ACC 51st Annual Scientific Session Late-Breaking Clinical Trials

Late-Breaking Clinical Trials III (#421), 8:30-10:00 a.m.
WEDNESDAY, MARCH 20, 2002

EMBARGOED FOR RELEASE
March 20, 2002
Time of Presentation
or News Conference (EST)
Contact: Lisa Clough or Katherine Doermann; March 17-20: 404-222-5272. After March 20: 301-897-2628, media@acc.org


Heartbeat-correcting implant safely improves lives of heart failure patients

(ATLANTA)—The debilitating symptoms of heart failure are characterized by inefficient heart pumping that can result partly from poorly synchronized contractions of the organ’s two largest chambers, the ventricles. Recent research has strongly suggested that an implanted electronic device that corrects the timing of heart-chamber contractions can reverse some of those symptoms. Now a multicenter, randomized study has demonstrated with more authority that such cardiac resynchronization therapy is not only safe, but that it can also reverse some of the symptoms that limit the daily lives of patients with heart failure.

In the InSynch ICD Trial, 362 patients with moderate-to-severe heart failure and poorly timed ventricular contractions were implanted with a pacemaker-like device that can resynchronize the contractions and, if needed, deliver a shock if the ventricles should stop pumping blood at all. The patients were randomly assigned to have the resynchronization feature of their implants turned either on or off.

Those who had their ventricular contractions resynchronized fared significantly better over six months with respect to quality-of-life measures and their ability to perform a standard walking endurance test, according to Dr. James B. Young, of the Cleveland Clinic Foundation, Cleveland, Ohio.

Dr. Young is scheduled to present the results of the InSynch ICD Trial here on Wednesday, March 20, at 8:30 a.m., at the American College of Cardiology 51st Annual Scientific Session.


** Do statin drugs protect the heart after a patient’s first angioplasty?

(ATLANTA)—A randomized study promises to clarify whether statins, a class of cholesterol-lowering drugs that have become a mainstay for heart-disease prevention and treatment, can benefit patients who have recently undergone their first angioplasty. Such patients tend to be in the early stages of heart disease, yet only a third of them survive or remain free of heart attack or other major heart problems for more than 10 years.

The Lescol Intervention Prevention Study (LIPS) compared the three-year outcomes of more than 1,600 patients who began treatment with fluvastatin after a recent first angioplasty, the procedure that uses tiny balloons or the metal scaffolds called stents to widen heart vessels. Average levels of LDL cholesterol, one of several kinds of “bad” cholesterol, “were not markedly elevated” among patients in the trial, said Dr. Patrick Serruys. The LIPS trial could therefore provide important insights about statin therapy in a group of patients who are at high-risk but might not qualify as such based on an important traditional heart-disease risk factor, said Dr. Serruys, of the Thoraxcenter, Erasmus University Hospital, Rotterdam, The Netherlands.

Dr. Serruys will present the results of the international LIPS trial here on Wednesday, March 20, at 8:48 a.m., at the American College of Cardiology 51st Annual Scientific Session.


Randomized study is the largest ever in patients with a major hypertension complication

(ATLANTA)—Years of high blood pressure can thicken the heart muscle, weakening its ability to contract and pump blood. Such muscle thickening in the heart’s major left chamber, called left-ventricular hypertrophy or LVH, can be at least partially reversed by a number of antihypertensive medications. A large randomized trial is comparing the effectiveness of two such agents—one well established and widely used, the other recently introduced—in reversing LVH.

The Losartan Intervention For Endpoint reduction in hypertension study (LIFE) compared the beta blocker atenolol, long prescribed for high blood pressure, to losartan, a member of the relatively new class of medications called angiotensin-II antagonists. Both drugs are highly effective in patients with hypertension and LVH, but work in the body by different biologic mechanisms.

“The LIFE study, the largest study ever in hypertensive patients with LVH, has accumulated more than 44,000 patient-years of follow-up information,” said Dr. Björn Dahlöf, University of Göteborg and Ostra University Hospital, Göteborg, Sweden. “Whatever the outcome, it is likely to have an impact on the management of hypertensive patients.”

Dr. Dahlöf will present results from the LIFE trial here on Wednesday, March 20, at 9:06 a.m. at the American College of Cardiology 51st Annual Scientific Session.


Clot-busters vs. stents for heart attack: New data on a key issue may be conclusive

(ATLANTA)—Caught early enough, major heart attacks can be treated with either clot-dissolving drugs or combined use of the tiny balloons and metal scaffolds that prop open arteries. The first option—thrombolytic therapy—is the traditional mainstay of heart-attack therapy at most hospitals. But the more invasive second choice of coronary stenting is increasingly preferred, without firm scientific backing. Now, researchers say, a randomized trial has conclusively shown that one of the treatments is significantly more effective than the other.

“This trial deals with a very common question in the Western world,” said Dr. Henning R. Andersen, of Skejby University Hospital in Aarhus, Denmark. “For the past 10 to 15 years, we have used predominantly thrombolytic agents to treat acute myocardial infarction. But there has been an undocumented shift in many countries, especially the United States, in favor of using balloons and stents instead, without any conclusive data to support it.”

Unlike earlier studies, said Dr. Andersen, the recently concluded Danish Multicenter Randomized Trial on Thrombolytic Therapy Versus Acute Coronary Angioplasty in Acute Myocardial Infarction (DANAMI-2) has clearly shown that one of the two treatments prevents subsequent clinical events better than the other. Dr. Anderson is scheduled to present the trial’s primary 30-day results here on Wednesday, March 20, at 9:23 a.m. at the American College of Cardiology 51st Annual Scientific Session.



Novel drug combination reverses heart-muscle thickening caused by high blood pressure

(ATLANTA)—Poorly controlled high blood pressure can thicken the wall of the heart’s largest blood-pumping chamber and keep it from contracting effectively, a condition called left-ventricular hypertrophy or LVH. Many patients with elevated blood pressure take medications, including angiotensin-converting-enzyme (ACE) inhibitors, that can partially reverse the heart-wall thickening. But the addition of a relatively new drug to standard ACE inhibitor treatment appears to reverse LVH more effectively than an ACE inhibitor alone.

In the randomized 4E Study of patients with mild-to-moderate high blood pressure and LVH, the aldosterone inhibitor eplerenone reversed LVH as effectively as the ACE inhibitor enalapril, but the two agents combined did significantly better, observed Dr. Bertram Pitt, University of Michigan, Ann Arbor. Both drugs work on the renin-angiotensin-aldosterone system, one of the body’s key regulators of circulation.

Dr. Pitt is slated to present the results of 4E, which stands for Eplerenone, Enalapril and Eplerenone/Enalapril Combination Therapy in Patients with Left Ventricular Hypertrophy, here on Wednesday, March 20, at 9:41 a.m. at the American College of Cardiology 51st Annual Scientific Session.


** OVERTURE study could dramatically reshape heart failure therapy

(ATLANTA)—Researchers will unveil the results of a potentially ground-breaking trial on the management of heart failure at the 2002 American College of Cardiology Annual Scientific Session in Atlanta, just days after the study’s completion. Designed to test one of a new family of medications known as vasopeptidase inhibitors, the Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events, or OVERTURE study, has the potential to topple angiotensin-converting-enzyme (ACE) inhibitors from their role as the cornerstone therapy for heart failure.

In heart failure, the heart isn’t strong enough to pump enough blood each time it contracts. One result is an increase in blood levels of stress hormones, which in turn act on the heart and blood vessels to make heart failure worse. One of the effects of ACE inhibitors is to reduce the levels of harmful hormones that cause blood vessels to constrict. Omapatrilat has the potential to go one step further, not only limiting constriction of blood vessels by interfering with the renin-angiotensin system, as ACE inhibitors do, but also enhancing the body’s companion system for promoting relaxation of blood vessels by blocking an enzyme known as neutral endopeptidase (NEP).

With an international enrollment of 5,770 patients, OVERTURE is the largest controlled study ever to test a new treatment for heart failure. Participants with mild-to-severe heart failure were randomly assigned to receive either omapatrilat or the ACE inhibitor enalapril, in addition to other standard heart failure medications, such as digitalis, diuretics, and beta blockers. To date, follow-up has averaged approximately two years. At the ACC meeting, investigators will for the first time announce whether omapatrilat holds an edge over ACE inhibitors in two key measures: improving patient survival and reducing the frequency of hospitalization for heart failure. An investigational new drug, omapatrilat has not yet been approved for commercial marketing by the Food and Drug Administration.

The American College of Cardiology, a 28,000-member nonprofit professional medical society and teaching institution, is dedicated to fostering optimal cardiovascular care and disease prevention through professional education, promotion of research, leadership in development of standards and guidelines, and the formulation of health care policy.

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

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