Serial Assessment by Optical Coherence Tomography of Early and Late Vascular Responses After Implantation of an Absorbable-Coating Sirolimus-Eluting Stent (from the First-in-Human DESSOLVE I Trial)

The initial enthusiasm caused by the potent antirestenotic effect of early generation drug-eluting stents was recently plagued by concerns regarding their safety profile. Investigators worldwide were stimulated, therefore, to seek for improvement in drug-eluting stent technology, such as eliminating their permanent polymer blamed for vascular inflammation and delayed healing. Optical coherence tomography (OCT) assessments of stent-vessel interactions are used as a surrogate for vessel healing after DES implantation. Herewith, we report serial OCT assessments of vascular reactions to the implantation of a novel absorbable polymer sirolimus-eluting stent (MiStent). In total, 30 patients were included. At 4-, 6-, and 8-month follow-up, different groups of 10 patients underwent OCT imaging, whereas all the patients had OCT assessments scheduled at 18-month follow-up. A total of 13,569 stent struts were analyzed. Low rates of uncovered (14.34 ± 15.35%, 6.62 ± 10.93%, 3.51 ± 2.87%, and 0.84 ± 1.15%, respectively, p 2 , respectively, p 2 , p = NS vs 8-month follow-up). Early tissue maturation and reduction of low signal intensity tissue covering stent struts (8.8%, 3.1%, 0.3%, and 0%, respectively, p