title: Long-term reduction of mortality in the 4-year follow up of tirofiban therapy in elective percutaneous coronary interventions (TOPSTAR) trial.
abstract: BACKGROUND
  TOPSTAR was a randomized, placebo-controlled trial studying the effects of adding the glycoprotein IIb/IIIa inhibitor tirofiban to conventional treatment with aspirin and clopidogrel in patients undergoing elective percutaneous coronary interventions (PCI). TOPSTAR demonstrated a lower periprocedural troponin release and a reduced 6-month mortality risk following PCI. The present study analyzed the corresponding long-term effects.
  
  
  METHODS
  All 96 patients who were initially included were followed for a minimum of 4 years (median follow-up time, 4.3 years). The prespecified endpoints were: 1) all-cause mortality and 2) the combined endpoint of all-cause death, myocardial infarction and target vessel revascularization by intention-to-treat analysis in patients randomly assigned to elective PCI. Survival analyses were carried out using Kaplan-Meier analysis and Cox proportional hazard regression.
  
  
  RESULTS
  After 4 years of follow up, no differences were observed between the two groups with respect to medical therapy, NYHA classification and number of reinterventions and target vessel revascularizations. All-cause mortality was still higher in the placebo group (10.9%; 5/46) compared with the tirofiban group (0%; 0/50; Kaplan-Meier log rank = 0.017). The combined endpoint occurred in 21.7% (10/46) in the placebo group versus 8.0% (4/50) in the tirofiban group (Kaplan-Meier log rank = 0.056).
  
  
  CONCLUSIONS
  The reduced 6-month mortality risk after elective PCI in the TOPSTAR trial persisted after 4 years of follow up. Even in this relatively small study, periprocedural effective platelet inhibition had a sustained impact on long-term mortality risk.
authors.affiliation: University Hospital Würzburg, Würzburg, Germany.
authors.forename: Bjoern
authors.initials: B
authors.lastname: Lengenfelder
authors.forename: Stefan
authors.initials: S
authors.lastname: Stoerk
authors.forename: Lena
authors.initials: L
authors.lastname: Boes
authors.forename: Joerg
authors.initials: J
authors.lastname: Strotmann
authors.forename: Georg
authors.initials: G
authors.lastname: Ertl
authors.forename: Wolfram
authors.initials: W
authors.lastname: Voelker
authors.forename: Andreas W
authors.initials: AW
authors.lastname: Bonz
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D001241:Aspirin / Q000627:therapeutic use; D000077144:Clopidogrel; D023903:Coronary Restenosis / Q000097:blood / Q000401:mortality* / Q000517:prevention & control*; D004359:Drug Therapy, Combination; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000097:blood / Q000401:mortality* / Q000517:prevention & control*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D015996:Survival Rate; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000077466:Tirofiban; D016896:Treatment Outcome; D014336:Troponin / Q000097:blood; D014443:Tyrosine / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D005343:Fibrinolytic Agents; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D014336:Troponin; D014443:Tyrosine; D000077144:Clopidogrel; D000077466:Tirofiban; D013988:Ticlopidine; D001241:Aspirin