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Randomized trials in cardiology

W Schuyler Jones, Matthew T Roe, Elliott M Antman, Mark J Pletcher, Robert A Harrington, Russell L Rothman, William J Oetgen, Sunil V Rao, Mitchell W Krucoff, Lesley H Curtis, Adrian F Hernandez, Frederick A Masoudi
Large randomized clinical trials in cardiovascular disease have proliferated over the past 3 decades, with results that have influenced every aspect of cardiology practice. Despite these advances, there remains a substantial need for more high-quality evidence to inform cardiovascular clinical practice, given the increasing prevalence of cardiovascular disease around the world. Traditional clinical trials are increasingly challenging due to rising costs, increasing complexity and length, and burdensome institutional and regulatory requirements...
October 25, 2016: Journal of the American College of Cardiology
Wojciech Kosmala, Aleksandra Rojek, Monika Przewlocka-Kosmala, Leah Wright, Andrzej Mysiak, Thomas H Marwick
BACKGROUND: Impaired functional capacity is a hallmark of patients with heart failure with preserved ejection fraction (HFpEF). Despite the association of HFpEF with reduced myocardial compliance attributed to fibrosis, spironolactone has not been shown to alter outcomes-perhaps reflecting the heterogeneity of underlying pathological mechanisms. OBJECTIVES: The authors sought to identify improvement in exercise capacity with spironolactone in the subset of patients with HFpEF with exercise-induced increase in ratio between early mitral inflow velocity and mitral annular early diastolic velocity (E/e') reflecting elevation of left ventricular (LV) filling pressure...
October 25, 2016: Journal of the American College of Cardiology
Franz Messerli
OBJECTIVE: To evaluate the outcomes with use of renin angiotensin system (RAS) blockers compared with other antihypertensive agents in people with diabetes. DESIGN: Meta-analysis. DATA SOURCES AND STUDY SELECTION: PubMed, Embase, and the Cochrane central register of controlled trials databases for randomized trials of RAS blockers versus other antihypertensive agents in people with diabetes mellitus. Outcomes were death, cardiovascular death, myocardial infarction, angina, stroke, heart failure, revascularization, and end stage renal disease...
September 2016: Journal of Hypertension
Antoni Bayes-Genis, Josep Lupón, Allan S Jaffe
Over the last 15 years, the hypothesis that intensified treatment directed at reducing natriuretic peptide (NP) concentrations may improve the outcomes of patients with heart failure (HF) has been scrutinized in several prospective clinical trials, with conflicting results. Collectively, however, the data suggest that NP concentrations may be useful in guiding HF management and improving HF-related morbidity and mortality. In this review, we summarize the existing data investigating the use of NPs as targets for outpatient HF therapy...
August 2016: EJIFCC
Ciro Indolfi, Salvatore De Rosa, Antonio Colombo
The introduction of percutaneous treatment of coronary artery stenosis with balloon angioplasty was the first revolution in interventional cardiology; the advent of metallic coronary stents (bare and drug-eluting) marked the second and third revolutions. However, the latest generation of drug-eluting stents is limited by several factors. Permanent vessel caging impairs arterial physiology, and the incidence of very late stent thrombosis - although lower with the second generation than with the first generation of drug-eluting stents - remains a major concern...
September 29, 2016: Nature Reviews. Cardiology
Jennifer G Robinson
PURPOSE OF REVIEW: Factors influencing guideline development may result in paradigm shifts in treatment recommendations. RECENT FINDINGS: The 2013 American College of Cardiology/American Heart Association cholesterol guideline provides an example of how new methodology and findings from randomized clinical trials can result in a paradigm shift in the approach to cardiovascular prevention. This guideline moved away from a treat to cholesterol goal approach. Based on strong evidence of a net benefit in randomized clinical trials, statins were recommended to reduce atherosclerotic cardiovascular disease risk in four groups of patient most likely to benefit...
September 26, 2016: Current Opinion in Lipidology
Muhammad Sohail Chaudhri, Muhammad Usman Ali Shah, Muhammad Imran Asghar, Rashad Siddiqi, Asif Mahmood Janjua, Afsheen Iqbal
OBJECTIVE: To compare mean per-operative flow capacity between skeletonized and pedicled left internal mammary artery (LIMA) in patients undergoing coronary artery bypass grafting (CABG) surgery. STUDY DESIGN: Randomized control trial. PLACE AND DURATION OF STUDY: Department of Cardiac Surgery, Armed Forces Institute of Cardiology and National Institute of Heart Diseases (AFIC-NIHD), Rawalpindi, Pakistan from February to August, 2013. METHODOLOGY: Patients undergoing CABG for coronary artery disease, under 80 years, excluded by the exclusion criteria; and fulfilling the inclusion criteria were randomly assigned to two groups of 70 each...
September 2016: Journal of the College of Physicians and Surgeons—Pakistan: JCPSP
Vicente Giner-Galvañ, María José Esteban-Giner, Vicente Pallarés-Carratalá
Modern medicine is characterized by a continuous genesis of evidence making it very difficult to translate the latest findings into a better clinical practice. Clinical practice guidelines (CPG) emerge to provide clinicians evidence-based recommendations for their daily clinical practice. However, the high number of existing CPG as well as the usual differences in the given recommendations usually increases the clinician's confusion and doubts. It has apparently been the case for the 2013 American College of Cardiology/American Heart Association (ACC/AHA) Guideline on the Treatment of Blood Cholesterol...
2016: Vascular Health and Risk Management
Franz Messerli
OBJECTIVE: To evaluate the outcomes with use of renin angiotensin system (RAS) blockers compared with other antihypertensive agents in people with diabetes. DESIGN: Meta-analysis. DATA SOURCES AND STUDY SELECTION: PubMed, Embase, and the Cochrane central register of controlled trials databases for randomized trials of RAS blockers versus other antihypertensive agents in people with diabetes mellitus. Outcomes were death, cardiovascular death, myocardial infarction, angina, stroke, heart failure, revascularization, and end stage renal disease...
September 2016: Journal of Hypertension
Francesco Barillà, Francesco Pelliccia, Mauro Borzi, Paolo Camici, Livio Dei Cas, Matteo Di Biase, Ciro Indolfi, Giuseppe Mercuro, Vincenzo Montemurro, Luigi Padeletti, Pasquale Perrone Filardi, Carmine D Vizza, Francesco Romeo
Definition of the optimal duration of dual anti-platelet therapy (DAPT) is an important clinical issue, given the large number of patients having percutaneous coronary intervention (PCI), the costs and risks of pharmacologic therapy, the consequences of stent thrombosis, and the potential benefits of DAPT in preventing ischaemic outcomes beyond stent thrombosis. Nowadays, the rationale for a prolonged duration of DAPT should be not only the prevention of stent thrombosis, but also the prevention of ischaemic events unrelated to the coronary stenosis treated with index PCI...
September 15, 2016: Journal of Cardiovascular Medicine
Edith Pituskin, Mark Haykowsky, Margaret McNeely, John Mackey, Neil Chua, Ian Paterson
BACKGROUND: Cancer is the leading cause of premature death in Canada. In the last decade, important gains in cancer survival have been achieved by advances in adjuvant treatment. However, many oncologic treatments also result in cardiovascular "toxicity". Furthermore, cardiac risk factors such as hypertension, dyslipidemia, and diabetes mellitus are known to contribute to the progression of cardiac damage and clinical cardiotoxicity. As such, for many survivors, the risk of death from cardiac disease exceeds that of recurrent cancer...
September 15, 2016: BMC Cancer
Mike Saji, D Scott Lim
Following the first successful transcatheter aortic valve replacement (TAVR) in 2002, TAVR has globally evolved to become a standard procedure in high-risk patients. Surgical aortic valve replacement in non-high-risk patients remains the gold standard for treatment of severe aortic stenosis. However, a paradigm shift appears to be occurring in the direction of treating lower-risk patients, and several studies have suggested its impact on clinical outcomes. In this review, we highlight the current status of TAVR in intermediate-risk patients and review major trials including Placement of AoRTic TraNscathetER (PARTNER) 2A randomized intermediate-risk trial using SAPIEN XT (Edwards Lifesciences Corp, Irvine, CA) recently presented with excellent outcomes and the lowest major complications rate at the American College of Cardiology's 65th Annual Scientific Session in Chicago...
October 2016: Current Cardiology Reports
Eric R Bates, Jacqueline E Tamis-Holland, John A Bittl, Patrick T O'Gara, Glenn N Levine
Recent randomized controlled trials have suggested that patients with ST-segment elevation myocardial infarction and multivessel coronary artery disease may benefit more from multivessel percutaneous coronary intervention (PCI) compared with culprit vessel-only primary PCI. The American College of Cardiology, American Heart Association, and Society for Cardiovascular Angiography and Interventions recently published an updated recommendation on this topic. The purpose of this State-of-the-Art Review is to accurately document existing published reports, describe their limitations, and establish a base for future studies...
September 6, 2016: Journal of the American College of Cardiology
Charles D Resor, Ashwin Nathan, Dean J Kereiakes, Robert W Yeh, Joseph M Massaro, Donald E Cutlip, P Gabriel Steg, Wen-Hua Hsieh, Laura Mauri
BACKGROUND: Continued dual antiplatelet therapy and optimal medical therapy (OMT) improve outcomes in selected patient populations with established coronary heart disease, but whether OMT modifies the treatment effect of dual antiplatelet therapy is unknown. METHODS: The DAPT (Dual Antiplatelet Therapy) Study, a double-blind trial, randomly assigned 11 648 patients who had undergone coronary stenting and completed 1 year of dual antiplatelet therapy without major bleeding or ischemic events to an additional 18 months of continued thienopyridine or placebo...
October 4, 2016: Circulation
Eve Hanna, Cecile Rémuzat, Pascal Auquier, Mondher Toumi
OBJECTIVE: Advanced therapy medicinal products (ATMPs) constitute a class of innovative products that encompasses gene therapy, somatic cell therapy, and tissue-engineered products (TEP). There is an increased investment of commercial and non-commercial sponsors in this field and a growing number of ATMPs randomized clinical trials (RCT) and patients enrolled in such trials. RCT generate data to prove the efficacy of a new therapy, but the discontinuation of RCTs wastes scarce resources...
2016: Journal of Market Access & Health Policy
Maria Drakopoulou, Konstantinos Toutouzas, Konstantinos Stathogiannis, Andreas Synetos, George Trantalis, Dimitrios Tousoulis
INTRODUCTION: Lipid profile management is even more critical in patients treated for secondary prevention, since patients with established coronary heart disease are at higher risk of developing events. Current guidelines encourage lifestyle modification and patient engagement in disease prevention. However, the American College of Cardiology/American Heart Association guidelines seem to differ considerably from their predecessors, having an impact on clinical practice of lipid management...
August 23, 2016: Expert Review of Cardiovascular Therapy
David M Dudzinski, R Sacha Bhatia, Michael Y Mi, Eric M Isselbacher, Michael H Picard, Rory B Weiner
Importance: Appropriate use criteria-based educational initiatives have been shown to improve transthoracic echocardiography (TTE) ordering practices of physicians in training. Whether such an intervention is successful with attending cardiologists remains unknown. Objective: To prospectively investigate the effect of an appropriate use criteria-based educational intervention on ordering of outpatient TTEs by attending academic cardiologists. Design, Setting, and Participants: We conducted a prospective, randomized clinical trial of an educational intervention designed to reduce the number of outpatient TTEs that were deemed to be rarely appropriate by published appropriate use criteria...
August 10, 2016: JAMA Cardiology
Humaira Jamshed, Anwar-Ul-Hassan Gilani, Fateh Ali Tipoo Sultan, Faridah Amin, Jamshed Arslan, Sumaira Ghani, Madiha Masroor
OBJECTIVE: Elevated serum uric acid (UA), a biomarker of renal insufficiency, is also an independent prognostic marker for morbidity in coronary artery disease (CAD) and poses serious health risks. This study reports the effect of almond consumption on UA in CAD patients. STUDY DESIGN: A randomized controlled clinical trial was conducted with three groups: no-intervention (NI), Pakistani almonds (PA) or American almonds (AA). Patients were recruited from the Cardiology Clinics, Aga Khan University Hospital...
2016: Nutrition Journal
Michael J Reardon, Neal S Kleiman, David H Adams, Steven J Yakubov, Joseph S Coselli, G Michael Deeb, Daniel O'Hair, Thomas G Gleason, Joon Sup Lee, James B Hermiller, Stan Chetcuti, John Heiser, William Merhi, George L Zorn, Peter Tadros, Newell Robinson, George Petrossian, G Chad Hughes, J Kevin Harrison, Brijeshwar Maini, Mubashir Mumtaz, John V Conte, Jon R Resar, Vicken Aharonian, Thomas Pfeffer, Jae K Oh, Jian Huang, Jeffrey J Popma
Importance: Transcatheter aortic valve replacement (TAVR) is now a well-accepted alternative to surgical AVR (SAVR) for patients with symptomatic aortic stenosis at increased operative risk. There is interest in whether TAVR would benefit patients at lower risk. Objective: The Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) has trended downward in US TAVR trials and the STS/American College of Cardiology Transcatheter Valve Therapy Registry. We hypothesized that if the Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) alone is sufficient to define decreased risk, the contribution to survival based on the degree of invasiveness of the TAVR procedure will decrease, making it more difficult to show improved survival and benefit over SAVR...
August 17, 2016: JAMA Cardiology
J Wouter Jukema, Maddalena Lettino, Petr Widimský, Nicolas Danchin, Alfredo Bardaji, Jose A Barrabes, Angel Cequier, Marc J Claeys, Leonardo De Luca, Jakob Dörler, David Erlinge, Paul Erne, Patrick Goldstein, Sasha M Koul, Gilles Lemesle, Thomas F Lüscher, Christian M Matter, Gilles Montalescot, Dragana Radovanovic, Jose Lopez-Sendón, Petr Tousek, Franz Weidinger, Clive F M Weston, Azfar Zaman, Uwe Zeymer
Patient registries that document real-world clinical experience play an important role in cardiology as they complement the data from randomized controlled trials, provide valuable information on drug use and clinical outcomes, and evaluate to what extent guidelines are followed in practice. The Platelet Inhibition Registry in ACS EvalUation Study (PIRAEUS) project is an initiative of registry holders who are managing national or international registries observing patients with acute coronary syndromes (ACS)...
October 2015: European Heart Journal. Cardiovascular Pharmacotherapy
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