title: The efficacy and safety of clopidogrel in vascular surgery patients with immediate postoperative asymptomatic troponin T release for the prevention of late cardiac events: Rationale and design of the Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echo-VII (DECREASE-VII) trial.
abstract: BACKGROUND
  Major vascular surgery patients are at high risk for developing asymptomatic perioperative myocardial ischemia reflected by a postoperative troponin release without the presence of chest pain or electrocardiographic abnormalities. Long-term prognosis is severely compromised and characterized by an increased risk of long-term mortality and cardiovascular events. Current guidelines on perioperative care recommend single antiplatelet therapy with aspirin as prophylaxis for cardiovascular events. However, as perioperative surgical stress results in a prolonged hypercoagulable state, the postoperative addition of clopidogrel to aspirin within 7 days after perioperative asymptomatic cardiac ischemia could provide improved effective prevention for cardiovascular events.
  
  
  METHODS
  DECREASE-VII is a phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial designed to evaluate the efficacy and safety of early postoperative dual antiplatelet therapy (aspirin and clopidogrel) for the prevention of cardiovascular events after major vascular surgery. Eligible patients undergoing a major vascular surgery (abdominal aorta or lower extremity vascular surgery) who developed perioperative asymptomatic troponin release are randomized 1:1 to clopidogrel or placebo (300-mg loading dose, followed by 75 mg daily) in addition to standard medical treatment with aspirin. The primary efficacy end point is the composite of cardiovascular death, stroke, or severe ischemia of the coronary or peripheral arterial circulation leading to an intervention. The evaluation of long-term safety includes bleeding defined by TIMI criteria. Recruitment began early 2010. The trial will continue until 750 patients are included and followed for at least 12 months.
  
  
  CONCLUSIONS
  DECREASE-VII is evaluating whether early postoperative dual antiplatelet therapy for patients developing asymptomatic cardiac ischemia after vascular surgery reduces cardiovascular events with a favorable safety profile.
authors.affiliation: Department of Anesthesiology, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Jan-Peter
authors.initials: JP
authors.lastname: van Kuijk
authors.forename: Michiel T
authors.initials: MT
authors.lastname: Voute
authors.forename: Willem-Jan
authors.initials: WJ
authors.lastname: Flu
authors.forename: Olaf
authors.initials: O
authors.lastname: Schouten
authors.forename: Michel
authors.initials: M
authors.lastname: Chonchol
authors.forename: Sanne E
authors.initials: SE
authors.lastname: Hoeks
authors.forename: Eric E
authors.initials: EE
authors.lastname: Boersma
authors.forename: Hence J M
authors.initials: HJ
authors.lastname: Verhagen
authors.forename: Jeroen J
authors.initials: JJ
authors.lastname: Bax
authors.forename: Don
authors.initials: D
authors.lastname: Poldermans
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D001241:Aspirin / Q000008:administration & dosage*; D000077144:Clopidogrel; D025401:Echocardiography, Stress; D006801:Humans; D009203:Myocardial Infarction / Q000517:prevention & control*; D017202:Myocardial Ischemia; D009426:Netherlands; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D011182:Postoperative Care / Q000379:methods*; D011183:Postoperative Complications / Q000517:prevention & control; D012107:Research Design; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D020107:Troponin T / Q000378:metabolism*; D014656:Vascular Surgical Procedures / Q000009:adverse effects
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010975:Platelet Aggregation Inhibitors; D020107:Troponin T; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin