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WASHINGTON -- In-stent restenosis from a drug-eluting stent (DES-ISR) was best treated with another drug-eluting stent rather than a drug-eluting balloon, researchers reported here.
Results from RIBS IV, a multicenter prospective randomized trial comparing the efficacy of a paclitaxel-eluting balloon with that of an everolimus-eluting stent for treating in-stent restenosis, were reported by, of the Hospital Universitario de La Princesa in Madrid in a late-breaking clinical session at the Transcatheter Cardiovascular Therapeutics meeting.
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
The findings may be the be the final gasp for drug-eluting balloon technology.
The study recruited 309 patients with DES-ISR and evenly randomized them to the drug-eluting balloon or the drug-eluting stent. The primary endpoint was minimal lumen diameter (MLD) at 9 months follow-up. Secondary endpoints, assessed at 9 months, included diameter stenosis, angiographic late lumen loss, and binary restenosis.
Late angiographic follow-up was obtained in 90% of eligible patients. According to the results:
- MLD was larger in DES arm (2.03 versus 1.80 P=0.004) at 9 month follow-up
- At 12 months the DES-treated patients were also more likely to be free from target lesion revascularization (96% versus 87% in the balloon group, P=0.008).
- At one year the MACE rate (cardiac death, myocardial infarction, and target vessel revascularization) was lower in the DES group (10% versus 18% P=0.044).
Alfonso noted that treating in-stent restenosis in a DES is much more challenging that treating in-stent restenosis in a bare-metal stent, but the best option was clearly another drug-eluting stent.
, director of the catheterization laboratory at the Northeast Georgia Heart Center in Gainesville, and a former president of the Society for Cardiovascular Angiography and Interventions, likened drug-eluting balloon technology to a sinking ship. "It may not be on the bottom, but it is headed down," he told ڴŮ.
director of the Heart & Vascular Division at Scottsdale Healthcare in Arizona, agreed that the drug-eluting balloon did not appear to be a good choice, but he said there was a clinical scenario in which it should be considered.
"If a patient is a candidate for surgery, the surgeon isn't going to want to operate when there is in-stent restenosis, but there is also the problem of extended dual antiplatelet therapy when a DES is used," Rizik said. "In that case, the balloon, which doesn't need dual antiplatelet therapy might be an option. But given the choice in nonsurgical patients, DES is preferred."
Rizik added that he was surprised by how well the balloon performed in the trial since previous studies of the technology had been more overwhelmingly negative.
Disclosures
RIBS IV trial was funded by unrestricted grants from B. Braun and Abbot Vascular.
Alfonso disclosed no relevant relationships with industry.
Primary Source
Transcatheter Cardiovascular Therapeutics
Source Reference: Alfonso F, et al "RIBS IV: A prospective, randomized trial of paclitaxel-eluting balloons versus everolimus-eluting Stents in patients with coronary in-stent restenosis of drug-eluting stents late-breaking clinical trials" TCT 2014.