Author(s): Ellis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG, , Ellis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG,
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Abstract BACKGROUND: In patients with coronary artery disease who receive metallic drug-eluting coronary stents, adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall. Bioresorbable vascular scaffolds have been developed to attempt to improve long-term outcomes. METHODS: In this large, multicenter, randomized trial, 2008 patients with stable or unstable angina were randomly assigned in a 2:1 ratio to receive an everolimus-eluting bioresorbable vascular (Absorb) scaffold (1322 patients) or an everolimus-eluting cobalt-chromium (Xience) stent (686 patients). The primary end point, which was tested for both noninferiority (margin, 4.5 percentage points for the risk difference) and superiority, was target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) at 1 year. RESULTS: Target-lesion failure at 1 year occurred in 7.8\% of patients in the Absorb group and in 6.1\% of patients in the Xience group (difference, 1.7 percentage points; 95\% confidence interval, -0.5 to 3.9; P=0.007 for noninferiority and P=0.16 for superiority). There was no significant difference between the Absorb group and the Xience group in rates of cardiac death (0.6\% and 0.1\%, respectively; P=0.29), target-vessel myocardial infarction (6.0\% and 4.6\%, respectively; P=0.18), or ischemia-driven target-lesion revascularization (3.0\% and 2.5\%, respectively; P=0.50). Device thrombosis within 1 year occurred in 1.5\% of patients in the Absorb group and in 0.7\% of patients in the Xience group (P=0.13). CONCLUSIONS: In this large-scale, randomized trial, treatment of noncomplex obstructive coronary artery disease with an everolimus-eluting bioresorbable vascular scaffold, as compared with an everolimus-eluting cobalt-chromium stent, was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year. (Funded by Abbott Vascular; ABSORB III ClinicalTrials.gov number, NCT01751906.).
This article was published in N Engl J Med
and referenced in Journal of Psychiatry