Adverse Events Observed in BVS vs. EES
Bioresorbable vascular scaffolds (BVS) were associated with increased rates of composite device-oriented and patient-oriented adverse events at the two-year follow-up compared with everolimus-eluting stents (EES), according to a study published July 18 in The Lancet.
In this systematic review and meta-analysis, Ziad A. Ali, MD, et al., identified seven randomized trials in which 5,583 patients were randomly assigned to Absorb BVS (n = 3,216) or metallic EES (n = 2,332) and followed for two years. The primary efficacy outcome measure was the device-oriented composite endpoint – cardiac mortality, target vessel-related myocardial infarction or ischemia-driven target lesion revascularization – and the primary safety outcome measure was definite or probable device thrombosis.
Two-year relative risks of the device-oriented composite endpoint were significantly higher with BVS than with EES. These differences were driven by increased target vessel-related myocardial infarction and ischemia-driven target lesion revascularization with BVS. Two-year relative risks of the patient-oriented composite endpoint were also higher with BVS than with EES, driven by increased rates of myocardial infarction with BVS. Device thrombosis throughout two years occurred more commonly with BVS than with EES.
In an accompanying editorial comment, Raffaele Piccolo, MD, et al., write that these findings “provide evidence beyond any reasonable doubt that Absorb BVS is inferior to new-generation EES on both efficacy and safety throughout two years.”
They add that the findings suggest that scaffold thrombosis is the key factor to be targeted in future device iterations.
Keywords: Drug-Eluting Stents, Risk, Absorbable Implants, Follow-Up Studies, Myocardial Infarction, Coronary Vessels, Stents, Venous Thrombosis, Outcome Assessment (Health Care)
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