Abstract
The impetus for developing drug-eluting bioresorbable scaffolds (BRS) has been driven by the need for elastic and transient platforms instead of stiff and permanent metallic implants in diseased coronary anatomies. This endeavor would prevent acute recoil or occlusion, allow sealing of post-procedural dissections following acute barotrauma, provide inhibition of in-segment restenosis through efficient drug-elution and would further prepare the vessel to enter a reparative phase following scaffold resorption. Biocorrodible metallic platforms have been introduced as alternatives to bioresorbable polymeric scaffolds for the treatment of significant atherosclerosis and in view of the body of evidence derived from recent clinical trials we elaborate on the clinical safety and efficacy of these devices in interventional cardiology.
Highlights
Similar to their bioresorbable scaffold (BRS) counterpart, biocorrodible metallic platforms provide a novel class device for treating coronary atherosclerosis with properties of improved tensile strength and more rapid biodegradation
We provide a comprehensive overview of the first-in-man PROGRESS-AMS study as well as the BIOSOLVE-I and BIOSOLVE-II trials indicating the clinical safety and efficacy of deployed biocorrodible metallic scaffolds for the treatment of non-complex coronary artery disease
There were no events of cardiac death, myocardial infraction, or stent thrombosis
Summary
Similar to their bioresorbable scaffold (BRS) counterpart, biocorrodible metallic platforms provide a novel class device for treating coronary atherosclerosis with properties of improved tensile strength and more rapid biodegradation. Preliminary observations from prospective, non-randomized clinical trials assessing the efficacy and clinical safety of deployed biocorrodible metallic stents in selected lesions and clinical subsets have been promising. We provide a comprehensive overview of the first-in-man PROGRESS-AMS study as well as the BIOSOLVE-I and BIOSOLVE-II trials indicating the clinical safety and efficacy of deployed biocorrodible metallic scaffolds for the treatment of non-complex coronary artery disease. PROGRESS-AMS Study design The PROGRESS-AMS clinical trial was a non-randomized, prospective, multi-center trial that was designed to assess the efficacy and clinical safety of the absorbable magnesium stent. (AMS-1) (BIOTRONIK, Berlin, Germany). AMS-1 was made of 93% Mg and 7% rare earth metals, had a strut thickness of 165 mm and carried two radiopaque markers at each proximal and distal ends as the device was radiolucent
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