title: Impact of preoperative maintenance or interruption of aspirin on thrombotic and bleeding events after elective non-cardiac surgery: the multicentre, randomized, blinded, placebo-controlled, STRATAGEM trial.
abstract: BACKGROUND
  Patients receiving anti-platelet agents for secondary cardiovascular prevention frequently require non-cardiac surgery. A substantial proportion of these patients have their anti-platelet drug discontinued before operation; however, there is uncertainty about the impact of this practice. The aim of this study was to compare the effect of maintenance or interruption of aspirin before surgery, in terms of major thrombotic and bleeding events.
  
  
  METHODS
  Patients treated with anti-platelet agents for secondary prevention and undergoing intermediate- or high-risk non-cardiac surgery were included in this multicentre, randomized, placebo-controlled, trial. We substituted non-aspirin anti-platelets with aspirin (75 mg daily) or placebo starting 10 days before surgery. The primary outcome was a composite score evaluating both major thrombotic and bleeding adverse events occurring within the first 30 postoperative days weighted by their severity (weights were established a priori using a Delphi consensus process). Analyses followed the intention-to-treat principle.
  
  
  RESULTS
  We randomized 291 patients (n=145, aspirin group, and n=146, placebo group). The most frequent surgical procedures were orthopaedic surgery (52.2%), abdominal surgery (20.6%), and urologic surgery (15.5%). No significant difference was observed neither in the primary outcome score [mean values (SD)=0.67 (2.05) in the aspirin group vs 0.65 (2.04) in the placebo group, P=0.94] nor at day 30 in the number of major complications between groups.
  
  
  CONCLUSIONS
  In these at-risk patients undergoing elective non-cardiac surgery, we did not find any difference in terms of occurrence of major thrombotic or bleeding events between preoperative maintenance or interruption of aspirin.
authors.affiliation: APHP, Hôpital Beaujon, Service d'Anesthésie Réanimation et SMUR, Clichy F-92110, France. jean.mantz@bjn.aphp.fr
authors.forename: J
authors.initials: J
authors.lastname: Mantz
authors.forename: C M
authors.initials: CM
authors.lastname: Samama
authors.forename: F
authors.initials: F
authors.lastname: Tubach
authors.forename: P J
authors.initials: PJ
authors.lastname: Devereaux
authors.forename: J-P
authors.initials: JP
authors.lastname: Collet
authors.forename: P
authors.initials: P
authors.lastname: Albaladejo
authors.forename: B
authors.initials: B
authors.lastname: Cholley
authors.forename: R
authors.initials: R
authors.lastname: Nizard
authors.forename: J
authors.initials: J
authors.lastname: Barré
authors.forename: V
authors.initials: V
authors.lastname: Piriou
authors.forename: N
authors.initials: N
authors.lastname: Poirier
authors.forename: A
authors.initials: A
authors.lastname: Mignon
authors.forename: S
authors.initials: S
authors.lastname: Schlumberger
authors.forename: D
authors.initials: D
authors.lastname: Longrois
authors.forename: F
authors.initials: F
authors.lastname: Aubrun
authors.forename: M E
authors.initials: ME
authors.lastname: Farèse
authors.forename: P
authors.initials: P
authors.lastname: Ravaud
authors.forename: P G
authors.initials: PG
authors.lastname: Steg
mesh_terms: D000368:Aged; D001241:Aspirin / Q000008:administration & dosage / Q000627:therapeutic use*; D017558:Elective Surgical Procedures; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D019106:Postoperative Hemorrhage / Q000139:chemically induced*; D011300:Preoperative Care; D013927:Thrombosis / Q000517:prevention & control*
chemical_list: D010975:Platelet Aggregation Inhibitors; D001241:Aspirin