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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.
Lee, Stephen W L; Lam, Simon C C; Tam, Frankie C C; Chan, Kelvin K W; Shea, Catherine P; Kong, Shun-Ling; Wong, Anthony Y T; Yung, Arthur; Zhang, Lei-Wei; Tse, Hung-Fat; Wu, Karl K Y; Chan, Raymond; Haude, Michael; Mehran, Roxana; Mintz, Gary S; Maehara, Akiko.
Afiliación
  • Lee SW; 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 Cardio
  • Lam SC; 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 Cardio
  • Tam FC; 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 Cardio
  • Chan KK; 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 Cardio
  • Shea CP; 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 Cardio
  • Kong SL; 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 Cardio
  • Wong AY; 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 Cardio
  • Yung A; 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 Cardio
  • Zhang LW; 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 Cardio
  • Tse HF; 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 Cardio
  • Wu KK; 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 Cardio
  • Chan R; 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 Cardio
  • Haude M; 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 Cardio
  • Mehran R; 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 Cardio
  • Mintz GS; 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 Cardio
  • Maehara A; 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 Cardio
Article en En | MEDLINE | ID: mdl-27418609
BACKGROUND: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01274234, NCT01756807, and NCT02263313.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedad de la Arteria Coronaria / Fármacos Cardiovasculares / Vasos Coronarios / Sirolimus / Tomografía de Coherencia Óptica / Stents Liberadores de Fármacos / Neointima / Intervención Coronaria Percutánea / Células Progenitoras Endoteliales Tipo de estudio: Etiology_studies / Guideline / Observational_studies / Prognostic_studies Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Circ Cardiovasc Interv Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA Año: 2016 Tipo del documento: Article Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedad de la Arteria Coronaria / Fármacos Cardiovasculares / Vasos Coronarios / Sirolimus / Tomografía de Coherencia Óptica / Stents Liberadores de Fármacos / Neointima / Intervención Coronaria Percutánea / Células Progenitoras Endoteliales Tipo de estudio: Etiology_studies / Guideline / Observational_studies / Prognostic_studies Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Circ Cardiovasc Interv Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA Año: 2016 Tipo del documento: Article Pais de publicación: Estados Unidos