Bivalirudin Tops Treatment Standard In STEMI Patients Undergoing PCI

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Main Category: Cardiovascular / Cardiology
Also Included In: Blood / Hematology;  Clinical Trials / Drug Trials
Article Date: 17 Oct 2008 - 7:00 PDT

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WASHINGTON DC- Bivalirudin (AngiomaxR) is more effective than conventional therapy involving heparin plus a platelet glycoprotein IIb/IIIa inhibitor (GPI) in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), according to updated results of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial.

The findings, reported here at the 20th Transcatheter Cardiovascular Therapeutics (TCT) meeting, showed that the direct thrombin inhibitor significantly decreased the incidence of cardiac-related death by 43 percent at one year compared with standard treatment and significantly reduced all-cause mortality by 31 percent. Bivalirudin monotherapy was also associated with a 39 percent decrease in major bleeding complications.

Gregg Stone, MD, with New York Hospital Presbyterian Hospital/Columbia University Medical Center in New York City and co-workers randomized 3,602 patients to bivalirudin with provisional use of GPI or heparin plus GPI. Participants in the trial were also randomized to receive either a drug-eluting or bare-metal stent.

The two primary study endpoints were major bleeding and net adverse clinical events, a composite of major adverse cardiovascular events (death, reinfarction, stroke or ischemic target vessel revascularization) and major bleeding at 30 days.

In addition to decreasing cardiac-related death, all-cause death, and major bleeding compared to conventional heparin plus GPI at one year, bivalirudin monotherapy also significantly reduced the incidence of net adverse clinical events by 16 percent. There were no differences between the two treatment groups in the rate of major adverse cardiac events.

The data are in line with previous studies demonstrating an association between decreased major bleeding in PCI patients and increased long-term survival.

"Mortality was a pre-specified endpoint in the trial, and we had a very powerful dataset," commented co-investigator Harvey White, MD, with Auckland City Hospital in Auckland, New Zealand. "The findings are very meaningful for patient care, and I can't think of a group where I wouldn't give bivalirudin."

He said that he would use bivalirudin in elderly patients, female patients, thrombocytopenic patients, "low-weight" patients, and renal failure patients, among others. More research into high-risk subsets, he said, will further refine who is likely to benefit most but "a priori, all patients should benefit."

Importantly, the treatment is easy to administer, added co-investigator Roxana Mehran, MD, with Columbia University, who presented the pharmacologic data. "It's very easy to use as long as you have an IV line. All it involves is a bolus dose followed by an infusion. What's great about is that is that at the end of the procedure, we just stop everything and the patient leaves after placement of a vascular closure device."

She added that she hopes that more emergency rooms start using bivalirudin monotherapy since most MI patients present to the emergency room rather than the cardiac catheterization laboratory.

The HORIZONS-AMI trial, which is the largest to date to examine the appropriate use of anticoagulation medications and stents in STEMI patients undergoing PCI, also found that the drug-eluting stent decreased target lesion revascularization and binary angiographic restenosis more than the bare-metal stent. There were similar rates of major adverse cardiovascular events with the two stents.

Nearly half a million Americans experience STEMI each year.

Written by Jill Stein
jillstein03<@)gmail.com
Jill Stein is a Paris-based freelance medical writer.
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