In a head-to-head comparison, bioresorbable vascular scaffolds were not inferior to the best performing drug-eluting stents, according to research published online March 3.
The EVERBIO II (Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents II) trial compared the Absorb BVS (Abbott Vascular), the Promus Element stent (Boston Scientific) and the Biomatrix Flex stent (Biosensors Europe SA). EVERBIO II researchers enrolled 240 patients, randomized at the time of implantation. Patients were enrolled between 2012 and 2013. Follow-up was at nine months.
Previous studies found the standard, metallic everolimus- and biolimus-eluting stents were noninferior to one another. Therefore, Serban Puricel, MD, and colleagues from the department of cardiology at Fribourg University and Hospital in Fribourg, Switzerland, combined the two into one cohort, comparing the bioresorbable scaffold in a two-to-one fashion.
Puricel et al found that in follow-up angiography, in-stent late lumen loss was similar between the two groups. Clinical outcomes were likewise similar. Major adverse event rates at the patient level were around 27 percent for bioresorbable scaffolds and 26 percent for drug-eluting stents. Device-oriented major adverse event rates were 12 percent and 9 percent, respectively.
Their findings were similar to those in trials comparing bioresorbable scaffolds to single drug-eluting stents. However, an important aspect to the study was in the choice of follow-up period. According to prior reports, bioresorbable scaffolds begin to break down between six and 12 months. The intent, therefore, was to compare the best competitors to the weakest time point for the bioresorbable technology.
“Although we believe particular attention should be paid to patients receiving BVS (bioresorbable vascular scaffolding) during the intermediate phase and possibly up to two years, the accumulated evidence of improved angiographic parameters 18 to 24 months after BVS implantation suggests a low clinical impact of in-segment LLL (late lumen loss),” Puricel et al wrote. The bioresorbable stent is, according to their findings, safe in all-comers.
The research appeared in the Journal of the American College of Cardiology.
For more on bioresorbable scaffolds, read “Disappearing Act: From Coatings to Cage-free Coronaries.”