St. Jude Medical Announces One-Year Results From MASCOT Trial

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials
Article Date: 08 Nov 2007 - 4:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

St. Jude Medical, Inc. (NYSE:STJ) announced the one-year results from its 409-patient Management of Atrial Fibrillation Suppression in AF-HF Comorbidity Therapy (MASCOT) trial. The findings were presented during a late-breaking clinical trials session of the American Heart Association Scientific Sessions 2007 in Orlando, Fla.

The MASCOT trial was designed to determine whether the St. Jude Medical Atrial Fibrillation (AF) Suppression pacing algorithm prevents permanent AF - the most severe stage of AF - in patients receiving cardiac resynchronization therapy (CRT). This AF Suppression algorithm already has been shown to decrease symptoms of paroxysmal AF (where patients experience episodes of AF) in certain pacemaker patients. MASCOT was a European multicenter, prospective randomized trial designed to evaluate the development of AF in CRT patients.

Unexpectedly, the incidence of permanent AF in the control group was much lower (3.3 percent, representing six patients) than anticipated. The incidence of permanent AF was also low, 3.3 percent (seven patients), in the study group. The low incidence in both groups made it difficult to measure the impact, or to draw conclusions, about AF Suppression therapy's effects in this subgroup of heart failure patients. Based on previous studies, the incidence of permanent AF in the control group was expected to be 8 percent to 9 percent.

Importantly, however, the study showed the AF Suppression algorithm is safe in these patients and does not impair patient response to CRT, confirming the results observed in a previous St. Jude Medical investigational device examination (IDE) clinical study.

"The historic incidence of permanent AF in heart failure patients is around 9 percent, but in our trial the surprisingly small percentage of patients with this condition complicated our efforts to assess the benefits of AF Suppression treatment," said Professor Luigi Padeletti, M.D., full professor of cardiology and director of the Postgraduate School of Cardiology, University of Florence, Italy, who was the principal investigator in the study. "Still, we are encouraged by the positive safety signal observed, and we continue to believe that this approach may represent a major advance in the treatment of AF and heart failure by electrical stimulation."

The MASCOT study was a single-blind, controlled clinical trial that enrolled two groups of patients, all of whom received CRT with a St. Jude Medical device. Most patients had severe (NYHA Class III) heart failure, and 19 percent had a history of paroxysmal AF. The active group had the devices programmed with the AF suppression algorithm; that algorithm was turned off in the control group. Patients will be followed for an additional year to evaluate the incidence of permanent AF at two years.

"While in the MASCOT trial the incidence of permanent AF in this subgroup of patients was too low to draw conclusions, the previous ADOPT study showed that the AF Suppression feature decreases symptoms of AF in a different subgroup of pacemaker patients, specifically patients with sinus bradycardia (slow heart rates) and paroxysmal (not permanent) AF," said Mark D. Carlson, M.D., chief medical officer and senior vice president of clinical affairs in St. Jude Medical's Cardiac Rhythm Management Division.

AF and chronic heart failure share many characteristics, with heart failure a common cause of AF and AF often exacerbating heart failure. Both conditions are increasing in prevalence and carry with them significant morbidity, mortality and health care costs.

CRT is a therapy that stimulates both the right and left side of the heart to improve the heart's ability to pump. Current eligibility requirements for implanting a CRT system focus on ejection fraction (the amount of blood the heart pumps with each beat from the ventricle), NYHA Class (severity of heart failure symptoms) and QRS duration (measurement of the heart's electrical dyssynchrony).

Heart failure is a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood to the body. About 5 million Americans, and 6 million Europeans, suffer from heart failure. AF is the most common abnormal heart rhythm and affects an estimated 2.3 million people in North America and 4.5 million Europeans.

About St. Jude Medical

St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 12,000 people worldwide. For more information, please visit http://www.sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings, and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Company's Annual Report on Form 10-K filed on February 28, 2007 (see pages 13-20) and Quarterly Report on Form 10-Q filed on August 9, 2007 (see pages 26-29). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

St. Jude Medical