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Metallic EES appear safer, more effective than first-generation BVS
Bioresorbable vascular scaffolds were linked to lower efficacy and higher thrombotic risk vs. everolimus-eluting bioresorbable scaffolds at 2-year follow-up, according to data published in the Journal of the American College of Cardiology.
“Prior studies and meta-analyses investigating the risk of BVS thrombosis were limited by the inclusion of a shorter time of follow-up or nonrandomized studies,” Sabato Sorrentino, MD, from the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and the division of cardiology and department of medical and surgery sciences at Magna Graecia University in Catanzaro, Italy, and colleagues wrote. “By including the latest evidence from [randomized controlled trials] using the longest follow-up available, we were able to more accurately characterize the risk of BVS thrombosis over time, particularly in the very late period.”
Researchers evaluated 5,583 patients who underwent PCI. The patients were randomly assigned to PCI with either the BVS (n = 3,261; Absorb, Abbott Vascular) or metallic EES (n = 2,322; Xience, Abbott Vascular; Promus Element, Boston Scientific) and had a median follow-up of 2 years.
BVS not favored
The risks for target lesion failure (9.6% vs. 7.2%; RR = 1.32; 95% CI, 1.1-1.59; number needed to harm = 41) and stent thrombosis (2.4% vs. 0.7%; RR = 3.15; 95% CI, 1.87-5.3; number needed to harm = 60) were significantly higher with BVS vs. metallic EES, according to the researchers.
The two groups showed no significant difference in all-cause and CV mortality.
The elevated stent thrombosis risk conferred by BVS was consistent over time (P for interaction = .49), Sorrentino and colleagues wrote.
“The clinical benefits of BVS may extend beyond the standard clinical endpoints implemented in coronary stent trials and remain to be explored and documented in further and longer-term clinical investigations,” the researchers wrote.
Size matters
In an editorial comment, Sripal Bangalore, MD, MHA, from the division of cardiology at New York University School of medicine and a Cardiology Today Editorial Board Member, and colleagues wrote that “now is the time to double down on investigation of what was appreciated relatively late in the [drug-eluting stent] era: that stent dimensions, rather than material characteristics, were dominant determinants of adverse effects.” They noted the first-generation BVS has a similar thickness to the first DES, “and it is therefore not surprising that the device, in general, would be more thrombogenic than a comparator thin-strut DES.”
The meta-analysis “further elevates the safety concerns with the first-generation BVS, and perhaps should kindle renewed research into revision of design and procedure,” they wrote. “Perhaps this meta-analysis is also a call to end the first phase of analysis and proceed to the second.” – by Dave Quaile
Disclosures: Sorrentino reports no relevant financial disclosures. Please see the full study for the other researchers’ relevant financial disclosures. Bangalore reports serving on an advisory board for Abbott Vascular, Daiichi Sankyo, Pfizer and The Medicines Company; receiving research grants from Abbott Vascular and NHLBI; and receiving honoraria from Abbott Vascular, AstraZeneca, Boehringer Ingelheim, Daiichi-Sankyo, Merck and Pfizer. Please see the editorial for a list of the other authors’ relevant financial disclosures.