WASHINGTON, DC — The latest study comparing a drug-eluting balloon (DEB) and a drug-eluting stent (DES) in patients with DES in-stent restenosis (ISR)—this time using a second-generation DES as the comparator—has come up empty-handed.
Dr Fernando Alfonso (Hospital Universitario de La Princesa, Madrid, Spain) presented the results of the 309-patient RIBS IV trial in a TCT 2014 late-breaking clinical-trial session yesterday.
For both the primary end point of in-segment minimum lumen diameter at eight months and major adverse cardiac events (MACE) at 12 months, the Xience Prime stent (Abbott Vascular) was superior to a paclitaxel-coated balloon.
In-segment late loss was also significantly higher in the DEB group. MACE was more than double, driven by a threefold-higher increase in repeat target lesion revascularization (TLR) in the DEB-treated patients than in the DES group.
At one year, freedom from TLR was 96% in the DES group and 87% in the DEB group.
"Treatment of [DES] in-stent restenosis remains challenging and is associated with poorer clinical and angiographic results than treatment of [bare-metal-stent] ISR," Alfonso said. "Further studies, with more patients and longer follow-up, are still warranted in this adverse setting."
Commenting on the study during a morning press conference, Dr William Fearon (Stanford University, CA) admitted he was "impressed that the DEB didn't do worse, it did okay, but it does look like the DES does even better."
Likewise, Dr David Rizik (Scottsdale Healthcare Hospitals, AZ) called the results for the DEB "admirable" but stressed that, in settings where a patient with in-stent restenosis has no contraindications to receiving a new DES, that should be the treatment of choice.
No DEB holds FDA approval for use in the US for the treatment of in-stent restenosis, although several are in use in Europe. Where there might be a role for such an approach in the future, Rizik said, is in patients who have recurring ISR. He likened the "head room" in an artery that is being treated with successive layers of stents to a room that grows smaller each time another layer of wallpaper is added to the walls. "Eventually we're going to decrease the size of the room; that's true in the coronaries too."
He also pointed to situations where a patient who needs to undergo surgery is found in their preoperative work-up to have in-stent restenosis.
"Surgeons and anesthesiologists are very reluctant to operate on patients who have recurrent coronary disease, and so the performance of the DEB in this study, irrespective of p values, may provide practitioners with another option than just to put another stent in there, which requires longer dual antiplatelet therapy that surgeons may not want on board at the time that they cut," Rizik said.
Alfonso, too, stressed that, at least in the patients studied, a newer-generation DES is the therapy of choice. But he kept the door open to other patients in whom a DEB strategy remains attractive, such as patients with side-branch lesions or patients with multiple stents.
Heartwire from Medscape © 2014
Cite this: Drug-Eluting Balloon Falls Short of Stenting in DES In-Stent Restenosis - Medscape - Sep 15, 2014.