DEBUT: Drug-coated Balloon for PCI Superior to Bare Metal

Percutaneous coronary intervention (PCI) with a drug-eluting balloon was superior to a bare metal balloon, results from the DEBUT study suggested.

The researchers, publishing in The Lancet, looked at 220 patients between 2013 and 2017, and assigned 208 to PCI with a drug-coated balloon (n=102) or a bare metal stent (n=106). Patients were eligible for inclusion if they had a de-novo lesion in a coronary artery or bypass graft treatable with drug-coated balloons, a reference vessel diameter of 2.5 to 4.0 mm, and at least one risk factor for bleeding. Those patients with ST-elevation myocardial infarction (STEMI)

The balloons were coated with either paclitaxel and iopromide. The outcome of interest was major adverse cardiac events at nine months, with all prespecified analyses performed in the intent-to-treat population. Noninferiority was determined if the absolute difference between the groups was greater than 3%.

According to the study results, only one patient had reported a major adverse cardiac event in the drug-coated balloon group, compared with 15 patients in the bare metal stent group (1% vs. 14%, absolute difference of 13.2% [95 %CI, 6.2 to 21.1]; RR=0.07, 95% CI, 0.01 to 0.52; P<0.00001 for noninferiority and P=0.00034 for superiority). There were two definite stent thromboses in the bare metal stent group. There were also no acute vessel closures in the drug-eluting group.

“Percutaneous coronary intervention with drug-coated balloon was superior to bare-metal stents in patients at bleeding risk,” the researchers wrote in there interpretation. “The drug-coated balloon-only coronary intervention is 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.”