Drug-Eluting Balloon in stable and Unstable angina: a randomized controlled non-inferiority Trial - DEBUT

Aug 12, 2019
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
B Braun Medical AG, AstraZeneca, and Competitive State Research Funding of the Kuopio University Hospital Catchment Area
Date Published:
06/13/2019
Date Updated:
08/12/2019
Original Posted Date:
06/26/2019
References

Contribution To Literature:

The DEBUT trial showed that use of a paclitaxel-based coronary DCB was superior to BMS implantation at 9 months among patients undergoing de novo PCI and high bleeding risk.

Description:

The goal of the trial was to compare the safety and efficacy of a paclitaxel-based drug-coated balloon (DCB) to bare-metal stent (BMS) implantation among patients with de novo lesions and high bleeding risk.

Study Design

Eligible patients were randomized in a 1:1 fashion to percutaneous coronary intervention (PCI) with a DCB (n = 102) or BMS (n = 106). Before randomization, predilation was performed, sized to the nominal diameter of the vessel. Patients with flow-limiting dissection or substantial recoil were excluded. The DCB used was SeQuent Please (B Braun Melsungen AG, Berlin, Germany) coated with paclitaxel (3 μg/mm²) and iopromide, and the BMS was either Integrity (Medtronic, Minneapolis, MN, USA) or Omega (Boston Scientific, Marlborough, MN, USA). After randomization to DCB, use of bailout BMS was mandatory in patients with flow-limiting dissection or substantial recoil after the DCB treatment. Dual antiplatelet therapy (DAPT) was continued for 1 month post-PCI.

  • Total number of enrollees: 208
  • Duration of follow-up: 9 months minimum
  • Mean patient age: 77 years
  • Percentage female: 37%
  • Percentage with diabetes: 37%

Inclusion criteria:

  • Age ≥18 years
  • Ischemic de novo lesion in a coronary artery or bypass graft that could be treated with a DCB
  • At least one of the following risk factors for bleeding:
    • Taking oral anticoagulants
    • Aged ≥80 years
    • Anemia or thrombocytopenia detected <6 months before the intervention, active malignancy
    • Previous ischemic stroke or intracranial bleeding
    • Severe renal dysfunction (estimated glomerular filtration rate <30 ml/kg/min) or hepatic failure
    • Planned elective noncardiac surgery within 12 months after PCI intervention
    • Substantial frailty (body mass index <20 kg/m²)
    • Previously documented poor drug compliance
    • Previous clinically significant bleeding requiring intervention

Exclusion criteria:

  • Myocardial infarction (MI) with ST elevation
  • Cardiogenic shock or resuscitation
  • Bifurcation lesion needing a two-stent technique
  • In-stent restenosis, reference diameter of the reference vessel <2.5 mm or >4.0 mm
  • Life expectancy of <1 year
  • Left main coronary artery lesion
  • Chronic total occlusion
  • Flow-limiting dissection or substantial recoil (>30%) of the target lesion after predilation

Other salient features/characteristics:

  • Previous MI: 22%, acute coronary syndrome presentation: 46%
  • Age ≥80 years: 52%
  • Anemia/thrombocytopenia: 32%
  • Use of oral anticoagulant: 60%
  • PCI location: left anterior descending artery 39%, right coronary artery 25%
  • Calcified lesion: 11%, bifurcation lesion: 15%
  • Bailout stenting in DCB arm: three lesions (2%)

Principal Findings:

The primary outcome, major adverse cardiac events (MACE; cardiovascular [CV] death, MI, target lesion revascularization [TLR]) at 9 months, for DCB vs. BMS, was 1% vs. 14% (p for noninferiority < 0.0001, p for superiority = 0.00034).

  • CV death, for DBS vs. BMS: 1% vs. 6% (p = 0.061)
  • MI, for DBS vs. BMS: 0% vs. 6% (p = 0.015)
  • TLR, for DBS vs. BMS: 0% vs. 6% (p = 0.15)

Secondary outcomes, for DCB vs. BMS:

  • Vessel closures/stent thrombosis: 0% vs. 1.9%
  • MACE at 12 months: 4% vs. 14% (p = 0.015)
  • TLR at 12 months: 2% vs. 6% (p = 0.28)
  • Bleeding event: 13% vs. 10% (p = 0.59)

Interpretation:

The results of this trial indicate that use of a paclitaxel-based coronary DCB was superior to BMS implantation among patients undergoing de novo PCI and high bleeding risk (9-month bleeding incidence ~12%); DAPT was used for 1 month only in this trial. These are important findings, as many of the prior DCB trials were conducted for small vessels (BASKET-SMALL 2). The MACE rates in this trial in the BMS group are higher than previously reported.

Of note, DCBs are approved for coronary PCI in Europe, but not Food and Drug Administration approved in the United States. Also, BMS use has declined significantly, and the most recent European Society of Cardiology guidelines recommend drug-eluting stents (DES) over BMS even in higher bleeding risk patients; durations as short as 3 months seem to be effective in specific scenarios. Also, the bioabsorbable polymer stent (BPS) trials such as LEADERS FREE have shown the safety of 1-month DAPT with those stents. Thus, the optimal control for comparison for DCBs may be DES with shorter durations or BPS-DES. DCBs could be a reasonable option based on the low MACE event rates noted in this trial.

References:

Rissanen TT, Uskela S, Eränen J, et al. Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial. Lancet 2019;394:230-9.

Keywords: Absorbable Implants, Acute Coronary Syndrome, Anemia, Anticoagulants, Body Mass Index, Brain Ischemia, Drug-Eluting Stents, Frail Elderly, Geriatrics, Glomerular Filtration Rate, Hemorrhage, Intracranial Hemorrhages, Liver Failure, Myocardial Revascularization, Neoplasms, Paclitaxel, Percutaneous Coronary Intervention, Risk Factors, Stents, Stroke, Thrombocytopenia, Thrombosis


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