21,621 results match your criteria endpoint events

Balloon- Versus Self-Expanding Valve Systems for Treating Small Failed Surgical Aortic Bioprostheses: The LYTEN Trial.

J Am Coll Cardiol 2022 May 13. Epub 2022 May 13.

Quebec Heart & Lung Institute, Laval University, Quebec City, Canada.

Background: Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field has been obtained from retrospective studies.

Objectives: To compare the hemodynamic results between the balloon-expandable SAPIEN (3/ULTRA) (BEV) and self-expanding Evolut (R/PRO/PRO+) (SEV) valves in ViV-TAVR.

Methods: Patients with a failed small (≤23 mm) surgical valve. Read More

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Ruxolitinib versus best available therapy in inadequately controlled polycythaemia vera without splenomegaly (RESPONSE-2): 5-year follow up of a randomised, phase 3b study.

Lancet Haematol 2022 May 18. Epub 2022 May 18.

University Clinic for Haematology, Oncology, Haemostaseology and Palliative Care, Johannes Wesling Medical Centre Minden, University of Bochum, Minden, Germany.

Background: The phase 3b, randomised, open-label RESPONSE-2 study in patients with inadequately controlled polycythaemia vera without splenomegaly showed superiority of the Janus kinase (JAK) 1 and JAK2 inhibitor ruxolitinib versus best available therapy for the primary endpoint of haematocrit control at week 28. Here, we present secondary endpoints of the RESPONSE-2 study after 5 years of follow-up.

Methods: RESPONSE-2 was an open-label, randomised, phase 3b study done at 48 hospitals or clinics across 12 countries in Asia, Australia, Europe, and Canada. Read More

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Two-year outcomes of Roux-en-Y gastric bypass vs medical treatment in type 2 diabetes with a body mass index lower than 32.5 kg/m: a multicenter propensity score-matched analysis.

J Endocrinol Invest 2022 May 21. Epub 2022 May 21.

Department of Metabolic and Bariatric Surgery, The Third Xiangya Hospital of Central South University, 138 Tongzipo Rd, Yuelu District, Changsha, 410013, China.

Background: Roux-en-Y gastric bypass (RYGB) has been widely reported to be safe and feasible, and has a powerful effect on improving metabolism and weight loss in patients with a high body mass index (BMI). A few studies have focused on the comparison of RYGB with medical treatment in type 2 diabetes (T2D) patients with a lower BMI.

Objectives: To compare the metabolic effects and safety of RYGB versus medical treatment during a 2 years follow-up in T2D patients with a BMI of 25 to 32. Read More

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Ertugliflozin and incident obstructive sleep apnea: an analysis from the VERTIS CV trial.

Sleep Breath 2022 May 20. Epub 2022 May 20.

Section of Pulmonary, Critical Care and Sleep Medicine, Yale School of Medicine, New Haven, CT, USA.

Purpose: The sodium-glucose transporter 2 inhibitor (SGLT2i) empagliflozin may reduce the incidence of obstructive sleep apnea (OSA) in patients with type 2 diabetes (T2D) and cardiovascular (CV) disease. This analysis of VERTIS CV, the CV outcome trial for the SGLT2i ertugliflozin conducted in a similar group of patients, explored the effects of ertugliflozin on reported incident OSA.

Methods: In VERTIS CV, patients ≥ 40 years with T2D and atherosclerotic CV disease (ASCVD) were randomized to ertugliflozin 5 or 15 mg or placebo. Read More

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Transcatheter Aortic Valve Replacement With Self-Expanding ACURATE neo2: Postprocedural Hemodynamic and Short-Term Clinical Outcomes.

JACC Cardiovasc Interv 2022 May 10. Epub 2022 May 10.

Civil Hospital and University of Brescia, Brescia, Italy.

Objectives: The aim of this study was to assess the efficacy and safety of the ACURATE neo2 transcatheter heart valve (THV) in patients with severe aortic valve stenosis.

Background: The first-generation ACURATE neo THV was associated with a non-negligible occurrence of moderate or greater paravalvular aortic regurgitation (AR) following transcatheter aortic valve replacement. To overcome this issue, the ACURATE neo2 iteration, which incorporates a taller outer skirt aimed at reducing the occurrence of paravalvular AR, has recently been developed. Read More

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Distal Versus Conventional Radial Access for Coronary Angiography and Intervention (DISCO RADIAL).

JACC Cardiovasc Interv 2022 May 10. Epub 2022 May 10.

Department of Cardiology, Shonan Kamakura General Hospital, Kanagawa, Japan.

Objectives: The aim of this study was to assess the superiority of DRA compared with conventional TRA with respect to forearm RAO.

Background: Currently, transradial access (TRA) is the recommended access for coronary procedures because of increased safety, with radial artery occlusion (RAO) being its most frequent complication, which will increasingly affect patients undergoing multiple procedures during their lifetimes. Recently, distal radial access (DRA) has emerged as a promising alternative access to minimize RAO risk. Read More

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Prediabetes versus type 2 diabetes in patients with acute myocardial infarction and current smoking.

Am J Med Sci 2022 May 17. Epub 2022 May 17.

Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.

Background: Smoking is linked with increased risk of cardiovascular events among diabetic patients. Prediabetes is associated with increased risk for microvascular and macrovascular complications. We compared the 2-year clinical outcomes of current smoking between prediabetic and type 2 diabetes mellitus (T2DM) patients with acute myocardial infarction (AMI) after newer-generation drug-eluting stent (DES) implantation. Read More

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Tislelizumab combined with chemotherapy as neoadjuvant therapy for surgically resectable esophageal cancer: A prospective, single-arm, phase II study (TD-NICE).

Int J Surg 2022 May 17:106680. Epub 2022 May 17.

Department of Thoracic Surgery, Tangdu Hospital, Air Force Military Medical University, No.1. Xinsi Road, Xi'an, Shaanxi, China. Electronic address:

Background: Clinical benefit of neoadjuvant immunotherapy in resectable esophageal squamous cell carcinoma (ESCC). remains unclear. This study evaluated the efficacy and safety of the programmed death 1 (PD-1) inhibitor tislelizumab combined with chemotherapy as neoadjuvant therapy in patients with resectable ESCC. Read More

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A randomized controlled trial of Everolimus for neurocognitive symptoms in PTEN hamartoma tumor syndrome.

Hum Mol Genet 2022 May 20. Epub 2022 May 20.

Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.

Background: PTEN hamartoma tumor syndrome (PHTS) is a complex neurodevelopmental disorder characterized by mTOR (mechanistic target of rapamycin) overactivity. Limited data suggest that mTOR inhibitors may be therapeutic. No placebo-controlled studies have examined mTOR inhibition on cognition and behavior in humans with PHTS with/without autism. Read More

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Renin-Angiotensin-Aldosterone System Inhibitors, Statins, and Beta-Blockers in Diabetic Patients With Critical Limb Ischemia and Foot Lesions.

J Cardiovasc Pharmacol Ther 2022 Jan-Dec;27:10742484221101980

46807Maria Cecilia Hospital, GVM Care & Research, Cotignola, Italy.

Medical therapy for secondary prevention is known to be under-used in patients with peripheral artery disease (PAD). Few data are available on the subgroup with critical limb ischemia (CLI). Prescription of cardiovascular preventive therapies was recorded at discharge in a large, prospective cohort of patients admitted for treatment of CLI and foot lesions, stratified for coronary artery disease (CAD) diagnosis. Read More

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Response to clopidogrel in patients undergoing lower extremity revascularization.

Vascular 2022 May 19:17085381221103417. Epub 2022 May 19.

Leon H. Charney Division of Cardiology, Department of Medicine, 12296New York University Grossman School of Medicine, New York, NY, USA.

Objectives: Clopidogrel is effective at decreasing cardiovascular events in patients with peripheral artery disease (PAD); however, its effect on limb outcomes are less known. This study investigated the variability in response to clopidogrel and its relationship with clinical limb outcomes.

Methods: Three hundred subjects were enrolled in the Platelet Activity and Cardiovascular Events (PACE) study prior to lower extremity revascularization, of whom 104 were on clopidogrel. Read More

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Inhibition of ketohexokinase in adults with NAFLD reduces liver fat and inflammatory markers: A randomized phase 2 trial.

Med (N Y) 2021 Jul 27;2(7):800-813.e3. Epub 2021 Apr 27.

Pfizer Inc., Worldwide Research, Development, and Medicine, Cambridge, MA 02139, USA. Electronic address:

Background: Increased consumption of the lipogenic sugar fructose promotes the current epidemic of metabolic disease. Ketohexokinase (KHK) catalyzes the first committed step in fructose metabolism. In animal models, KHK inhibition decreases hepatic de novo lipogenesis and steatosis and corrects many metabolic abnormalities associated with insulin resistance. Read More

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Cardiovascular risk and mortality in patients with hyperuricemia treated with febuxostat or allopurinol: a retrospective nation-wide cohort study in Austria 2014-2017.

Rheumatol Int 2022 May 19. Epub 2022 May 19.

Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.

Patients with hyperuricemia and gout are at an increased risk for cardiovascular (CV) disease. Inhibition of the xanthine oxidase with allopurinol or febuxostat have become the mainstay for urate lowering therapy. However, it has been suggested that febuxostat increases the risk for CV mortality as compared to allopurinol. Read More

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Ladarixin, an inhibitor of IL-8 receptors CXCR1 and CXCR2, in new-onset type 1 diabetes: a multicenter, randomized, double-blind, placebo-controlled trial.

Diabetes Obes Metab 2022 May 19. Epub 2022 May 19.

Research and Development, Dompé farmaceutici S.p.A., Milano, Italy.

Aim: To evaluate the ability of ladarixin, an inhibitor of the CXCR1/2 chemokine receptors (LDX, 400 mg b.i.d for 3 cycles of 14 days on/14 days off) to maintain C-peptide production in adult patients with newly diagnosed type 1 diabetes. Read More

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[Benefits and risks of prolonged dual antiplatelet therapy after percutaneous coronary intervention with drug-eluting stent in patients with stable coronary artery disease and diabetes].

Zhonghua Xin Xue Guan Bing Za Zhi 2022 May;50(5):458-465

Cardiometabolic Medicine Center, Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.

To compare the efficacy and safety of prolonged dual antiplatelet therapy (DAPT>1 year) in patients with stable coronary artery disease (CAD) and diabetes who were event-free at 1 year after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) in a large and contemporary PCI registry. A total of 1 661 eligible patients were selected from the Fuwai PCI Registry, of which 1 193 received DAPT>1 year and 468 received DAPT ≤1 year. The primary endpoint was major adverse cardiac and cerebrovascular event (MACCE) and Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding, MACCE was defined as a composite of all-cause death, myocardial infarction or stroke. Read More

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[Multimorbidity in elderly patients with acute coronary syndrome: insights from BleeMACS registry].

Zhonghua Xin Xue Guan Bing Za Zhi 2022 May;50(5):443-449

Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China.

To assess the prevalence, pattern and outcome of multimorbidity in elderly patients with acute coronary syndrome (ACS). Secondary analysis was performed based on the data from the BleeMACS registry, which was conducted between 2003 and 2014. We stratified elderly patients (≥65 years) according to their multimorbidity. Read More

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Safety and efficacy of holmium-166 radioembolization in hepatocellular carcinoma - the HEPAR Primary study.

J Nucl Med 2022 May 19. Epub 2022 May 19.

University Medical Center Utrecht, Netherlands.

Hepatocellular carcinoma (HCC) is the sixth most common cancer and second in cancer-related deaths. Radioembolization using holmium-166 (Ho)-microspheres is new in the HCC treatment landscape. Safety and efficacy of Ho-radioembolization was first determined in the HEPAR and HEPAR II studies, however excluding patients with HCC. Read More

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Arterial Ultrasound Testing to Predict Atherosclerotic Cardiovascular Events.

J Am Coll Cardiol 2022 May;79(20):1969-1982

Bristol Medical School, Population Health Sciences, Bristol, United Kingdom.

Background: Studies have indicated that the presence and size of subclinical atherosclerotic plaques improve the prediction of atherosclerotic cardiovascular events (ASCVE) over and above that provided by conventional risk factors alone. However, the relative contribution of different ultrasonographic measurements and sites of measurements on the 10-year ASCVD risk is largely unknown.

Objectives: Our aims were to determine the relative performance of carotid intima-media thickness, plaque thickness, and plaque area in 10-year ASCVD prediction when added to conventional risk factors as well as whether the vascular territory of these measurements, carotid or common femoral bifurcation, and the number of bifurcations with plaque (NBP) influence prediction. Read More

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EZH2 inhibitor tazemetostat in patients with relapsed or refractory, BAP1-inactivated malignant pleural mesothelioma: a multicentre, open-label, phase 2 study.

Lancet Oncol 2022 May 16. Epub 2022 May 16.

Leicester Cancer Research Centre, University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, UK. Electronic address:

Background: Treatment options for malignant pleural mesothelioma are scarce. Tazemetostat, a selective oral enhancer of zeste homolog 2 (EZH2) inhibitor, has shown antitumour activity in several haematological cancers and solid tumours. We aimed to evaluate the anti-tumour activity and safety of tazemetostat in patients with measurable relapsed or refractory malignant pleural mesothelioma. Read More

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Transjugular intrahepatic portosystemic shunt with or without gastro-oesophageal variceal embolisation for the prevention of variceal rebleeding: a randomised controlled trial.

Lancet Gastroenterol Hepatol 2022 May 16. Epub 2022 May 16.

Department of Liver Diseases and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China; Department of Liver Diseases and Interventional Radiology, Digestive Diseases Hospital, Xi'an International Medical Center Hospital, Northwest University, Xi'an, China. Electronic address:

Background: The role of variceal embolisation at the time of transjugular intrahepatic portosystemic shunt (TIPS) creation for the prevention of gastro-oesophageal variceal rebleeding remains controversial. This study aimed to evaluate whether adding variceal embolisation to TIPS placement could reduce the incidence of rebleeding after TIPS in patients with cirrhosis.

Methods: We did an open-label, randomised controlled trial at one university hospital in China. Read More

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EPIdemiology of Surgery-Associated Acute Kidney Injury (EPIS-AKI): study protocol for a multicentre, observational trial.

BMJ Open 2021 Dec 30;11(12):e055705. Epub 2021 Dec 30.

Department of Anaesthesiology, Intensive Care and Pain Medicine, Universitätsklinikum Münster, Münster, Germany

Introduction: More than 300 million surgical procedures are performed each year. Acute kidney injury (AKI) is a common complication after major surgery and is associated with adverse short-term and long-term outcomes. However, there is a large variation in the incidence of reported AKI rates. Read More

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December 2021

Long-term open-label phase I/II extension study of intrathecal idursulfase-IT in the treatment of neuronopathic mucopolysaccharidosis II.

Genet Med 2022 May 19. Epub 2022 May 19.

Takeda Development Center Americas, Inc, Lexington, MA; Affinia Therapeutics, Waltham, MA.

Purpose: Intrathecal (IT) idursulfase-IT for the treatment of cognitive impairment is being investigated in pediatric patients with neuronopathic mucopolysaccharidosis II (MPS II) in addition to intravenous idursulfase. In this article, we report the findings for 54 months of idursulfase-IT treatment in an ongoing phase I/II extension trial (NCT01506141).

Methods: A total of 15 male participants with neuronopathic MPS II (aged 3-11 years at enrollment) who were previously treated with intravenous idursulfase entered the extension study. Read More

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ARISE: First-In-Human Evaluation of a Novel Stent Graft to Treat Ascending Aortic Dissection.

J Endovasc Ther 2022 May 19:15266028221095018. Epub 2022 May 19.

Houston Methodist Hospital, Houston, TX, USA.

Background: Operative mortality for type A aortic dissection is still 10-20% at centers of excellence. Additionally, 10-20% are not considered as viable candidates for open surgical repair and not offered life-saving emergency surgery. ARISE is a multicenter investigation evaluating the novel GORE® Ascending Stent Graft (ASG; Flagstaff, AZ). Read More

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Real time monitoring and prediction of time to endpoint maturation in clinical trials.

Stat Med 2022 May 19. Epub 2022 May 19.

Data and Statistical Sciences, AbbVie Inc., North Chicago, Illinois, USA.

In clinical trials, almost all key milestone dates can be defined in terms of time to endpoint maturation (TTEM). The real time monitoring and accurate prediction of TTEM have a significant impact on clinical trial planning and execution and can bring significant value to clinical trial practitioners. TTEM is defined as the time to achieve or observe a certain number or percentage of some endpoint of interest. Read More

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Prognostic value of nutritional parameters in systolic heart failure with renal dysfunction.

PLoS One 2022 19;17(5):e0266839. Epub 2022 May 19.

Depeatment of of Functional Imaging and Artificial Intelligence, Kanazawa University, Kanazawa, Japan.

Although it is known that assessment and management of the nutritional status of patients are important for treatment of patients with heart failure (HF), there are currently no established indicators. Therefore, we investigated the effects of nutritional parameters as well as conventional parameters on the prognosis of HF patients. A total of 1954 consecutive HF patients with left ventricular ejection fraction (LVEF) less than 50% were enrolled in this study. Read More

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Prognosis of Adults With Isolated Left Ventricular Non-Compaction: Results of a Prospective Multicentric Study.

Front Cardiovasc Med 2022 2;9:856160. Epub 2022 May 2.

Cardiology Department, Assistance Publique Hopitaux de Marseille (APHM), La Timone Hospital, Marseille, France.

Background: Whether left ventricular non-compaction (LVNC) bears a different prognosis than dilated cardiomyopathy (DCM) is still a matter of debate.

Methods: From a multicenter French prospective registry, we compared the outcomes of 98 patients with LVNC and 65 with DCM. The primary endpoint combined cardiovascular death, heart transplantation, and hospitalization for cardiovascular events. Read More

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Comparative efficacy and safety of mizoribine and mycophenolate mofetil for treating systemic lupus erythematosus: a retrospective cohort study.

Ther Adv Musculoskelet Dis 2022 13;14:1759720X221096367. Epub 2022 May 13.

Department of Medical Education, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.

Background: Mizoribine (MZR) is an immunosuppressive agent that selectively inhibits inosine monophosphate dehydrogenase; its actions are considerably similar to those of mycophenolate mofetil (MMF). This study aimed to clarify whether MZR can be a good treatment option for systemic lupus erythematosus (SLE) and to compare the efficacy and safety of MZR and MMF in patients with active SLE.

Methods: We retrospectively compared the efficacy, continuation rate, and safety of MZR (52 patients) and MMF (31 patients) after adjusting for stabilized inverse probability of treatment weighting based on propensity scores. Read More

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Modulation of ATP8B1 gene expression in colorectal cancer cells suggest its role as a tumor suppressor.

Curr Cancer Drug Targets 2022 May 17. Epub 2022 May 17.

King Abdullah International Medical Research Center (KAIMRC), King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City Hospital, Ministry of National Guard Health Affairs, Al Hasa, 31982, Saudi Arabia.

Aim: The study aims to understand the role of tumor suppressor genes in colorectal cancer initiation and progression.

Background: Sporadic colorectal cancer (CRC) develops through distinct molecular events. Loss of the 18q chromosome is a conspicuous event in the progression of adenoma to carcinoma. Read More

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Reducing the risk of Plasmodium vivax after falciparum infections in co-endemic areas-a randomized controlled trial (PRIMA).

Trials 2022 May 18;23(1):416. Epub 2022 May 18.

Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Australia.

Background: Plasmodium vivax forms dormant liver stages that can reactivate weeks or months following an acute infection. Recurrent infections are often associated with a febrile illness and can cause a cumulative risk of severe anaemia, direct and indirect mortality, and onward transmission of the parasite. There is an increased risk of P. Read More

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Early P2Y Inhibitor Single Antiplatelet Therapy for High-Bleeding Risk Patients After Stenting - PENDULUM Mono 24-Month Analysis.

Circ J 2022 May 17. Epub 2022 May 17.

Division of Cardiovascular Medicine, Toho University Ohashi Medical Center.

Background: In PENDULUM mono, Japanese patients with high bleeding risk (HBR) received short-term dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) with prasugrel after percutaneous coronary intervention (PCI). One-year data from PENDULUM mono showed better outcomes with prasugrel monotherapy after short-term DAPT compared with matched patients in the PENDULUM registry with longer DAPT durations according to guidelines at that time. This study presents 2-year results. Read More

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