title: Clopidogrel increases bleeding complications in patients undergoing heart rhythm device procedures.
abstract: BACKGROUND
  Management of antiplatelet therapy at the time of device implantation remains controversial. This study aimed to assess the risk of bleeding complications in patients receiving clopidogrel at the time of cardiac device surgery.
  
  
  METHODS
  We performed a retrospective case-control study. Between 2004 and 2010, 101 consecutive patients receiving clopidogrel underwent cardiac device surgery (pacemaker or implantable cardioverter-defibrillator implantation, and generator replacement) in our institution. Controls were 1:1 matched on age, sex, device, type of procedure, number of leads implanted, and venous approach (cephalic or subclavian). A significant bleeding complication was defined as pocket hematoma requiring surgical evacuation or prolonged hospitalization, hemothorax, pericardial effusion, or tamponade.
  
  
  RESULTS
  Bleeding complications occurred more frequently in patients receiving clopidogrel at the time of device procedure: 11.9% versus 4.0% (P = 0.037; odds radio [OR] 3.27 [1.02-10.5]). Significant bleeding complications were noted in 12 patients (11.9%) receiving clopidogrel, including two patients with pericardial effusion and one patient with hemothorax. Four controls (4.0%) had bleeding complications (three pocket hematomas and one pericardial effusion). The single factor associated with increased bleeding complications in patients receiving clopidogrel was subclavian puncture (P = 0.008). In the entire cohort (n = 202), multivariate analysis identified two independent predictors of significant bleeding complications: clopidogrel treatment at the time of surgery (P = 0.03; OR 3.7 [1.1-12.6]) and subclavian venous puncture (P = 0.03; OR 3.44 [1.1-10.4]).
  
  
  CONCLUSIONS
  Clopidogrel treatment at the time of heart rhythm device procedures is associated with an increased risk of significant bleeding complications. Subclavian puncture seems to strongly increase hemorrhagic complications in this setting.
authors.affiliation: Department of Cardiovascular Medicine, Lille University Hospital, Lille, France. stephane.boule@chru-lille.fr
authors.forename: Stéphane
authors.initials: S
authors.lastname: Boulé
authors.forename: Christelle
authors.initials: C
authors.lastname: Marquié
authors.forename: Claire
authors.initials: C
authors.lastname: Vanesson-Bricout
authors.forename: Claude
authors.initials: C
authors.lastname: Kouakam
authors.forename: François
authors.initials: F
authors.lastname: Brigadeau
authors.forename: Laurence
authors.initials: L
authors.lastname: Guédon-Moreau
authors.forename: Charles
authors.initials: C
authors.lastname: Acheré
authors.forename: Céline
authors.initials: C
authors.lastname: Goéminne-Boulé
authors.forename: Dominique
authors.initials: D
authors.lastname: Lacroix
authors.forename: Didier
authors.initials: D
authors.lastname: Klug
authors.forename: Salem
authors.initials: S
authors.lastname: Kacet
mesh_terms: D058406:Cardiac Resynchronization Therapy / Q000706:statistics & numerical data*; D016022:Case-Control Studies; D000077144:Clopidogrel; D015897:Comorbidity; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005602:France / Q000453:epidemiology; D006470:Hemorrhage / Q000453:epidemiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013927:Thrombosis / Q000453:epidemiology* / Q000517:prevention & control*; D013988:Ticlopidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine