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Randomized Trial to Compare BVS with EES in Patients with CAD
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Abbott has initiated the randomized, controlled, multicenter ABSORB II trial to test the safety and efficacy of its bioresorbable vascular scaffold against its everolimus-eluting stent in patients with CAD.
The trial will enroll approximately 500 patients from 40 investigational sites in Europe and New Zealand and will randomly assign patients 2:1 to either a fully dissolvable bioresorbable vascular scaffold (BVS; Absorb) or an everolimus-eluting stent (EES; Xience Prime).
The study’s primary endpoints will be change in dimension of lumen over time and vasomotion at the treated vessel segment. Additionally, death, MI, target lesion revascularization and scaffold/stent thrombosis will be assessed at 30 and 180 days, and at 1, 2 and 3 years post-treatment, while quality of life will be determined before treatment, at 180 days, and at 1, 2, and 3 years post-treatment.
The BVS received CE mark approval for the treatment of CAD in January 2011 and is currently investigational in the United States.