Key result
Novel prasugrel, enoxaparin, and bivalirudin regimen shows comparable severe bleeding risk versus other treatments.
Why the study?
Does a novel antithrombotic regimen combining pre-hospital prasugrel and enoxaparin with in-hospital bivalirudin reduce major bleeding in patients undergoing primary PCI for STEMI?
Observational (n=390)
No
Does a novel antithrombotic regimen combining pre-hospital prasugrel and enoxaparin with in-hospital bivalirudin reduce major bleeding in patients undergoing primary PCI for STEMI?
Absolute Event Rate: 0% vs 1%
p-value: p=0.311
A novel antithrombotic regimen of pre-hospital prasugrel and enoxaparin followed by in-hospital bivalirudin appears safe with low bleeding rates in STEMI patients undergoing pPCI, though the treated group had lower baseline risk scores.
May support regimen safety in lower-risk STEMI pPCI; hypothesis-generating and requires randomized confirmation before practice change.
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.
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Viikilä et al. (2016) conducted an observational in Acute ST-segment elevation myocardial infarction (STEMI) (n=390). Prasugrel, enoxaparin, and bivalirudin vs. Other antithrombotic treatment was evaluated on Severe GUSTO bleeding within 30 days (p=0.311). A novel antithrombotic regimen combining pre-hospital prasugrel, enoxaparin, and in-hospital bivalirudin resulted in 0% severe GUSTO bleeding at 30 days, comparable to 1.0% with other treatments.
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