Abstract 5489: Provisional (bail-out) Use versus Routine Use of Glycoprotein 2b/3a Blockers in Stemi: A Sub-analysis From the On-time 2 Trial
Background: In daily practice, in patients (pts) with acute ST-elevation myocardial infarction, glycoprotein 2b/3a blockers use is often limited to the provisional use in case of complications after PCI. However, it is unknown whether this strategy is of any value as compared to the routine use of these agents before PCI.
Methods: The On-TIME 2 trial compared routine pre-hospital initiation of high dose Tirofiban (HDT) versus provisional use of HDT in a randomized placebo controlled design. Thrombotic bail-out use of study medication was pre-defined and part of the combined clinical end-point. Within the pts who received blinded bail-out treatment, we compared pts who were pre-treated with placebo and received bail-out HDT (Tirofiban bail-out) versus those who were pre-treated with HDT and received bail-out placebo (Placebo bail-out).
Results: Blinded bail-out use of study medication was used in 24% (237/980) of pts, with a significant higher use in pts pre-treated with placebo (29% (140/492) versus 20% (97/488), p=0.002). The indication for bail-out use of study medication was mostly distal embolisation or no-reflow after PCI and did not differ between the groups (73.6% vs 75.3% p=NS). As expected, bail-out use of study medication was associated with more residual ST deviation (5.5±7.2 vs 3.7±4.8mm), larger infarct size (median (IQR): 1750 (674–3117) vs 948 (379–2278) IU), and worse outcome (MACE 12.2% vs 5.6%, p<0.01 for all comparisons) as compared to no-bail-out treatment, table⇓.
Conclusion: Routine pre-hospital treatment with HDT significantly reduced the use of blinded bail-out study medication. Bail-out study medication was associated with larger infarct size and poor outcome, especially in those pts pre-treated with placebo. Therefore, routine pre-treatment with HDT is preferred over provisional use of HDT in pts with STEMI. It is highly questioned whether provisional use of glycoprotein 2b3a blockers in case of complications after PCI is effective at all.