Will Drug-Eluting Devices Suffer from JAHA Publication?

A meta-analysis of randomized clinical trials concluded that there is an increased risk of death for patients treated with paclitaxel‐coated balloons and stents in the femoral and/or popliteal arteries of the lower limbs. At least two drug-eluting device trials have been paused since this analysis was published late last month in the Journal of the American Heart Association (JAHA). Investigators of the BASIL-3 trial and the SWEDEPAD 1 and SWEDEPAD 2 trials have paused recruitment efforts in response to the published findings. Konstantinos Katsanos, MD, PhD of Patras University Hospital in Rion, Greece is the lead author of the analysis. VIVA Physicians, a not-for-profit organization dedicated to peripheral artery disease (PAD) education and research, said it will host a forum in February to discuss the Katsanos analysis. The Birmingham Clinical Trials Unit at the University of Birmingham's College of Medical and Dental Sciences in Birmingham, United Kingdom is directing the BASIL-3 trial. BASIL-3 is a multicenter, randomized controlled trial evaluating the clinical efficacy and cost-effectiveness of drug-coated balloons, drug-eluting stents, and plain balloon angioplasty with bailout bare-metal stent revascularization strategies for severe limb ischemia caused by atherosclerotic femoropopliteal PAD. The trial investigators said that although the population of the reviewed trials differs from those ...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Business Source Type: news

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AbstractPurposeTo investigate risk factors for severe bleeding during warfarin treatment, including the influence of sex, age, comorbidity and co-medication on bleeding risk.MethodsPatients initiating warfarin treatment between 2007 and 2011 were identified in the nationwide Swedish Prescribed Drug Register, and diagnoses of severe bleeding were retrieved from the National Patient Register. Hazard ratios (HR) with 95% confidence intervals (CI) for severe bleeding were estimated using multiple Cox regression adjusting for indications and including covariates age, sex, comorbidities and co-medications. Interactions between s...
Source: European Journal of Clinical Pharmacology - Category: Drugs & Pharmacology Source Type: research
CONCLUSIONS: The co-existence of abnormal ABI and a history of CV events identifies subjects at higher risk, who call for a more aggressive approach. Abnormal ABI is also a predictor of cancer mortality. PMID: 32151490 [PubMed - as supplied by publisher]
Source: European Journal of Internal Medicine - Category: Internal Medicine Authors: Tags: Eur J Intern Med Source Type: research
Gore Has a New Challenger in SFA PQ Bypass is set to become the first company since 2004 to have an IDE trial for a stent to treat peripheral artery disease in the superficial femoral artery (SFA). If all goes as planned for the company, its Torus Stent Graft will compete head-to-head with W.L. Gore's Viabahn system. PQ Bypass could potentially file for FDA approval in 2021.   Should This Blood Test Be Part of the Standard Pre-Op for Most Surgeries? A common cardiac blood test done before surgery can predict who will experience adverse outcomes after most types of surgery, said researchers from Hami...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news
AbstractAlthough a number of comorbidities have been associated with development of bloodstream infection, actual risk factors have not been well defined and quantified in nonselected populations. We sought to quantify population-based risk factors for development of community-onset bloodstream infection (COBSI). Surveillance was conducted among all residents of the Western Interior of British Columbia, Canada, during 2011 –2018. Risks were expressed as incidence rate ratios (IRR) with 95% confidence intervals (CI). The annual incidence was 147.1 per 100,000 and older individuals, and males were at overall higher ris...
Source: European Journal of Clinical Microbiology and Infectious Diseases - Category: Microbiology Source Type: research
ConclusionsWe found indications of a U-shaped association between adipose tissue content of ALA and the rate of PAD, but the association was not statistically significant.
Source: European Journal of Nutrition - Category: Nutrition Source Type: research
Publication date: Available online 23 November 2019Source: Regulatory Toxicology and PharmacologyAuthor(s): I. Palma-Lara, M. Martínez-Castillo, J.C. Quintana-Pérez, M.G. Arellano-Mendoza, F. Tamay-Cach, O.L. Valenzuela-Limón, E.A. García-Montalvo, A. Hernández-ZavalaAbstractArsenic, a metalloid and naturally occurring element, is one of the most abundant elements in the earth's crust. Water is contaminated by arsenic through natural sources (underground water, minerals and geothermal processes) and anthropogenic sources such as mining, industrial processes, and the production and use of ...
Source: Regulatory Toxicology and Pharmacology - Category: Toxicology Source Type: research
EA, Hernández-Zavala A Abstract Arsenic, a metalloid and naturally occurring element, is one of the most abundant elements in the earth's crust. Water is contaminated by arsenic through natural sources (underground water, minerals and geothermal processes) and anthropogenic sources such as mining, industrial processes, and the production and use of pesticides. Humans are exposed to arsenic mainly by drinking contaminated water, and secondarily through inhalation and skin contact. Arsenic exposure is associated with the development of vascular disease, including stroke, ischemic heart disease and peripheral ...
Source: Regulatory Toxicology and Pharmacology : RTP - Category: Toxicology Authors: Tags: Regul Toxicol Pharmacol Source Type: research
Although attention has been paid to the relationship between malignant diseases and cardiovascular diseases, few data have been reported. Moreover, there have also been few reports in which the preventive factors were examined in patients with or without malignant disease histories requiring percutaneous coronary intervention (PCI). This was a retrospective, single-center, observational study. A total of 1003 post-PCI patients were divided into a malignant group, with current or past malignant disease, and a nonmalignant group. The primary endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, s...
Source: Medicine - Category: Internal Medicine Tags: Research Article: Observational Study Source Type: research
DISCUSSION: Mortality and cardiovascular disease burden have declined for dialysis patients in the United States despite an aging population that is increasingly hypertensive and diabetic. Comorbid disease burdens among HD and PD patients have diverged over time, with PD patients having fewer comorbid conditions.
. PMID: 31599226 [PubMed - as supplied by publisher]
Source: Clinical Nephrology - Category: Urology & Nephrology Authors: Tags: Clin Nephrol Source Type: research
In this study, the most common reason that patients or their doctors stopped statins was the development of advanced cancer or other major illness. In my practice, I have also cared for many patients who have stopped taking statins or who express reluctance to take statins due to side effects. The most common side effect is muscle ache (typically tenderness or soreness of the large muscle groups, such as the biceps and thighs), which affects about 20% of statin takers and reverses when the statin is discontinued. There is also a slightly increased risk of diabetes with long-term statin use and, very rarely, liver problems....
Source: Harvard Health Blog - Category: Consumer Health News Authors: Tags: Drugs and Supplements Health Healthy Aging Heart Health Source Type: blogs
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