What have we learned from meta-analysis of 1-year outcomes with the ABSORB bioresorbable scaffold in patients with coronary artery disease?
The Absorb BVSs (Abbott Vascular, Santa Clara, CA; hereafter referred to as BVSs) is a 150 µm thick bioresorbable poly(l-lactide) scaffold with a conformal bioresorbable poly(d, l-lactide) coating (total thickness 7 µm) that elutes everolimus. Randomized trials comparing this device to the XIENCE cobalt-chromium everolimus-eluting stent (CoCr-EESs; Abbott Vascular) were done to support regulatory approval in Europe, Asia, and the United States, and have only recently been reported. These studies were designed to show the noninferiority of the BVSs compared with the CoCr-EESs for 1-year clinical and angiographic outcomes, since improved results with the BVSs compared with drug-eluting stents are not expected to become evident until 3-5 years after implantation. However, none of these trials were powered to exclude small differences in composite adverse event rates between devices, or to detect differences in rarely occurring safety endpoints, and their outcomes according to specific patient and lesion characteristics. Currently, several meta-analyses have been published [1-7]. In this chapter, we present the summary of what we have learned from these meta-analyses.
|Persistent URL||dx.doi.org/10.1201/9781315380629, hdl.handle.net/1765/111573|
Sotomi, Y, Collet, C, Kimura, T, Gao, R, Kereiakes, D.J, Stone, G.W, … Serruys, P.W.J.C. (2017). What have we learned from meta-analysis of 1-year outcomes with the ABSORB bioresorbable scaffold in patients with coronary artery disease?. In Bioresorbable Scaffolds: From Basic Concept to Clinical Applications (pp. 254–262). doi:10.1201/9781315380629