title: [Statistical notes. Which risks do the patient incur if his own cardiologist accepts to be involved in a clinical trial without deep consideration of the a priori available evidence?].
abstract: The aim of this statistical note is to describe the results of the randomized controlled clinical trial TARGET, which compared the effect of tirofiban (new treatment) and abciximab (standard treatment) in patients who were expected to undergo coronary stenting. Primary aim of TARGET was to evaluate the non-inferiority of tirofiban with respect to abciximab, but it concluded in favor of superiority of the standard treatment. The authors of this study point out that a deep consideration regarding a priori available evidence could have avoided to expose 2398 patients randomized to tirofiban to the risk of death or non-fatal myocardial infarction.
authors.affiliation: Istituto di Statistica Medica e Biometria, Università degli Studi, Milano. ettore.marubini@unimi.it
authors.forename: Ettore
authors.initials: E
authors.lastname: Marubini
authors.forename: Paola
authors.initials: P
authors.lastname: Rebora
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Reina
mesh_terms: D000077284:Abciximab; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000925:Anticoagulants / Q000627:therapeutic use*; D016001:Confidence Intervals; D003627:Data Interpretation, Statistical; D005069:Evaluation Studies as Topic; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D010817:Physician-Patient Relations; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D012307:Risk Factors; D015607:Stents; D000077466:Tirofiban; D016896:Treatment Outcome; D014443:Tyrosine / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000911:Antibodies, Monoclonal; D000925:Anticoagulants; D005343:Fibrinolytic Agents; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D014443:Tyrosine; D000077466:Tirofiban; D000077284:Abciximab