title: Novel Sirolimus-Coated Balloon Catheter: In Vivo Evaluation in a Porcine Coronary Model.
abstract: BACKGROUND
  Limus-eluting stents are dominating coronary interventions, although paclitaxel is the only drug on balloon catheters with proven inhibition of restenosis. Neointimal inhibition by limus-coated balloons has been shown in few animal studies, but data from randomized clinical trials are not available. The aim of the present preclinical studies was to achieve high and persistent sirolimus levels in the vessel wall after administration by a coated balloon.
  
  
  RESULTS
  Different coating formulations and doses were studied in the porcine coronary model to investigate sirolimus tissue levels at different time points as well as efficacy at 1 month using quantitative coronary angiography and histomorphometry. Loss of the selected coating in the valve, guiding catheter, and blood was low (2±14% of dose). Acute drug transfer to the vessel wall was 14.4±4.6% with the crystalline coating, whereas the amorphous coatings were less effective in this respect. Persistence of sirolimus in the vessel wall until 1 month was 40% to 50% of the transferred drug. At 1-month follow-up, a modest but significant reduction of neointimal growth was demonstrated in a dose range from 4 μg/mm(2) to 2×7 μg/mm(2), for example, maximum neointimal thickness of 0.38±0.13 versus 0.65±0.21 mm in the uncoated control group.
  
  
  CONCLUSIONS
  Various sirolimus-coated balloons effectively reduce neointimal proliferation in the porcine coronary model but differ considerably in retention time in the vessel wall. It has to be determined if such a formulation with persistent high vessel concentration will result in a relevant clinical effect.
authors.affiliation: From the Klinik für Innere Medizin III, Kardiologie, Angiologie und internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany (Y.P.C., S.B., B.C., M.B., B.S.); Institut für Radiologie, Charité-Universitätsmedizin Berlin, Campus Mitte, Humboldt Universität zu Berlin, Germany (D.P., B.K., U.S.); and B. Braun Melsungen AG, Berlin, Germany (J.C., M.-C.B., C.S., M.S.).
authors.forename: Yvonne Patricia
authors.initials: YP
authors.lastname: Clever
authors.affiliation: From the Klinik für Innere Medizin III, Kardiologie, Angiologie und internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany (Y.P.C., S.B., B.C., M.B., B.S.); Institut für Radiologie, Charité-Universitätsmedizin Berlin, Campus Mitte, Humboldt Universität zu Berlin, Germany (D.P., B.K., U.S.); and B. Braun Melsungen AG, Berlin, Germany (J.C., M.-C.B., C.S., M.S.).
authors.forename: Daniel
authors.initials: D
authors.lastname: Peters
authors.affiliation: From the Klinik für Innere Medizin III, Kardiologie, Angiologie und internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany (Y.P.C., S.B., B.C., M.B., B.S.); Institut für Radiologie, Charité-Universitätsmedizin Berlin, Campus Mitte, Humboldt Universität zu Berlin, Germany (D.P., B.K., U.S.); and B. Braun Melsungen AG, Berlin, Germany (J.C., M.-C.B., C.S., M.S.).
authors.forename: Jorge
authors.initials: J
authors.lastname: Calisse
authors.affiliation: From the Klinik für Innere Medizin III, Kardiologie, Angiologie und internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany (Y.P.C., S.B., B.C., M.B., B.S.); Institut für Radiologie, Charité-Universitätsmedizin Berlin, Campus Mitte, Humboldt Universität zu Berlin, Germany (D.P., B.K., U.S.); and B. Braun Melsungen AG, Berlin, Germany (J.C., M.-C.B., C.S., M.S.).
authors.forename: Stephanie
authors.initials: S
authors.lastname: Bettink
authors.affiliation: From the Klinik für Innere Medizin III, Kardiologie, Angiologie und internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany (Y.P.C., S.B., B.C., M.B., B.S.); Institut für Radiologie, Charité-Universitätsmedizin Berlin, Campus Mitte, Humboldt Universität zu Berlin, Germany (D.P., B.K., U.S.); and B. Braun Melsungen AG, Berlin, Germany (J.C., M.-C.B., C.S., M.S.).
authors.forename: Madeleine-Caroline
authors.initials: MC
authors.lastname: Berg
authors.affiliation: From the Klinik für Innere Medizin III, Kardiologie, Angiologie und internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany (Y.P.C., S.B., B.C., M.B., B.S.); Institut für Radiologie, Charité-Universitätsmedizin Berlin, Campus Mitte, Humboldt Universität zu Berlin, Germany (D.P., B.K., U.S.); and B. Braun Melsungen AG, Berlin, Germany (J.C., M.-C.B., C.S., M.S.).
authors.forename: Christian
authors.initials: C
authors.lastname: Sperling
authors.affiliation: From the Klinik für Innere Medizin III, Kardiologie, Angiologie und internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany (Y.P.C., S.B., B.C., M.B., B.S.); Institut für Radiologie, Charité-Universitätsmedizin Berlin, Campus Mitte, Humboldt Universität zu Berlin, Germany (D.P., B.K., U.S.); and B. Braun Melsungen AG, Berlin, Germany (J.C., M.-C.B., C.S., M.S.).
authors.forename: Michael
authors.initials: M
authors.lastname: Stoever
authors.affiliation: From the Klinik für Innere Medizin III, Kardiologie, Angiologie und internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany (Y.P.C., S.B., B.C., M.B., B.S.); Institut für Radiologie, Charité-Universitätsmedizin Berlin, Campus Mitte, Humboldt Universität zu Berlin, Germany (D.P., B.K., U.S.); and B. Braun Melsungen AG, Berlin, Germany (J.C., M.-C.B., C.S., M.S.).
authors.forename: Bodo
authors.initials: B
authors.lastname: Cremers
authors.affiliation: From the Klinik für Innere Medizin III, Kardiologie, Angiologie und internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany (Y.P.C., S.B., B.C., M.B., B.S.); Institut für Radiologie, Charité-Universitätsmedizin Berlin, Campus Mitte, Humboldt Universität zu Berlin, Germany (D.P., B.K., U.S.); and B. Braun Melsungen AG, Berlin, Germany (J.C., M.-C.B., C.S., M.S.).
authors.forename: Bettina
authors.initials: B
authors.lastname: Kelsch
authors.affiliation: From the Klinik für Innere Medizin III, Kardiologie, Angiologie und internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany (Y.P.C., S.B., B.C., M.B., B.S.); Institut für Radiologie, Charité-Universitätsmedizin Berlin, Campus Mitte, Humboldt Universität zu Berlin, Germany (D.P., B.K., U.S.); and B. Braun Melsungen AG, Berlin, Germany (J.C., M.-C.B., C.S., M.S.).
authors.forename: Michael
authors.initials: M
authors.lastname: Böhm
authors.affiliation: From the Klinik für Innere Medizin III, Kardiologie, Angiologie und internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany (Y.P.C., S.B., B.C., M.B., B.S.); Institut für Radiologie, Charité-Universitätsmedizin Berlin, Campus Mitte, Humboldt Universität zu Berlin, Germany (D.P., B.K., U.S.); and B. Braun Melsungen AG, Berlin, Germany (J.C., M.-C.B., C.S., M.S.).
authors.forename: Ulrich
authors.initials: U
authors.lastname: Speck
authors.affiliation: From the Klinik für Innere Medizin III, Kardiologie, Angiologie und internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany (Y.P.C., S.B., B.C., M.B., B.S.); Institut für Radiologie, Charité-Universitätsmedizin Berlin, Campus Mitte, Humboldt Universität zu Berlin, Germany (D.P., B.K., U.S.); and B. Braun Melsungen AG, Berlin, Germany (J.C., M.-C.B., C.S., M.S.). bruno.scheller@uks.eu.
authors.forename: Bruno
authors.initials: B
authors.lastname: Scheller
mesh_terms: D000818:Animals; D062906:Cardiac Catheters; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000378:metabolism; D049109:Cell Proliferation / Q000187:drug effects; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000378:metabolism / Q000473:pathology; D054855:Drug-Eluting Stents; D004867:Equipment Design; D008297:Male; D023421:Models, Animal; D058426:Neointima; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation*; D020123:Sirolimus / Q000008:administration & dosage* / Q000378:metabolism; D013552:Swine; D013997:Time Factors
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D020123:Sirolimus
keywords: angioplasty; drug-coated balloon; drug-eluting stent; neointima; sirolimus