Studies highlight advances in diagnosis, medical therapy

At one year, death occurred in 4.4 percent of patients treated with heparin plus GPI, 4.2 percent of patients treated with bivalirudin plus GPI, and 3.8 percent of patients treated with bivalirudin alone, differences that were not statistically significant. The trend toward a reduced late death rate among patients treated with bivalirudin alone could be attributed to a reduction in major bleeding at 30 days, which was shown to affect late mortality. At one year, the three groups of patients had nearly identical combined rates of death, heart attack, or unplanned procedures to relieve ischemia, a shortfall of blood and oxygen to the heart muscle (16.3 percent vs. 16.5 percent vs. 16.4 percent, respectively).

"These results, in concert with the 30-day data previously published from ACUITY, demonstrate that bivalirudin alone results in similar rates of long-term survival and freedom from adverse ischemic events as more complicated and expensive medical regimens, and reduces major bleeding, minor bleeding, and the need for blood transfusions while simplifying care in high-risk patients with acute coronary syndromes," said Dr. Stone.

In the 7,158 patients who were treated with stents, the ACUITY investigators also evaluated the risk of blood clotting, or thrombosis, in or near the stent—a complication that can cause heart attack and even death, and has been shown in some studies to be more common with drug-eluting stents. The results of the ACUITY trial showed that, at one year, stent thrombosis occurred in 2.2 percent of patients. A similar rate of stent thrombosis was noted in the 4,630 patients treated with one or more drug-eluting stents (2.2 percent) and the 2,528 patients treated with only bare metal stents (2.3 percent). The rate of stent thrombosis was similar with the three anticlotting regimens tested in the ACUITY trial.

"The incidence of stent thrombosis is a critically relevant topic today, especially in high-risk patients with acute coronary syndromes," said Dr. Stone. "These data, carefully collected and adjudicated by a committee blinded to stent type, provide reassuring evidence that long-term stent thrombosis rates are not higher with drug-eluting stents when compared to bare metal stents," Dr. Stone said.

Dr. Stone will present the one-year results of the ACUITY trial at a Late Breaking Clinical Trials session on Monday, March 26, at 2 p.m.

Significant Reduction in Mitral Regurgitation Twelve Months Following Percutaneous Mitral Valve Repair: Initial Experience With the MitraClip Device (Presentation Number: 2414-3)

A catheter-mounted device that acts like a clothespin to clip together the flaps of a leaky heart valve is offering patients with moderate-to-severe mitral regurgitation a long-lasting alternative to open-chest surgery. One-year results from the first phase of the Endovascular Valve Edge-to-Edge REpair STudies (EVEREST I) confirm earlier findings that after successful treatment with the MitraClip, a substantial majority of patients continue to experience only mild leakage, or regurgitation, through the mitral valve separating the left atrium (the upper chamber of the heart) from the left ventricle (the lower chamber). Several patients have also been followed-up for three years, with similarly long-lasting benefits.