Can an ultrathin strut stent design and a polymer free, proendothelializing probucol matrix coating improve early strut healing? The FRIENDLY-OCT trial. An intra-patient randomized study with OCT, evaluating early strut coverage of a novel probucol coated polymer-free and ultra-thin strut sirolimus-eluting stent compared to a biodegradable polymer sirolimus-eluting stent

Abstract

Backgroundincomplete strut coverage determines the risk of stent thrombosis in the first months after stent implantation. AimsTo evaluate the potential better early healing of a novel probucol coated polymer free ultra-thin strut sirolimus eluting stent (PF-SES). [Clinical trial unique identifier: NCT02785237]. MethodsPatients with two (angiographically similar) lesions with clinical indication for PCI were enrolled. The investigated stent was compared to a thin strut, bioresorbable polymer, sirolimus eluting stent (BP-SES). Every patient received both stents, one in each lesion, assigned in a randomized sequence. OCT was systematically performed at 3 months.Primary end point was the difference in the proportion of covered struts at 3 months (defined as ≥20 μm of tissue coverage). Secondary end points included differences in percentage of uncovered struts (0 μm coverage), mean strut coverage thickness, and malapposed struts' coverage proportion. Major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization, and definite or probable stent thrombosis) at 12 months were also evaluated. Results70 patients were included. At 3 months, a consistent and significantly higher strut coverage rate (≥20 μm) was observed in PF-SES as compared to BP-SES, both for well apposed (87.3% versus 79.1%, p < 0.001) and malapposed struts (50.4% vs 37.8%, p 0.00). Uncoverage rate (0 μm) was also significantly lower for the PF-SES (3.1% vs 5.3%, p < 0.001). There were no differences in clinical endpoints. ConclusionThe probucol coated non-polymeric ultra-thin strut sirolimus eluting stent showed a significantly better early strut coverage at 3 months.