ACC 50th Annual Scientific Session
Late-Breaking Clinical Trials II

(#414) 8:30-10:00 a.m.

TUESDAY, MARCH 20, 2001

EMBARGOED FOR RELEASE
March 20, 2001
Time of Presentation
or News Conference (EST)
Contact: Melanie Caudron or Katherine Doermann; March 18-21: 407-685-5410. After March 21: 301-897-2628, media@acc.org

Two atrial fibrillation treatments yield similar outcomes in preliminary study

(ORLANDO, FLA.)—Patients with atrial fibrillation fare about equally well with either of an abnormal heart rhythm's two major treatment approaches—rhythm control and rate control—according a randomized controlled study. The pilot trial, "Strategies of Treatment of Atrial Fibrillation," or STAF, is the first study of its kind to use clinical events as measures of treatment success.

The goal of rhythm control, currently the most common way to manage atrial fibrillation, is to use drugs or electrical shocks to convert the heart rhythm from abnormal to normal. Other drugs may be given in an attempt to maintain the normal rhythm, but subsequent recurrences are common.

With rate control, little effort is made to normalize the abnormal heart rhythm. Instead, drugs are used to control its various consequences. For example, antiarrhythmic agents may be given to keep the heart pumping blood at a normal rate. And blood thinners can be used to prevent the formation of clots, which can potentially cause strokes.

In STAF, the rate of death, stroke, and other clinical events over one and a half years in the trial's 200 randomized patients was about same on either treatment strategy. Although it is a pilot trial designed to guide further research, said Dr. Joerg Carlsson, "The trial's strong message is that rhythm and rate control lead to similar outcomes."

Dr. Carlsson, of Klinikum Lippe, Detmold, Germany, will present the results of STAF onTuesday, March 20, at 8:30 a.m. at the American College of Cardiology 50th Annual Scientific Session in Orlando, Fla.

**Pacemaker-Synchronized Heart Pumping Explored as a Treatment for Heart Failure

(ORLANDO, FLA.)—A randomized, double-blind trial has tested whether a form of pacemaker therapy might join the wide array of medications already used for the treatment of heart failure.

Heart failure, a chronic disorder in which the heart's pumping action is insufficient to meet the body's need for blood, "is not simply a problem of heart muscle weakness," said Dr. William T. Abraham. "In up to 50 percent of patients, heart failure also involves an electrical abnormality," one that causes the four heart chambers to contract out of sync, reducing pumping efficiency. Although no medications are available to correct the electrical problem, Dr. Abraham said, cardiac resynchronization therapy using atrial-synchronous biventricular pacemaker devices have shown promise in prior preliminary studies.

The "Multicenter In-Sync Randomized Clinical Evaluation" (MIRACLE) is the largest double-blind controlled trial of cardiac resynchronization therapy for chronic heart failure, said Dr. Abraham, chief of the Division of Cardiovascular Medicine at the University of Kentucky, Lexington. He will present six-month clinical, functional, and quality-of-life results for the study's approximately 600 patients on Tuesday, March 20, at 8:45 a.m. at the American College of Cardiology 50th Annual Scientific Session in Orlando, Fla.

**Beta blocker reduces hospitalizations in patients with the most advanced chronic heart failure

(ORLANDO, FLA.)—Treatment with the beta blocker carvedilol significantly reduced the risk of hospitalization in patients with the most advanced form of chronic heart failure in the "Carvedilol Prospective Randomized Cumulative Survival" trial (COPERNICUS).

COPERNICUS investigators last year reported that carvedilol was associated with a significant 35 percent decline in the risk of death in their patients with such advanced, so-called New York Heart Association class IV heart failure. But, in addition, "We found a rather dramatic reduction in the risk of hospitalization, which was true regardless of whether we looked at hospitalization for any reason, for only heart failure or for any other cardiovascular cause," said Dr. Milton Packer, of Columbia University College of Physicians and Surgeons, New York City.

COPERNICUS patients had the most advanced stable heart failure ever studied in a beta blocker trial, Dr. Packer observed. He is scheduled to present the trial's results on hospitalizations, clinical outcomes, and drug safety at 9 a.m. on Tuesday, March 20, at the American College of Cardiology 50th Annual Scientific Session in Orlando, Fla.

**Beta-blocker carvedilol tested in heart-attack patients with reduced cardiac function

(ORLANDO, FLA.)—Patients who have recently suffered a heart attack often have reduced cardiac function, which may or may not cause symptoms but generally gets worse if left untreated. A number of available medications can greatly improve the condition, postinfarction left ventricular dysfunction, but they don't work well by themselves in everyone who might benefit.

The large, placebo-controlled CAPRICORN trial has tested whether the addition of carvedilol, a beta blocker, to standard medications in heart-attack survivors with left ventricular dysfunction might improve their survival or reduce their chances of being hospitalized. More than 1,900 patients were enrolled in the trial and followed for an average of 1.25 years.

CAPRICORN, whose full name is "Carvedilol Post-Infarct Survival Control in Left Ventricular Dysfunction," is the first randomized trial of its kind to test whether a beta blocker can improve survival in patients with postinfarction left ventricular dysfunction, according to Dr. Henry J. Dargie.

Dr. Dargie, of the University of Glasgow, United Kingdom, is scheduled to present the trial's results on Tuesday, March 20, at 9:15 a.m. at the American College of Cardiology 50th Annual Scientific Session in Orlando, Fla.

**Endothelin-blocker may provide treatment alternative for acute heart failure

(ORLANDO, FLA.)—Patients with advanced heart disease can be stricken with an episode of heart failure so severe it is a life-threatening emergency. Available medications for such acute decompensated heart failure have a number of drawbacks. They can cause irregular heart rhythms, for example, or dangerously reduce the amount of blood flow to the heart muscle. But a recently introduced class of drugs, called endothelin receptor antagonists, may provide a safer alternative.

"This kind of drug therapy could provide a whole new strategy for treating a condition that costs us a high number of hospitalizations," said Dr. Guillermo Torre-Amione, Baylor College of Medicine, Houston.

The RITZ-2 study, a "Prospective Randomized, Double-Blind Placebo-Controlled Multicenter Study of the Efficacy and Safety of Tezosentan in Patients With Acute, Decompensated Heart Failure," tested whether the novel treatment can improve the clinical outcome of patients when added to standard treatments.

Tezosentan, like other endothelin receptor antagonists, blocks the function of endothelins. They are natural proteins that elevate blood pressure by constricting blood vessels, temporarily fighting off the effects of heart failure. Over time, however, the effects of too much endothelin can further damage the heart, said Dr. Torre-Amione, who directs the Heart Transplant Center at Baylor.

"Vasodilators like tezosentan improve the amount of blood pumped by the heart without necessarily stressing the heart more," said Dr. Torre-Amione. He will present the results of RITZ-2 on Tuesday, March 20, at 9:30 a.m. at the American College of Cardiology 50th Annual Scientific Session in Orlando, Fla.

Ultrasound Catheter Improves the Outcome of Stenting in Long Arterial Narrowings

(ORLANDO, FLA.)—X-ray images of the heart vessels are typically used to guide the placement of coronary stents, tiny metal scaffolds that are better, overall, than angioplasty balloons at keeping diseased arteries open. But stents have reduced effectiveness in keeping open long coronary lesions—narrowings that occupy long heart-vessel segments. According to a randomized study, the outcome of coronary stenting of lesions longer than 20 millimeters is greatly improved if the procedure is guided by intravascular ultrasound, an imaging technique that can visualize arterial segments from the inside out.

"In the difficult subset of patients with long coronary artery lesions, intravascular ultrasound guidance of stent implantation is superior to the common practice of using only angiography to guide the procedure," said Dr. Pranobe Oemrawsingh, of Leiden University Medical Center, the Netherlands.

Dr. Oemrawsingh is scheduled to present preliminary six- to 12-month follow-up results of the study, called HARTZ, on Tuesday, March 20, at 9:45 a.m. at the American College of Cardiology 50th Annual Scientific Session in Orlando, Fla.

** Denotes news conference. See the news conference schedule for more information.

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