title: Impact of severe lesion calcification on clinical outcome of patients with stable angina, treated with newer generation permanent polymer-coated drug-eluting stents: A patient-level pooled analysis from TWENTE and DUTCH PEERS (TWENTE II).
abstract: BACKGROUND
  The outcome of percutaneous coronary intervention with newer generation permanent polymer-coated drug-eluting stents (DES) in patients with severely calcified lesions is greatly unknown. We assessed the impact of severe lesion calcification on clinical outcome in patients with stable angina who underwent percutaneous coronary intervention with newer generation DES.
  
  
  METHODS
  TWENTE and DUTCH PEERS randomized trials enrolled 1423 patients with stable angina, who were categorized into patients with versus without severe target lesion calcification. A patient-level pooled analysis assessed clinical outcome, including target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization (TVR).
  
  
  RESULTS
  Patients with severe calcification (n = 342) were older (66.6 ± 9.1 vs 64.2 ± 9.8 years, P < .001) and had more diabetes (25.7% vs 20.4%, P = .04) than other patients (n = 1081). Patients with calcified lesions had higher rates of TVF (16.4% vs 9.8%, pLogrank = .001), cardiac death (4.4% vs 1.5%, P = .03), target vessel myocardial infarction (7.6% vs 3.4%, P = .001), and definite stent thrombosis (1.8% vs 0.4%, P = .02). Multivariate analysis demonstrated that severe calcification was an independent risk factor of 2-year TVF (HR 1.42, 95% CI: 1.02-1.99, pLogrank = .04); landmark analysis showed that this was based on a difference during the first year (periprocedural: 5.8% vs. 3.1%, pLogrank = .02; first year: 7.5% vs. 3.8%, pLogrank = .007; second year: 4.1% vs. 3.3%, pLogrank = .54).
  
  
  CONCLUSIONS
  In patients with stable angina, severe target lesion calcification is associated with an increased risk of adverse cardiovascular events following treatment with newer generation permanent polymer-coated DES. This increase in risk is restricted to the first year of follow-up, which is an encouraging finding.
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Huisman
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands.
authors.forename: Liefke C
authors.initials: LC
authors.lastname: van der Heijden
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands.
authors.forename: Marlies M
authors.initials: MM
authors.lastname: Kok
authors.affiliation: Department of Cardiology, Rijnstate Hospital, Arnhem, Netherlands.
authors.forename: Peter W
authors.initials: PW
authors.lastname: Danse
authors.affiliation: Department of Cardiology, Treant Zorggroep, Emmen, Netherlands.
authors.forename: Gillian A J
authors.initials: GA
authors.lastname: Jessurun
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands.
authors.forename: Martin G
authors.initials: MG
authors.lastname: Stoel
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands.
authors.forename: K Gert
authors.initials: KG
authors.lastname: van Houwelingen
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands.
authors.forename: Marije M
authors.initials: MM
authors.lastname: Löwik
authors.affiliation: Department of Cardiology, Medical Center Alkmaar, Alkmaar, Netherlands.
authors.forename: Raymond W M
authors.initials: RW
authors.lastname: Hautvast
authors.affiliation: Health Technology and Services Research, MIRA, Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, Netherlands.
authors.forename: Maarten J
authors.initials: MJ
authors.lastname: IJzerman
authors.affiliation: Health Technology and Services Research, MIRA, Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, Netherlands.
authors.forename: Carine J
authors.initials: CJ
authors.lastname: Doggen
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, Netherlands; Health Technology and Services Research, MIRA, Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, Netherlands. Electronic address: c.vonbirgelen@mst.nl.
authors.forename: Clemens
authors.initials: C
authors.lastname: von Birgelen
mesh_terms: D000368:Aged; D060050:Angina, Stable / Q000175:diagnosis / Q000209:etiology / Q000628:therapy; D020099:Coated Materials, Biocompatible / Q000627:therapeutic use; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000473:pathology*; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D011108:Polymers / Q000627:therapeutic use; D012720:Severity of Illness Index; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome; D061205:Vascular Calcification / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology
chemical_list: D020099:Coated Materials, Biocompatible; D007166:Immunosuppressive Agents; D011108:Polymers; C489443:zotarolimus; D020123:Sirolimus