Introduction Successful treatment of STEMI requires early diagnosis and urgent passivation of the culprit lesion by antithrombotic therapy and mechanical revascularisation. A delicate balance exists between the risk of thrombosis and bleeding, consequently the choice of antithrombotic therapy is critical. Bivalirudin, a direct thrombin inhibitor, has been shown to offer a superior safety profile over heparin and GP2b3a inhibition in STEMI (Horizons-AMI). Similarly, the novel P2Y12-receptor inhibitor, Prasugrel, achieves faster and more consistent platelet inhibition than clopidogrel with improved clinical outcomes in STEMI (TRITON-TIMI 38). Although untested in a randomised clinical trial, the combination of bivalirudin and prasugrel for the treatment of STEMI appears to offer fast and effective inhibition of thrombosis with an acceptable bleeding profile. A randomised trial is in progress (BRAVE 4) but data will not be available until 2013.
Methods Since June 2010 our preferred treatment strategy for patients presenting with STEMI has been pre-loading with prasugrel 60 mg and peri-procedural bivalirudin (0.75 mg/kg bolus followed by an infusion of 1.75 mg/kg/h). Patients >75 yrs, <65 kg, with a history of cerebrovascular accident, pre-treated with clopidogrel or intubated without NG tube access were excluded and received treatment according to operator preference. The preferred access site was the radial artery and all operators were experienced in performing percutaneous coronary intervention from this route. Patients were discharged on lifelong aspirin and prasugrel 10 mg for 12 months. Additionally, patients routinely received statin, ACE inhibitor and β-blocker therapy. Consecutive patients were enrolled over a 12-month period commencing in July 2010.
Results In total 533 patients presented with STEMI and underwent treatment with PPCI in the study period. Of these 345 received a prasugrel loading dose and bivalirudin treatment (Group A). The remaining 188 patients received alternative therapy (Group B). Baseline demographics (Abstract 132 table 1) differ significantly between groups due to the criteria used for drug regimen selection. Procedural outcomes are summarised in Abstract 132 table 2. Procedural success was achieved in 97.6% of patients, using radial access in 79.9%. Bleeding occurred in 1.9% of all patients (Group A 1.2%). Stent thrombosis occurred in 1.1% of patients and no definite early stent thrombosis was observed in Group A. The 30-day death rate was 6% with 2.6% in Group A.
Conclusions Use of bivalirudin and prasugrel in the acute treatment of STEMI demonstrates excellent efficacy and safety. The Horizons-AMI data suggested a risk of early stent thrombosis in the absence of heparin, however, our heparin-naive cohort were free of this complication. Furthermore, our combined strategy of anti-thrombotic therapy and preferred radial access maintains very low access-site complication rates. Randomised trial data confirming this strategy is awaited.
- Acute coronary syndrome
- anti-platelet therapy
- primary percutaneous coronary intervention