Abstract
Early-generation drug-eluting stents (DES) have been demonstrated to delay vascular healing. Limited optical coherence tomography (OCT) data on the very long-term neointimal response after DES implantation are available. The aim of this study was a serial OCT assessment of neointimal thickness, stent strut coverage, malapposition, and protrusion as markers of neointimal response at 3 and 9 years after implantation of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). In this single-centre, longitudinal study consecutive patients undergoing elective PCI with SES or PES were included. OCT analysis was performed after 3 and 9 years by the independent core laboratory. A total of 22 subjects (8 SES and 14 PES) underwent an OCT assessment at 3 and 9 years post index procedure. The lumen, neointimal and malapposition area and the neointimal thickness (SES ∆50 µm, p = 0.195, PES ∆10 µm, p = 0.951) did not change significantly over the 6 year follow-up. No differences in the incidence of uncovered, malapposed or protruding struts were found in each type of stent. At 3 and 9 years after PCI, implantation of early-generation SES and PES may be associated with similar neointimal thickness, strut coverage, malapposition and protrusion, as assessed by serial OCT examination among patients with uneventful follow-up at 3 years post procedure. The small size of the study warrants judicious interpretation of our results and confirmation in larger multimodality imaging studies, including patients treated with contemporary stent platforms.
Highlights
Late adverse events such as stent thrombosis and in-stent restenosis have been recognized as major concerns after early-generation drug-eluting stents (DES) implantation [1,2,3,4,5,6]
Over the 6-year observation four patients died, six refused to participate in optical coherence tomography (OCT) follow-up and a contact was lost for five individuals
The principal findings of this vascular healing response analysis performed among stable CAD patients treated with PCI with early-generation SES or paclitaxel-eluting stents (PES) that were event-free at 3 years post index procedure, could be summarized as follows: (1) at 3 and 9 years a similar neointimal thickness was observed, potentially suggesting lack of the ‘very late catch-up’ phenomenon after either SES or PES implantation; (2) the lumen, neointimal and malapposition areas remained stable over the 6-year follow up both in SES and PES patients; (3) a low, though still persistent, rates of strut malapposition, protrusion and uncoverage were observed at 3 and 9 years in both groups; (4) some stents presented a clustering of uncovered struts at 3 and 9 years
Summary
Late adverse events such as stent thrombosis and in-stent restenosis have been recognized as major concerns after early-generation drug-eluting stents (DES) implantation [1,2,3,4,5,6]. Autopsy studies of early generation DES demonstrated features of continuous neointimal growth at the extended follow-up, referred to as late catch-up phenomenon [2, 7, 12, 13], prompting the need for long-term evaluation of vessel healing response to this polymer-coated metallic devices. The longest systematic follow-ups in autopsy studies evaluating neointimal growth after DES implantation reached up to maximally 6 years after PCI [2, 13]
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