For patients with ischemic de novo lesions in a coronary artery with a high bleeding risk, a percutaneous coronary intervention (PCI) with a drug-coated balloon may provide superior safety and efficacy when compared with PCI with a bare-metal stent, according to study results published in The Lancet.

The aim of the Drug-Eluting Balloon in stable and Unstable angina: a randomized controlled noninferiority Trial (DEBUT) was to assess the noninferiority of a drug-coated balloon-only strategy compared with a bare-metal stent strategy in patients with coronary artery lesions with a bleeding risk. Patients with an ischemic de novo lesion in a coronary artery or a bypass graft who also had a risk factor for bleeding were randomly assigned to either a drug-coated balloon cohort or a bare-metal stent cohort. Patients were blinded from their assigned cohort.

The primary outcome was major adverse cardiovascular events (MACE) at 9 months, with secondary outcomes of ischemia-driven target-lesion revascularization at 9 months and estimated MACE and target-lesion revascularization at 36 months.

Of the 208 patients included in this study, the mean age was 76.9±8.5 years old, 63% were men, and 46% had acute coronary syndrome; 102 were assigned to the drug-coated balloon cohort, and 106 were assigned to the bare-metal stent cohort.

At 9 months, 1% of the drug-coated balloon cohort and 14% of the bare-metal stent cohort experienced MACE (risk ratio [RR] 0.07; 95% CI, 0.01-0.52; Pnoninferiority <.0001 and Psuperiority =.00034). Also at 9 months, none of the drug-coated balloon cohort and 6% of the bare-metal stent cohort experienced target-lesion revascularization (RR 0.08; 95% CI, 0.01-1.4; Pnoninferiority <.0001 and Psuperiority =.015).

At 36 months, Kaplan-Meier estimates indicated that the drug-coated balloon cohort experienced a lower proportion of MACE (P =.013) with a similar proportion of target-lesion revascularization (P =.33) when compared with the bare-metal stent cohort.

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Limitations of this study include a smaller sample size than originally planned, more patients with diabetes than the drug-coated balloon cohort in the bare-metal stent cohort, a smaller number of adverse cardiac events than anticipated, and other treatment protocols used to treat different lesions.

The researchers concluded that “[PCI] using the drug-coated balloons only was superior to using bare metal stents in patients with a high bleeding risk.”

Disclosure: This study was supported by B. Braun Medical Inc. and AstraZeneca Pharmaceuticals LP. Please see the original reference for a full list of authors’ disclosures.


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;394:230-239.