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

Shahzad, Adeel; Kemp, Ian; Mars, Christine; Wilson, Keith; Roome, Claire; Cooper, Robert; Andron, Mohammed; Appleby, Clare; Fisher, Mike; Khand, Aleem; Kunadian, Babu; Mills, Joseph; Morris, John L.; Morrison, W.L.; Munir, Shahzad; Palmer, Nick; Perry, Raphael A.; Ramsdale, David R.; Velavan, Periaswamy; Stables, Rod

doi:10.1016/s0140-6736(14)60924-7

Cited by 487 publications

(452 citation statements)

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“…21 Our study confirmed an excess of definite stent thrombosis among patients in the bivalirudin group; this higher rate in the bivalirudin group than in the heparin group appeared to be less pronounced on either an absolute basis (0.4 percentage points) or a relative basis (71%) than that reported previously. [7][8][9] This finding may reflect the inclusion of patients with non-ST-segment elevation acute coronary syndromes, 10 the early administration of oral P2Y 12 inhibitors, 22 or both. Prolonging the administration of bivalirudin well after completion of the intervention did not result in a lower risk of definite stent thrombosis after coronary revascularization, a finding that was consistent with the results of the EUROMAX study.…”

Section: Discussionmentioning

confidence: 98%

“…Previous studies that have compared these two options among patients who were undergoing invasive treatment for an acute coronary syndrome have provided conflicting results with respect to ischemic, bleeding, or combined outcomes. 3,[6][7][8][9][10] We therefore conducted a large multicenter, randomized trial involving patients with an acute coronary syndrome who were undergoing coronary angiography and anticipated percutaneous coronary intervention (PCI) with access through the radial or femoral route to assess whether bivalirudin is superior to unfractionated heparin and discretionary use of glycoprotein IIb/IIIa inhibitors.…”

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confidence: 99%

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Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes

et al. 2015

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BACKGROUNDConflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome. METHODSWe randomly assigned 7213 patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin. Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion. Primary outcomes for the comparison between bivalirudin and heparin were the occurrence of major adverse cardiovascular events (a composite of death, myocardial infarction, or stroke) and net adverse clinical events (a composite of major bleeding or a major adverse cardiovascular event). The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events. RESULTSThe rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin (10.3% and 10.9%, respectively; relative risk, 0.94; 95% confidence interval [CI], 0.81 to 1.09; P = 0.44), nor was the rate of net adverse clinical events (11.2% and 12.4%, respectively; relative risk, 0.89; 95% CI, 0.78 to 1.03; P = 0.12). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (11.0% and 11.9%, respectively; relative risk, 0.91; 95% CI, 0.74 to 1.11; P = 0.34). CONCLUSIONSIn patients with an acute coronary syndrome, the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin. The rate of the composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion. (Funded by the Medicines Company and Terumo Medical; MATRIX ClinicalTrials.gov number, NCT01433627.)

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Section: Discussionmentioning

confidence: 98%

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confidence: 99%

Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes

et al. 2015

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“…The recently published Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI) trial (20), a single-centre study comparing bivalirudin to UFH alone in all-comers with STEMI, reported a numerical increase in major bleeding and a significantly higher rate of major adverse cardiac events with bivalirudin compared to UFH alone. The excess of major adverse cardiac events was attributed mainly to higher rates of MI in the bivalirudin group.…”

Section: Discussionmentioning

confidence: 99%

Comparative efficacy and safety of anticoagulant strategies for acute coronary syndromes

Navarese

Andreotti²,

Kołodziejczak³

et al. 2015

Thromb Haemost

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SummaryInternational guidelines differ in strengths of recommendation for anticoagulation strategies in acute coronary syndromes (ACS). We performed a comprehensive network meta-analysis (NMA) of randomised controlled trials (RCTs) to investigate the comparative efficacy and safety of parenteral anticoagulants in ACS. MEDLINE, Cochrane, EM-BASE, Google Scholar, major cardiology websites, and abstracts/presentations were searched. Six treatments were identified: 1) unfractionated heparin (UFH) + glycoprotein IIb/IIIa inhibitor (GPI)[UFH+GPI], 2) UFH±GPI, 3) bivalirudin, 4) low-molecular-weight heparins (LMWHs), 5) otamixaban, and 6) fondaparinux. Prespecified outcomes (death, myocardial infarction [MI], revascularisation, major bleeding [MB], minor bleeding, and stent thrombosis [ST]) were evaluated up to 30 days. Forty-two RCTs involving 117,353 patients were included. No significant differences in mortality rates were found among strategies. Compared to UFH+GPI, bivalirudin reduced the odds of MB but increased the odds of ST and MI. LMWHs vs bivalirudin reduced MI risk at the price of MB excess. UFH±GPI significantly increased the odds of MI vs LMWHs, of ST vs UFH+GPI, and of MB vs bivalirudin. Reduced ST risk with otamixaban vs UFH±GPI and vs bivalirudin was offset by a marked 2.5-to four-fold MB excess. Fondaparinux showed an intermediate profile. Results for ST-segment elevation MI were consistent with the overall findings. Early anticoagulant strategies for ACS differ in efficacy and safety, with UFH+GPI and LMWHs reducing ischaemic but increasing bleeding risk, and bivalirudin reducing MB but increases MI and ST. The findings support individualised therapy based on patients' bleeding and ischaemic risks.

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“…This is a particular consideration in patients undergoing PCI who receive in any case aspirin, a P2Y 12 inhibitor and an anticoagulant so that also administering a GPIIb/IIIa antagonist means inhibiting a fourth pathway involved in platelet activation and aggregation and thus compounding the bleeding risk ( Figure 1). Having said this, the use of only oral therapies and short courses of anticoagulation are associated with unacceptable rates of acute stent thrombosis in patients undergoing PCI for ST-elevation myocardial infarction [34,35].…”

Section: Unmet Need In Antiplatelet Therapymentioning

confidence: 99%

Cangrelor for the management and prevention of arterial thrombosis

Storey

Sinha

2016

Expert Review of Cardiovascular Therapy

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SUMMARYCangrelor is an intravenous, reversibly-binding platelet P2Y 12 receptor antagonist with ultra-rapid onset and offset of action. It is approved in Europe and United States for use in patients undergoing percutaneous coronary intervention, a setting in which it has proven superiority to initial treatment with clopidogrel. Preliminary clinical evidence suggests it would also be a favourable option in bridging patients from discontinuation of oral antiplatelet therapy to the time of major surgery. This review describes the background for the development of cangrelor, the biology, pharmacology and clinical evidence supporting its use, and its likely position in the future.

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

Cited by 487 publications

References 14 publications

Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes

Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes

Comparative efficacy and safety of anticoagulant strategies for acute coronary syndromes

Cangrelor for the management and prevention of arterial thrombosis

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