title: Clinical outcomes according to diabetic status in patients treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents: prespecified subgroup analysis of the BIOSCIENCE trial.
abstract: BACKGROUND
  Ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES) proved noninferior to durable polymer everolimus-eluting stents (DP-EES) for a composite clinical end point in a population with minimal exclusion criteria. We performed a prespecified subgroup analysis of the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularisation (BIOSCIENCE) trial to compare the performance of BP-SES and DP-EES in patients with diabetes mellitus.
  
  
  RESULTS
  BIOSCIENCE trial was an investigator-initiated, single-blind, multicentre, randomized, noninferiority trial comparing BP-SES versus DP-EES. The primary end point, target lesion failure, was a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization within 12 months. Among a total of 2119 patients enrolled between February 2012 and May 2013, 486 (22.9%) had diabetes mellitus. Overall diabetic patients experienced a significantly higher risk of target lesion failure compared with patients without diabetes mellitus (10.1% versus 5.7%; hazard ratio [HR], 1.80; 95% confidence interval [CI], 1.27-2.56; P=0.001). At 1 year, there were no differences between BP-SES versus DP-EES in terms of the primary end point in both diabetic (10.9% versus 9.3%; HR, 1.19; 95% CI, 0.67-2.10; P=0.56) and nondiabetic patients (5.3% versus 6.0%; HR, 0.88; 95% CI, 0.58-1.33; P=0.55). Similarly, no significant differences in the risk of definite or probable stent thrombosis were recorded according to treatment arm in both study groups (4.0% versus 3.1%; HR, 1.30; 95% CI, 0.49-3.41; P=0.60 for diabetic patients and 2.4% versus 3.4%; HR, 0.70; 95% CI, 0.39-1.25; P=0.23, in nondiabetics).
  
  
  CONCLUSIONS
  In the prespecified subgroup analysis of the BIOSCIENCE trial, clinical outcomes among diabetic patients treated with BP-SES or DP-EES were comparable at 1 year.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT01443104.
authors.affiliation: From the Department of Cardiology, Swiss Cardiovascular Center (A.F., T.P., L.R., S.S., P.W., S.W.), Institute of Social and Preventive Medicine and Clinical Trials Unit (D.H., P. Jüni), University Hospital, Bern, Switzerland; Department of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Department of Cardiology, University Hospital, Lausanne, Switzerland (A.V., O.M.); Department of Cardiology, Kantonsspital, Aarau, Switzerland (A.V.); Department of Cardiology, University Hospital, Fribourg, Switzerland (S.C.); Department of Cardiology, Kantonsspital, St. Gallen, Switzerland (D.W.); Department of Cardiology, University Hospital, Basel, Switzerland (C.K.); and Department of Cardiology, Kantonsspital, Luzern, Switzerland (P. Jamshidi).
authors.forename: Anna
authors.initials: A
authors.lastname: Franzone
authors.affiliation: From the Department of Cardiology, Swiss Cardiovascular Center (A.F., T.P., L.R., S.S., P.W., S.W.), Institute of Social and Preventive Medicine and Clinical Trials Unit (D.H., P. Jüni), University Hospital, Bern, Switzerland; Department of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Department of Cardiology, University Hospital, Lausanne, Switzerland (A.V., O.M.); Department of Cardiology, Kantonsspital, Aarau, Switzerland (A.V.); Department of Cardiology, University Hospital, Fribourg, Switzerland (S.C.); Department of Cardiology, Kantonsspital, St. Gallen, Switzerland (D.W.); Department of Cardiology, University Hospital, Basel, Switzerland (C.K.); and Department of Cardiology, Kantonsspital, Luzern, Switzerland (P. Jamshidi). thomas.pilgrim@insel.ch.
authors.forename: Thomas
authors.initials: T
authors.lastname: Pilgrim
authors.affiliation: From the Department of Cardiology, Swiss Cardiovascular Center (A.F., T.P., L.R., S.S., P.W., S.W.), Institute of Social and Preventive Medicine and Clinical Trials Unit (D.H., P. Jüni), University Hospital, Bern, Switzerland; Department of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Department of Cardiology, University Hospital, Lausanne, Switzerland (A.V., O.M.); Department of Cardiology, Kantonsspital, Aarau, Switzerland (A.V.); Department of Cardiology, University Hospital, Fribourg, Switzerland (S.C.); Department of Cardiology, Kantonsspital, St. Gallen, Switzerland (D.W.); Department of Cardiology, University Hospital, Basel, Switzerland (C.K.); and Department of Cardiology, Kantonsspital, Luzern, Switzerland (P. Jamshidi).
authors.forename: Dik
authors.initials: D
authors.lastname: Heg
authors.affiliation: From the Department of Cardiology, Swiss Cardiovascular Center (A.F., T.P., L.R., S.S., P.W., S.W.), Institute of Social and Preventive Medicine and Clinical Trials Unit (D.H., P. Jüni), University Hospital, Bern, Switzerland; Department of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Department of Cardiology, University Hospital, Lausanne, Switzerland (A.V., O.M.); Department of Cardiology, Kantonsspital, Aarau, Switzerland (A.V.); Department of Cardiology, University Hospital, Fribourg, Switzerland (S.C.); Department of Cardiology, Kantonsspital, St. Gallen, Switzerland (D.W.); Department of Cardiology, University Hospital, Basel, Switzerland (C.K.); and Department of Cardiology, Kantonsspital, Luzern, Switzerland (P. Jamshidi).
authors.forename: Marco
authors.initials: M
authors.lastname: Roffi
authors.affiliation: From the Department of Cardiology, Swiss Cardiovascular Center (A.F., T.P., L.R., S.S., P.W., S.W.), Institute of Social and Preventive Medicine and Clinical Trials Unit (D.H., P. Jüni), University Hospital, Bern, Switzerland; Department of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Department of Cardiology, University Hospital, Lausanne, Switzerland (A.V., O.M.); Department of Cardiology, Kantonsspital, Aarau, Switzerland (A.V.); Department of Cardiology, University Hospital, Fribourg, Switzerland (S.C.); Department of Cardiology, Kantonsspital, St. Gallen, Switzerland (D.W.); Department of Cardiology, University Hospital, Basel, Switzerland (C.K.); and Department of Cardiology, Kantonsspital, Luzern, Switzerland (P. Jamshidi).
authors.forename: David
authors.initials: D
authors.lastname: Tüller
authors.affiliation: From the Department of Cardiology, Swiss Cardiovascular Center (A.F., T.P., L.R., S.S., P.W., S.W.), Institute of Social and Preventive Medicine and Clinical Trials Unit (D.H., P. Jüni), University Hospital, Bern, Switzerland; Department of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Department of Cardiology, University Hospital, Lausanne, Switzerland (A.V., O.M.); Department of Cardiology, Kantonsspital, Aarau, Switzerland (A.V.); Department of Cardiology, University Hospital, Fribourg, Switzerland (S.C.); Department of Cardiology, Kantonsspital, St. Gallen, Switzerland (D.W.); Department of Cardiology, University Hospital, Basel, Switzerland (C.K.); and Department of Cardiology, Kantonsspital, Luzern, Switzerland (P. Jamshidi).
authors.forename: André
authors.initials: A
authors.lastname: Vuilliomenet
authors.affiliation: From the Department of Cardiology, Swiss Cardiovascular Center (A.F., T.P., L.R., S.S., P.W., S.W.), Institute of Social and Preventive Medicine and Clinical Trials Unit (D.H., P. Jüni), University Hospital, Bern, Switzerland; Department of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Department of Cardiology, University Hospital, Lausanne, Switzerland (A.V., O.M.); Department of Cardiology, Kantonsspital, Aarau, Switzerland (A.V.); Department of Cardiology, University Hospital, Fribourg, Switzerland (S.C.); Department of Cardiology, Kantonsspital, St. Gallen, Switzerland (D.W.); Department of Cardiology, University Hospital, Basel, Switzerland (C.K.); and Department of Cardiology, Kantonsspital, Luzern, Switzerland (P. Jamshidi).
authors.forename: Olivier
authors.initials: O
authors.lastname: Muller
authors.affiliation: From the Department of Cardiology, Swiss Cardiovascular Center (A.F., T.P., L.R., S.S., P.W., S.W.), Institute of Social and Preventive Medicine and Clinical Trials Unit (D.H., P. Jüni), University Hospital, Bern, Switzerland; Department of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Department of Cardiology, University Hospital, Lausanne, Switzerland (A.V., O.M.); Department of Cardiology, Kantonsspital, Aarau, Switzerland (A.V.); Department of Cardiology, University Hospital, Fribourg, Switzerland (S.C.); Department of Cardiology, Kantonsspital, St. Gallen, Switzerland (D.W.); Department of Cardiology, University Hospital, Basel, Switzerland (C.K.); and Department of Cardiology, Kantonsspital, Luzern, Switzerland (P. Jamshidi).
authors.forename: Stéphane
authors.initials: S
authors.lastname: Cook
authors.affiliation: From the Department of Cardiology, Swiss Cardiovascular Center (A.F., T.P., L.R., S.S., P.W., S.W.), Institute of Social and Preventive Medicine and Clinical Trials Unit (D.H., P. Jüni), University Hospital, Bern, Switzerland; Department of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Department of Cardiology, University Hospital, Lausanne, Switzerland (A.V., O.M.); Department of Cardiology, Kantonsspital, Aarau, Switzerland (A.V.); Department of Cardiology, University Hospital, Fribourg, Switzerland (S.C.); Department of Cardiology, Kantonsspital, St. Gallen, Switzerland (D.W.); Department of Cardiology, University Hospital, Basel, Switzerland (C.K.); and Department of Cardiology, Kantonsspital, Luzern, Switzerland (P. Jamshidi).
authors.forename: Daniel
authors.initials: D
authors.lastname: Weilenmann
authors.affiliation: From the Department of Cardiology, Swiss Cardiovascular Center (A.F., T.P., L.R., S.S., P.W., S.W.), Institute of Social and Preventive Medicine and Clinical Trials Unit (D.H., P. Jüni), University Hospital, Bern, Switzerland; Department of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Department of Cardiology, University Hospital, Lausanne, Switzerland (A.V., O.M.); Department of Cardiology, Kantonsspital, Aarau, Switzerland (A.V.); Department of Cardiology, University Hospital, Fribourg, Switzerland (S.C.); Department of Cardiology, Kantonsspital, St. Gallen, Switzerland (D.W.); Department of Cardiology, University Hospital, Basel, Switzerland (C.K.); and Department of Cardiology, Kantonsspital, Luzern, Switzerland (P. Jamshidi).
authors.forename: Christoph
authors.initials: C
authors.lastname: Kaiser
authors.affiliation: From the Department of Cardiology, Swiss Cardiovascular Center (A.F., T.P., L.R., S.S., P.W., S.W.), Institute of Social and Preventive Medicine and Clinical Trials Unit (D.H., P. Jüni), University Hospital, Bern, Switzerland; Department of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Department of Cardiology, University Hospital, Lausanne, Switzerland (A.V., O.M.); Department of Cardiology, Kantonsspital, Aarau, Switzerland (A.V.); Department of Cardiology, University Hospital, Fribourg, Switzerland (S.C.); Department of Cardiology, Kantonsspital, St. Gallen, Switzerland (D.W.); Department of Cardiology, University Hospital, Basel, Switzerland (C.K.); and Department of Cardiology, Kantonsspital, Luzern, Switzerland (P. Jamshidi).
authors.forename: Peiman
authors.initials: P
authors.lastname: Jamshidi
authors.affiliation: From the Department of Cardiology, Swiss Cardiovascular Center (A.F., T.P., L.R., S.S., P.W., S.W.), Institute of Social and Preventive Medicine and Clinical Trials Unit (D.H., P. Jüni), University Hospital, Bern, Switzerland; Department of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Department of Cardiology, University Hospital, Lausanne, Switzerland (A.V., O.M.); Department of Cardiology, Kantonsspital, Aarau, Switzerland (A.V.); Department of Cardiology, University Hospital, Fribourg, Switzerland (S.C.); Department of Cardiology, Kantonsspital, St. Gallen, Switzerland (D.W.); Department of Cardiology, University Hospital, Basel, Switzerland (C.K.); and Department of Cardiology, Kantonsspital, Luzern, Switzerland (P. Jamshidi).
authors.forename: Lorenz
authors.initials: L
authors.lastname: Räber
authors.affiliation: From the Department of Cardiology, Swiss Cardiovascular Center (A.F., T.P., L.R., S.S., P.W., S.W.), Institute of Social and Preventive Medicine and Clinical Trials Unit (D.H., P. Jüni), University Hospital, Bern, Switzerland; Department of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Department of Cardiology, University Hospital, Lausanne, Switzerland (A.V., O.M.); Department of Cardiology, Kantonsspital, Aarau, Switzerland (A.V.); Department of Cardiology, University Hospital, Fribourg, Switzerland (S.C.); Department of Cardiology, Kantonsspital, St. Gallen, Switzerland (D.W.); Department of Cardiology, University Hospital, Basel, Switzerland (C.K.); and Department of Cardiology, Kantonsspital, Luzern, Switzerland (P. Jamshidi).
authors.forename: Stefan
authors.initials: S
authors.lastname: Stortecky
authors.affiliation: From the Department of Cardiology, Swiss Cardiovascular Center (A.F., T.P., L.R., S.S., P.W., S.W.), Institute of Social and Preventive Medicine and Clinical Trials Unit (D.H., P. Jüni), University Hospital, Bern, Switzerland; Department of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Department of Cardiology, University Hospital, Lausanne, Switzerland (A.V., O.M.); Department of Cardiology, Kantonsspital, Aarau, Switzerland (A.V.); Department of Cardiology, University Hospital, Fribourg, Switzerland (S.C.); Department of Cardiology, Kantonsspital, St. Gallen, Switzerland (D.W.); Department of Cardiology, University Hospital, Basel, Switzerland (C.K.); and Department of Cardiology, Kantonsspital, Luzern, Switzerland (P. Jamshidi).
authors.forename: Peter
authors.initials: P
authors.lastname: Wenaweser
authors.affiliation: From the Department of Cardiology, Swiss Cardiovascular Center (A.F., T.P., L.R., S.S., P.W., S.W.), Institute of Social and Preventive Medicine and Clinical Trials Unit (D.H., P. Jüni), University Hospital, Bern, Switzerland; Department of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Department of Cardiology, University Hospital, Lausanne, Switzerland (A.V., O.M.); Department of Cardiology, Kantonsspital, Aarau, Switzerland (A.V.); Department of Cardiology, University Hospital, Fribourg, Switzerland (S.C.); Department of Cardiology, Kantonsspital, St. Gallen, Switzerland (D.W.); Department of Cardiology, University Hospital, Basel, Switzerland (C.K.); and Department of Cardiology, Kantonsspital, Luzern, Switzerland (P. Jamshidi).
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.affiliation: From the Department of Cardiology, Swiss Cardiovascular Center (A.F., T.P., L.R., S.S., P.W., S.W.), Institute of Social and Preventive Medicine and Clinical Trials Unit (D.H., P. Jüni), University Hospital, Bern, Switzerland; Department of Cardiology, University Hospital, Geneva, Switzerland (M.R.); Department of Cardiology, Triemlispital, Zurich, Switzerland (D.T.); Department of Cardiology, University Hospital, Lausanne, Switzerland (A.V., O.M.); Department of Cardiology, Kantonsspital, Aarau, Switzerland (A.V.); Department of Cardiology, University Hospital, Fribourg, Switzerland (S.C.); Department of Cardiology, Kantonsspital, St. Gallen, Switzerland (D.W.); Department of Cardiology, University Hospital, Basel, Switzerland (C.K.); and Department of Cardiology, Kantonsspital, Luzern, Switzerland (P. Jamshidi).
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D017023:Coronary Angiography; D003925:Diabetic Angiopathies / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000706:statistics & numerical data*; D000068338:Everolimus / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation*; D011108:Polymers; D020123:Sirolimus / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D011108:Polymers; D000068338:Everolimus; D020123:Sirolimus
keywords: biodegradable polymer sirolimus-eluting stents; diabetes mellitus; durable polymer everolimus-eluting stents