Safety of the primary percutaneous coronary intervention strategy combining pre-hospital prasugrel, enoxaparin and in-hospital bivalirudin in acute ST-segment elevation myocardial infarction

Backround: The optimal antithrombotic treatment during a primary percutaneous coronary intervention (pPCI) is not known. This single center registry study aims to assess the safety of a novel antithrombotic regimen combining enoxaparine and prasugrel at presentation, followed by bivalirudin at the catheterisation laboratory. Methods: All consecutive patients who underwent a pPCI were collected prospectively. The primary endpoint was major bleeding within 30 days. The secondary endpoints were a composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, a new target vessel revascularisation and all-cause mortality at 30 days. Results: Ninety-nine out of the total of 390 patients were treated according to the new regimen (protocol-treated group). The rest received other antithrombotic treatment (non-protocol-treated group). The protocol-treated group had a lower risk than the non-protocol-treated group according to the GRACE ischaemic (112 vs. 124, p = 0.002) and CRUSADE bleeding scores (21 vs. 28, p < 0.0001). The incidences of bleeding were similar: severe GUSTO or TIMI bleeding occurred in 0 % of the protocol-treated group and in 1.0 and 0.3 %, respectively, of the other group (p = 0.311 for GUSTO and p = 0.559 for TIMI). The incidence of MACE in the groups was 6.1 and 10.7 %, respectively (p = 0.178). The respective incidences of all-cause mortality were 5.1 and 9.6 % (p = 0.158). Conclusions: Administration of the novel antithrombotic regimen seems to be safe.