Cath Lab Digest - September 2007 - (Page 33)

SEPTEMBER 2007 YOUR PATH TO SUCCESS: CAREER ADVICE 33 DRUG-ELUTING STENT SOLUTIONS Evidence-Based Medicine with Drug-Eluting Stents This monthly column in Cath Lab Digest reviews important points of distinction in drug-eluting stents, from characteristics to techniques, to provide valuable and relevant information about this technology. This article, the second of a two-part series on clinical data, focuses on evidence-based medicine and its role with drugeluting stents. By Dr. Sigmund Silber Sigmund Silber, MD, FACC, FESC, is Professor of Medicine at the University of Munich, and is in private cardiology practice in Munich, Germany. Q A What is evidence-based medicine? In my opinion, evidence-based medicine is the treatment of patients according to current knowledge, that is, evidence from major randomized controlled studies. Due to the large number of exclusion criteria in most of these studies, you will probably not be able to treat the majority of your patients according to evidence-based medicine. Evidence-based medicine can only be applied if your patient is similar to those who have been studied in these trials. How do you assess evidence? The first question you have to answer when applying evidence-based medicine is, what is the primary goal? Do I want to improve the patient’s quality of life, or do I want to treat a surrogate parameter, like late loss? A surrogate parameter substitutes for a clinical endpoint. Clinical endpoints are defined as clinical events, for example death, heart attack and repeat procedure. Surrogate endpoints, for example, late loss, serve as a proxy for the clinical endpoints. A surrogate endpoint, however, does not necessarily correlate with the clinical outcome. In other words, a primary clinical endpoint provides an indication of how well a treatment may affect the patient’s quality of life, such as need for reintervention with another hospitalization. The history of medicine is full of errors introduced by underpowered studies with surrogate endpoints. Most studies use surrogate parameters, not primary clinical endpoints, because surrogate endpoint studies are smaller and more cost-effective. But, with a small, underpowered study, you have a higher likelihood of arriving at the wrong conclusion. For example, in Europe, many drug-eluting stent (DES) trials are small, with only 20 to 25 patients. A stent may be approved in Europe (CE-marked) based on these small, underpowered trials. However, larger, randomized clinical trials later show that the stent does not work, or even worse, is harmful. A study that has a primary clinical endpoint is powered to evaluate whether a patient will have a better quality of life or not. For these larger trials, important points to note are whether the study is double-blinded and the timeframe of the primary endpoint. Effects of DES also occur after nine months, so longer observation periods are needed. Studies like TAXUS-IV, SIRIUS and ENDEAVOR-II are examples of good trials. Q A You make a good point about underpowered studies and surrogate endpoints. Do meta-analyses help to compensate for these shortcomings? You have a higher chance of being wrong. Meta-analyses attempt to compensate for this, but if you have many small, underpowered studies that lead to wrong conclusions, putting them together does not make them better. I think meta-analyses are good for generating a hypothesis, but then the hypothesis must be proven in a large, randomized clinical trial. continued on next page Back to School: The Value of Education in Cardiovascular Services Carol Dombrowicki, Recruitment Consultant, Corazon, Inc., Pittsburgh, Pennsylvania education or training is a crucial step in your pursuit of a higher-paid or higher-profile position at your organization. As we recruit cath lab directors, department managers, and service line administrators across the country, it’s clear that hospitals not only require clinical expertise, but also prefer candidates to have experience or higher degrees showing skills in the business and operational aspects of healthcare. In Corazon’s experience recruiting for cardiac and vascular management-level positions, 100% of our clients across the country require at least a bachelor’s degree for consideration. Also, with a higher degree in hand, your salary opportunity is greater. The time and money you spend for continuing education will pay off down the road with a higherpaying job, more responsibility, increased credibility and respect from colleagues and superiors, or just greater knowledge about your area of expertise. According to Salary.com, and using the Pittsburgh, PA market as an example, the difference in yearly salary for a cath lab tech with an associate’s degree and a manager of the cath lab with a bachelor’s degree can range between $10,000 and $25,000, with years of experience, tenure at the organization and other factors playing a part. Certainly, these are different jobs with different responsibilities, but if that is your desired career path, and the goal you have set for yourself is to climb the corporate ladder, the hard work will bring not only professional growth, but also salary growth. So, where do you begin? There are four key considerations when thinking about your professional education: Q A W ith the hazy hot days of August behind us, September brings thoughts of textbooks and homework. We all tell our children, nieces, nephews and even the kids next door how important education is to succeed in today’s world. But, have YOU ever thought about going “back to school”? The value of continued education in healthcare cannot be discounted, especially in the dynamic cardiovascular industry. In fact, one of the most important things you can do to ensure future success in your career is to remain on top of the latest industry trends and happenings by whatever means are available to you. There are many educational options, including formal classes at colleges or universities, online courses, seminars and educational conferences, as well as literature and periodicals, which can provide the additional knowledge necessary to make the most of your current role and also position you for the next step on the career ladder at your organization. Continuing education is not only time well-spent, but it will increase your earning power. Gaining additional

Table of Contents Feed for the Digital Edition of Cath Lab Digest - September 2007

St. Dominic Hospital The Genous Bio-engineered R Stent Percutaneous Treatment of Peripheral Arterial Chronic Total Occlusions: Device Options and Clinical Outcomes Contents Clinical Editor’s Corner Percutaneous Revascularization of Peripheral Chronic Total Occlusion — Which Patients, Why, and How? Myocardial Infarction and Syncope: A Manifestation of the “Raynaud-Prinzmetal Syndrome”? Essential Technical Components of the Transradial Approach If You Build It, Will They Come? Evidence-Based Medicine with Drug-Eluting Stents Back to School: The Value of Education in Cardiovascular Services The ACVP Standards and Competencies: Are You Using Them Effectively? What Do You Think? My Experience with Fibromuscular Dysplasia and Stroke A Brief Review of Fibromuscular Dysplasia Letter to the Editor A Look at On-the-Job Training: Perceptions, Reality and Our Profession Doing the Wave: Inventory Management with RFID The Ten-Minute Interview with… Paul Pinsker, RCIS CLD’s Annual Salary Survey Harrisburg Area Community College Volunteer Survey CEU Education Center SICP* Section Ask the Clinical Instructor: A Q&A Column for Those New to the Cath Lab Clinical & Industry News

Cath Lab Digest - September 2007

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