Home > Interventional Cardiology, Journal Club > Journal Club 8 July 2014

Journal Club 8 July 2014

Paper

Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): an open-label, single centre, randomised controlled trial

Presenter

KL

Summary

Background

Bivalirudin, with selective use of glycoprotein (GP) IIb/IIIa inhibitor agents, is an accepted standard of
care in primary percutaneous coronary intervention (PPCI). We aimed to compare antithrombotic therapy with
bivalirudin or unfractionated heparin during this procedure.

Methods

In our open-label, randomised controlled trial, we enrolled consecutive adults scheduled for angiography in
the context of a PPCI presentation at Liverpool Heart and Chest Hospital (Liverpool, UK) with a strategy of delayed
consent. Before angiography, we randomly allocated patients (1:1; stratifi ed by age [<75 years vs ≥75 years] and
presence of cardiogenic shock [yes vs no]) to heparin (70 U/kg) or bivalirudin (bolus 0·75 mg/kg; infusion
1·75 mg/kg per h). Patients were followed up for 28 days. The primary effi cacy outcome was a composite of all-cause
mortality, cerebrovascular accident, reinfarction, or unplanned target lesion revascularisation. The primary safety
outcome was incidence of major bleeding (type 3–5 as per Bleeding Academic Research Consortium defi nitions).
This study is registered with ClinicalTrials.gov, number NCT01519518.

Findings

Between Feb 7, 2012, and Nov 20, 2013, 1829 of 1917 patients undergoing emergency angiography at our
centre (representing 97% of trial-naive presentations) were randomly allocated treatment, with 1812 included in the
final analyses. 751 (83%) of 905 patients in the bivalirudin group and 740 (82%) of 907 patients in the heparin group
had a percutaneous coronary intervention. The rate of GP IIb/IIIa inhibitor use was much the same between groups
(122 patients [13%] in the bivalirudin group and 140 patients [15%] in the heparin group). The primary effi cacy
outcome occurred in 79 (8·7%) of 905 patients in the bivalirudin group and 52 (5·7%) of 907 patients in the heparin
group (absolute risk diff erence 3·0%; relative risk [RR] 1·52, 95% CI 1·09–2·13, p=0·01). The primary safety outcome
occurred in 32 (3·5%) of 905 patients in the bivalirudin group and 28 (3·1%) of 907 patients in the heparin group
(0·4%; 1·15, 0·70–1·89, p=0·59).

Interpretation

Compared with bivalirudin, heparin reduces the incidence of major adverse ischaemic events in the
setting of PPCI, with no increase in bleeding complications. Systematic use of heparin rather than bivalirudin would
reduce drug costs substantially.

Supplementary Material

Commentary 1
Commentary 2

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