Abstract
Bioresorbable polymers and biocorrodible metals are the latest developments in biodegradable materials used in interventional cardiology for the mechanical treatment of coronary atherosclerosis. Poly-L-lactic acid is the most frequently used bioresorbable polymer and initial evidence of feasibility, efficacy and clinical safety following deployment of polymer-based platforms was gained after completion of the first-in-man longitudinal ABSORB registries, Cohorts A and B and ABSORB Extend.In these studies, the biologic interaction of the first-generation Absorb Bioresorbable Vascular Scaffold (BVS) (Abbott Vascular, SC, Calif., US) with the underlying vascular tissue was evaluated in vivo with multiple imaging modalities such as intravascular ultrasound (IVUS), virtual histology-IVUS, IVUS-palpography, optical coherence tomography as well as ex vivo with coronary computed tomography. Efficacy measures following this in vivo multi-imaging assessment as well as clinical safety were comparable with current generation drug-eluting stents (DES) (Abbott Vascular, SC, Calif., US) in non-complex lesions over a 3-year follow-up. Furthermore, novel properties of functional and anatomic restoration of the vessel wall during the late phases of resorption and vascular healing were observed transforming the field of mechanical treatment of atherosclerosis from delivering only acute revascularization to additionally enable late repair and subsequent restoration of a more physiologic underlying vascular tissue.Despite the sufficient evidence and the subsequent Conformité Européenne mark approval of the first fully biodegradable scaffold (Absorb BVS) in 2012 for revascularizing non-complex lesions, the paucity of randomized comparisons of fully bioresorbable scaffolds (BRS) with metallic DES in a “real-world” clinical setting raised controversies among the interventional community for the merit of these technologies. Only recently, results from international large-scale randomized trials from the United States (U.S.), China and Japan were revealed.Herein we provide a comprehensive overview of the ABSORB III, ABSORB China and ABSORB Japan studies demonstrating the consistent non-inferiority in clinical safety and efficacy measures of the Absorb BVS vs. current generation DES.
Highlights
The development of novel drug-eluting stents (DES) with more efficacious platforms have minimized risks of clinical restenosis and stent thrombosis to below 4.0% and < 0.5% respectively, remaining the standard of care in interventional cardiology.[1]
target-lesion failure (TLF) occurred in 7.8% vs. 6.1% in the Absorb Bioresorbable Vascular Scaffold (BVS) arm vs. the Xience arm (Figure 2)
It should be noted that the in-device late lumen loss (LLL) was significantly different among the Absorb BVS vs. the Xience V stent groups: 0.23 ^ 0.03 mm vs. 0.10 ^ 0.02 mm, (p 1⁄4 0.0001) respectively
Summary
The development of novel DES with more efficacious platforms have minimized risks of clinical restenosis and stent thrombosis to below 4.0% and < 0.5% respectively, remaining the standard of care in interventional cardiology.[1]. Polymer-based scaffolds and to a lesser extend scaffolds made of biocorrodible metals have limited expansion properties and over dilation entails the risk of strut fracture or discontinuity. It is imperative for operators who implant current generation drug-eluting BRS to perform aggressive lesion preparation by adequate predilatation with a near optimal size non-compliant balloon to high pressures. The only procedural characteristics different among the groups were the rates of post-dilatation which reached in the Absorb BVS vs. Xience treated vessels: 65.5% vs. 51.2%, (p , 0.001) respectively
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