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BVS implantation consistently confers device thrombosis risk
The implantation of a bioresorbable vascular scaffold was associated with increased risk for early, late and very late scaffold thrombosis compared with current-generation metallic drug-eluting stents, according to a meta-analysis published in EuroIntervention.
According to the study from Si-Hyuck Kang, MD, from the division of cardiology, department of internal medicine at the College of Medicine, Seoul National University and Cardiovascular Center and Seoul National University Bundang Hospital in Seongnam, South Korea, and colleagues, the risk for scaffold thrombosis continued to increase beyond 1 year after implantation of the BVS (Absorb, Abbott Vascular).
To further understand the long-term safety and efficacy of biodegradable scaffolds and metallic stents, Kang and colleagues conducted an analysis of 105,842 patients from 91 randomized controlled trials comparing two or more coronary metallic stents or biodegradable scaffolds and reported the long-term clinical outcomes (mean follow-up, 3.7 years).
Through meta-analysis, the researchers found that patients who were implanted with the BVS had a significantly higher risk for definite or probable scaffold thrombosis compared with patients treated with metallic DES.
The risk for very late scaffold thrombosis was highest with the BVS among comparators.
Pairwise conventional meta-analysis demonstrated that the elevated risk for scaffold thrombosis with BVS compared with cobalt-chromium everolimus-eluting stents was consistent across the time points of early ( 30 days; fixed-effects OR = 2.01; 95% CI, 1.05-3.85), late (31 days to 1 year; fixed-effects OR = 3.87; 95% CI, 1.15-13; random-effects OR = 3.13; 95% CI, 0.93-11.8) and very late (> 1 year; fixed-effects OR = 5.09; 95% CI, 1.94-13.3; random-effects OR = 4.5; 95% CI, 1.67-12.1) scaffold thrombosis.
The rates of target lesion failure were significantly increased among patients implanted with the BVS, driven by both increased risk for target-vessel MI and ischemia-driven target lesion revascularization, according to the researchers.
“While previous studies have shown the Absorb BVS to be associated with an increased risk of late [scaffold thrombosis] compared to contemporary DES, this study suggests that the risk is not attenuated and rather continues to widen beyond 1 year,” Kang and colleagues wrote. by Dave Quaile
Disclosures: The authors report no relevant financial disclosures.