title: Evaluation of Early Healing Profile and Neointimal Transformation Over 24 Months Using Longitudinal Sequential Optical Coherence Tomography Assessments and 3-Year Clinical Results of the New Dual-Therapy Endothelial Progenitor Cell Capturing Sirolimus-Eluting Combo Stent: The EGO-Combo Study.
abstract: Current monotherapy drug-eluting stents are associated with impaired healing, neoatherosclerosis, and late stent thrombosis. The healing profile and neointimal transformation of the first dual-therapy endothelial progenitor cell-capturing sirolimus-eluting stent are unknown.
  
  
  
  In this prospective, single-center study, 61 patients treated with the Combo stent had optical coherence tomography at baseline, early follow-up (4 monthly groups in a 1:2:2:1 ratio from 2 to 5 months), 9 months, and 24 months. Optical coherence tomography early strut coverage increased from 77.1% to 92.5% to 92.7% to 94.9% between 2 and 5 months. At 9 months, the major adverse cardiac event rate was 1.64%, and angiographic in-stent late loss was 0.24 mm (0.08-0.40). The 36-month major adverse cardiac event rate was 3.3%. From 9 to 24 months, neointimal regression was confirmed by optical coherence tomography: neointimal thickness (median [first quartile and third quartile]), 0.14 mm (0.08 and 0.21) versus 0.12 mm (0.07 and 0.19), P<0.001; neointimal volume, 29.9 mm(3) (22.1 and 43.2) versus 26.2 mm(3) (19.6 and 35.8), P=0.003; and percent neointimal volume, 17.8% (12.2 and 21.2) versus 15.7% (11.2 and 19.4), P=0.01. No definite or probable late stent thrombosis was recorded.
  
  
  
  With additional endothelial progenitor cell-capturing technology, the Combo stent exhibits a unique late neointimal regression (from 9 to 24 months) that has not been reported in any drug-eluting stents, translating into good 36-month clinical results with minimal restenosis and no late stent thrombosis. This is the first study testing the concept of using a longitudinal sequential optical coherence tomography protocol to continuously document early healing profile and late neointimal transformation, predicting long-term outcomes of a new novel stent platform.
  
  
  
  URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01274234, NCT01756807, and NCT02263313.
authors.affiliation: From The University of Hong Kong, Queen Mary Hospital, Hospital Authority (S.W.L.L., S.C.C.L., F.C.C.T., K.K.W.C., C.P.S., S.-L.K., A.Y.T.W., A.Y., L.-W.Z., H.-F.T., K.K.Y.W., R.C.), China; Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.); Cardiovascular Research Foundation, New York, NY (R.M., G.S.M., A.M.); and Columbia University Medical Center, New York, NY (R.M., G.S.M., A.M.). leewls@ha.org.hk.
authors.forename: Stephen W L
authors.initials: SW
authors.lastname: Lee
authors.affiliation: From The University of Hong Kong, Queen Mary Hospital, Hospital Authority (S.W.L.L., S.C.C.L., F.C.C.T., K.K.W.C., C.P.S., S.-L.K., A.Y.T.W., A.Y., L.-W.Z., H.-F.T., K.K.Y.W., R.C.), China; Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.); Cardiovascular Research Foundation, New York, NY (R.M., G.S.M., A.M.); and Columbia University Medical Center, New York, NY (R.M., G.S.M., A.M.).
authors.forename: Simon C C
authors.initials: SC
authors.lastname: Lam
authors.affiliation: From The University of Hong Kong, Queen Mary Hospital, Hospital Authority (S.W.L.L., S.C.C.L., F.C.C.T., K.K.W.C., C.P.S., S.-L.K., A.Y.T.W., A.Y., L.-W.Z., H.-F.T., K.K.Y.W., R.C.), China; Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.); Cardiovascular Research Foundation, New York, NY (R.M., G.S.M., A.M.); and Columbia University Medical Center, New York, NY (R.M., G.S.M., A.M.).
authors.forename: Frankie C C
authors.initials: FC
authors.lastname: Tam
authors.affiliation: From The University of Hong Kong, Queen Mary Hospital, Hospital Authority (S.W.L.L., S.C.C.L., F.C.C.T., K.K.W.C., C.P.S., S.-L.K., A.Y.T.W., A.Y., L.-W.Z., H.-F.T., K.K.Y.W., R.C.), China; Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.); Cardiovascular Research Foundation, New York, NY (R.M., G.S.M., A.M.); and Columbia University Medical Center, New York, NY (R.M., G.S.M., A.M.).
authors.forename: Kelvin K W
authors.initials: KK
authors.lastname: Chan
authors.affiliation: From The University of Hong Kong, Queen Mary Hospital, Hospital Authority (S.W.L.L., S.C.C.L., F.C.C.T., K.K.W.C., C.P.S., S.-L.K., A.Y.T.W., A.Y., L.-W.Z., H.-F.T., K.K.Y.W., R.C.), China; Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.); Cardiovascular Research Foundation, New York, NY (R.M., G.S.M., A.M.); and Columbia University Medical Center, New York, NY (R.M., G.S.M., A.M.).
authors.forename: Catherine P
authors.initials: CP
authors.lastname: Shea
authors.affiliation: From The University of Hong Kong, Queen Mary Hospital, Hospital Authority (S.W.L.L., S.C.C.L., F.C.C.T., K.K.W.C., C.P.S., S.-L.K., A.Y.T.W., A.Y., L.-W.Z., H.-F.T., K.K.Y.W., R.C.), China; Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.); Cardiovascular Research Foundation, New York, NY (R.M., G.S.M., A.M.); and Columbia University Medical Center, New York, NY (R.M., G.S.M., A.M.).
authors.forename: Shun-Ling
authors.initials: SL
authors.lastname: Kong
authors.affiliation: From The University of Hong Kong, Queen Mary Hospital, Hospital Authority (S.W.L.L., S.C.C.L., F.C.C.T., K.K.W.C., C.P.S., S.-L.K., A.Y.T.W., A.Y., L.-W.Z., H.-F.T., K.K.Y.W., R.C.), China; Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.); Cardiovascular Research Foundation, New York, NY (R.M., G.S.M., A.M.); and Columbia University Medical Center, New York, NY (R.M., G.S.M., A.M.).
authors.forename: Anthony Y T
authors.initials: AY
authors.lastname: Wong
authors.affiliation: From The University of Hong Kong, Queen Mary Hospital, Hospital Authority (S.W.L.L., S.C.C.L., F.C.C.T., K.K.W.C., C.P.S., S.-L.K., A.Y.T.W., A.Y., L.-W.Z., H.-F.T., K.K.Y.W., R.C.), China; Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.); Cardiovascular Research Foundation, New York, NY (R.M., G.S.M., A.M.); and Columbia University Medical Center, New York, NY (R.M., G.S.M., A.M.).
authors.forename: Arthur
authors.initials: A
authors.lastname: Yung
authors.affiliation: From The University of Hong Kong, Queen Mary Hospital, Hospital Authority (S.W.L.L., S.C.C.L., F.C.C.T., K.K.W.C., C.P.S., S.-L.K., A.Y.T.W., A.Y., L.-W.Z., H.-F.T., K.K.Y.W., R.C.), China; Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.); Cardiovascular Research Foundation, New York, NY (R.M., G.S.M., A.M.); and Columbia University Medical Center, New York, NY (R.M., G.S.M., A.M.).
authors.forename: Lei-Wei
authors.initials: LW
authors.lastname: Zhang
authors.affiliation: From The University of Hong Kong, Queen Mary Hospital, Hospital Authority (S.W.L.L., S.C.C.L., F.C.C.T., K.K.W.C., C.P.S., S.-L.K., A.Y.T.W., A.Y., L.-W.Z., H.-F.T., K.K.Y.W., R.C.), China; Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.); Cardiovascular Research Foundation, New York, NY (R.M., G.S.M., A.M.); and Columbia University Medical Center, New York, NY (R.M., G.S.M., A.M.).
authors.forename: Hung-Fat
authors.initials: HF
authors.lastname: Tse
authors.affiliation: From The University of Hong Kong, Queen Mary Hospital, Hospital Authority (S.W.L.L., S.C.C.L., F.C.C.T., K.K.W.C., C.P.S., S.-L.K., A.Y.T.W., A.Y., L.-W.Z., H.-F.T., K.K.Y.W., R.C.), China; Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.); Cardiovascular Research Foundation, New York, NY (R.M., G.S.M., A.M.); and Columbia University Medical Center, New York, NY (R.M., G.S.M., A.M.).
authors.forename: Karl K Y
authors.initials: KK
authors.lastname: Wu
authors.affiliation: From The University of Hong Kong, Queen Mary Hospital, Hospital Authority (S.W.L.L., S.C.C.L., F.C.C.T., K.K.W.C., C.P.S., S.-L.K., A.Y.T.W., A.Y., L.-W.Z., H.-F.T., K.K.Y.W., R.C.), China; Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.); Cardiovascular Research Foundation, New York, NY (R.M., G.S.M., A.M.); and Columbia University Medical Center, New York, NY (R.M., G.S.M., A.M.).
authors.forename: Raymond
authors.initials: R
authors.lastname: Chan
authors.affiliation: From The University of Hong Kong, Queen Mary Hospital, Hospital Authority (S.W.L.L., S.C.C.L., F.C.C.T., K.K.W.C., C.P.S., S.-L.K., A.Y.T.W., A.Y., L.-W.Z., H.-F.T., K.K.Y.W., R.C.), China; Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.); Cardiovascular Research Foundation, New York, NY (R.M., G.S.M., A.M.); and Columbia University Medical Center, New York, NY (R.M., G.S.M., A.M.).
authors.forename: Michael
authors.initials: M
authors.lastname: Haude
authors.affiliation: From The University of Hong Kong, Queen Mary Hospital, Hospital Authority (S.W.L.L., S.C.C.L., F.C.C.T., K.K.W.C., C.P.S., S.-L.K., A.Y.T.W., A.Y., L.-W.Z., H.-F.T., K.K.Y.W., R.C.), China; Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.); Cardiovascular Research Foundation, New York, NY (R.M., G.S.M., A.M.); and Columbia University Medical Center, New York, NY (R.M., G.S.M., A.M.).
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.affiliation: From The University of Hong Kong, Queen Mary Hospital, Hospital Authority (S.W.L.L., S.C.C.L., F.C.C.T., K.K.W.C., C.P.S., S.-L.K., A.Y.T.W., A.Y., L.-W.Z., H.-F.T., K.K.Y.W., R.C.), China; Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.); Cardiovascular Research Foundation, New York, NY (R.M., G.S.M., A.M.); and Columbia University Medical Center, New York, NY (R.M., G.S.M., A.M.).
authors.forename: Gary S
authors.initials: GS
authors.lastname: Mintz
authors.affiliation: From The University of Hong Kong, Queen Mary Hospital, Hospital Authority (S.W.L.L., S.C.C.L., F.C.C.T., K.K.W.C., C.P.S., S.-L.K., A.Y.T.W., A.Y., L.-W.Z., H.-F.T., K.K.Y.W., R.C.), China; Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.); Cardiovascular Research Foundation, New York, NY (R.M., G.S.M., A.M.); and Columbia University Medical Center, New York, NY (R.M., G.S.M., A.M.).
authors.forename: Akiko
authors.initials: A
authors.lastname: Maehara
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003131:Combined Modality Therapy; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology; D003331:Coronary Vessels / Q000000981:diagnostic imaging* / Q000187:drug effects*; D054855:Drug-Eluting Stents; D066026:Endothelial Progenitor Cells / Q000637:transplantation*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058426:Neointima; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014945:Wound Healing
chemical_list: D002317:Cardiovascular Agents; D020123:Sirolimus
keywords: coronary disease; drug-eluting stents; optical coherence tomography; sirolimus; stents