Tirofiban bij STEMI patiënten na PCI
De On-TIME 2 studie heeft aangetoond dat vroege behandeling met hoge bolus dosis van tirofiban leidt tot verbetering ST afwijkingen. In deze studie is tirofiban op harde eindpunten onderzocht.
De auteurs concluderen dat 'STEMI patiënten die een PCI ondergaan en een vroege, voor-aankomst-in-het-ziekenhuis, hoge bolus tirofiban krijgen in combinatie met een hoge dosis clopidogrel op klinische eindpunten verbeteren'.Nieuws - 1 juni 2010
Effect hoge bolus tirofiban bij patiënten met STEMI op korte- en lange termijn klinische eindpunten
Objectives: The purpose of this trial was to study the effect of a high bolus dose (HBD) of tirofiban on clinical outcome in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI).
Background: The On-TIME 2 (Ongoing Tirofiban In Myocardial infarction Evaluation 2) placebo-controlled, double-blind, randomized trial showed that early administration of HBD tirofiban in the ambulance improves ST-segment resolution in patients with STEMI undergoing primary percutaneous coronary intervention. The effect of early tirofiban treatment on clinical outcome is unclear.
Methods: The On-TIME 2 trial consisted of 2 phases: an open-label phase, followed by a double-blind, placebo-controlled phase. STEMI patients were randomized to either HBD tirofiban or no tirofiban (phase 1) or placebo (phase 2) in addition to aspirin, heparin, and high-dose clopidogrel. The protocol pre-specified a pooled analysis of the 2 study phases to assess the incidence of major adverse cardiac events at the 30-day follow-up and on total mortality at the 1-year follow-up.
Results: During a 3-year period, 1,398 patients were randomized, 414 in phase 1 and 984 in phase 2. Major adverse cardiac events at 30 days were significantly reduced (5.8% vs. 8.6%, p = 0.043). There was a strong trend toward a decrease in mortality (2.2% vs. 4.1%, p = 0.051) in patients who were randomized to tirofiban pre-treatment, which was maintained during the 1-year follow-up (3.7% vs. 5.8%, p = 0.08). No clinically relevant difference in bleeding was observed.
Conclusions: Early, pre-hospital initiation of HBD tirofiban, in addition to high-dose clopidogrel, improves the clinical outcome after primary percutaneous coronary intervention in patients with STEMI.
St Antonius Hospital, Nieuwegein, the Netherlands.
ten Berg JM
SOURCE: J Am Coll Cardiol. 2010 Jun 1;55(22):2446-55.