MedicalResearch.com Interview with:
Sripal Bangalore, MD, MHA, FACC, FAHA, FSCAI
Director of Research, Cardiac Catheterization Laboratory,
Director, Cardiovascular Outcomes Group,
Associate Professor of Medicine,
New York University School of Medicine,
New York, NY 10016
Medical Research: What is the background for this study? What are the main findings?
Dr. Bangalore: Prior studies have shown a mortality benefit of bypass surgery over stenting. But these studies compared bypass surgery with older generation stents which are no longer used. We used data from the New York state registry of patients who underwent stenting or bypass surgery for 2 or more blockages of coronary arteries. With data from over 18,000 patients we found that there was no difference between stenting and bypass surgery for long term mortality. In addition we found that both procedures have trade offs. Bypass surgery has upfront risk of death and stroke whereas PCI has long term risk of needing a repeat procedure. In addition, in patients who underwent incomplete revascularization, there was increase in myocardial infarction with PCI.
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MedicalResearch.com Interview with:
Jonathan L. Halperin, M.D.
The Robert and Harriet Heilbrunn Professor of Medicine
Mount Sinai School of Medicine
Dr. Halperin is a member of the Steering Committee for the GLORIA-AF program and a consultant to Boehringer Ingelheim, which sponsored this research.Medical Research: What is the background for this study? What are the main findings?
Dr. Halperin: The two analyses come from the GLORIA-AF Registry Program, a global, prospective, observational study supported by Boehringer Ingelheim, which is designed to characterize the population of newly diagnosed patients with non-valvular atrial fibrillation (NVAF) at risk for stroke, and to study patterns, predictors and outcomes of different treatment regimens for stroke risk reduction in non-valvular atrial fibrillation patients. The data is based on treatment trends in 3,415 patients who entered the registry from November 2011 to February 2014 in North America. All patients had a recent diagnosis of NVAF, and 86.2 percent had a CHA2DS2-VASc score of 2 or higher.
Results from the first analysis demonstrated that patients with the paroxysmal (occasional) form of non-valvular atrial fibrillation and at a high risk for stroke (CHA2DS2-VASc score of 2 or higher) were given an anticoagulant medication less often than those with persistent or permanent forms of NVAF, and a CHA2DS2-VASc score of 2 or higher. This pattern runs counter to NVAF guidelines calling for patients to receive oral anticoagulant therapy based on their risk of stroke, rather than the type of atrial fibrillation.
In the second analysis, researchers found that despite high stroke risk, a considerable number of patients receive only aspirin or no medication.
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MedicalResearch.com Interview with:
Prof. Ran Kornowski, M.D, FACC, FESC
Chairman - Division of Cardiology,
Rabin Medical Center
Petah-Tikva, Israel
MedicalResearch: What is the background for this study? Prof. Kornowski: Over the years, the PCI procedure went-through many progresses. Among those are some angioplasty techniques, generalize use of stents and drug eluting stents, and adjuvant novel antithrombotic therapy. Unmistakably, these were associated with an overall improved PCI outcome. As many of the data on PCIs’ adverse outcomes predictors come from predates studies, we sought to update this matter.
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MedicalResearch.com Interview with: Dr Rajeev Kumar Pathak MBBS, FRACP
Cardiologist and Electrophysiology Fellow
Centre for Heart Rhythm Disorders | University of Adelaide
Cardiovascular Investigation Unit | Royal Adelaide Hospital Adelaide Australia
Medical Research: What is the background for this study? What are the main findings?Response: Obesity and atrial fibrillation (AF) are dual epidemics that frequently coexist. Weight-loss reduces atrial fibrillation burden; however, whether this is sustained, has a dose effect or is influenced by weight-fluctuation is not known. In this study we evaluated the long-term impact of weight-loss and weight-fluctuation on rhythm control in obese individuals with atrial fibrillation.
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MedicalResearch.com Interview with:Marco Valgimigli, MD, PhD
Erasmus MC, Thoraxcenter,
Rotterdam The Netherlands
MedicalResearch: What is the background for this study? What are the main findings?Dr. Valgimigli: Interventional cardiologists can choose between two entry sites in order to perform a diagnostic coronary angiography and or a percutaneous coronary intervention, namely an artery which is in the groin called femoral artery or an artery which is located in the wrist which is called radial artery. The latter is more superficial and has small calibre as compared to the former. Femoral artery is the entry site which is most frequently used in the world especially in US where the use of radial artery is relatively limited.
Our study randomly allocated 8,404 patients to undergo diagnostic coronary angiography and PCI, if clinically indicated, either vie the femoral or the radial artery.
The main results of our study are that radial access reduced the composite of net adverse clinical events driven by a reduction of mortality and of major bleeding, including transfusions and need for surgical repair or the entry site.
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MedicalResearch.com Interview with: Pam R. Taub, MD, FACC
Assistant Professor of Medicine
UC San Diego Health System
Division of Cardiology Encinitas, CA 92024
Medical Research: What is the background for this study?Dr. Taub: Epidemiological studies indicate that the consumption of modest amounts of dark chocolate (DC), which contains the natural cacao flavanol (-)-epicatechin (Epi,) is associated with reductions in the incidence of cardiovascular diseases (CVD). The health benefits of dark chocolate have been attributed to Epi. Clinical studies using cocoa and/or DC in normal volunteers or subjects with CVD have reported improvements in peripheral and coronary vascular endothelial function, blood pressure, lipids, insulin resistance, and inflammatory markers. The mechanism underlying these improvements is thought to be due to increased nitric oxide levels and improved endothelial function. We have also shown that capacity of Epi to favorable impact mitochondria under normal and disease states.
We previously conducted pilot study in five patients with heart failure and type II diabetes, and showed that in skeletal muscle (SkM) biopsies there is a severe reduction in mitochondrial volume and cristae, as well as, in structural/functional proteins. After treatment with Epi rich dark chocolate , there was a significant recovery of SkM mitochondrial cristae, structural/functional proteins (e.g. mitofilin), as well as in regulators of mitochondrial biogenesis. However, no studies have examined the capacity of Epi rich dark chocolate to enhance exercise capacity in normal subjects and assess its impact on mitochondrial and oxidative control systems.
Medical Research: What are the main findings?Dr. Taub: Seventeen subjects were randomized to placebo (n=8) or DC groups (n=9) and consumed 2 squares of chocolate (20 g, provided by Hershey) for 3 months.
We showed in the chocolate group subjects had improved levels of HDL cholesterol and enhanced exercise capacity that is linked to the stimulation of SkM metabolic control endpoints which enhance mitochondrial function.
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MedicalResearch.com Interview with:
Sameer Bansilal, MD, MS
Asst. Prof.- Medicine and Cardiology
Clinical Trials & Global Health Studies
Icahn School of Medicine at Mount Sinai
Medical Research: What is the background for this study? What are the main findings?
Dr. Bansilal: Our group has previously published data from FREEDOM, COURAGE and BARI showing that adherence to recommended therapies are low in diabetic (DM) patients. We have spent the last decade developing a potential solution to this- the Fuster-Ferrer polypill. This study was done to better inform the association between levels of medication adherence and long term major adverse cardiovascular events (MACE) in high risk diabetic patients.
We analyzed a U.S. health insurers’ claims data for 19,962 high risk diabetic subjects. Using proportion of days covered (PDC) for 1 year after first refill, we stratified patients as fully adherent (FA≥80%), partially adherent (PA ≥40- ≤79%) or non-adherent (NA <40%) and examined the associations with a primary cardiovascualr outcome measure of death, myocardial infarction, stroke and coronary revascularization. We found that only 34% participants were fully adherent to therapy. When compared to being non-adherent at 2 yrs follow up,, being fully adherent was associated with a 28% lower rate of MACE; being partially adherent was associated with a 21% lower rate of MACE. Efforts towards improving adherence in diabetic subjects may lead to substantial reductions in MACE.
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MedicalResearch.com Interview with:
Jonathan D. Newman, MD, MPH
Instructor of Medicine
The Leon H Charney Division of Cardiology and
The Center for the Prevention...
MedicalResearch.com Interview with:
Colleen K. McIlvennan, DNP, ANP
Assistant Professor of Medicine
University of Colorado, Division of Cardiology
Section of Advanced Heart Failure and Transplantation
Medical Research: What is the background for this study?Response: Destination therapy left ventricular assist device (DT LVAD) patients are often older with significant comorbidities that preclude heart transplantation. As such, the decision to get a DT LVAD is arguably more complicated than the decision to receive a temporary LVAD in anticipation of a transplant. Centers offering LVADs often require the identification of a caregiver prior to proceeding with the implant. Caregivers are commonly female spouses of DT LVAD patients, who are also older with co-morbidities. Understanding their perspective in DT LVAD decision making is extremely important as they are at particular risk for experiencing stress and caregiver burden due to the increased demands on caregiving with DT LVAD.
Medical Research: What are the main findings?Response: We performed semi-structured qualitative interviews with 17 caregivers: 10 caregivers of patients living with DT LVAD, 6 caregivers of patients who had died with DT LVAD, and 1 caregiver of a patient who had declined DT LVAD. Throughout the interviews, the overarching theme was that considering a DT LVAD is a complex decision-making process.
Additionally, three dialectical tensions emerged:
1) the stark decision context, with tension between hope and reality;
2) the challenging decision process, with tension between wanting loved ones to live and wanting to respect loved ones’ wishes; and
3) the downstream decision outcome, with tension between gratitude and burden.
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MedicalResearch.com Interview with:
Prof. David Newby
British Heart Foundation Professor of Cardiology
University of Edinburgh
Director of the Wellcome Trust Clinical Research Facility
MedicalResearch: What is the background for this study? What are the main findings?Dr. Newby: The diagnosis of angina (chest pain) due to coronary heart disease can be very challenging and we often get it wrong. We have a wide range of tests that can try and identify patients with angina due to coronary heart disease. However, even with these tests, we fail to identify 1 in 3 patients who go on to have heart attacks. So we need better tests.
The study shows that if you add CTCA to a clinic consultation, you clarify the diagnosis in 1 in 4 patients, alter the investigations in 1 in 6 and change the subsequent treatments in 1 in 4. This did appear not only to increase the use of coronary revascularisation but also reduce the risk of subsequent heart attacks by 38-50%. (more…)
Prof Samir R Kapadia MD Director, Sones Cardiac Catheterization Laboratories
Cleveland Clinic Cleveland, OH
For patients with severe symptomatic aortic stenosis (AS) who are not candidates for surgical valve replacement, transcatheter aortic valve replacement (TAVR) offers superior benefit to standard therapy, as measured by all-cause mortality, cardiovascular mortality, repeat hospital admission and functional status. PARTNER 1B 5 year data were published simultaneously with PARTNER 1A 5 year data in 2 separate manuscripts in the Lancet (March 15 2105).
In this landmark trial, TAVR produced a 22 percent survival benefit and a 28 percent reduced risk of cardiovascular mortality, compared with standard treatment.
According to Cleveland Clinic interventional cardiologist Samir Kapadia, MD, lead author of PARTNER 1B, these findings have changed the treatment paradigm for severe Aortic Stenosis patients who can’t undergo surgical Aortic Valve Replacement.
“This trial is the first—and will probably be the only—randomized AS trial that includes a standard treatment group, since these results will make it unethical to treat severe AS patients with medical therapy alone without aortic valve replacement. ” he says.
Superior survival benefit with TAVR
PARTNER 1B is the only rigorous randomized trial of extreme-risk aortic stenosis patients that has prospectively reported the outcomes of TAVR versus standard treatment in patients for whom the estimated probability of death or serious irreversible morbidity after surgical aortic valve replacement was 50 percent or greater.
The trial enrolled 358 patients between May 11, 2007 and March 16, 2009; 179 patients were assigned to TAVR with the first-generation Sapien valve and 179 to standard therapy which includes medical therapy and balloon aortic valvuloplasty. TAVR was performed under general anesthesia with common femoral artery access. Guidance was provided by transesophagel echocardiography and fluoroscopy. The mean age of participants was 83.
The primary endpoint was all-cause survival. Secondary endpoints included cardiovascular mortality, stroke, vascular complications, major bleeding and functional status.
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MedicalResearch.com Interview with:
Barnaby C. Reeves, D.Phil.
Professor of Health Services Research, Clinical Trials & Evaluation Unit
School of Clinical Sciences, University of Bristol
Bristol Royal Infirmary Bristol
Medical Research: What is the background for this study?
Response: Variable decisions are made about when to transfuse patients after cardiac surgery. The circumstances of particular patients influence decisions about whether to give a transfusion.
Transfusion is a life-saving intervention when a patient is experiencing life-threatening bleeding but most patients have only one or two units of red cells transfused. These transfusions are given at varying levels of anaemia. Some doctors prefer to give a transfusion after cardiac surgery when a patient is only mildly anaemic, believing that the transfusion will promote recovery, while other doctors prefer to wait to transfuse until a patient is substantially anaemic, believing that a transfusion may do more good than harm and is wasteful if it is not needed. Therefore, we carried out a randomized controlled trial comparing restrictive (transfuse when haemoglobin <7.5 g/dL) and liberal transfusion thresholds (transfuse when haemoglobin <9.0 g/dL).*
Medical Research: What are the main findings?
Response: We obtained written informed consent before surgery but only randomized participants after surgery, in intensive care, if their Hb dropped below 9 g/dL. (Hence, we recruited over 3,500 patients but randomized only 2007.) This design avoids ‘diluting’ any difference between groups by including participants who would not usually be ‘considered’ for transfusion.
The primary outcome was the occurrence of one or more serious complications: heart attack, stroke, acute kidney injury, bowel infarction, infection; this included/involved 35.1% of the patients in the restrictive-threshold group and 33.0% of the patients in the liberal-threshold group. This slight difference – more in the restrictive group – was not statistically significant.
We then compared the percentages of patients who died; these were 4.2% in the restrictive group and 2.6% in the liberal group. The difference in this secondary outcome was of borderline statistical significance. Frequencies of other secondary outcomes (infections, ischaemic events, days in critical care and hospital, pulmonary complications) were not different in the two groups.
We also carried out some pre-specified sensitivity analyses for the primary outcome and all-cause mortality. The two most important ones aimed to avoid dilution of the difference between groups as a result of patients having transfusions or outcome events before randomization. Excluding patients who were transfused before randomization shifted the treatment effect to favour the liberal threshold more strongly, for both the primary outcome and mortality. Excluding patients who experienced an outcome event in the first 24 hours after randomization did not change the treatment effect for either outcome. (more…)
MedicalResearch.com Interview with:
Heidi May, Ph.D., M.S.P.H.
Cardiovascular Epidemiologist
Intermountain Medical Center Heart Institute
Salt Lake City
Medical Research: What is the background for this study? What are the main findings?
Dr. Heidi May: Cardiovascular disease remains the leading cause of morbidity and mortality worldwide. Statin therapy is known to reduce the risk of cardiovascular disease incidence through the reduction of blood cholesterol levels and through its pleiotropic cardioprotective properties. Depression is a risk factor for cardiovascular disease. It has been recommended that antidepressant medications should be considered first-line treatment for depression of any severity. We hypothesized that taking both statins and antidepressants would reduce cardiovascular risk more than either medication alone. However, we did not find this. Instead we found that the effectiveness of antidepressants and statin therapy to reduce death and incident cardiovascular disease at 3 years varied by the severity of depressive symptoms. Among those with none to mild depressive symptoms, statin use, with or without antidepressant therapy, was associated with a decrease in risk, but among those with moderate to severe depression, antidepressant use was associated with a decrease in risk. The combination of antidepressant and statin use did not result in a greater risk reduction in either depressive symptom category.
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MedicalResearch.com Interview with: Dr. Rebecca Clark Thurston Ph.D
Associate Professor of Psychiatry, Epidemiology, Psychology, and Clinical and Translational Science
University of Pittsburgh
MedicalResearch: What is the background for these studies? What are the main findings?Dr. Clark Thurston: The understanding of women’s cardiovascular disease and the role that reproductive factors play in women’s cardiovascular health is evolving. There are some studies showing links between menopausal hot flashes and cardiovascular disease risk in women. These studies help further refine this understanding. We showed in two separate studies that women who have hot flashes, particularly frequent hot flashes early in midlife, have poorer vascular health on certain indices.
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