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RIBS VI: For in-stent restenosis, BVS safe but inferior to EES
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A bioresorbable vascular scaffold treated patients with in-stent restenosis safely, but was not as effective as an everolimus-eluting stent, according to results from the RIBS VI study.
However, the BVS (Absorb, Abbott Vascular) was noninferior in efficacy to drug-eluting balloons in this population, researchers reported.
In the investigator-initiated, prospective RIBS VI study, Fernando Alfonso, MD, from Hospital Universitario de La Princesa, Madrid, and colleagues analyzed 141 patients treated at 19 sites in Spain with the BVS for restenosis of a bare-metal stent or a drug-eluting stent. They compared safety and efficacy outcomes in this cohort with patients with in-stent restenosis treated with EES (n = 249) or drug-eluting balloons (n = 249) in the RIBS IV and RIBS V studies.
All patients in the RIBS VI cohort underwent late angiography at 6 to 9 months.
At time of late angiography (n = 134), the primary endpoint of in-segment minimal lumen diameter was 1.87 mm, late lumen loss was 0.23 mm and the rate of restenosis was 11%, according to the researchers.
Among those in the RIBS VI cohort, at 1 year, no patients died, 2.8% had MI, 11.3% needed target lesion revascularization and 0.7% of patients had definite stent thrombosis after discontinuing antiplatelet therapy. The rate of freedom from cardiac death, MI and TLR was 86%.
In-segment minimal lumen diameter among those treated with BVS was similar to those treated with drug-eluting balloon (1.88 mm), but smaller than those treated with EES (2.16 mm; P < .001), Alfonso and colleagues wrote.
Rates of TLR at 1 year were similar between the BVS group and the drug-eluting balloon group (10.4%), but those treated with EES had a lower rate (3.2%; P vs. BVS < .001), according to the researchers.
In a related editorial, Frederick G.P. Welt, MS, MD, FACC, FSCAI, from the division of cardiovascular medicine at University of Utah Health, wrote that the struts of the BVS are thicker than those of contemporary EES, so the results for BVS in in-stent restenosis may improve in later iterations of the technology.
“At first glance, it does not appear that treatment of in-stent restenosis is a natural niche for use of BVS given similar outcomes with [drug-eluting balloons],” he wrote. “Yet, [drug-eluting balloons] are not currently FDA-approved for coronary use in the United States, so in the interim, BVS may be an attractive choice. Until longer-term data are available, it will remain unclear in what patients BVS may offer a demonstrable advantage.” – by Erik Swain
Disclosure: The authors report no relevant financial disclosures. Welt reports that he serves on an advisory board for Medtronic.
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