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Randomized trials in cardiology

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https://www.readbyqxmd.com/read/28434948/international-and-multidisciplinary-expert-recommendations-for-the-use-of-biologics-in-systemic-lupus-erythematosus
#1
REVIEW
Jean-François Kleinmann, Florence Tubach, Véronique Le Guern, Alexis Mathian, Christophe Richez, David Saadoun, Karim Sacre, Jérémie Sellam, Raphaèle Seror, Zahir Amoura, Emmanuel Andres, Sylvain Audia, Brigitte Bader-Meunier, Gilles Blaison, Bernard Bonnotte, Patrice Cacoub, Sophie Caillard, Laurent Chiche, Olivier Chosidow, Nathalie Costedoat-Chalumeau, Claire Daien, Eric Daugas, Nairouz Derdèche, Andrea Doria, Olivier Fain, Fadi Fakhouri, Dominique Farge, Cem Gabay, Sylvie Guillo, Eric Hachulla, Najia Hajjaj-Hassouni, Mohamed Hamidou, Frédéric A Houssiau, Noémie Jourde-Chiche, Isabelle Koné-Paut, Aïcha Ladjouz-Rezig, Olivier Lambotte, Dan Lipsker, Xavier Mariette, Nicolas Martin-Silva, Thierry Martin, François Maurier, Roderich Meckenstock, Arsène Mékinian, Olivier Meyer, Shirine Mohamed, Jacques Morel, Bruno Moulin, Denis Mulleman, Thomas Papo, Vincent Poindron, Xavier Puéchal, Leonardo Punzi, Pierre Quartier, Laurent Sailler, Amar Smail, Martin Soubrier, Agnès Sparsa, Zoubida Tazi-Mezalek, Leith Zakraoui, Stéphane Zuily, Jean Sibilia, Jacques-Eric Gottenberg
BACKGROUND/PURPOSE: Despite conventional immunosuppressants, active and steroid-dependent systemic lupus erythematosus (SLE) represents a therapeutic challenge. Only one biologic, belimumab, has been approved, but other biologics are sometimes used off-label. Given the lack of evidence-based data in some clinical situations encountered in real life, we developed expert recommendations for the use of biologics for SLE. METHODS: The recommendations were developed by a formal consensus method...
April 18, 2017: Autoimmunity Reviews
https://www.readbyqxmd.com/read/28434933/assessing-the-eligibility-criteria-in-phase-iii-randomized-controlled-trials-of-drug-therapy-in-heart-failure-with-preserved-ejection-fraction-the-critical-play-off-between-a-pure-patient-phenotype-and-the-generalizability-of-trial-findings
#2
Hitesh C Patel, Carl Hayward, Jason Dungu, Sofia Papadopoulou, Abdel Saidmeerasah, Carlo Di Mario, Nesan Shanmugam, Martin R Cowie, Lisa J Anderson
AIMS: To investigate the effect of the different eligibility criteria used by phase III clinical studies in heart failure with preserved ejection fraction (HFpEF) on patient selection, phenotype and survival. METHODS AND RESULTS: We applied the key eligibility criteria of seven phase III HFpEF studies (DIG-Ancillary, CHARM-Preserved, PEP-CHF, I-PRESERVE, J-DHF, TOPCAT and PARAGON-HF [on-going]) to a typical and well-characterised HFpEF population (n=557) seen in modern European cardiological practice...
April 18, 2017: Journal of Cardiac Failure
https://www.readbyqxmd.com/read/28420661/person-centred-transition-programme-to-empower-adolescents-with-congenital-heart-disease-in-the-transition-to-adulthood-a-study-protocol-for-a-hybrid-randomised-controlled-trial-stepstones-project
#3
Mariela Acuña Mora, Carina Sparud-Lundin, Ewa-Lena Bratt, Philip Moons
INTRODUCTION: When a young person grows up, they evolve from an independent child to an empowered adult. If an individual has a chronic condition, this additional burden may hamper adequate development and independence. Transition programmes for young persons with chronic disorders aim to provide the necessary skills for self-management and participation in care. However, strong evidence on the effects of these interventions is lacking. Therefore, as part of the STEPSTONES project (Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS), we propose a trial to assess the effectiveness of a structured, person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood...
April 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28364270/safe-trial-an-ongoing-randomized-clinical-study-to-assess-the-role-of-cardiotoxicity-prevention-in-breast-cancer-patients-treated-with-anthracyclines-with-or-without-trastuzumab
#4
REVIEW
Icro Meattini, Giuseppe Curigliano, Francesca Terziani, Carlotta Becherini, Mario Airoldi, Giacomo Allegrini, Domenico Amoroso, Sandro Barni, Carmelo Bengala, Valentina Guarneri, Paolo Marchetti, Francesca Martella, Pierluigi Piovano, Agnese Vannini, Isacco Desideri, Roberto Tarquini, Giorgio Galanti, Giuseppe Barletta, Lorenzo Livi
Over the years, thanks to the addition of new generation systemic agents, as well as the use of more advanced and precise radiotherapy techniques, it was able to obtain a high curability rate for breast cancer. Anthracyclines play a key role in the treatment of breast disease, with a well-known benefit on disease-free survival of patients with positive nodal status. Trastuzumab have shown a significant outcome advantage after 1-year administration in case of HER2-positive disease. Unfortunately, significant increase in cardiotoxicity has been observed after anthracyclines and trastuzumab therapies...
May 2017: Medical Oncology
https://www.readbyqxmd.com/read/28336789/percutaneous-therapy-for-tricuspid-regurgitation-a-new-frontier-for-interventional-cardiology
#5
Samir R Kapadia, Amar Krishnaswamy, E Murat Tuzcu
Functional tricuspid regurgitation (FTR) is common, whether in association with mitral or aortic valve disease or presenting as an isolated valvular disease. Several studies have shown that TR is associated with poor patient outcomes, though a cause-and-effect relationship of TR to mortality has not been proven. Similarly the impact of surgical treatment of TR on outcomes needs well-controlled randomized trials that are under planning. The current professional society guidelines for treatment of TR are based on expert opinions with a level of evidence C for all indications...
March 23, 2017: Circulation
https://www.readbyqxmd.com/read/28329235/improving-public-health-by-improving-clinical-trial-guidelines-and-their-application
#6
Martin J Landray, Jeroen J Bax, Laurence Alliot, Marc Buyse, Adam Cohen, Rory Collins, Gerhard Hindricks, Stefan K James, Sile Lane, Aldo P Maggioni, Ann Meeker-O'Connell, Gunnar Olsson, Stuart J Pocock, Michael Rawlins, Jonathan Sellors, Kaori Shinagawa, Karin R Sipido, Liam Smeeth, Richard Stephens, Murray W Stewart, Wendy Gattis Stough, Fergus Sweeney, Frans Van de Werf, Kerrie Woods, Barbara Casadei
Evidence generated from randomized controlled trials forms the foundation of cardiovascular therapeutics and has led to the adoption of numerous drugs and devices that prolong survival and reduce morbidity, as well as the avoidance of interventions that have been shown to be ineffective or even unsafe. Many aspects of cardiovascular research have evolved considerably since the first randomized trials in cardiology were conducted. In order to be large enough to provide reliable evidence about effects on major outcomes, cardiovascular trials may now involve thousands of patients recruited from hundreds of clinical sites in many different countries...
March 8, 2017: European Heart Journal
https://www.readbyqxmd.com/read/28316035/management-of-percutaneous-coronary-intervention-complications
#7
REVIEW
Gregory Means, Christopher End, Prashant Kaul
With the recent increase in complex coronary interventions including percutaneous coronary intervention (PCI) for chronic total occlusions and complex higher risk (and indicated) patients, the spectrum of potential periprocedural complications and their prompt management has become even more relevant. Vascular access-related problems remain the most prevalent of all PCI complications and with randomized controlled trial data from over 20,000 patients supporting the superiority of radial over femoral access in reducing bleeding and vascular complications, a default radial strategy should be promoted...
April 2017: Current Treatment Options in Cardiovascular Medicine
https://www.readbyqxmd.com/read/28294862/-revascularization-in-stable-ischemic-heart-disease-whether-to-change-the-approach
#8
L L Bershtein, N O Katamadze, A E Golovina, S A Sayganov
Current international guidelines on stable ischemic heart disease (IHD) state that coronary revascularization is indicated in cases of: limiting ischemic symptoms while on optimal medical therapy (OMT); high risk coronary anatomy; high risk stress test result. At the same time, many results supporting these conclusions were obtained in relatively old studies, conducted when the approaches to medical therapy and revascularization techniques differed greatly from contemporary practice. Many of the conclusions have been based on data from observational studies and subanalyses of randomized clinical trials, therefore methodologically are not sufficiently reliable...
April 2016: Kardiologiia
https://www.readbyqxmd.com/read/28290558/-real-world-data-on-novel-oral-anticoagulants-the-added-value-of-registries-and-observational-studies-focus-on-apixaban
#9
Francesco Pelliccia, Gaetano Tanzilli, Michele Schiariti, Nicola Viceconte, Cesare Greco, Carlo Gaudio
Anticoagulant therapy has been used with great effect for decades for the prevention of stroke among patients with atrial fibrillation. In recent years, the therapeutic armamentarium has been strengthened considerably, with the addition of anticoagulants acting through novel pathways. The currently available novel agents are apixaban, rivaroxaban and dabigatran. These novel oral anticoagulants (NOACs) were approved for use on the basis of major clinical trials clearly demonstrating improved risk reductions compared to warfarin for stroke and/or major bleeding events...
December 2016: Giornale Italiano di Cardiologia
https://www.readbyqxmd.com/read/28290162/tavr-in-intermediate-risk-patients-a-review-of-the-partner-2-trial-and-its-future-implications
#10
Sameer Arora, Cassandra J Ramm, Jacob A Misenheimer, John P Vavalle
BACKGROUND: Following publication of the results of the PARTNER trial, the American College of Cardiology/American Heart Association recognized the success of transcatheter aortic valve replacement (TAVR) by incorporating it as a feasible option in high-surgical risk patients, and recommending it as the standard of care for patients at prohibitive risk of surgery. Although this was recognized as a major success in the field of percutaneous valve replacement, surgical aortic valve replacement (SAVR) continued to be realized as the procedure of choice for low and intermediate surgical risk patients...
November 2016: Journal of Heart Valve Disease
https://www.readbyqxmd.com/read/28289528/clinical-cardiac-regenerative-studies-in-children
#11
REVIEW
Imre J Pavo, Ina Michel-Behnke
Although the incidence of pediatric heart failure is low, the mortality is relatively high, with severe clinical symptoms requiring repeated hospitalization or intensive care treatment in the surviving patients. Cardiac biopsy specimens have revealed a higher number of resident human cardiac progenitor cells, with greater proliferation and differentiation capacity, in the neonatal period as compared with adults, demonstrating the regeneration potential of the young heart, with rising interest in cardiac regeneration therapy in critically ill pediatric patients...
February 26, 2017: World Journal of Cardiology
https://www.readbyqxmd.com/read/28286245/pacing-as-a-treatment-for-reflex-mediated-vasovagal-situational-or-carotid-sinus-hypersensitivity-syncope-a-systematic-review-for-the-2017-acc-aha-hrs-guideline-for-the-evaluation-and-management-of-patients-with-syncope-a-report-of-the-american-college-of-cardiology
#12
Paul D Varosy, Lin Y Chen, Amy L Miller, Peter A Noseworthy, David J Slotwiner, Venkatesh Thiruganasambandamoorthy
OBJECTIVE: To determine, using systematic review of the biomedical literature, whether pacing reduces risk of recurrent syncope and relevant clinical outcomes among adult patients with reflex-mediated syncope. METHODS: MEDLINE (through PubMed), EMBASE, and the Cochrane Central Register of Controlled Trials (through October 7, 2015) were searched for randomized trials and observational studies examining pacing and syncope, and the bibliographies of known systematic reviews were also examined...
March 9, 2017: Heart Rhythm: the Official Journal of the Heart Rhythm Society
https://www.readbyqxmd.com/read/28286220/pacing-as-a-treatment-for-reflex-mediated-vasovagal-situational-or-carotid-sinus-hypersensitivity-syncope-a-systematic-review-for-the-2017-acc-aha-hrs-guideline-for-the-evaluation-and-management-of-patients-with-syncope-a-report-of-the-american-college-of-cardiology
#13
Paul D Varosy, Lin Y Chen, Amy L Miller, Peter A Noseworthy, David J Slotwiner, Venkatesh Thiruganasambandamoorthy
OBJECTIVE: To determine, using systematic review of the biomedical literature, whether pacing reduces risk of recurrent syncope and relevant clinical outcomes among adult patients with reflex-mediated syncope. METHODS: MEDLINE (through PubMed), EMBASE, and the Cochrane Central Register of Controlled Trials (through October 7, 2015) were searched for randomized trials and observational studies examining pacing and syncope, and the bibliographies of known systematic reviews were also examined...
March 3, 2017: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/28275942/bioresorbable-polymers-and-stent-devices
#14
REVIEW
Payam Dehghani
Percutaneous coronary interventions will never become obsolete, as evolution is inherent to interventional cardiology. Current drug-eluting platforms have appreciably improved their safety and efficacy profiles in different clinical settings compared to first-generation devices such that it is difficult to consider other alternatives. However, there is definite biological plausibility to consider devices with bioabsorbable polymers and/or scaffolds. It is also an undeniable fact that many patients, based on variety of belief systems, would prefer not to have a permanently implanted device...
February 2017: Current Treatment Options in Cardiovascular Medicine
https://www.readbyqxmd.com/read/28267469/acute-coronary-syndrome-quality-improvement-in-kerala-acs-quik-rationale-and-design-for-a-cluster-randomized-stepped-wedge-trial
#15
Mark D Huffman, Padinhare Purayil Mohanan, Raji Devarajan, Abigail S Baldridge, Dimple Kondal, Lihui Zhao, Mumtaj Ali, Donald M Lloyd-Jones, Dorairaj Prabhakaran
Ischemic heart disease is the leading cause of death in India, and there are likely more myocardial infarctions in India than in any other country in the world. We have previously reported heterogeneous care for patients with myocardial infarction in Kerala, a state in southern India, including both gaps in optimal care and inappropriate care. Based on that prior work, limitations from previous nonrandomized quality improvement studies and promising gains in process of care measures demonstrated from previous randomized trials, we and the Cardiological Society of India-Kerala chapter sought to develop, implement, and evaluate a quality improvement intervention to improve process of care measures and clinical outcomes for these patients...
March 2017: American Heart Journal
https://www.readbyqxmd.com/read/28255434/efficacy-and-safety-of-the-target-specific-oral-anticoagulants-for-stroke-prevention-in-atrial-fibrillation-the-real-life-evidence
#16
REVIEW
Vincenzo Russo, Anna Rago, Riccardo Proietti, Federica Di Meo, Andrea Antonio Papa, Paolo Calabrò, Antonio D'Onofrio, Gerardo Nigro, Ahmed AlTurki
The aim of our article is to provide a concise review for clinicians entailing the main studies that evaluated the efficacy and safety of target-specific oral anticoagulants (TSOAs) for thromboembolic stroke prevention in the real-world setting. Atrial fibrillation (AF) is one of the most common supraventricular arrhythmias that requires anticoagulation therapy to prevent stroke and systemic embolism. TSOAs, dabigatran, apixaban and rivaroxaban have become available as an alternative to warfarin anticoagulation in nonvalvular atrial fibrillation (NVAF)...
February 2017: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/28243397/effect-of-fluoxetine-administration-on-clinical-and-echocardiographic-findings-in-patients-with-mitral-valve-prolapse-and-generalized-anxiety-disorder-randomized-clinical-trial
#17
Reza Jafarzadeh Esfehani, Homan Kamranian, Majid Jalalyazdi
BACKGROUND: Mitral valve prolapse (MVP) is accompanied by mental disorders including anxiety, which has similar presentations as MVP. It is hypothesised that treatment of anxiety might reduce the symptoms of MVP. OBJECTIVE: The aim of this study was to assess the clinical and echocardiographic effects of fluoxetine administration in patients with MVP and anxiety. METHODS: This randomized clinical trial was conducted on patients with documented MVP and generalised anxiety disorder (GAD) who were referred to Mashhad University of Medical Sciences cardiology clinics, Mashhad, Iran in 2015...
January 2017: Electronic Physician
https://www.readbyqxmd.com/read/28242586/feasibility-and-safety-of-direct-catheter-based-thrombectomy-in-the-treatment-of-acute-ischemic-stroke-cooperation-of-cardiologists-neurologists-and-radiologists-prospective-registry-prague-16
#18
Petr Widimsky, Boris Koznar, Tomas Peisker, Peter Vasko, Filip Rohac, Jana Vavrova, Josef Kroupa, Ivana Stetkarova
AIMS: The aim of this study was to evaluate the role of direct catheter-based thrombectomy (d-CBT, without thrombolysis) and the feasibility and safety of d-CBT performed in an interventional cardiology center. METHODS AND PATIENTS: Single center, prospective observational registry based on the prespecified protocol included 3 months follow-up. The decision to perform acute stroke intervention was done by a neurologist based on the clinical and imaging findings...
February 28, 2017: EuroIntervention
https://www.readbyqxmd.com/read/28236615/effects-of-music-therapy-on-endothelial-function-in-patients-with-coronary-artery-disease-participating-in-aerobic-exercise-therapy
#19
Marina Deljanin Ilic, Radmila F Pavlovic, Gordana Kocic, Dejan Simonovic, Gordana Lazarevic
Context • Pleasant music that evokes a positive emotional response may activate brain pathways of the insular cortex, central nucleus of the amygdala, and lateral hypothalamus, which are involved in the integration of emotional and ambient sensory input, with corresponding autonomic responses. Exercise training can improve endothelium-dependent vasodilatation, both in epicardial coronary vessels and in resistance vessels, for patients with coronary heart disease. Objective • The aim of the present study was to evaluate the effects on endothelial function when patients with stable coronary artery disease (CAD) listened to their favorite music...
February 27, 2017: Alternative Therapies in Health and Medicine
https://www.readbyqxmd.com/read/28208200/massive-pulmonary-embolism-extracorporeal-membrane-oxygenation-and-surgical-pulmonary-embolectomy
#20
Aaron Weinberg, Victor F Tapson, Danny Ramzy
Massive pulmonary embolism (PE) refers to large emboli that cause hemodynamic instability, right ventricular failure, and circulatory collapse. According to the 2016 ACCP Antithrombotic Guidelines, therapy for massive PE should include systemic thrombolytic therapy in conjunction with anticoagulation and supportive care. However, in patients with a contraindication to systemic thrombolytics or in those who fail the above interventions, extracorporeal membrane oxygenation (ECMO) and/or surgical embolectomy may be used to improve oxygenation, achieve hemodynamic stability, and successfully treat massive PE...
February 2017: Seminars in Respiratory and Critical Care Medicine
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