Cath Lab Digest - May 2008 - (Page 11)

11 the summation of the contribution of every wall of the heart and its loading conditions. The EF misses changes occurring at a regional level, such as improvement in wall motion with exercise. This is especially important in evaluating areas that have been injected with cells. Importantly, even small changes in EF may result in significant clinical outcome for individuals, as well as for groups of patients. While we may envision an increase in EF from 35% to 50% (normal), that degree of improvement is unlikely to be achieved. So I would caution the use of EF as a primary efficacy endpoint in clinical studies, especially in the stem cell field. Still, in a study like SEISMIC, where patients were not blinded, there may be a placebo effect. That’s the advantage of a placebo-controlled study and the logical next step to eliminate patient and investigator bias. We have introduced this in the MARVEL study. Can you discuss the upcoming MARVEL study? The first thing people should be looking for are potential subjects — this is a recruitment pitch! The MARVEL study has the potential to transform how we will treat congestive heart failure patients in the future. This is an exciting opportunity for study site teams, to fully engage in enrolling patients and be a part of history. Patients we refer for treatment today, or never get a chance to treat in the cath lab, may become our patients tomorrow. The target population, and the largest component of the heart failure patient population in the U.S., is comprised of patients who have had heart attacks, who have had coronary disease, and who may have undergone percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) to rectify coronary disease and salvage whatever is possible by way of ventricular function. We are looking for a group of patients who have New York Heart Association class II, III or early IV heart failure; patients whose prognosis clearly sets them apart from those who have class I or early II heart failure, and those who have no heart failure. MARVEL is a randomized, placebo-controlled study of patients with heart failure after a heart attack, with two treatment groups and one placebo group. The two treatment groups will each have a different MyoCell dosing level based on dosefinding data gathered prior to MARVEL. The low-dose group will receive 400 million cells and the high-dose group will receive 800 million cells. The control group will receive injections of a control media (placebo), such that the patients will not know what they received. We are looking to enroll a minimum of 330 patients, evenly distributed between the three groups. Each group will be carefully followed to assess both efficacy and safety. In the follow-up period their levels of activity will be monitored. The primary efficacy endpoint relates to how they feel and how far they can walk. These are the key elements of what the patients and their physicians are looking for: to feel better and to be more active. Hopefully, in doing so, we will enable them to live longer. (Note: the study is not powered to look at differences in mortality.). At the same time, we are investigating very careful parameters of ventricular function, building on what I had mentioned about EF and the other components that go into it. MARVEL will involve a very meticulous analysis of how various regions of the heart are working in response to either cell injection or placebo injection over time (at 3, 6 and 12 months). The other very, very important aspect for patients and physicians taking care of them is how we can keep patients out of the hospital. With current therapies, the incidence of admission of patients to the hospital is quite high, especially in those patients with class IV heart failure. This is a burden to all, especially to patients and their families and the healthcare system. In MARVEL, we will monitor the frequency of admissions for heart failure or worsening of heart failure in each treatment group. As a result, we expect the MARVEL trial to provide us with a better clinical handle on the effects of skeletal myoblast therapy than that of any other study undertaken to date. ■ Dr. Sherman can be contacted at the Center for Interventional Vascular Therapies, Columbia University Medical Center, New York, NY. In fact, ejection fraction is a fairly imprecise and somewhat variable number even in a single patient, because it represents the summation of the contribution of every wall of the heart and its loading conditions. http://www.lumedx.com/1point/

Table of Contents Feed for the Digital Edition of Cath Lab Digest - May 2008

Cath Lab Digest - May 2008 The King Faisal Specialist Hospital and Research Centre Cell Therapy in the Cath Lab for Heart Failure: A Look at MyoCell® Therapy and the SEISMIC Trial Performance Improvement Strategies Speed Up Treatment Times in the Management of ST-Elevation Myocardial Infarction (STEMI) Patients Contents Clinical Editor’s Corner Commentary: Performance Improvement Strategies Speed Up Treatment Times in the Management of ST-Elevation Myocardial Infarction (STEMI) Patients Ask the STEMI Expert Comparing Drug-Eluting Stents and Bare-Metal Stents SICP: The Ten-Minute Interview with… Christopher Kambak, RT(R) Cardiac Cath Lab Economics in a Public Hospital of a Developing Country Keeping Your Heart & Vascular Employees: Proven Ideas for an Effective Retention Plan Unspoken Words Ask the Clinical Instructor Society of Invasive Cardiovascular Professionals Meetings Calendar Education Center What Do You Think? Clinical & Industry News Classifieds Advertisers Index

Cath Lab Digest - May 2008

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