title: Everolimus-eluting bioresorbable scaffold implantation for the treatment of bifurcation lesions - Implications from early clinical experience during daily practice.
abstract: OBJECTIVE
  The clinical performance of bioresrobable scaffolds (BRSs) in bifurcation lesion is not well investigated so far and information can currently mostly be gleaned from the results of bench testing. The present analysis evaluates the technical feasibility of BRS use in this type of lesion and its mid-term clinical outcome.
  
  
  METHODS
  Consecutive patients with bifurcation lesions treated with at least one everolimus-eluting BRS were enrolled. Procedural success was defined as successful delivery and deployment of at least one BRS and a residual diameter stenosis ≤30%. The primary endpoint (major adverse cardiac events, MACE) included death due to cardiac cause, clinically driven percutaneous or surgical target lesion revascularization (TLR), and any myocardial infarction at the 12-month follow-up.
  
  
  RESULTS
  A total of 28 patients were eligible for this evaluation. Median age was 67 (52-73) years and in 46.4% (13/28) an acute coronary syndrome was present. The procedural success rate was 97.1% (33/34). The 1-year Kaplan Meier event rates for MACE, target lesion revascularization, and scaffold thrombosis were 16.1%, 12.1%, and 8.1%, respectively. Half of these patients discontinued the antiplatelet therapy prematurely.
  
  
  CONCLUSIONS
  The results for BRS use in bifurcation lesions are not in line with previous studies investigating primarily simple lesions. The impaired outcomes are most likely related to the early stage of BRS use and an exacerbated risk of scaffold thrombosis due to premature discontinuation of the antiplatelet therapy. Hypothesis generated from this investigation has to be proven in further studies.
  
  
  CONCLUSIONS
  Technical feasibility of everolimus-eluting bioresorbable scaffold implantation in bifurcation lesion and the clinical mid-term outcomes were evaluated in a real world scenario. Technical success rate was high; however the clinical results were not in line with previous studies investigating primarily simple lesions. The impaired outcomes were mostly driven by an exacerbated risk of scaffold thrombosis due to premature discontinuation of the antiplatelet therapy.
authors.affiliation: University of Giessen, Medizinische Klinik I, Department of Cardiology, Klinikstrasse 33, 35392 Giessen, Germany; Deutsches Herzzentrum München, Lazarettstr. 36, 80636 Munich, Germany. Electronic address: jens.wiebe@googlemail.com.
authors.forename: Jens
authors.initials: J
authors.lastname: Wiebe
authors.affiliation: University of Giessen, Medizinische Klinik I, Department of Cardiology, Klinikstrasse 33, 35392 Giessen, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Dörr
authors.affiliation: University of Giessen, Medizinische Klinik I, Department of Cardiology, Klinikstrasse 33, 35392 Giessen, Germany.
authors.forename: Timm
authors.initials: T
authors.lastname: Bauer
authors.affiliation: Kerckhoff Heart and Thorax Center, Department of Cardiology, Benekestrasse 2-8, 61231 Bad Nauheim, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Liebetrau
authors.affiliation: University of Giessen, Medizinische Klinik I, Department of Cardiology, Klinikstrasse 33, 35392 Giessen, Germany.
authors.forename: Niklas
authors.initials: N
authors.lastname: Boeder
authors.affiliation: Kerckhoff Heart and Thorax Center, Department of Cardiology, Benekestrasse 2-8, 61231 Bad Nauheim, Germany.
authors.forename: Helge
authors.initials: H
authors.lastname: Möllmann
authors.affiliation: University of Giessen, Medizinische Klinik I, Department of Cardiology, Klinikstrasse 33, 35392 Giessen, Germany; Kerckhoff Heart and Thorax Center, Department of Cardiology, Benekestrasse 2-8, 61231 Bad Nauheim, Germany.
authors.forename: Christian W
authors.initials: CW
authors.lastname: Hamm
authors.affiliation: University of Giessen, Medizinische Klinik I, Department of Cardiology, Klinikstrasse 33, 35392 Giessen, Germany.
authors.forename: Holger M
authors.initials: HM
authors.lastname: Nef
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology / Q000517:prevention & control; D003328:Coronary Thrombosis / Q000209:etiology / Q000517:prevention & control; D004334:Drug Administration Schedule; D000068338:Everolimus / Q000008:administration & dosage*; D005240:Feasibility Studies; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D011474:Prosthesis Design; D012042:Registries; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D010975:Platelet Aggregation Inhibitors; D000068338:Everolimus
keywords: Bifurcation; Bioresorbable scaffold; Coronary artery disease; Percutaneous coronary intervention