MADIT II at 8 years: 1 life saved for every six patients 2

Eight year followup of the MADIT II trial provides the first substantial evidence for the long term mortality benefits of ICDs. Mortality at 8 years was 45% in the ICD group compared to 61% in controls. The mortality difference was statistically significant in the first 4 years of the study and also in the last 4 years. The results were presented at the annual meeting of the Heart Rhythm Society in Boston.

ICD benefits were significantly greater in those patients who had symptomatic heart failure during the trial. In addition, patients with dual chamber devices had a higher risk of death during the extended followup, while patients with single-chamber devices enjoyed enhanced benefits.

“The results of the extended follow-up of the MADIT-II trial provide hope for long-term survival among patients suffering from life-threatening heart conditions that can often times lead to sudden cardiac death, a leading killer in this country and abroad,” stated lead author Ilan Goldenberg, in an HRS press release. “This study proves that ICD therapy, sustained for over eight years, does in fact improve survival rates and ultimately save lives.”

You can download the PDF of the abstract.

Here is the press release from HRS:

Late-Breaking Clinical Trial Results Announced at Heart Rhythm 2009: MADIT-II Trial
New trial reveals long-term outcomes of patients treated with an ICD, sustained survival benefits after eight years of follow-up

BOSTON, May 14, 2009 — Results of the Multicenter Automatic Defibrillator Trial II (MADIT-II), a late-breaking clinical trial presented today at Heart Rhythm 2009, the Heart Rhythm Society’s 30th annual Scientific Sessions, show a significant reduction in the risk of long-term mortality in patients with an implantable cardioverter defibrillator (ICD) versus patients without an ICD. During an eight-year follow-up period, multivariate analysis demonstrated that ICD therapy is associated with improved survival for patients with serious heart health risks.
» Download Long-Term Outcome after Implantation of a Cardioverter Defibrillator: An Eight Year Follow-Up Study of the Multicenter Automatic Defibrillator Trial II abstract (PDF, 111K)

The MADIT-II trial enrolled 1,232 patients with ischemic left ventricular dysfunction and follow-up was conducted through November 2001. For the current long-term efficacy study, researchers acquired post-trial mortality data for all study patients from the U.S. and European National Death Registries. Modeling was carried out to determine the long-term outcomes of patients with an ICD versus patients not treated with an ICD.

“The results of the extended follow-up of the MADIT-II trial provide hope for long-term survival among patients suffering from life-threatening heart conditions that can often times lead to sudden cardiac death, a leading killer in this country and abroad,” stated lead author Ilan Goldenberg, MD, of the Heart Research Follow-up Program at the University of Rochester Medical Center in Rochester, New York. “This study proves that ICD therapy, sustained for over eight years, does in fact improve survival rates and ultimately save lives.”

After a cumulative follow-up period of eight years, results of the MADIT-II trial reveal an all-cause mortality probability of 45 percent among patients with an ICD as compared to 61 percent among patients without an ICD. The 16 percent increase corresponds to 1.2 life-years saved with an ICD during an eight-year period.

While ICD therapy was shown to result in significant survival benefits in the first four years of follow-up, analysis proves that ICD therapy was associated with additional life-saving benefits during the extended four to eight years of follow-up, proving the overall survival benefit from an ICD was sustained over an eight year period. The study also found that long-term device efficacy was enhanced among patients who received a limited amount of right ventricular pacing from the ICD and among those who did not develop heart failure progression during the study.

About Heart Rhythm 2009
Heart Rhythm 2009 takes place May 13-16 at the Boston Exhibition and Convention Center. The meeting is the most comprehensive educational event on heart rhythm disorders, offering approximately 250 educational opportunities in multiple formats. The world’s most renowned scientists and physicians will present a wide range of heart rhythm topics including cardiac resynchronization therapy, catheter ablation, cardiac pacing and heart failure as well as the latest technology, including state-of-the-art pacemakers and defibrillators.

Here is the press release from Boston Scientific:

New MADIT II Clinical Data Analysis Shows Long-Term Survival Benefit for Implantable Defibrillator Therapy

Analysis indicates that one life is now saved for every six patients who receive an ICD

NATICK, Mass., May 14 /PRNewswire-FirstCall/ — Boston Scientific Corporation (NYSE: BSX) today announced that an analysis of long-term data from the MADIT II clinical study demonstrates that the life-saving benefits of implantable cardioverter defibrillator (ICD) therapy remain sustainable at eight years. This is the first time long-term data have been presented regarding the life-saving benefits of ICDs in a primary prevention population. The analysis was presented during a late-breaking session at the Heart Rhythm Society Scientific Sessions in Boston.

The analysis shows a sustainable mortality benefit over time, including:

* At eight years, one life is saved for every six patients who receive an ICD. This represents a significant improvement over the two-year MADIT II data, which showed one life saved for every 17 patients.
* A 41 percent relative reduction in the risk of death for ICD patients at four years
* A 37 percent relative reduction in the risk of death for ICD patients at eight years

The MADIT II study, sponsored exclusively by Boston Scientific, was designed to determine whether ICDs improve survival when compared to drug therapy alone in heart attack survivors with moderate impairment of the left ventricle, the heart’s main pumping chamber. Initial results published in the New England Journal of Medicine (March 21, 2002) demonstrated that ICD therapy reduced the relative risk of death by 31 percent at 20 months follow-up.

“ICD therapy has proved effective in patients at risk of sudden cardiac death, and now the long-term MADIT II data show the life-saving benefits of these devices continue over time,” said Arthur J. Moss, M.D., Professor of Medicine at the University of Rochester Medical Center and Principal Investigator of the MADIT, MADIT II and MADIT-CRT trials.

“We are proud to have been the exclusive sponsor of landmark trials like MADIT II,” said Fred Colen, President, Boston Scientific Cardiac Rhythm Management. “More than 80 percent of U.S. patients who receive an ICD or CRT-D were first indicated for this life-saving therapy through Boston Scientific clinical research.”(1)

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our product performance, clinical outcomes, regulatory approval of our products, and our growth strategy. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and, future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A- Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file thereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.

(1) Trials include MADIT, MADIT II, CONTAK-CD, and COMPANION.

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