The results of the HEAT-PPCI trial suggest that systematic use of heparin rather than bivalirudin after primary percutaneous coronary intervention (PPCI) - the most commonly used treatment for heart attack, which unblocks the arteries carrying blood to the heart - could save health services substantial sums of money, at the same time as potentially improving patient outcomes.
Patients who undergo PPCI usually receive a combination of antithrombotic drugs to prevent any further blood clots forming during the procedure and after it has been completed. The most commonly used antithrombotic drugs are unfractionated heparin and bivalirudin, and although several previous trials have compared the two drugs, the evidence is unclear as to which drug results in better outcomes.
The trial took place at the Liverpool Heart and
The results show that overall rates of major adverse cardiac events were significantly lower in the group who received heparin, although the rates of adverse events were low, as expected, in both groups. Within 28 days after surgery, 46 patients (5•1%) in the bivalirudin group died, compared to 39 (4•3%) of patients in the heparin group; 24 patients (2•7%) in the bivalirudin group had another heart attack in the same period, compared to 7 patients (0•8%) in the heparin group. Although bleeding complications are an acknowledged risk of antithrombotic drugs, there was no significant difference between the groups in the rate of complications.
According to lead author
In a linked Comment,
The design of the HEAT-PPCI trial has attracted some criticism within the medical community because of its use of delayed consent: patients provided their consent to participate only after they had been given either heparin or bivalirudin, leading some doctors to raise concerns that the trial design did not conform to medical ethics standards.
However, in a second linked Comment,
"Informed consent for percutaneous coronary intervention is frequently not sought at all; why patients should be asked to consent in advance to formal randomisation of a drug used in the intervention is thus unclear. It would have been unethical to have done the study differently. Attempting to get consent from patients would have increased the risk of harming them by delaying treatment, and could also have affected recruitment."
Keywords for this news article include: Anticoagulants, Antithrombotic, Pharmaceuticals, Drugs, Surgery, Hospital, Angiology, Cardiology, The Lancet, Bivalirudin, Heparin Therapy, Thrombin Inhibitors.
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