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HEAT-PPCI TRIAL |
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| Problem | Primary PCI for acute myocardial infarction |
| Format | Open-label, single centre, randomised controlled trial |
| Treatment | Heparin (70 U/kg) |
| Control | Bivalirudin (bolus 0.75 mg/kg; infusion 1.75 mg/kg per h) |
| Population | 1829 patients |
| Inclusion criteria | All patients presenting with a suspected myocardial infarction event with PPCI as the proposed index reperfusion strategy will be included in the trial. |
| Exclusion criteria | ≤ 18 years of age Known intolerance, hypersensitivity or contraindication to any trial medication Active bleeding at presentation Artificial ventilation, reduced conscious level or other factors precluding the administration of oral antiplatelet therapy Previous enrolment in this trial |
| Follow-up | 28 days |
| Primary endpoint | Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition |
| Secondary endpoint(s) | CKMB Release Following Index Revascularisation Measured With a Single Estimation 12-18 Hours After the Procedure Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition Stent Thrombosis Rate (ARC Definite or Probable) For Illustration, and to Allow Comparison With Existing Trials the Rate of Net Adverse Clinical Events (NACE), Combining the Primary Safety and Efficacy Outcomes All Cause Mortality [ Time Frame: 1 year ] Development of Thrombocytopenia Door-to-first Device Time |
| Details | 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). |
| Brief summary: | Heparin reduces the incidence of major adverse ischaemic events in the setting of PPCI, with no increase in bleeding complications |
| PAPER: Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): an open-label, single centre, randomised controlled trial. | |
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| Date | 4 Jul 2014 |
| Journal | Lancet. 2014 Nov 22;384(9957):1849-58. doi: 10.1016/S0140-6736(14)60924-7. Epub 2014 Jul 4. |
| Information | Unlike previous studies, GP IIb/IIIa inhibitor use was similar between both arms (unlike HORIZONS-AMI). MACE at 28 days higher for bivalirudin arm vs UFH -(79 of 905 (8·7%)) vs (52 of 907 (5·7%)) -Relative risk [RR] 1·52, 95% CI 1·09–2·13, p=0·01). Difference powered by reduction in re-infarction and target vessel revasc for UFH Bleeding was similar -32 (3·5%) of 905 patients in the bivalirudin group -28 (3·1%) of 907 patients in the heparin group -(0·4%; 1·15, 0·70–1·89, p=0·59). |