Author Interviews, Heart Disease, Lancet, Surgical Research / 31.08.2016
Early Invasive Cardiac Treatment Provided Longterm Benefit For Patients With Non-STEMI Acute Coronary Syndrome
MedicalResearch.com Interview with:
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Prof. Lars Wallentin[/caption]
Prof Lars Wallentin, MD PHD
Senior Professor Cardiology
Uppsala Clinical Research Center,
Uppsala University
MedicalResearch.com: What is the background for this study?
Response: The FRISC2 study was performed 1996 – 1998 and reported 1999 for the first time a significant reduction in death and myocardial infarction by early invasive compared to non-invasive treatment strategy in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS). The results at 6 months, 1, 2 and 5 years were published in The Lancet and pivotal in changing the treatment guidelines and thereby improving outcomes in patients with NSTE-ACS. These findings were within the next few years verified in the TACTICS-TIMI18 and RITA3 trials. However the later performed ICTUS trial, starting after these results were published and accordingly with a substantial early crossover to the invasive arm, showed neutral results. Recently the reduction in event rates by an early invasive strategy was again validated in patients above 80 years of age, which were less well represented in the initial trials. These benefits of an early invasive strategy have previously been shown sustained for at least five years based on results from the FRISC2, RITA3, and ICTUS trials. The FRISC2 and TACTICS-TIMI18 trials also showed that the benefits with an early invasive strategy seemed confined to patients with signs of myocardial necrosis as indicated by elevated troponin level at entry. In addition the FRISC2 trial found that the benefits were larger in patients with signs of inflammatory activity as indicated by a high level of growth differentiation factor 15 (GDF-15) at entry. These pivotal results have been the basis for the current international treatment guidelines recommending an early invasive treatment strategy in patients with NSTE-ACS and elevated troponin and/or other indicators of a raised risk.
Prof. Lars Wallentin[/caption]
Prof Lars Wallentin, MD PHD
Senior Professor Cardiology
Uppsala Clinical Research Center,
Uppsala University
MedicalResearch.com: What is the background for this study?
Response: The FRISC2 study was performed 1996 – 1998 and reported 1999 for the first time a significant reduction in death and myocardial infarction by early invasive compared to non-invasive treatment strategy in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS). The results at 6 months, 1, 2 and 5 years were published in The Lancet and pivotal in changing the treatment guidelines and thereby improving outcomes in patients with NSTE-ACS. These findings were within the next few years verified in the TACTICS-TIMI18 and RITA3 trials. However the later performed ICTUS trial, starting after these results were published and accordingly with a substantial early crossover to the invasive arm, showed neutral results. Recently the reduction in event rates by an early invasive strategy was again validated in patients above 80 years of age, which were less well represented in the initial trials. These benefits of an early invasive strategy have previously been shown sustained for at least five years based on results from the FRISC2, RITA3, and ICTUS trials. The FRISC2 and TACTICS-TIMI18 trials also showed that the benefits with an early invasive strategy seemed confined to patients with signs of myocardial necrosis as indicated by elevated troponin level at entry. In addition the FRISC2 trial found that the benefits were larger in patients with signs of inflammatory activity as indicated by a high level of growth differentiation factor 15 (GDF-15) at entry. These pivotal results have been the basis for the current international treatment guidelines recommending an early invasive treatment strategy in patients with NSTE-ACS and elevated troponin and/or other indicators of a raised risk.















Dr. Sunita Sah[/caption]
Sunita Sah MD PhD
Management & Organizations
Johnson Graduate School of Management
Cornell University
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Sah: Physicians often recommend the treatment they specialize in, e.g., surgeons are more likely to recommend surgery than non-surgeons. Results from an observational study and a randomized controlled laboratory experiment found that when physicians revealed their bias toward their own specialty, patients were more likely to report increased trust in the physician’s expertise and take the treatment in accordance with the physician’s specialty.
Dr. Giovanni Esposito[/caption]
Giovanni Esposito MD, PhD
Associate Professor of Cardiology
Department of Advanced Biomedical Sciences
Federico II University, Naples
Napoli - Italy and
Giuseppe Gargiulo, MD
PhD Student
Federico II University of Naples, Italy
Dr. Jeffrey Schussler[/caption]
Jeffrey M. Schussler, MD, FACC, FSCAI, FSCCT, FACP
Baylor Scott & White Health Care System
Cardiology: Baylor University Medical Center, Dallas, Tx
Medical Director: CVICU Hamilton Heart and Vascular Hospital
Professor of Medicine: Texas A&M School of Medicine
MedicalResearch.com: What is the background for this study?
Dr. Schussler: For the past few years, there has been an increased interest in performing coronary catheterization through the wrist. This is a technique that has been done (with great success and low complication rate) in other countries for years, with adoption rates >90% in some places. The US has been slower to adopt performing catheterization from the wrist, but the rate of using this approach has grown tremendously in the last 5 years. While less than 5% of all interventions were done using radial access previously, it now appraches 30% nationally. This increased rate of adoption been spurred on by studies which have shown lower incidences of complications, as well as some mortality benefit, and in particular in those patients who are highest risk for complications.
Dr. Sarmad Sadeghi[/caption]
Sarmad Sadeghi MD, MS, PhD
Assistant Professor of Medicine
Norris Comprehensive Cancer Center
University of Southern California
MedicalResearch.com: What is the background for this study?
Dr. Sadeghi: Several years ago analyses of outcomes for radical prostatectomy highlighted the significant impact of surgical experience on the oncological outcome for the patients. In this case experience was measured by the number of radical prostatectomies performed by the surgeon, and oncological outcome was measured by treatment failure rates (rising PSA). Despite this data, the move for redirecting patients to “high volume centers” where more experienced surgeons perform the operation has been sluggish. There was insufficient data on what is involved in referring patients to high volume centers and whether or not such action is cost effective.
In a previous study we demonstrated that for every referral to a high volume center, there would be an average of $1,800 over a follow-up period of 20 years in societal cost savings. The main source of these savings is fewer treatment failures.
The next question was who is a good candidate for referral and whether these savings can offset the referral costs.
Dr. Mary Forhan[/caption]
Dr. Mary Forhan OT Reg (Alberta), PhD, Assistant Professor ad
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Dr-Tasuku-Terada[/caption]
Dr. Tasuku Terada, post-doctoral research fellow
Faculty of Rehabilitation Medicine
University of Alberta
MedicalResearch.com: What is the background for this study?
Response: The prevalence of obesity has increased. Notably, a proportion of severe obesity (body mass index: body weight [kg] divided by height squared [m2]: >40kg/m2) has shown the most significant increase. Greater body mass increases the risk of cardiovascular disease and referrals for coronary artery graft surgery (CABG) have increased in patients with severe obesity. Interestingly, while obesity is often considered to increase the risk of complications and associated health care costs, many studies have reported better prognosis in patients with obesity compared to patients with normal weight, a phenomenon referred to as the obesity paradox. Therefore, it was not clear if patients with severe obesity were at higher risk of complications and contributed to greater resource use. A better understanding of the relationship between obesity and post-surgical adverse outcomes was needed to provide quality and efficient care.
Dr. Nombela Franco[/caption]
Luis Nombela-Franco, MD, PhD
Structural cardiology program.
Interventional Cardiology department.
Hospital Clínico San Carlos, Cardiovascular Institute
Madrid, Spain
(Dr. Nombela-Franco, has a special interest in interest on percutaneous treatment of structural heart disease and coronary interventions with special focus on chronic total occlusion)
MedicalResearch.com: What is the background for this study?
Dr. Nombela-Franco: In-hospital infections are one of the most common complications that may occur following medical and surgical admissions, significantly impacted length of hospital stay, costs and clinical outcomes. In addition, approximately one third of hospital-acquired infections are preventable.
Transcatheter aortic valve replacement (TAVR) is currently the standard of care for symptomatic patients with severe aortic stenosis deemed at high surgical risk or inoperable. Patients undergoing TAVR have several comorbidities and the invasive (although less invasive the surgical treatment) nature of the procedure and peri-operative care confers a high likelihood in-hospital infections in such patients. This study analyzed the incidence, predictive factors and impact of in-hospital infections in patients undergoing transcatheter aortic valve implantation.
Dr. Mark Cohen[/caption]
Mark E. Cohen, PhD
Statistical Manager
Continuous Quality Improvement
Division of Research and Optimal Patient Care
American College of Surgeons
Chicago, IL
MedicalResearch.com: What is the background for this study?
Dr. Cohen: The ACS NSQIP Surgical Risk Calculator (built from 2.7 million patient records from nearly 600 hospitals) has been widely adopted as a decision aid and informed consent tool by surgeons and patients. Predictive accuracy can be assessed in terms of discrimination, calibration, and combined discrimination and calibration. In this study, we focused primarily on calibration. Calibration refers to the consistency of agreement between observed and predicted risk across the range of predicted risk. One would not want, for example, a model that dramatically overestimates risk for low-risk patients and underestimates risk for high-risk patients – this sort of systematic error, if of sufficient magnitude, would make a risk calculator unacceptable for clinical use. We also assessed the potential benefits of statistical recalibration using restricted cubic splines.
MedicalResearch.com: What are the main findings?
Dr. Cohen: Without recalibration, the Risk Calculator was shown to have excellent calibration, though there was, at times, a slight tendency for predicted risk to be overestimated for lowest- and highest-risk patients and underestimated for moderate-risk patients. After recalibration this distortion was eliminated.