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Study: Cheaper Drug for Heart Attack Procedure Could Improve Outcomes, Save Health Budgets Millions

Heparin preferable to bivalirudin after coronary intervention, authors find

A new study published in The Lancet compares outcomes for two drugs used to prevent blood-clot formation during emergency treatment of a heart attack.

The study suggests that the use of heparin could result in improved outcomes (such as a reduced rate of repeat heart attacks) compared with bivalirudin (Angiomax, The Medicines Company), which is in widespread use in high-income countries and is around 400 times more expensive than heparin.

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 — could save health services substantial sums of money while potentially improving patient outcomes.

Patients who undergo PPCI usually receive a combination of antithrombotic drugs to prevent further blood clots during the procedure and after it has been completed. The most commonly used antithrombotic drugs are unfractionated heparin and bivalirudin. Although several trials have compared the two treatments, the evidence was unclear as to which drug provides better outcomes.

The new study was conducted at the Liverpool Heart and Chest Hospital in the U.K., where 1,829 patients undergoing emergency angiography were recruited. More than 80% of these patients went on to receive PPCI; approximately half received heparin, and half received bivalirudin. The researchers then recorded how many patients in both groups experienced a major adverse cardiac event, such as death or another heart attack, within 28 days after surgery.

The results showed that overall rates of major adverse cardiac events were significantly lower in the group that received heparin. Within 28 days after surgery, 46 patients (5.1%) in the bivalirudin group died compared with 39 patients (4.3%) in the heparin group. Moreover, 24 patients (2.7%) in the bivalirudin group experienced another heart attack during the same period, compared with seven patients (0.8%) in the heparin group.

Although bleeding complications are an acknowledged risk of antithrombotic drugs, there was no significant difference between the two groups in the rate of complications.

A related editorial points out that although the study had several limitations — including an open-label, single-center design — it has the advantage of resembling actual clinical practice as it included patients who would have been excluded from earlier trials that compared the two drugs.

The editorial notes: “Even if heparin alone had produced statistically similar outcomes to bivalirudin, it would have been a win for heparin. A drug that costs less than 1/400th of another that has similar efficacy and safety ought to be used preferentially.”

The design of the HEAT-PPCI trial has drawn some criticism in 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.

Sources: Lancet; July 5, 2014; and EurekaAlert; July 4, 2014.

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