI 0.30-0.84), p = 0.009
  • Periprocedural MI (within 48 hours): 4.6% vs. 7.4%, difference -2.8 (-6.23 to 0.59), p = 0.13
  • Spontaneous MI: 1.0% vs. 3.6%, HR 0.27 (95% CI 0.09-0.81), p = 0.029
  • Clinically driven TLR: 1.3% vs. 1.5%, HR 0.81 (95% CI 0.25-.2.66), p = 1.00
  • Definite or probable stent thrombosis: 1.0% vs. 0%, difference 1.0 (95% CI -0.13 to 2.60), p = 0.06

Quantitative angiographic outcomes for DCB vs. NCB immediately post-procedure:

  • Side branch acute luminal gain: 0.63 vs. 0.55, difference 0.07 (95% CI 0.01-0.12), p = 0.045
  • Side branch diameter stenosis: 25.1% vs. 27.2%, difference -2.06% (95% CI -3.96 to -0.17), p = 0.033

Interpretation:

This is the first large multicenter trial to demonstrate superiority of DCB to NCB side branch angioplasty in provisional stenting of simple coronary bifurcation lesions. The preceding neutral BEYOND trial of a paclitaxel DCB should be considered within the context of its low overall MACE incidence of 2.3%, whereas rates in the NCB arm of DCB-BIF are more comparable to contemporary trials. The observed benefit was largely due to a reduction in target-vessel MI, including numerically fewer periprocedural and spontaneous events. However, >70% of MI events were periprocedural, and it is unclear how many of these were subclinical events captured due to post-procedure biomarker collection rather than patient symptoms. Rates of TLR were ultimately low (<1.5%) and did not differ between groups. Clinical outcomes in extended follow-up beyond 1 year, side branch DCB predilation before main vessel stenting, comparison to two-stent strategies in complex bifurcation disease, and efficacy in different patient demographics all represent potential areas of further investigation.

References:

Gao X, Tian N, Kan J, et al. Drug-Coated Balloon Angioplasty of the Side Branch During Provisional Stenting: The Multicenter Randomized DCB-BIF Trial. J Am Coll Cardiol 2024;Oct 28:[Epub ahead of print].

Editorial Comment: Ali Z, Yong CM. Drug-Coated Balloons to Keep Interventions of the Side Branch Simple (KISS): KISS or Be KISS’D. J Am Coll Cardiol 2024;Oct 28:[Epub ahead of print].

Presented by Dr. Shao-Liang Chen at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2024), Washington, DC, October 28, 2024.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Angioplasty, Balloon, Drug-Eluting Stents, TCT24, Transcatheter Cardiovascular Therapeutics


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