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PCI with DCB superior to bare-metal stents
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Among patients with high bleeding risk undergoing PCI, the use of a balloon coated with paclitaxel and iopromide was superior to use of bare-metal stents, according to the results of the DEBUT trial published in The Lancet.
Although DCB use in PCI was superior to BMS, comparing its effectiveness to that of drug-eluting stents is needed, according to the researchers.
Tuomas T. Rissanen, MD, PhD, and colleagues investigated whether the DCB strategy, with the possibility for bailout stenting, was noninferior to PCI with BMS for atherosclerotic de novo coronary artery lesions in patients at bleeding risk.
“In the current American College of Cardiology and American Heart Association guidelines, the use of drug-coated balloons is not recommended at all,” Rissanen, of the Heart Center at the North Karelia Central Hospital in Finland, and colleagues wrote. “In Europe and Asia, however, good results from large registry-based studies showing low target lesion revascularization rates and low risk for acute vessel occlusion have encouraged the use of drug-coated balloons for de novo lesions.”
DCB vs. BMS
For the DEBUT trial, 208 patients were assigned PCI with a balloon coated with paclitaxel and iopromide (SeQuent Please, B. Braun Medical) or PCI with a BMS.
The primary outcome was MACE, defined as CV mortality, nonfatal MI or ischemia-driven TLR at 9 months, Rissanen and colleagues wrote. Noninferiority was shown if the absolute risk difference was no more than 3%.
Rissanen and colleagues found that, at 9 months, MACE occurred in a higher percentage of patients in the BMS group compared with the DCB group (14% vs. 1%; absolute risk difference, – 13.2 percentage points; 95% CI, –6.2 to –21.1; RR = 0.07; 95% CI, 0.01-0.52; P for noninferiority < .00001).
According to the researchers, two definitive stent thrombosis events occurred in the BMS group compared with none in the DCB group.
“The drug-coated balloon-only strategy is a novel approach to treat these patients,” the researchers wrote. “In the future, a randomized controlled trial is need to compare the drug-coated balloon strategy with percutaneous coronary intervention using newer-generation drug-eluting stents for de novo lesions in patients with high bleeding risk.”
‘An important contribution’
In a related editorial, Bruno Scheller, MD, a professor of clinical and experimental interventional cardiology at the University of Saarland in Germany, wrote: “Despite the limitations of the DEBUT trial, such as using bare-metal stents as a control group and the medium sample size, it is an important contribution to the clinical evidence of drug-coated balloon therapy. Analogous to trials in small coronary arteries, a risk population was selected and the safety and effectiveness of the concept of ‘leaving nothing behind’ with drug-coated balloon therapy — unlike metallic stents when a permanent implant remains in the body — have been confirmed in the DEBUT trial.” – by Earl Holland Jr.
Disclosures: The study was funded in part by AstraZeneca and B. Braun Medical. Rissanen reported he received travel grants and lecture honoraria from B. Braun Medical. Scheller reports he was named a co-inventor on submitted patent applications and has received travel support from B. Braun Medical. Please see the study for all other authors’ relevant financial disclosures.
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