Five-year first-in-human clinical outcomes of the PLA-coated biodegradable iron stent (IMAGE)
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Comprehensive validation of the PLA-coated metal–polymer composite stent from preclinical to clinical translation. Top: Preclinical results in Bama mini-pigs — representative H&E stained image of a stented artery 1 year post-implantation (left) and statistical distribution of diameter stenosis rate (n = 20) with all values below the 50% clinical criterion (right). Bottom: Clinical results from 45 first-in-human (FIH) cases at 5-year follow-up — coronary angiography images of a male patient’s LCx artery show stenosis reduced from 90% pre-treatment to 12% at 2 years; OCT images confirm good strut apposition and progressive degradation (almost complete at 2 years); core statistical outcomes — 0 cardiac deaths, 0 target vessel myocardial infarctions, 5 clinically indicated target lesion revascularizations, 11.1% target lesion failure (TLF) rate, and 0% stent thrombosis — compare favorably with Absorb BVS (17.5% TLF, 2.5% thrombosis) and Xience (14.5% TLF, 0.8% thrombosis).
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