Key result
BVS increases target lesion failure ~32% compared with metallic everolimus-eluting stents.
Why the study?
Recent evidence suggested that bioresorbable vascular scaffolds are associated with excess thrombotic complications compared with metallic everolimus-eluting stents, necessitating comparative effectiveness evaluation at longest available follow-up.
Does everolimus-eluting bioresorbable scaffolds reduce target lesion failure and stent thrombosis compared to everolimus-eluting metallic stents in patients undergoing percutaneous coronary intervention?
Meta-Analysis (n=5,583)
Does everolimus-eluting bioresorbable scaffolds reduce target lesion failure and stent thrombosis compared to everolimus-eluting metallic stents in patients undergoing percutaneous coronary intervention?
Relative Risk: 1.32 (95% CI 1.1–1.59)
Absolute Event Rate: 9.6% vs 7.2%
p-value: p=0.003
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“It's another signal confirming that there are reasonable concerns about bioresorbable vascular scaffolds. We're seeing [adverse events] in multiple databases fairly consistently. This is coming in at the end after it's already being pulled off the market, so the clinical implications are somewhat limited at this point. Nevertheless, it really highlights the need for surveillance of new devices.”
“We've since learned that the techniques that we used to implant the device were suboptimal”
In patients undergoing PCI, bioresorbable vascular scaffolds are associated with lower efficacy and higher thrombotic risk compared to metallic everolimus-eluting stents at 2-year follow-up.
BACKGROUND: Recent evidence suggests that bioresorbable vascular scaffolds (BVS) are associated with an excess of thrombotic complications compared with metallic everolimus-eluting stents (EES). OBJECTIVES: This study sought to investigate the comparative effectiveness of the Food and Drug Administration-approved BVS versus metallic EES in patients undergoing percutaneous coronary intervention at longest available follow-up. METHODS: The authors searched MEDLINE, Scopus, and web sources for randomized trials comparing BVS and EES. The primary efficacy and safety endpoints were target lesion failure and definite or probable stent thrombosis, respectively. RESULTS: Seven trials were included: in sum, 5,583 patients were randomized to receive either the study BVS (n = 3,261) or the EES (n = 2,322). Median time of follow-up was 2 years (range 2 to 3 years). Compared with metallic EES, risk of target lesion failure (9.6% vs. 7.2%; absolute risk difference: +2.4%; risk ratio: 1.32; 95% confidence interval: 1.10 to 1.59; number needed to harm: 41; p = 0.003; I CONCLUSIONS: Compared with metallic EES, the BVS appears to be associated with both lower efficacy and higher thrombotic risk over time. (Bioresorbable vascular scaffold compare to everolimus stents in long term follow up; CRD42017059993).
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Sorrentino et al. (2017) conducted a meta-analysis in percutaneous coronary intervention (n=5,583). Bioresorbable vascular scaffolds (BVS) vs. Metallic everolimus-eluting stents (EES) was evaluated on Target lesion failure (RR 1.32, 95% CI 1.10 to 1.59, p=0.003). Bioresorbable vascular scaffolds increased the risk of target lesion failure compared with metallic everolimus-eluting stents (9.6% vs. 7.2%; RR 1.32; 95% CI 1.10-1.59; P=0.003).
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