title: Diazepam versus fentanyl for premedication during percutaneous coronary intervention: results from the Myocardial Protection by Fentanyl during Coronary Intervention (PROFIT) Trial.
abstract: BACKGROUND
  Sedation is a cornerstone in the premedication for percutaneous coronary intervention (PCI). Benzodiazepines and opioids are frequently used. Previous results suggest that opioids mimic the adaptation to ischemia during repeated balloon inflations and may provide direct myocardial protection in addition to their sedative effect. However, no comparative data exist.
  
  
  METHODS
  We conducted a prospective, randomized, controlled, single-blind trial comparing diazepam and fentanyl in 276 patients undergoing elective PCI. Patients were randomized to either diazepam 5 mg sublingually or fentanyl 0.05 mg or 0.1 mg intravenously at least 5 minutes prior to the first balloon inflation. The primary end-point was the postprocedural elevation of myocardial markers of necrosis defined as an elevation of cardiac troponin T > or = 0.01 ng/ml.
  
  
  RESULTS
  The three groups had similar baseline clinical, angiographic, and procedural characteristics, with no significant differences in lesion morphology, procedural complexity, or adjunctive medical treatment. No significant variation in the hemodynamic response to the study drugs was observed in the three groups. The rate of postprocedural troponin T elevation was 28% in the diazepam group, 20% in the fentanyl 0.05 mg group, and 30% in the fentanyl 0.1 mg group (P = 0.26). Rates of postprocedural myocardial infarction were 3%, 2%, and 2%, respectively (P = 0.84), with one case of in-hospital death in the diazepam group and no urgent TVR in the whole study population.
  
  
  CONCLUSIONS
  Although providing a well-tolerated alternative to diazepam for sedation during PCI, fentanyl did not provide additional cardioprotection assessed through the postinterventional elevation of cardiac troponin T during elective coronary intervention.
authors.affiliation: Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH (Academic Teaching Hospital of the University of Kiel), Bad Segeberg, Germany.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abdel-Wahab
authors.forename: Ahmed A
authors.initials: AA
authors.lastname: Khattab
authors.forename: Branislav
authors.initials: B
authors.lastname: Liska
authors.forename: Guido
authors.initials: G
authors.lastname: Kassner
authors.forename: Volker
authors.initials: V
authors.lastname: Geist
authors.forename: Ralph
authors.initials: R
authors.lastname: Toelg
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
mesh_terms: D000759:Adjuvants, Anesthesia / Q000627:therapeutic use; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D002316:Cardiotonic Agents / Q000627:therapeutic use*; D003975:Diazepam / Q000627:therapeutic use*; D005260:Female; D005283:Fentanyl / Q000627:therapeutic use*; D006801:Humans; D019157:Ischemic Preconditioning, Myocardial / Q000379:methods; D008297:Male; D011292:Premedication; D011300:Preoperative Care / Q000379:methods*; D011446:Prospective Studies; D020107:Troponin T / Q000187:drug effects
chemical_list: D000759:Adjuvants, Anesthesia; D002316:Cardiotonic Agents; D020107:Troponin T; D003975:Diazepam; D005283:Fentanyl