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Agent ISR: Coronary DCBs similar for treatment of in-stent restenosis
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A novel coronary drug-coated balloon using a reduced dose of paclitaxel was noninferior at 1 year to a commercially available one for treatment of patients with in-stent restenosis, according to findings presented at EuroPCR.
Holger Nef, MD, from the department of cardiology and angiology at University of Giessen, Medizinische Klinik I, Germany, and colleagues randomly assigned 125 patients with in-stent restenosis of a lesion previously treated with a drug-eluting stent or bare-metal stent to the novel DCB (Agent, Boston Scientific; mean age, 68 years; 22% women) or the commercially available DCB (Sequent Please, B. Braun; mean age, 69 years; 15% women).
Nef said during his presentation that the Agent ISR trial was the first to compare head-to-head two coronary DCBs with different drug formulations: the novel DCB uses an excipient coating of acetyl tri-butyl citrate and elutes 2 µg/mm2 of paclitaxel, whereas the established DCB uses an excipient coating of iopromide and elutes 3 µg/mm2 of paclitaxel. In-stent restenosis affects approximately 10% of patients who have undergone coronary stenting globally, he said.
The primary endpoint of in-stent late loss at 6 months was met (novel DCB, 0.397 mm; established DCB, 0.393 mm; difference, 0.004; 95% CI, –0.189 to 0.196; noninferiority margin, 2; P for noninferiority = .046), Nef said.
At 1 year, there were no differences between the groups in target lesion failure (P = .88), death/MI/stent thrombosis (P > .99), death/MI (P > .99), death (P > .99), MI (P > .99), target vessel revascularization (P = .44), target lesion revascularization (P = .41) and stent thrombosis (P = .22), according to the researchers.
Eight quality-of-life parameters were similar between the groups at 1 year, Nef said.
“In this first head-to-head comparison of two DCBs with different drug formulations, the Agent DCB, with a lower drug concentration, proved noninferior to the Sequent Please DCB for in-stent late loss at 6 months,” Nef said during the presentation. “There were numeric increases in revascularization and stent thrombosis [associated with Sequent Please], but this did not reach significance. Longer-term follow-up is currently under evaluation.” – by Erik Swain
Reference:
Nef H, et al. Coronary outcomes with DEB. Presented at: EuroPCR; May 22-25, 2018; Paris.
Disclosure: The study was funded by Boston Scientific. Nef reports no relevant financial disclosures.