DEBUT Trial Supports DCB-Only PCI in High-Bleeding-Risk Patients
June 26, 2019—Findings from the DEBUT trial were published by Tuomas T. Rissanen, MD, et al online ahead of print in The Lancet. DEBUT is a single-blind, randomized, noninferiority trial of a drug-coated balloon for treatment of de novo coronary artery lesions in patients with high bleeding risk.
According to the investigators, the hypothesis of the DEBUT trial was that percutaneous coronary intervention (PCI) with DCBs is noninferior to PCI with bare-metal stents for this population. However, it is not known what the optimal technique of PCI in patients at high bleeding risk is.
The DEBUT trial was conducted at five sites in Finland. Patients were eligible if they had an ischemic de novo lesion in a coronary artery or bypass graft that could be treated with DCBs, at least one risk factor for bleeding, and a reference vessel diameter of 2.5–4.0 mm.
The trial excluded patients with ST-segment elevation myocardial infarction, bifurcation lesions needing a two-stent technique, in-stent restenosis, and flow-limiting dissection or substantial recoil (>30%) of the target lesion after predilation.
As summarized in The Lancet, after successful predilation of the target lesion, patients were randomly assigned (1:1), by use of a computer-generated random sequence, to PCI with a balloon coated with paclitaxel and iopromide or a bare-metal stent. The primary outcome was major adverse cardiac events at 9 months. Noninferiority was shown if the absolute risk difference was no more than 3%. All prespecified analyses were done in the intention-to-treat population.
There were 220 patients recruited for the study between May 22, 2013, and January 16, 2017. Of these, 208 patients were randomized to PCI with DCB (n = 102) or PCI with bare metal stent (n = 106).
The investigators reported that at 9 months, major adverse cardiac events had occurred in one patient (1%) in the DCB balloon group and in 15 patients (14%) in the bare-metal stent group, with an absolute risk difference of −13.2 percentage points (95% confidence interval, −6.2 to −21.1) and risk ratio of 0.07 (95% CI, 0.01 to 0.52; P < .00001 for noninferiority and P = .00034 for superiority). Additionally, there were two definitive stent thrombosis events in the bare-metal stent group but no acute vessel closures in the DCB group.
The investigators concluded that PCI with DCB was superior to bare-metal stents in patients at bleeding risk and offers a novel strategy to treat this difficult patient population. Comparison of this approach to the new generation drug-eluting stents is warranted in the future, noted the investigators in The Lancet.