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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)

Published:September 03, 2013DOI:https://doi.org/10.1016/j.amjcard.2013.07.013
      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 <0.05 for 8- vs 18-month follow-up) and malapposed (3.74 ± 7.35%, 3.15 ± 6.13%, 0.48 ± 0.56%, and 0.09 ± 0.28%, respectively, p = NS) stent struts coupled with thin and increasingly homogenous neointimal proliferation were demonstrated. Neointimal area increased from 4- to 8-month follow-up (0.46 ± 0.29 and 1.12 ± 0.73 mm2, respectively, p <0.05), whereas no “late catch up” was demonstrated at 18-month follow-up (1.28 ± 0.66 mm2, 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 <0.05 for 4- vs 8-month follow-up comparison) were revealed by optical density analysis. In addition, high rates of strut coverage overlying the ostia of side branches without proliferative pattern were demonstrated. In conclusion, this comprehensive OCT analysis depicted favorable absorbable polymer sirolimus-eluting stent–vessel interactions up to 18-month follow-up.
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      References

        • Joner M.
        • Finn A.V.
        • Farb A.
        • Mont E.K.
        • Kolodgie F.D.
        • Ladich E.
        • Kutys R.
        • Skorija K.
        • Gold H.K.
        • Virmani R.
        Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk.
        J Am Coll Cardiol. 2006; 48: 193-202
        • Finn A.V.
        • Nakazawa G.
        • Joner M.
        • Kolodgie F.D.
        • Mont E.K.
        • Gold H.K.
        • Virmani R.
        Vascular responses to drug eluting stents: importance of delayed healing.
        Arterioscler Thromb Vasc Biol. 2007; 27: 1500-1510
        • Guagliumi G.
        • Sirbu V.
        • Musumeci G.
        • Bezerra H.G.
        • Aprile A.
        • Kyono H.
        • Fiocca L.
        • Matiashvili A.
        • Lortkipanidze N.
        • Vassileva A.
        • Popma J.J.
        • Allocco D.J.
        • Dawkins K.D.
        • Valsecchi O.
        • Costa M.A.
        Strut coverage vessel wall response to a new-generation paclitaxel-eluting stent with an ultrathin biodegradable abluminal polymer optical coherence tomography drug-eluting stent investigation (OCTDESI).
        Circ Cardiovasc Interv. 2010; 3: 367-375
        • Barlis P.
        • Regar E.
        • Serruys P.
        • Dimopoulos K.
        • van der Giessen W.J.
        • van Geuns R.J.
        • Ferrante G.
        • Wandel S.
        • Windecker S.
        • van Es G.A.
        • Eerdmans P.
        • Jüni P.
        • di Mario C.
        An optical coherence tomography study of a biodegradable vs. durable polymer coated limus-eluting stent: a LEADERS trial sub study.
        Eur Heart J. 2010; 31: 165-176
        • Attizzani G.F.
        • Bezerra H.G.
        • Chamié D.
        • Fujino Y.
        • Spognardi A.M.
        • Stanley J.R.
        • Yamamoto H.
        • Mehanna E.
        • Wang W.
        • Carlyle W.C.
        • McClain J.B.
        • Costa M.A.
        Serial valuation of vascular response after implantation of a new sirolimus-eluting stent with bioabsorbable polymer (MiStent™): an optical coherence tomography and histopathological study.
        J Invasive Cardiol. 2012; 24: 560-568
        • Ormiston J.
        • Webster M.
        • Stewart J.
        • Vrolix M.
        • Whitbourn R.
        • Donohoe D.
        • Knape C.
        • Lansky A.
        • Attizzani G.F.
        • Fitzgerald P.
        • Kandzari D.
        • Wijns W.
        First-in-human evaluation of a bioabsorbable polymer-coated sirolimus-eluting stent—imaging and clinical results of the DESSOLVE I Trial.
        J Am Coll Cardiol Intv. 2013; (“In Press”)
        • Bezerra H.G.
        • Costa M.A.
        • Guagliumi G.
        • Rollins A.M.
        • Simon D.I.
        Intracoronary optical coherence tomography: a comprehensive review.
        J Am Coll Cardiol Intv. 2009; 2: 1035-1046
        • Kyono H.
        • Guagliumi G.
        • Sirbu V.
        • Rosenthal N.
        • Tahara S.
        • Musumeci G.
        • Trivisonno A.
        • Bezerra H.G.
        • Costa M.A.
        Optical coherence tomography strut-level analysis of drug-eluting stents in human coronary bifurcations.
        Eurointervention. 2010; 6: 69-77
        • Gonzalo N.
        • Garcia-Garcia H.M.
        • Serruys P.W.
        • Commissaris K.H.
        • Bezerra H.
        • Gobbens P.
        • Costa M.
        • Regar E.
        Reproducibility of quantitative optical coherence tomography for stent analysis.
        Eurointervention. 2009; 5: 224-232
        • Kume T.
        • Akasaka T.
        • Kawamoto T.
        • Ogasawara Y.
        • Watanabe N.
        • Toyota E.
        • Neishi Y.
        • Sukmawan R.
        • Sadahira Y.
        • Yoshida K.
        Assessment of coronary arterial thrombus by optical coherence tomography.
        Am J Cardiol. 2006; 97: 1713-1717
        • Kume T.
        • Okura H.
        • Kawamoto T.
        • Akasaka T.
        • Toyota E.
        • Watanabe N.
        • Neishi Y.
        • Sadahira Y.
        • Yoshida K.
        Images in cardiovascular medicine. Fibrin clot visualized by optical coherence tomography.
        Circulation. 2008; 118: 426-427
        • Kang S.J.
        • Mintz G.S.
        • Akasaka T.
        • Park D.W.
        • Lee J.Y.
        • Kim W.J.
        • Lee S.W.
        • Kim Y.H.
        • Whan Lee C.
        • Park S.W.
        • Park S.J.
        Optical coherence tomographic analysis of in-stent neoatherosclerosis after drug-eluting stent implantation.
        Circulation. 2011; 123: 2954-2963
        • Guagliumi G.
        • Bezerra H.G.
        • Sirbu V.
        • Ikejima H.
        • Musumeci G.
        • Biondi-Zoccai G.
        • Lortkipanidze N.
        • Fiocca L.
        • Capodanno D.
        • Wang W.
        • Tahara S.
        • Vassileva A.
        • Matiashvili A.
        • Valsecchi O.
        • Costa M.A.
        Serial assessment of coronary artery response to paclitaxel-eluting stents using optical coherence tomography.
        Circ Cardiovasc Interv. 2012; 5: 30-38
        • Suzuki N.
        • Guagliumi G.
        • Bezerra H.G.
        • Sirbu V.
        • Rosenthal N.
        • Musumeci G.
        • Aprile A.
        • Wang H.
        • Kyono H.
        • Tahara S.
        • Simon D.I.
        • Rollins A.
        • Costa M.A.
        The impact of an eccentric intravascular ImageWire during coronary optical coherence tomography imaging.
        Eurointervention. 2011; 6: 963-969
        • Templin C.
        • Meyer M.
        • Muller M.F.
        • Djonov V.
        • Hlushchuk R.
        • Dimova I.
        • Flueckiger S.
        • Kronen P.
        • Sidler M.
        • Klein K.
        • Nicholls F.
        • Ghadri J.R.
        • Weber K.
        • Paunovic D.
        • Corti R.
        • Hoerstrup S.P.
        • Lüscher T.F.
        • Landmesser U.
        Coronary optical frequency domain imaging (OFDI) for in vivo evaluation of stent healing: comparison with light and electron microscopy.
        Eur Heart J. 2010; 31: 1792-1801
        • Guagliumi G.
        • Musumeci G.
        • Sirbu V.
        • Bezerra H.G.
        • Suzuki N.
        • Fiocca L.
        • Matiashvili A.
        • Lortkipanidze N.
        • Trivisonno A.
        • Valsecchi O.
        • Biondi-Zoccai G.
        • Costa M.A.
        Optical coherence tomography assessment of in vivo vascular response after implantation of overlapping bare-metal and drug-eluting stents.
        J Am Coll Cardiol Intv. 2010; 3: 531-539
        • Guagliumi G.
        • Sirbu V.
        • Bezerra H.
        • Biondi-Zoccai G.
        • Fiocca L.
        • Musumeci G.
        • Matiashvili A.
        • Lortkipanidze N.
        • Tahara S.
        • Valsecchi O.
        • Costa M.
        Strut coverage and vessel wall response to zotarolimus-eluting and bare-metal stents implanted in patients with ST-segment elevation myocardial infarction.
        J Am Coll Cardiol Intv. 2010; 3: 680-687
        • Collet C.A.
        • Costa J.R.
        • Abizaid A.
        • Chamié D.
        • Staico R.
        • Costa R.
        • Siquera D.
        • Obregon J.
        • Feres F.
        • Sousa A.
        • Sousa J.E.
        Assessing the temporal course of neointimal hyperplasia formation after different generations of drug-eluting stents.
        J Am Coll Cardiol Intv. 2011; 4: 1067-1074
        • Takano M.
        • Yamamoto M.
        • Mizuno M.
        • Murakami D.
        • Inami T.
        • Kimata N.
        • Murai K.
        • Kobayashi N.
        • Okamatsu K.
        • Ohba T.
        • Seino Y.
        • Mizuno K.
        Late vascular responses from 2 to 4 years after implantation of sirolimus-eluting stents: serial observations by intracoronary optical coherence tomography.
        Circ Cardiovasc Interv. 2010; 3: 476-483
        • Park S.J.
        • Kang S.J.
        • Virmani R.
        • Nakano M.
        • Ueda Y.
        In-stent neoatherosclerosis. A final common pathway of late stent failure.
        J Am Coll Cardiol. 2012; 59: 2051-2057
        • Yonetsu T.
        • Kato K.
        • Kim S.J.
        • Xing L.
        • Jia H.
        • McNulty I.
        • Lee H.
        • Zhang S.
        • Uemura S.
        • Jang Y.
        • Kang S.J.
        • Park S.J.
        • Lee S.
        • Yu B.
        • Kakuta T.
        • Jang I.K.
        Predictors for neoatherosclerosis: a retrospective observational study from the optical coherence tomography registry.
        Circ Cardiovasc Imaging. 2012; 5: 660-666
        • Finn A.V.
        • Joner M.
        • Nakazawa G.
        • Kolodgie F.
        • Newell J.
        • John M.C.
        • Gold H.K.
        • Virmani R.
        Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization.
        Circulation. 2007; 115: 2435-2441
        • Hassan A.
        • Bergheanu S.
        • Stijnen T.
        • van der Hoeven B.L.
        • Snoep J.D.
        • Plevier J.W.
        • Schalij M.J.
        • WouterJukema J.
        Late stent malapposition risk is higher after drug-eluting stent compared with bare-metal stent implantation and associates with late stent thrombosis.
        Eur Heart J. 2010; 31: 1172-1180
        • Cook S.
        • Eshtehardi P.
        • Kalesan B.
        • Räber L.
        • Wenaweser P.
        • Togni M.
        • Moschovitis A.
        • Vogel R.
        • Seiler C.
        • Eberli F.R.
        • Lüscher T.
        • Meier B.
        • Jüni P.
        • Windecker S.
        Impact of incomplete stent apposition on long-term clinical outcome after drug-eluting stent implantation.
        Eur Heart J. 2012; 33: 1334-1343
        • Guagliumi G.
        • Sirbu V.
        • Musumeci G.
        • Gerber R.
        • Biondi-Zoccai G.
        • Ikejima H.
        • Ladich E.
        • Lortkipanidze N.
        • Matiashvili A.
        • Valsecchi O.
        • Virmani R.
        • Stone G.W.
        Examination of the in vivo mechanisms of late drug-eluting stent thrombosis findings from optical coherence tomography and intravascular ultrasound imaging.
        J Am Coll Cardiol Intv. 2012; 5: 12-20
        • Bezerra H.G.
        • Attizzani G.F.
        • Sirbu V.
        • Musumeci G.
        • Lortkipanidze N.
        • Fujino Y.
        • Wang W.
        • Nakamura S.
        • Erglis A.
        • Guagliumi G.
        • Costa M.A.
        Optical coherence tomography versus intravascular ultrasound to evaluate coronary artery disease and percutaneous coronary intervention.
        J Am Coll Cardiol Intv. 2013; 6: 228-236
        • Landmesser U.
        Optical coherence tomography (OCT) evaluation after coronary stenting: the “black hole” and other low OCT signal-intensity areas.
        Eurointervention. 2012; 7: 1367-1371
        • Nakano M.
        • Vorpahl M.
        • Otsuka F.
        • Taniwaki M.
        • Yazdani S.K.
        • Finn A.V.
        • Ladich E.R.
        • Kolodgie F.D.
        • Virmani R.
        Ex vivo assessment of vascular response to coronary stents by optical frequency domain imaging.
        J Am Coll Cardiol Img. 2012; 5: 71-82