American College of Cardiology

Clinical trials broaden treatment options for heart failure patients
News Conference: 7:30-8:15 a.m., EST, Tuesday, March 20

(ORLANDO, FLA.)— Four clinical trials, being presented at the American College of Cardiology 50th Annual Scientific Session, March 18-21, 2001, provide advances for treating heart failure patients who suffer from irregular heartbeats, have the most advanced chronic heart failure or suffer from reduced heart function, or experience a severe, acute attack of the disease. These studies will be the focus of a news conference on Tuesday, March 20, at 7:30 a.m.

A randomized, double-blind trial (#414-3) 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. (Original presentation on March 20, 8:45 a.m.)

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, #414-5).

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. (Original presentation on March 20, 9 a.m.)

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 (#414-7) 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, of the University of Glasgow, United Kingdom. (Original presentation on March 20, 9:15 a.m.)

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 they could 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 (#414-9), 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. (Original presentation on March 20, 9:30 a.m.)

Moderator: Dr. Barry Massie, University of California, San Francisco, VA Medical Center.

Studies highlight progress in lipid-lowering therapy
News conference: 10:15-11 a.m., EST, Tuesday, March 20

(ORLANDO, FLA.)—Several studies being presented at the American College of Cardiology 50th Annual Scientific Session in Orlando, Fla., March 18-21, 2001, explore advances in lipid-lowering therapy, including an expanded understanding of which patients benefit from these medications and how to better achieve target cholesterol levels. New, more effective medications are also the focus of ongoing research.

Four studies that together enrolled nearly 1,700 patients from the United States and Europe compared the effectiveness of an experimental statin, ZD4522 (rosuvastatin), to other forms of therapy for high blood cholesterol. When considered as a whole, the evidence showed that rosuvastatin was significantly more effective than diet or other statins in reducing blood levels of total and low-density lipoprotein (LDL) cholesterol—so-called "bad" cholesterol—and increasing blood levels of high-density lipoprotein (HDL) cholesterol—so-called "good" cholesterol. Rosuvastatin was effective both in patients with a severe form of inherited high cholesterol (Evan A. Stein, #1261-175 and #1261-176) and in those with a more common form of high cholesterol not caused by a genetic abnormality (Rodolfo Paoletti, #1261-174; Michael H. Davidson, #1261-175). (Original presentations on March 20 at a 3-4 p.m. poster session.)

Too few patients with coronary artery disease receive cholesterol-lowering therapy, according to a report from University Hospital, Maastricht, the Netherlands (Frank Vermeer, #1095-181). Data from two research projects with a combined total of more than 4,800 patients showed that only 45-76 percent were receiving cholesterol-lowering therapy at the time of enrollment and that fewer than half had been prescribed a drug dosage high enough to achieve an acceptable blood cholesterol level. (Original presentation on March 19 at a 9-10 a.m. poster session.)

A study from Essen, Germany, found that getting patients involved in monitoring their own cholesterol levels was an effective way to improve blood lipid levels (Johannes Schaar, #1161-175). All 135 patients in the study were on statins and had been counseled by a dietitian. Half of the patients were randomly assigned to check their own cholesterol levels approximately every other week and seek additional counseling if cholesterol levels worsened. At the end of six months, total and LDL cholesterol levels were significantly lower in the self-assessment group. (Original presentation on March 19 at a 3-4 p.m. poster session.)

After a heart attack or episode of unstable angina, an early start on lipid-lowering therapy can be lifesaving, according to a study from the Cleveland Clinic Foundation (Herbert D. Aronow, #831-1). Researchers analyzed data from nearly 21,000 patients enrolled in the GUSTO IIb and PURSUIT trials. They found that patients who were taking lipid-lowering medications at discharge were 20 percent less likely to experience a heart attack or die within six months when compared to patients sent home without these medications. (Original presentation on March 19, 2-2:15 p.m.)

A similar study from Brigham and Women's Hospital in Boston found that long-term survival was better among patients who received early lipid-lowering therapy while hospitalized for a heart attack (Robert P. Giugliano, #1053-91). The study analyzed the clinical outcomes of more than 14,000 patients enrolled in the InTIME-II trial, whose main purpose was to compare the effectiveness of two different types of clot-dissolving medications. The researchers found that the approximately one-third of patients who also received lipid-lowering medications while in the hospital were 20-36 percent less likely to die within one year when compared to those who did not receive these medications. (Original presentation on March 18 at a 4-5 p.m. poster session.)

Moderator: Dr. Richard Pasternak, Massachusetts General Hospital, Boston

Experts focus cardiovascular spotlight on women and minorities
News conference: 11:15-noon, EST, Tuesday, March 21

(ORLANDO, FLA.)—Two symposia being presented at the American College of Cardiology (ACC) 50th Annual Scientific Session in Orlando, Fla., March 18-21, 2001, explore both the clinical and socioeconomic factors that influence the risk for heart disease in a variety of ethnic groups. Why women and minorities are less likely to receive high-quality cardiovascular care and how to remedy the problem also will be addressed.

At a symposium sponsored by both the ACC and the Association of Black Cardiologists, experts will report the findings of a joint committee established in March 2000 to study ethnic and gender disparities in the access to cardiovascular care (#650). Co-chaired by Dr. George A. Mensah, Centers for Disease Control and Prevention, Atlanta, and Dr. Marian C. Limacher, University of Florida, Gainesville, the symposium will explore the scope of the problem, factors that contribute to it, and recommendations for its elimination. (Original presentation on March 20 at a 4-5 p.m. symposium.)

A separate symposium will focus on cardiovascular risk factors in minority groups (#650). Among the topics on the agenda are hypertension in African Americans (Elizabeth O. Ofili) and genetics and cardiovascular disease in Hispanic populations (Jerry Nadler. (Original presentations on March 21 at a 8:30-10 a.m. symposium.)

Moderator: Dr. Charles Francis, Charles R. Drew University of Medicine & Science, Los Angeles

Sessions highlight importance—and controversies—of heart-healthy diets
News conference: 1-1:45 p.m., EST, Tuesday, March 20

(ORLANDO, FLA.)—One of the first steps in preventing and treating heart disease is adopting a heart-healthy diet. But which is the right one? High-fat, low-carbohydrate or low-fat, vegetarian? That question will be debated by two leading diet gurus at the American College of Cardiology 50th Annual Scientific Session in Orlando, Fla., March 18-21, 2001. Two research studies shed additional light on the subject as well.

Facing off on which foods should fill a heart patient's cupboards are Dr. Robert Atkins, founder of the Atkins Center for Complementary Medicine in New York City, and Dr. Dean Ornish, founder of the Preventive Medicine Research Institute in Sausalito, Calif. (#635). Dr. Atkins champions a high-fat, low-carbohydrate diet, while Dr. Ornish advocates a low-fat, vegetarian approach, coupled with exercise, stress reduction, and smoking cessation. Each will present arguments and data on why he believes his diet is the best. (Original presentations on March 20 at a 10:30 a.m.-noon symposium.)

The high-fat, low-carbohydrate diet gained support from a study from Mount Sinai Medical Center in Miami Beach, Fla. (Y. Wady Aude, #1226-164). Researchers randomly assigned 45 adults to eat either a low-fat, high-carbohydrate diet or a more conventional heart-healthy diet with a limited intake of saturated fats and cholesterol. After three months, they found that the conventional heart-healthy diet was significantly more effective in reducing blood levels of low-density lipoprotein (LDL, or "bad") cholesterol. However, only the high-fat, low-carbohydrate diet produced a significant reduction in the number of small, dense LDL particles, a type of LDL cholesterol that is believed responsible for damaging coronary arteries and causing them to narrow with cholesterol plaque. (Original presentation on March 20 at a noon-1 p.m. poster session.)

Evidence supporting the vegetarian diet came from a study that used fast computed tomography to image the arteries of elderly members of the Adventist faith (David Grout, #1059-61). Researchers from Sydney Heart Image of Sydney Adventist Hospital and West Australian Heart Research Institute, Perth, found that the Adventist group—who were vegetarians and did not smoke—had significantly lower coronary calcium scores when compared to a matched group of elderly healthy volunteers. The calcium score indicates how much hardened cholesterol plaque—or atherosclerosis—is in the coronary artery. (Original presentation on March 18 at a 3-4 p.m. poster session.)

Moderator: Dr. Paul Thompson, Preventive Cardiology and Cholesterol Management Center, Hartford Hospital, Hartford, Conn.